IFPMA COVID-19 Hub

COVID-19: The biopharmaceutical industry is leading the way in developing vaccines, treatments & diagnostics 

As a science-driven industry that aims to address some of the world’s biggest healthcare challenges, the biopharmaceutical industry is uniquely positioned to respond rapidly to COVID-19. It has gained profound scientific insights from decades of experience in developing solutions for infectious diseases such as MERS, SARS, Ebola and influenza as well as in working with health authorities and regulators to swiftly bring safe and effective medicines, vaccines and diagnostics to patients.

The rapid worldwide spread of SARS-CoV-2 is a public health emergency. More than ever, we need effective international cooperation to ensure that no-one is left behind in the race to tackle this crisis. This requires coordinated, multi-stakeholder action embracing the private sector as a critical partner. IFPMA members are fully committed to bringing their unique expertise in R&D and manufacturing of therapeutics, vaccines and diagnostics to the table.

IFPMA members are also committed to collaborate closely with national regulatory agencies, academia and global health stakeholders to retain access to existing medicines and vaccines for treatment and prevention of other conditions. Clinical research into new options and treatments for serious, life-threatening diseases also remains a priority (read our Regulatory Guiding Principles here).

IFPMA has joined the global public-private partnership, ACT Accelerator, as founding partner, offering its knowledge and expertise in finding/developing novel medicines and vaccines and in building manufacturing capacity and distribution networks. IFPMA has published the Vaccines policy principles that will guide its work with the ACT Accelerator Vaccines Partnership (COVAX). On 24 February 2021, COVAX and UNICEF began to roll out 2 billion doses of COVID-19 vaccines (to be delivered by the end of 2021) to protect high risk and vulnerable people, and frontline healthcare workers in low- and middle-income countries (LMICs). Since then, GAVI has announced various deliveries of COVAX COVID-19 vaccines, with millions of doses to reach 147 countries by the end of May 2021.

Repurpose existing & test new treatments

Rapidly screen the industry’s vast libraries of medicines to identify potential treatments and undertake numerous clinical trials to test new and existing therapies.

IFPMA members reviewed their drug portfolios for potentially safe and effective assets that could help with the development of new or repurposed treatments. Gilead’s remdesivir was approved as the first COVID-19 treatment by the US FDA in May 2020, and the EMA in June 2020.  Various authorities, including the EMA  and US FDA endorsed the use of dexamethasone for treating adult cases requiring respiratory support. Regarding antibodies, in November 2020, the US FDA was the first to grant EUA to Eli Lilly’s bamlanivimab (LY-CoV555), and Regeneron‘s antibody cocktail (casirivimab and imdevimab administered together). In February 2021, the US FDA granted EUA for Eli Lilly‘s investigational antibody cocktail of bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016).

Large-scale COVID-19 partnerships with broad industry involvement to speed up COVID-19 Therapeutics R&D

The following IFPMA member companies have partnered with the COVID-19 Therapeutics Accelerator initiative, initiated by the Gates Foundation, Wellcome and Mastercard, to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck (known as MSD outside the US and Canada), Merck KGaA, Novartis, Pfizer, and Sanofi.

The NIH set up the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. The following IFPMA member companies have partnered with the ACTIV initiative: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eisai, Eli Lilly and Company, Gilead, GSK, Johnson & Johnson, Merck & Co., Inc., Novartis, Pfizer, Roche-Genentech, Sanofi, and Takeda.

The Corona Accelerated R&D in Europe (CARE) consortium, a coalition of 37 globally renowned academic institutions, pharmaceutical companies and non-profit research organizations, committed to the development of therapeutics (i) to provide an emergency response towards the current COVID-19 pandemic by drug repositioning and (ii) to address the current and/or future coronavirus outbreaks by broad-spectrum small-molecule drug discovery and/or virus-neutralizing antibody discovery. The following IFPMA members have joined the consortium: AbbVie, Astellas, Boehringer Ingelheim, Johnson & Johnson, Merck, Novartis, Pfizer, and Takeda.

AbbVie AbbVie partnered with global authorities to determine the effectiveness of HIV drugs lopinavir/ritonavir in treating COVID-19. WHO interim trial results showed that lopinavir/ritonavir produced little or no reduction in mortality of hospitalized COVID-19 patients, hence trials were interrupted with immediate effect.

AbbVie also entered into a collaboration with Harbour BioM, Utrecht University, and Erasmus Medical Center to develop a novel antibody therapeutic.

AbbVie, and partners of the COVID R&D Alliance, Amgen, and Takeda, announced the start of the I-SPY COVID trial evaluating the efficacy of cenicriviroc, apremilast, and icatibant in hospitalized COVID-19 patients.

Amgen Amgen and Adaptive Biotechnologies are partnering to combine expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2.

Amgen, and partners of the COVID R&D Alliance, AbbVie, and Takeda, announced the start of the I-SPY COVID trial evaluating the efficacy of cenicriviroc, apremilast, and icatibant in hospitalized COVID-19 patients.

Astellas In Japan, Astellas is providing compounds in response to a request from the government to cooperate in the “Basic Screening Plan for Drugs for Coronavirus Disease”.

Astellas is also responding to requests from EFPIA and IMI to cooperate in “Activities Aimed at Developing Drugs for the Novel Virus” and providing consultation on countermeasures.

AstraZeneca AstraZeneca signed an interagency agreement with DARPA, part of the US Department of Defense, and BARDA to support the company’s efforts to develop a mAb treatment against SARS-CoV-2. The company has announced the advancement of its LAAB combination, AZD7442,  into two Phase III clinical trials in more than 6,000 participants at sites in and outside the US.

In ongoing trials supported by AstraZeneca, results published in Science Immunology showed that acalabrutinib, a Bruton’s tyrosine kinase inhibitor, reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease.

BMS BMS and The Rockefeller University announced that they entered into a definitive agreement under which Bristol Myers Squibb was granted a global exclusive license to develop, manufacture and commercialize Rockefeller’s novel mAb duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19.
Boehringer IngelHeim Boehringer Ingelheim is a member of the CARE consortium, leading the work stream focusing on the development of virus neutralizing antibodies. The company will also provide antiviral molecules from its legacy HIV and HCV portfolio and small molecule candidates from a complete screen of its molecule library.

Boehringer Ingelheim announced the initiation of a Phase 2 clinical trial of BI 764198, an inhibitor of TRPC6 that may alleviate the damage to the lung and decrease the risk or severity of acute respiratory complications in patients hospitalized for COVID-19.

UKK, UMR, the DZIF and Boehringer Ingelheim announced the initiation of Phase 1/2a clinical investigation of BI 767551, a new SARS-CoV-2 neutralizing antibody.

Chugai Chugai Pharmabody Research Pte. Ltd. and the Agency for Science, Technology and Research in Singapore are jointly researching a therapeutic antibody to fight COVID-19.

Chugai entered into a license agreement for worldwide non-exclusive rights of several Chugai’s antibody engineering technologies with Eli Lilly.

Chugai announced that it concluded a license agreement with Roche for the development and commercialization in Japan for the antibody cocktail of casirivimab and imdevimab (formerly known as REGN-COV2) for COVID-19.

Chugai announced that it concluded a license agreement with Roche for the development and marketing in Japan for AT-527, an oral drug candidate for COVID-19.

CSL Group/ Seqirus CSL Group is collaborating with Takeda, Biotest AG, Bio Products Laboratory, LFB and Octapharma to accelerate development of a potential COVID-19 Hyperimmune therapy.

The CoVIg-19 Plasma Alliance announced that the Phase 3 ITAC clinical trial sponsored and funded by the NNIAID, part of the NIH, did not meet its endpoints.

Daiichi Sankyo Daiichi Sankyo reached a basic agreement with the University of Tokyo, RIKEN and Nichi-Iko Pharmaceutical Co., Ltd. on collaborative R&D on a Nafamostat inhalation formulation for treating COVID-19.
EFPIA EFPIA, through the IMI, IMI associated partners and other organisations provided up to 45 million EUR to fund 8 COVID-19 R&D projects with 3 focusing on treatments.
Eli Lilly In June, Eli Lilly dosed first patients in a Phase 1 study of LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera. Eli Lilly also announced the start of a Phase 1 study for its second potential COVID-19 antibody treatment in collaboration with Junshi Biosciences. Eli Lilly and UnitedHealth Group announced a partnership to conduct a pragmatic study of LY-CoV555 in high-risk, COVID-19 infected individuals.

Eli Lilly entered into an agreement with NIAID to study baricitinib as an arm in NIAID’s Adaptive COVID-19 Treatment Trial. Complementing this data, Eli Lilly separately started a Phase 3 study to evaluate the efficacy and safety of baricitinib in hospitalized adults with COVID-19.

Eli Lilly is also advancing its investigational selective monoclonal antibody LY3127804 against Angiopoietin 2 to Phase 2 testing in pneumonia patients hospitalized with COVID-19.

Eli Lilly received the rights to use Chugai’s antibody engineering technologies for their research activities to develop next-generation COVID-19 treatments and the rights for the development and marketing of therapeutic antibodies applying the technologies.

Eli Lilly, Vir Biotechnology and GSK announced a collaboration to evaluate a combination of two COVID-19 therapies, bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, in low-risk patients with mild to moderate COVID-19.

Eli Lilly announced that the U.S. FDA granted EUA for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together. Eli Lilly also announced that the EMA CHMP issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab.

Eisai Eisai, in collaboration with the Global Coalition for Adaptive Research and the University of Pittsburgh Medical Center, joined REMAP-COVID, a study that tests multiple interventions for the treatment of patients hospitalized with COVID-19. Eritoran, an investigational TLR4 antagonist discovered and developed by Eisai, was selected as the first investigational immune modulation therapy to be evaluated.

Eisai announced that it has entered into a joint research agreement with four research organizations in Japan concerning the “Development of Therapeutics to Prevent the Aggravation of the Novel Coronavirus Infectious Disease (COVID-19)” (Grant Number: 20fk0108255).

Gilead Gilead identified remdesivir as a potential COVID-19 treatment. In April 2020, positive data emerged from the NIAID study of remdesivir. Additional data from a Phase 3 SIMPLE-severe study, and new analyses of the company’s compassionate use program revealed remdesivir to improve recovery time and reduce mortality in COVID-19 patients.

Gilead received an authorization from the US FDA for remdesivir in October 2020, regulatory approval by Japan in May, and conditional approval from the EMA in July.

Gilead initiated a Phase 1a clinical study to evaluate the safety, tolerability and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers, for potential outpatient treatment of COVID-19.

Gilead and the US FDA launched an open-label, single-arm phase 2/3 clinical trial to evaluate safety, tolerability, pharmacokinetics and efficacy of remdesivir in treating paediatric patients with moderate-to-severe COVID-19, across 30 sites in the US and Europe.

GSK GSK and Vir Biotechnology Inc entered into a collaboration using Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies. Vir Biotechnology and GSK announced that the first patient was dosed in a phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. The two companies announced that the first patient has been dosed in a new sub-trial of the NIH ACTIV Program Phase 3 clinical trial.

GSK initiated clinical trials of otilimab, an experimental rheumatoid arthritis drug, on patients suffering from severe pulmonary COVID-19 related disease, running from May to December 2020.

Ipsen Ipsen donated financial resources to the Institut Pasteur that has devoted a portion of its research, since January, to understanding SARS-CoV-2 in terms of epidemiology, biological characteristics and pathogenicity.
Johnson & Johnson Johnson & Johnson expand its partnership with BARDA to accelerate the discovery of potential COVID-19 treatments.

Johnson & Johnson, in partnership with the Rega Institute for Medical Research, and the University of Leuven (Belgium), are working to identify existing or new compounds with antiviral activity against COVID-19.

LEO Pharma LEO Pharma is participating in a pharma industry initiative supported by the EU Commission to identify active compounds and compile a sample library for testing with the potential of reducing lead time for treatment development for COVID-19.
Merck Merck donated a supply of interferon beta-1a (Rebif®) to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial to investigate it as a potential therapeutic for COVID-19.

Merck donated 290,000 units of its interferon beta-1a (Rebif®) to the WHO for use in their global SOLIDARITY trial which investigates several potential therapeutics for the treatment of COVID-19.

MSD MSD and Ridgeback Biotherapeutics LP entered into a collaboration agreement to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19. The candidate antiviral, renamed to MK-4882, is currently in phase 2 clinical trials.
Novartis Novartis initiated a 450-person study in the US to determine if the malaria drug hydroxychloroquine can effectively treat COVID-19. Novartis discontinued the study due to feasibility of recruitment.

Novartis initiated a Phase III clinical trial for canakinumab to treat cytokine release syndrome (CRS) in people with COVID-19 pneumonia. Novartis announced that interim data showed that the trial failed to meet its primary and secondary endpoint.

Novartis initiated a Phase III clinical trial in collaboration with Incyte to evaluate the use of ruxolitinib for the treatment of CRS that can lead to life-threatening respiratory complications in patients with COVID-19.

Novartis and Molecular Partners announced a collaboration in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program, consisting of two therapeutic candidates, MP0420 and MP0423.

Pfizer Pfizer confirmed a lead compound and analogues as potent inhibitors of the SARS-CoV-2 3C-like protease. In addition, preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. Pfizer will perform pre-clinical confirmatory studies.

Pfizer shared in vitro and clinical data regarding azithromycin which may facilitate the use of azithromycin in future research on COVID-19.

Pfizer is supporting an independent Phase 2 investigator-initiated study for the use of tofacitinib in patients with SARS-CoV-2 with a grant.

Pfizer and the Liverpool School of Tropical Medicine’s Respiratory Infection Clinical Research Group launched two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2.

Roche Roche’s tocilizumab was approved by China on March 5 to treat COVID-19 patients with lung complications and subsequently entered phase III clinical trials in the REMDACTA and COVACTA clinical trials. On 29 July, Roche announced that tocilizumab did not meet its primary and secondary endpoints of improved clinical status and mortality in COVID-19 associated pneumonia.

Roche initiated a phase 3 clinical trial of tocilizumab plus remdesivir in hospitalised patients with severe COVID-19 pneumonia.

Roche and Atea Pharmaceuticals announced that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral, to people around the globe.

Regeneron announced that the antibody cocktail casirivimab and imdevimab administered together, received EUA from the U.S. FDA. Regeneron is responsible for the development and distribution of the treatment in the US, and Roche is primarily responsible for the development and distribution outside the US. Regeneron announced the EMA CHMP issued a positive opinion for the company’s investigational COVID-19 antibody cocktail (casirivimab with imdevimab). The CHMP recommends that the antibody cocktail, known as REGEN-COVTM in the U.S., can be used to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

Roche confirmed that the EMA CHMP issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

Sanofi Sanofi entered into a partnership with Regeneron Pharmaceuticals to start a clinical program evaluating sarilumab, a drug originally to treat arthritis, in patients hospitalized with severe COVID-19. A US phase 3 clinical trial in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints, and was subsequently halted. Detailed results will be submitted to a peer-reviewed publication later this year.
Shionogi Shionogi identified various number of promising lead compounds against SARS-CoV-2 through a collaborative research effort with the Hokkaido University Research Center for Zoonosis Control. The company aims to start clinical trials in FY2020.
Sumitomo Dainippon Pharma Sumitomo Dainippon Pharma donated 10 million yen to the Kitasato Institute’s Project for COVID-19 to identify clinical candidates for the treatment of COVID-19 through a large-scale screening of approved pharmaceuticals.
Takeda Takeda and CSL Group formed the CoVIg-19 Plasma Alliance with other leading global plasma companies to develop a potential plasma-derived therapy for treating COVID-19. The CoVIg-19 Plasma Alliance expanded to comprise 10 companies and attracted the support of major companies and organizations. In parallel, the Alliance confirmed it will work with NIAID to test the safety, tolerability and efficacy of the hyperimmune therapy in adult patients with COVID-19. The CoVIg-19 Plasma Alliance announced that the Phase 3 ITAC clinical trial sponsored and funded by the NNIAID, part of the NIH, did not meet its endpoints.

Takeda, and partners of the COVID R&D Alliance AbbVie and Amgen, announced the start of the I-SPY COVID trial evaluating the efficacy of cenicriviroc, apremilast, and icatibant in hospitalized COVID-19 patients who require high-flow oxygen.

Teva Teva is actively looking through its range of products to determine if any products may be relevant for COVID-19.
UCB In the US, UCB is working with the Seattle Structural Genomics Center for Infectious Disease to identify crystal structures of SARS-CoV-2 proteins. In the UK, the company partnered with Diamond Light Source and the University of Oxford to design inhibitors of SARS-CoV-2’s main protease for treatment of COVID-19 patients.

Share real-time clinical trial data with governments, companies & the public

Share real-time clinical trial data with governments and other companies around the world to advance the development of additional therapies.

“Open Access” data-sharing channels are key to securing a response capacity as we have seen with influenza networks. The speed with which researchers have understood this novel strain of virus and got therapeutics and vaccines into clinical trials is unprecedented. The Global Initiative on Sharing All Influenza Data (GISAID), an open access platform part- funded by the private sector, played a critical role in sharing the first genome sequences of the novel coronavirus – a vital element in speeding up information sharing among scientists  and public health authorities.

IFPMA & EFPIA support EMA’s initiative to implement exceptional transparency measures that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19. The biopharmaceutical industry represented by IFPMA and EFPIA encourage other national regulatory authorities to follow EMA’s example.

In less than a year, several vaccine candidates have concluded or are in advanced Phase III clinical trials with encouraging results. On 31 December 2020, Pfizer and BioNTech announced the granting of a temporary EUL for their COVID-19 mRNA vaccine  (BNT162b2) after thorough review of clinical trial data. On 15 February 2020, the WHO granted temporary EUL to AstraZeneca’s COVID-19 vaccine (AZD1222). On 12 March 2021, the WHO listed the COVID-19 vaccine Ad26.COV2.S, developed by Johnson & Johnson, for emergency use in all countries and for COVAX roll-out.

AbbVie AbbVie worked closely with European health authorities, US FDA, US CDC, NIH, and BARDA to research the effectiveness of lopinavir/ritonavir in clinical studies. Trials were interrupted immediately after no reduction in mortality of hospitalized COVID-19 patients was noticed.
Amgen Amgen’s subsidiary deCODE genetics, Iceland’s Directorate of Health and the National University Hospital published a population-based study of the early spread of SARS-Cov-2 in Iceland’s population in the NEJM.

Amgen, together with AstraZeneca, Eli Lilly, Roche’s Genentech subsidiary, GSK and AbCellera, has been allowed to share manufacturing information that could help speed up coronavirus antibody production by the US Department of Justice, since 23 July.

Astellas In Japan, Astellas is providing compounds in response to a request from the government to cooperate in the “Basic Screening Plan for Drugs for Coronavirus Disease”.

Astellas is also responding to requests from EFPIA and IMI to cooperate in “Activities Aimed at Developing Drugs for the Novel Virus” and providing consultation on countermeasures.

AstraZeneca AstraZeneca and partner Oxford University have been undertaking clinical trials for their co-developed candidate COVID-19 vaccine AZD1222. Early interim results, published in The Lancet on 20 July 2020, showed that AZD1222 was tolerated and generated a robust immune response against SARS-CoV-2 in all evaluated participants. In November, Astrazeneca announced that its AZD1222 vaccine was highly effective in preventing COVID-19, the primary efficacy endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. Positive high-level results showed the vaccine had efficacy of up to 90%. Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet , demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.

AstraZeneca published the full protocol for its COVID-19 vaccine study.

AstraZeneca announced the advancement of its Long-Acting AntiBody (LAAB) combination, AZD7442,  into two Phase III clinical trials with more than 6,000 participants at sites in and outside the US.

AstraZeneca is sharing manufacturing information concerning COVID-19 antibody production with other companies. Please see previous entries on Amgen for more info.

Results published in Science Immunology for acalabrutinib initially showed promising clinical improvements in hospitalised COVID-19 patients with respiratory symptoms, but did not meet the primary efficacy endpoint in the CALAVI Phase II trials.

The primary analysis of the Phase III clinical trials from the UK, Brazil and South Africa, published as a preprint in The Lancet confirmed that the vaccine is safe and effective at preventing COVID-19, with no severe cases and no hospitalisations, more than 22 days after the first dose.

AstraZeneca’s COVID-19 vaccine has been approved for EUA in the UK on 30 December 2020.

AstraZeneca’s COVID-19 vaccine has been granted EUA in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults by 6 January 2021.

AstraZeneca’s COVID-19 vaccine has been granted a CMA in the EU for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older, by 29 January 2021.

AstraZeneca’s COVID-19 vaccine has been granted EUL by the WHO for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65, on 15 February 2021.

On 14 March 2021, AstraZeneca provided an update on the safety of COVID-19 Vaccine AstraZeneca. A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca showed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country. The WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue. On 18 March 2021, AstraZeneca announced that the MHRA and EMA reaffirmed  the  benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks.

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The numbers published were based on a pre-specified interim analysis with a data cut-off of 17 February. AstraZeneca has reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021.

Bayer Bayer Canada partnered with the Population Health Research Institute to launch a major clinical research program to evaluate the safety and efficacy of different combination therapies including Bayer’s chloroquine and interferon beta-1b.
Biogen Biogen, Broad Institute of MIT and Harvard and Partners HealthCare announced a consortium to build and share a COVID-19 biobank to help scientists study a large collection of de-identified biological and medical data, advancing knowledge and the search for potential vaccines and treatments.
Boehringer Ingelheim Boehringer Ingelheim supports scientists worldwide with its open innovation portal opnMe.com, which offers 6 anti-viral compounds out of 43 high quality pharmacological tool compounds at no cost for testing of research hypotheses.
Bristol-Myers Squibb Bristol-Myers Squibb identified 1,000 compounds which it made available to collaborators for screening for potential COVID-19 treatments.
Chugai Chugai announced results from Phase III J-COVACTA clinical study in Japan for the humanized anti-human IL-6 receptor monoclonal antibody “Actemra® Intravenous Infusion 80 mg, 200 mg, and 400 mg” in patients with COVID-19 associated pneumonia.
Eli Lilly Eli Lilly is sharing manufacturing information concerning COVID-19 antibody production with other companies. Please see previous entries on Amgen for more info.

Eli Lilly and Incyte announced positive early data on baricitinib emerging from the ACTT-2 trial sponsored by NIAID and shared additional data on its effectiveness in combination with remdesivir, reducing patient recovery time and improving clinical outcomes. US FDA granted EUA to Eli Lilly and Incyte announced for distribution of baricitinib in combination with remdesivir in hospitalized patients with COVID-19.

Eli Lilly announced additional data from a new interim analysis of the BLAZE-1 clinical trial showing that combination therapy of two of its SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and ER visits. EUA by the US FDA was granted to Eli Lilly’s bamlanivimab (LY-CoV555) for the treatment of mild to moderate COVID-19 in adults and pediatric patients from the age of 12.

Eli Lilly and Incyte announced results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint.

Eli Lilly announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19, in collaboration with major local institutions in the state of New Mexico.

Eli Lilly announced that Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities.

Eli Lilly announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths (“events”) in high-risk patients recently diagnosed with COVID-19.

Eli Lilly announced that he US FDA granted EUA for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together.

Eli Lilly, Vir Biotechnology, and GSK announced positive topline data from the expanded Phase 2 BLAZE-4 trial studying evaluating bamlanivimab with VIR-7831 in low-risk adults with COVID-19.

Gilead Gilead identified remdesivir as a potential COVID-19 treatment. In April 2020, positive data emerged from the NIAID study of remdesivir. Additional data from a Phase 3 SIMPLE-severe study, and new analyses of the company’s compassionate use program revealed remdesivir to improve recovery time and reduce mortality in COVID-19 patients. Further results demonstrate that treatment with remdesivir result in a faster time to recovery than previously reported.

Gilead announced that the US FDA has approved the antiviral drug Veklury® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization.

GSK GSK is sharing manufacturing information concerning COVID-19 antibody production with other companies. Please see previous entries on Amgen for more info.

GSK and Vir Biotechnology announced the global expansion to Phase 3 of the COMET-ICE study evaluating VIR-7831, a fully human antiSARS-CoV-2 monoclonal antibody for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. The two companies also announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in a Phase 1b/2a clinical trial.

Vir Biotechnology and GSK announced that an IDMC recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation be stopped for enrolment due to evidence of profound efficacy. Vir and GSK plan to submit an EUA application to the U.S FDA and for authorisations in other countries. GSK and Vir Biotechnology announced submission of Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19.

Sanofi and GSK announced the initiation of a Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.

GSK announced results from the phase 2 proof of concept OSCAR study with otilimab, an investigational anti-GM-CSF monoclonal antibody. Given these data suggest a potentially important clinical benefit in a pre-defined sub-group of high-risk patients and the public health need, GSK decided to amend the OSCAR study to expand this cohort to confirm these potentially significant findings.

Medicago and GSK announced the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study.

Eli Lilly, Vir Biotechnology, and GSK announced positive topline data from the expanded Phase 2 BLAZE-4 trial studying evaluating bamlanivimab with VIR-7831 in low-risk adults with COVID-19.

Johnson & Johnson Johnson & Johnson and BARDA partnered in August 2020 for phase 1/2a first-in-human clinical trials of the candidate vaccine Ad26.COV2.S. Johnson & Johnson announced that they selected a lead COVID-19 vaccine candidate, Ad26.COV2-S, in March 2020. Results from pre-clinical studies showed a robust immune response in non-human primates against SARS-CoV-2. Following positive interim results from Phase 1/2a clinical study, a Phase 3 clinical trial commenced in September 2020, and enrolled up to 60,000 volunteers across three continents in order to study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19. In addition to the single-dose regimen ENSEMBLE study, Janssen initiated a two-dose regimen ENSEMBLE 2 trial that would study the safety and efficacy of the COVID-19 vaccine candidate in up to 30,000 participants worldwide. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. On 13 January 2021, interim Phase 1/2a data were published in the New England Journal of Medicine demonstrating that Johnson & Johnson’s single-dose investigational COVID-19 vaccine candidate provided an immune response that lasted for at least 71 days in participants aged 18-55 years.

Johnson & Johnson announced on 29 January 2021 efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine met all primary and key secondary endpoints. Among all participants from different geographies and including those infected with an emerging viral variant, the COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.

Johnson & Johnson announced on 16 February 2021 that it was seeking conditional marketing authorisation from the EMA for its investigational single-dose COVID-19 vaccine candidate Ad26.COV2-S.

Johnson & Johnson announced on 19 February 2021 that it submitted a request for WHO EUL for its investigational single-dose COVID-19 vaccine candidate Ad26.COV2-S.

Johnson & Johnson announced that the U.S. FDA issued an EUA for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. Johnson & Johnson also announced that the EC granted a CMA for its single-dose COVID-19 vaccine, developed by Janssen, to prevent COVID-19 in individuals 18 years of age and older. Johnson & Johnson welcomed the interim recommendation by the SAGE on Immunization for the WHO supporting the use of Johnson & Johnson’s single-shot COVID-19 vaccine to prevent COVID-19 in persons aged 18 years and above.

MSD MSD, BARDA and the US-based ISB are collaborating to investigate and define the molecular mechanisms of SARS-CoV-2, COVID-19 and identifying targets for medicines and vaccines. Findings will be made available to the worldwide scientific and biomedical community.

MSD and Ridgeback Biotherapeutics announced preliminary results from Ridgeback’s Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral agent. The companies reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture.

Novartis Novartis announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint

Molecular Partners, a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, and its collaborator Novartis, announced initial results from its phase 1 study of its first tri-specific COVID-19 antiviral treatment, ensovibep (MP0420), in healthy volunteers. The initial findings show ensovibep to be safe and well tolerated with no significant adverse events.

Pfizer In its Five-Point-Plan published in March, Pfizer commits to making tools that they develop available on an open source platform and to share data and learnings gained with other companies in real time to advance therapy and vaccine development. The company also commits to sharing clinical development and regulatory expertise to support promising drug candidates of smaller biotech companies.

Following up on its commitments, Pfizer confirmed that a lead protease inhibitor shows antiviral activity against SARS-CoV-2. Pfizer will perform pre-clinical confirmatory studies. Pfizer also shared data regarding azithromycin which may facilitate the use of azithromycin in future research on COVID-19.

Early positive data from Pfizer & BioNTech’s vaccine development partnership was published in July 2020. Initial data from their Phase 1/2 trial, released in July 2020, demonstrated the ability of one of their vaccine candidates, BNT162b1, to elicit high SARS-CoV-2 neutralizing titers. In August 2020, the companies shared additional Phase 1 safety and immunogenicity data.

Pfizer and BioNTech announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine development program against SARS-CoV-2.

Pfizer published the full protocol for its COVID-19 vaccine study to reinforce Pfizer’s commitment to scientific and regulatory rigor.

As part of a two-day virtual Investor Day, Pfizer and BioNTech continued to share several updates from their BNT162 mRNA-based vaccine program against SARS-CoV-2.

Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection. Primary efficacy analysis demonstrates the vaccine to be 95% effective against COVID-19 beginning 28 days after the first dose.

Pfizer and BioNTech announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity.

Pfizer and BioNTech announced results from an in vitro study conducted by Pfizer and UTMB that show the antibodies from people who have received the BNT162b2 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. Pfizer and BioNTechSE also announced results from an in vitro study that provides additional data showing the BNT162b2 vaccine eliciting antibodies that neutralize pseudovirus bearing the SARS-CoV-2 UK strain spike protein in cell culture.

Pfizer and BioNTech announced that the UK-based MHRA granted a temporary EUA for the COVID-19 mRNA vaccine BNT162b2.  The US FDA also authorized emergency use of the mRNA vaccine in individuals 16 years of age or older. The US CDC ACIP voted to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the EUA issued by the US FDA. The two companies announced that the EU granted a conditional marketing authorization (cMAA) to Pfizer and BioNTech for BNT162b2. WHO listed the COVID-19 mRNA vaccine for EUL, making the Pfizer/BioNTech vaccine the first to receive WHO emergency validation since the outbreak began.

Pfizer and BioNTech announced that the first participants had been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the BNT162b2 vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older.

Pfizer and BioNTech announced the submission of new data to the US FDA demonstrating the stability of their COVID-19 vaccine when stored at temperatures between -25°C to -15°C (-13°F to 5°F), which are more commonly found across pharmaceutical freezers and refrigerators. Pfizer and BioNTech announced that the EMA approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

Pfizer and BioNTech announced they began an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants.

The Israel MoH, Pfizer and BioNTech announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

Pfizer and BioNTech announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.

Pfizer and BioNTech confirmed high efficacy and no serious safety concerns through up to six months following second dose in updated topline analysis of landmark COVID-19 vaccine study.

Roche In late July, Roche announced that tocilizumab did not meet its primary and secondary endpoints of improved clinical status and mortality in COVID-19 associated pneumonia in their global clinical trial.

Roche announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received tocilizumab plus standard of care were less likely to progress to mechanical ventilation or death.

Roche’s subsidiary Genentech is sharing manufacturing information concerning COVID-19 antibody production with other companies. Please see previous entries on Amgen for more info.

Regeneron announced changes to the Phase 3 trial assessing investigational REGEN-COV™ (casirivimab with imdevimab) in non-hospitalized patients (“outpatients”) with COVID-19, following recommendations from the IDMC. The IDMC found clear clinical efficacy on reducing the rate of hospitalization and death with both the 1,200 mg and 2,400 mg doses of REGEN-COV compared to placebo, and recommended stopping enrollment into the placebo group. Regeneron has collaborated with Roche to develop and manufacture the antibody cocktail; Roche is responsible ex-U.S. and has already begun distribution in the EU. Regeneron announced positive topline results from the largest trial to date assessing the investigational REGEN-COV™ (casirivimab with imdevimab), a COVID-19 treatment in infected non-hospitalized patients.

Roche announced that the global phase III randomised, double-blind, multicentre REMDACTA study of Actemra®/RoActemra® (tocilizumab) plus Veklury® (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint.

Sanofi Sanofi is collaborating with CEPI and sharing its vaccine R&D experience and expertise to advance vaccine solutions.

In July, Sanofi announced that a US phase 3 clinical trial of sarilumab 400mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints, and was subsequently halted. Detailed results will be submitted to a peer-reviewed publication later this year. In September, the company also announced that sarilumab at a dose of 200 mg or 400 mg in severely or critically ill patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint when comparing it to placebo added to usual hospital care.

Sanofi and GSK started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. Sanofi and GSK announced a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.

Sanofi and Translate Bio announced the preclinical results for MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2, which demonstrated a favorable immune response profile against SARS-CoV-2. These data supported the selection of MRT5500 for clinical development. Full results are available here. Sanofi Pasteur and Translate Bio announced the start of the Phase 1/2 clinical trial for MRT5500.

Sanofi and GSK announced the initiation of a Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.

Sumitomo Dainippon Pharma Sumitomo Dainippon Pharma collaborates in the “COVID-19 Research Database” consortium to provide researchers with free access to the medical information database.
Takeda Takeda partnered with IMI to leverage collective expertise to develop inhibitors to help prevent future outbreaks.

The CoVIg-19 Plasma Alliance, an unprecedented collaboration of leading plasma companies supported by global organizations outside the plasma industry, confirmed that patients are being enrolled in the ITAC Phase 3 clinical trial sponsored by the NIAID, part of the NIH. The investigational H-Ig materials for the trial would be provided by CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance, as well as by two other companies. The CoVIg-19 Plasma Alliance announced that the Phase 3 ITAC clinical trial sponsored and funded by the NNIAID, part of the NIH, did not meet its endpoints.

Develop and test vaccine candidates for COVID-19 through a sound, scientific and deliberative process

Use our expertise and know-how to speed up the development of safe and effective vaccines to prevent COVID-19 in partnership with others.

As of 6 April 2021, the WHO reports 86 candidate vaccines in clinical evaluation and 186 candidate vaccines in preclinical evaluation. IFPMA member companies are at the forefront of the global effort to develop a safe and effective COVID-19 vaccine and scale up manufacturing to ensure equitable access to people around the world. The CEOs of of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, have made a historic pledge to the world, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential regulatory filings and approvals of the first COVID-19 vaccines.

In less than a year, several vaccine candidates have concluded or are in advanced Phase III clinical trials with encouraging results. On 31 December 2020, Pfizer and BioNTech announced the granting of a temporary EUL for their COVID-19 mRNA vaccine  (BNT162b2) after thorough review of clinical trial data. On 15 February 2020, the WHO granted temporary EUL to AstraZeneca’s COVID-19 vaccine (AZD1222). On 12 March 2021, the WHO listed the COVID-19 vaccine Ad26.COV2.S, developed by Johnson & Johnson, for emergency use in all countries and for COVAX roll-out. For more information on the EUL of the individual vaccines and their manufacturer, please refer to the commitment “Share real-time clinical trial data with governments, companies & the public”.

AstraZeneca AstraZeneca and the University of Oxford joined forces for the development and distribution of the University’s potential recombinant adenovirus vaccine. A Phase I/II vaccine clinical trial to assess safety, immunogenicity and efficacy of the vaccine candidate, AZD1222, was initiated in April 2020. Interim results, published in The Lancet, showed that AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.

AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine. The development programme would include a Phase III clinical trial with 30,000 participants and a paediatric trial.

AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK.

AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults.

AstraZeneca’s COVID-19 vaccine has been granted a CMA in the EU for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

AstraZeneca’s COVID-19 vaccine has been granted EUL by the WHO for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65.

Bayer Bayer has signed a collaboration and services agreement with CureVac. Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate CVnCoV.
CSL Group/ Seqirus CSL/ Seqirus partnered with the University of Queensland’s COVID-19 vaccine development program to provide technical expertise as well as a donation of Seqirus’ proprietary adjuvant technology, MF59®, to the University’s pre-clinical development program. CSL announced that its vaccine candidate would not proceed to Phase 2/3 clinical trials.
Daiichi Sankyo Daiichi Sankyo is developing an mRNA vaccine for COVID-19. The company is also participating in “Fundamental Research on the Control of a Novel Coronavirus”, an initiative supported by the AMED.
GSK GSK and Sanofi joined forces to develop an adjuvanted vaccine for COVID-19, using innovative technologies from both companies. The vaccine candidate started the Phase 1/2 clinical trial.

GSK is also collaborating with the University of Queensland, Clover Biopharmaceuticals and Xiamen Innovax Biotech Co. GSK’s scientific collaboration with Clover Pharmaceuticals to develop an adjuvanted COVID-19 vaccine entered into a Phase 1 human clinical study in June 2020.

GSK and Medicago collaborate on developing and evaluating a COVID-19 candidate vaccine combining their technologies. They announced Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity.

GSK and CureVac announced a €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.

Johnson & Johnson Johnson & Johnson expedited its investigational coronavirus vaccine program through an expanded collaboration with BARDA. Both have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Research teams at Janssen, in collaboration with the Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac® technology. Johnson & Johnson selected a lead COVID-19 vaccine candidate, Ad26.COV2-S, in March 2020. Results from pre-clinical studies showed a robust immune response in non-human primates against SARS-CoV-2. Following positive interim results from Phase 1/2a clinical study, A Phase 3 clinical trial of the vaccine commenced in September, and would enroll up to 60,000 volunteers across three continents and in order to study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

Johnson & Johnson also established a collaboration with Beth Israel Deaconess Medical Center to support the development of a preventive vaccine candidate for COVID-19.

Johnson & Johnson announced that Janssen-Cilag International submitted a cMAA to the EMA seeking authorisation for its investigational single-dose Janssen COVID-19 vaccine candidate.

Johnson & Johnson also announced that Janssen-Cilag International submitted for EUL to the WHO for the investigational single-dose Janssen COVID-19 vaccine candidate.

Johnson & Johnson announced that the U.S. FDA issued an EUA for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. Johnson & Johnson also announced that the EC granted a CMA for its single-dose COVID-19 vaccine, developed by Janssen, to prevent COVID-19 in individuals 18 years of age and older.

Johnson & Johnson began vaccinating adolescent participants in the Phase 2a clinical trial for its COVID-19 vaccine candidate.

MSD MSD and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, partnered to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate. This vaccine candidate would use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for MSD’s Ebola Zaire virus vaccine, ERVEBO®.

MSD acquired Vienna-based biotech company Themis. The acquisition is expected to accelerate the development of Themis’ COVID-19 vaccine candidate in the near term and in the longer-term MSD is planning to establish a pandemic preparedness capability.

MSD announced the discontinuation of the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines.

Novartis Novartis‘ AveXis division partnered with Massachusetts Eye and Ear and Massachusetts General Hospital, members of Mass General Brigham, entering into a manufacturing agreement to contribute to the development and production of their novel genetic vaccine.
Pfizer Pfizer and BioNTech entered into a partnership to jointly develop BioNTech’s an mRNA-based vaccine candidate to prevent a COVID-19 infection.

Early positive data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, emerged in early July 2020. Initial data from their ongoing German Phase 1/2 trial, released in late July, further demonstrated the ability of BNT162b1 to elicit high SARS-CoV-2 neutralizing titers. In August 2020, the companies shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study. A global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate their chosen lead COVID-19 vaccine, BNT162b2, commenced on 28 July 2020.

Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95%.

Pfizer and BioNTech also received a Fast Track designation from the US FDA for two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program. The two companies submitted an amended protocol to the US FDA to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.

Pfizer and BioNTech announced the initiation of a rolling submission to the EMA for BNT162b2.

Pfizer and BioNTech announced that the MHRA in the U.K. granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19.  The US FDA also authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The US CDC ACIP voted to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the EUA issued by the US FDA. The two companies announced that the EC granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2). The WHO listed the Comirnaty COVID-19 mRNA vaccine for EUL, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began.

Sanofi Sanofi and GSK joined forces to develop an adjuvanted vaccine for COVID-19, using innovative technologies from both companies. The vaccine candidate started Phase 1/2 clinical trial.

Sanofi announced a collaboration with BARDA to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development efforts of a SARS vaccine candidate using Sanofi’s recombinant DNA technology.

Sanofi and Translate Bio partnered to develop a novel mRNA vaccine for COVID-19. This collaboration leverages an existing agreement from 2018 between the two companies to develop mRNA vaccines for infectious diseases, which was expanded in 2020. Sanofi and Translate Bio announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2.

Shionogi Shionogi’s subsidiary UMN Pharma Inc. is pursuing the discovery and development of a recombinant protein vaccine, supported by the AMED. Shionogi reports that, in parallel and in collaboration with the NIID, an immunogenicity testing of protein antigens and adjuvant candidates added to vaccine formulations have been initiated.
Takeda Takeda announced today that the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan. Earlier in February 2021, Takeda completed enrollment in the company’s Phase 1/2 immunogenicity and safety study of Moderna’s COVID-19 vaccine candidate (TAK-919) in Japan.
UCB UCB is collaborating with the University of Oxford on developing a vaccine.

Develop diagnostic testing & secure continuous supply

Develop and scale up the capacity of diagnostics testing for COVID-19 patients as much as possible and secure the continuous supply of diagnostic test kits to countries around the world.

Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread. However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world and governments are ramping up their testing capacities. Moreover, diagnostics are an essential enabler of COVID-19 vaccine development, both in the R&D phase and for monitoring the impact of the introduction of vaccines, as part of public health surveillance. The biopharmaceutical industry is therefore pushing the boundaries, uniting and collaborating to increase and secure the production and development of diagnostics for COVID-19.

AstraZeneca AstraZeneca is accelerating the development of its diagnostic testing capabilities to scale-up screening and is also working in partnership with governments on existing screening programmes to supplement testing.

AstraZeneca is collaborating with GSK and Cambridge University by setting up a new testing laboraty at the University’s facilities for high throughput screening for COVID-19 testing. It will also explore the use of alternative chemical reagents for test kits to help overcome current supply shortages.

Bayer Bayer is making more than 40 virus diagnostics devices available from its research operations to scale up Germany’s COVID-19 analysis by several thousand tests daily. It is also freeing up specially trained personnel for this purpose.
EFPIA EFPIA, through the IMI, with IMI Associated Partners and other organisations has provided up to 45 million EUR to fund 8 COVID-19 R&D projects with 5 focusing on diagnostics.
GSK GSK is partnering with AstraZeneca and Cambridge University to create a state-of-the-art, high-throughput testing laboratory in Cambridge, which is introducing state-of-the-art robotics, automation and other diagnostic innovations to optimise COVID-19 testing.

GSK is also conducting large-scale testing at its facility in Rixensart, Belgium.

GSK Consumer Healthcare is teaming up with Mammoth Biosciences to develop an accurate, easy-to-use, fully disposable, rapid and handheld test that consumers and healthcare providers in clinics can use to detect active SARS-CoV-2. The companies are aiming to have a device submitted for FDA EUA review before the end of 2020.

Johnson & Johnson Johnson & Johnson entered into a research collaboration with Alveo Technologies to advance Alveo’s be.well™ platform of analyzers, nasal swabs and cartridges for the detection of viral infectious diseases, including potentially SARS-CoV-2. J&J will provide Alveo with financial support as well as technical and regulatory counsel.
Menarini Menarini Diagnostics and Credo Diagnostics Biomedical entered into an exclusive distribution agreement for the VitaPCRTM SARS-CoV-2 assay kit.
Novo Nordisk Novo Nordisk scientists are working in R&D laboratories to boost Denmark’s COVID-19 testing capacity.
Otsuka Otsuka and Denka Company announced to co-market the rapid-diagnostic test kit QuickNavi™ to medical institutions across Japan.
Roche Roche received an EUA from the US FDA for its diagnostic kit cobas® SARS-CoV-2 Test. Roche is committed to delivering as many tests as possible and is going to the limits of production capacity. Roche has also received an EUA from the US FDA for its diagnostic kit the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800/8800 Systems. This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B.

Roche announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche filed for EUA from the US FDA. The company intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of SARS-CoV-2 infection.

Roche also received an EUA from the US FDA for its COVID-19 antibody test. Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month.

Roche announced the upcoming launch of a SARS-CoV-2 Rapid Antigen Test, for markets accepting the CE Mark. Roche also intends to file for EUA to the US FDA.

Sanofi Sanofi joined forces with Luminostics to develop a COVID-19 smartphone-based self-testing solution. Luminostics would contribute its proprietary technology for consumer-diagnostics for COVID-19 testing while Sanofi would bring its clinical research testing experience and capabilities.
Shionogi Shionogi marketed the IgG/IgM Antibody-test Kit for COVID-19 as a research reagent in Japan since June 3, 2020 to be useful for epidemiological surveillance and studies of SARS-CoV-2/COVID-19 aiming to determine the number of individuals previously infected with SARS-CoV-2. Shionogi had entered into an agreement with Micro Blood Science Inc., the licensor of the kit.

Shionogi signed a license agreement with Nihon University, Gunma University, and Tokyo Medical University to develop new rapid diagnostic methods for COVID-19, using an innovative nucleic acid amplification technique

Takeda Takeda is partnering with public entities and other pharmaceutical companies through the IMI in Europe to leverage collective expertise in the hope of developing diagnostics for COVID-19.
UCB UCB is working closely with the Belgian government to scale up COVID-19 testing capabilities. It is looking at similar possibilities in the UK.

Secure essential supplies for other medicines & vaccines

Work to secure continuity of supply for all essential medicines, and vaccines for patients with other life-threatening diseases, urging governments to implement policies and decisions that facilitate access for all those in need.

IFPMA member companies are committed to ensure the continued supply of essential medicines and vaccines for patients suffering from chronic illnesses and other health conditions. So far, they have found no obvious near-term impacts on medicine and vaccine availability. Companies are working to prevent and mitigate any potential shortages through close coordination with national regulatory authorities and other global stakeholders, including the WHO.

The threat of falsified medicines is rising and targeting existing products but also new potential treatments against COVID-19. IFPMA and its members continue to tackle  the global public health threat posed by falsified medical products, and to support the Fight the Fakes Alliance (Statement).

AbbVie AbbVie does not anticipate disruption to the supply of HIV medicines as a result of investigating their effectiveness against COVID-19.
Almirall Almirall continued production of all its essential products and increased production of specific medicines, such as paracetamol.
Astellas Astellas maintains an adequate inventory level of raw materials and finished products, cooperating with outsourcing manufacturers and suppliers of raw materials.
Bayer Bayer continued the production of medicines and health care products at their plant in Garbagnate, Italy for both the Italian and global market during the lockdown.
Biogen Biogen does not anticipate any interruptions to its supply chain, and is diminishing any impact the COVID-19 pandemic has on future manufacturing capabilities.
Boehringer Ingelheim Boehringer Ingelheim ensured further discovery, development, production and supply of its products that are needed by patients around the globe.
Bristol-Myers Squibb Bristol-Myers Squib has made sure raw materials and products reach their markets and clinical sites and does not foresee any disruption due to the pandemic.
Chiesi Chiesi continued production of all medicines without interruption at sites in Italy, Brazil, France and other countries.
CSL Group/ Seqirus Seqirus has enacted its business continuity plans across the globe to minimise disruption to the manufacturing and supply of influenza vaccines.
Daiichi-Sankyo Daiichi-Sankyo was monitoring the evolving situation very carefully to maintain supply and delivery of these medicines, and does not foresee any shortages.
Eisai Eisai maintained necessary stocks for the stable supply of medicines in addition to stable production.
Eli Lilly Eli Lilly launched the Lilly Insulin Value Program in the US allowing anyone with commercial insurance and those without insurance to fill their monthly prescription of Lilly insulin for $35.
Gilead Gilead has no manufacturing issues or supply shortages with any Gilead products, including HIV and hepatitis portfolios.
Grünenthal Grünenthal is not experiencing any significant supply shortages and is continuously monitoring the current situation.
GSK GSK increased production of high demand products (e.g. multi-vitamins, respiratory medicines and antibiotics).
Ipsen Ipsen is monitoring supply chains with national and international suppliers and does not anticipate any supply shortages.
LEO Pharma LEO Pharma is taking additional measures to avoid any shortages of medicines or raw materials and to mitigate any interruptions.
Lundbeck Lundbeck announced that its supply chain remains intact and it has not experienced any supply disruptions.
Novartis Novartis subsidiary Sandoz was maintaining prices on a basket of essential medicines that may help in the treatment of COVID-19.

Novartis and the AU through the AMSP announced a new collaboration to facilitate the supply of medicines from the Novartis Pandemic Response Portfolio to the AU member states and Caricom countries.

Novo Nordisk Novo Nordisk is ensuring the supply of lifesaving medicines for people with serious chronic diseases across the globe, using their experience with Chinese lockdown measures to assure continuity of service.
Roche Roche is ensuring an adequate supply of medicines, calling upon governments to work with the industry to keep global manufacturing and supplies running.
Servier Servier is ensuring the continuity of its products and is providing its expertise to the multi-stakeholder partnership “Health Innovation Coalition – Health Crisis” in France.
Sumitomo Dainippon Pharma Sumitomo Dainippon Pharma strives to ensure a stable supply of products and business continuity.
Takeda Takeda is monitoring the situation as it evolves and will take all necessary actions in an effort to ensure supply continuity for patients.
Teva Teva has inventory and redundancy plans in place to address potential shortfalls, with their supply chain remaining largely uninterrupted.

Increase and share manufacturing capacity & secure essential supplies for COVID-19 medicines and vaccines

Increase our manufacturing capabilities and share available capacity to ramp up production once a successful vaccine or treatment is developed.

Collaboration in fast-tracking the development of therapeutics and new vaccines creates networks of centres of excellence that can deliver a real impact and a preparedness infrastructure that in turn can be mobilized for future outbreaks. Companies are partnering with manufacturers and other biopharmaceutical companies to extensively scale-up at-risk production capacity, particularly for COVID-19 vaccines. 

IFPMA has joined the global public-private partnership, ACT Accelerator, as founding partner, offering its knowledge and expertise  in building manufacturing capacity and distribution networks. IFPMA has published the Vaccines policy principles that will guide its work with the ACT Accelerator Vaccines Partnership (COVAX). On 24 February 2021, COVAX and UNICEF began to roll out 2 billion doses of COVID-19 vaccines to protect high risk and vulnerable people, and frontline healthcare workers in low- and middle-income countries (LMICs).

COVID-19 vaccines

AstraZeneca In April 2020, AstraZeneca (AZ) and the University of Oxford joined forces for the development, worldwide manufacturing and distribution of the vaccine, developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford.

By May 2020, AZ concluded the first agreements for at least 400 million doses and secured total manufacturing capacity for one billion doses.

In June 2020, AZ reached a $750m agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million vaccine doses to low- and middle-income countries (LMICs). In addition, AstraZeneca has partnered with  the Serum Institute of India to supply one billion doses of its COVID-19 vaccine to a large number of low and middle-income countries through the COVAX Facility.

AZ reached manufacturing und supply deals with various countries and regional organisations, including the European Union, India, Switzerland.

To expand manufacturing capacity of AZ’s vaccine candidate AZD1222, the company also entered into collaborations with Catalent Biologics (Italy), Symbiosis Pharmaceutical Services (UK), Oxford Biomedica (UK), Emergent BioSolutions, BioKangtai (China), R-Pharm (Russia), CSL (Australia).

AstraZeneca and IDT Biologika signed a letter of intent to increase COVID-19 vaccine manufacturing in Europe and secure long-term supply capacity.

On 2 March 2021, AstraZeneca announced that the first of many millions of doses of AstraZeneca’s COVID-19 vaccine had begun arriving in low and middle-income countries across the world through the multilateral COVAX initiative, the first steps in fulfilling the Company’s efforts to provide broad and equitable access to the vaccine. Further shipments would arrive in the coming weeks with the aim of supplying a total of 142 countries with hundreds of millions of doses of the vaccine in the coming months.

Bayer Bayer has signed a collaboration and services agreement with CureVac. Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate CVnCoV. Bayer plans to add an additional 160 million doses of CureVac’s vaccine in 2022 to further expand their supply network and overall capacity using the manufacturing network of Bayer.
Daiichi Sankyo Daiichi Sankyo was selected by the Ministry of Health, Labour and Welfare of Japan to be a provider for the Japanese Government’s “Emergent Initiative to Build Production Capacity for COVID-19 Vaccines” with respect to Daiichi Sankyo’s mRNA vaccine for COVID-19.

Daiichi Sankyo announced that it entered into an outsourcing agreement with AstraZeneca to manufacture the AstraZeneca-developed COVID-19 vaccine, AZD1222, in Japan. Daiichi Sankyo announced that it started manufacturing the AstraZeneca COVID-19 vaccine in Japan. The marketing approval application for AZD1222 in Japan was submitted by AstraZeneca on 5 February 2021.

GSK GSK and Sanofi are collaborating and committing to creating and supplying sufficient quantities of their vaccine candidate. If successful, they will jointly be able to increase manufacturing capacity to hundreds of millions of doses annually by the end of 2021. Both publicly committed to making any vaccine that is developed through the collaboration affordable to the public and through mechanisms that offer fair access for people in all countries.

In late May, GSK confirmed its intention to manufacture 1 billion doses of its pandemic vaccine adjuvant system, in 2021, to support the development of multiple adjuvanted COVID-19 vaccine candidates.

GSK and Sanofi reached manufacturing and supply deals with various countries and regional organisations, including UK, US, European Union, Canada and Gavi.

GSK would support the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021.

GSK reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK.

Johnson & Johnson In April 2020, Johnson & Johnson (J&J) announced a collaboration with Emergent BioSolutions to expand the manufacturing capacity of its lead investigational COVID-19 vaccine candidate, Ad26.COV2-S. In July, Emergent BioSolutions and Janssen Pharmaceutical Companies of J&J announced a five-year manufacturing services agreement for large-scale drug substance manufacturing for Ad26.COV2-S. J&J also signed a deal with Catalent to accelerate rapid scale-up of manufacturing capacity over the coming months to support the production of J&J’s vaccine candidate.

Aspen announced that it entered into a preliminary agreement with Janssen Pharmaceuticals, for the technical transfer and proposed commercial manufacture of their COVID-19 vaccine candidate, Ad26.COV2-S.

Sanofi entered into an agreement with Janssen Pharmaceutical Companies of Johnson & Johnson, under which Sanofi will support manufacturing of Janssen´s COVID-19 vaccine in order to address the COVID-19 pandemic and supply needs. Sanofi would provide Johnson & Johnson access to the established infrastructure and expertise of its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of Janssen’s COVID-19 vaccine candidate in 2021, at a rate of approximately 12 million doses per month.

Johnson & Johnson announced it entered into a collaboration with Biological E. on the manufacturing of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S.

Johnson & Johnson announced that it entered a collaboration with Merck as part of its global network to manufacture its COVID-19 vaccine.

The company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.

Johnson & Johnson announced it would provide up to 500 million doses of its COVID-19 vaccine candidate to lower-income countries through the COVAX Facility as part of an agreement in principle with Gavi.

Johnson & Johnson signed manufacturing und supply deals with various countries and regional organisations, including Canada, European Union, UK, US, AVAT.

Merck Merck partnered with the Jenner Institute for the large-scale production of its Covid-19 vaccine candidate, ChAdOx1 nCoV-19.

Merck expanded its capacity to keep up with a surge in demand of materials to mass-produce COVID-19 vaccines.

Merck and BioNTech announced the further expansion of their strategic partnership to significantly accelerate the supply of urgently needed lipids and increase the amount of lipid delivery towards the end of 2021, which will be used for the production of the Pfizer-BioNTech Covid-19 Vaccine (BNT162b2).

Novartis Novartis announced that it signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine.

Novartis announced that it signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Novartis plans to produce up to 50 million doses of the mRNA and bulk drug product for the CureVac vaccine in 2021 and up to a further 200 million doses in 2022. First deliveries of the bulk drug product to CureVac are expected in the summer 2021.

Pfizer Pfizer and BioNTech are jointly developing a COVID-19 vaccine, to be produced initially in the US and Europe. Manufacturing capacity will be scaled up to support global supply. Pfizer will contribute its leading global vaccine clinical R&D, regulatory, manufacturing and distribution infrastructure and capabilities. The companies plan to supply up to 100 million doses worldwide by the end of 2020 of their lead vaccine candidate BNT162b2 against SARS-CoV-2 and approximately 1.3 billion doses by the end of 2021.

Sanofi and BioNTech have entered into an agreement under which Sanofi will support manufacturing and supply of 125 million doses of BioNTech’s COVID-19 vaccine which is being co-developed with Pfizer.

Pfizer reached an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered throughout 2021. UNICEF announced the signing of an agreement with Pfizer on behalf of the COVAX Facility for the supply of the Pfizer-BioNTech COVID-19 Vaccine through 2021.

Pfizer and BioNTech also reached manufacturing and supply deals with various countries and regional organisations, including Australia, Canada, European Union (1,2,3), Japan, UK, US (1,2,3).

Sanofi Sanofi and GSK are collaborating and committing to creating and supplying sufficient quantities of their vaccine candidate. See GSK for more details regarding their joint COVID-19 vaccine development.

Sanofi will invest €610 million to create a new production site and research center in France, both dedicated to increase its vaccines research and production capacities. This way it will also contribute in responding to future pandemic risks.

Sanofi and BioNTech have entered into an agreement under which Sanofi will support manufacturing and supply of 125 million doses of BioNTech’s COVID-19 vaccine which is being co-developed with Pfizer.

Sanofi entered into an agreement with Janssen Pharmaceutical Companies of Johnson & Johnson, under which Sanofi will support manufacturing of Janssen´s COVID-19 vaccine in order to address the COVID-19 pandemic and supply needs. Sanofi would provide Johnson & Johnson access to the established infrastructure and expertise of its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of Janssen’s COVID-19 vaccine candidate in 2021, at a rate of approximately 12 million doses per month.

CSL/ Seqirus CSL partners with CEPI and the University of Queensland to accelerate the development, manufacture and distribution of the University’s COVID-19 vaccine candidate. If trials are successful, initial large-scale production of the vaccine will happen at CSL’s biotech manufacturing headquarters in Melbourne. The company estimates that the scale-up can help generate millions of doses by the end of next year.

CSL announced it has signed a Heads of Agreement (HoA) with the Australian Government for the supply of 51 million doses of the University of Queensland’s (UQ) COVID-19 vaccine candidate (V451), and a separate HoA with AstraZeneca to manufacture the Oxford University candidate (AZD1222), should clinical trials of both prove successful.

CSL announced that its vaccine candidate would not proceed to Phase 2/3 clinical trials.

Shionogi Shionogi is making preparations to offer its vaccine to 10 million people as early as possible by collaboration with Api Co., Ltd. and its group company UNIGEN Inc. It also applied for the “Grant to Promote the Domestic Investment Project to Combat the Supply Chain” publicly established by the Japanese Ministry of Economy, Trade and Industry and three companies. It has begun preparing commercial production in advance of the Ministry’s review of the application.
Takeda Takeda, Novavax and the Japanese Ministry of Health, Labour and Welfare are partnering to increase manufacturing capacity of Novavax’s COVID-19 vaccine candidate NVX‑CoV2373 in Japan. Takeda anticipates to manufacture over 250 million doses of the COVID-19 vaccine per year. Takeda also announced that it would import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, pending licensure in Japan.

 COVID-19 therapeutics

AstraZeneca AstraZeneca modified an agreement with the US Government to supply up to 500,000 additional doses of AZD7442, a long-acting antibody (LAAB) combination which is in late-stage development for the prevention and treatment of COVID-19.
Eli Lilly Eli Lilly and AbCellera collaborate on AbCellera’s rapid pandemic response platform for the rapid development, manufacturing and distribution of therapeutic antibodies.

Eli Lilly and Amgen announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies.

Eli Lilly is collaborating with Fujifilm and the Bill & Melinda Gates Foundation for Supply of Potential COVID-19 Antibody Therapy for LMICs.

Eli Lilly announced an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. The U.S. government will accept the vials of bamlanivimab if it is granted an EUA by the U.S. FDA.

Eli Lilly announced that the U.S. government agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together.

Eli Lilly announced that it was working with global regulators to make bamlanivimab available for emergency use in countries around the world. Global allocation would be made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet need, no matter where they live.

Gilead Gilead has proactively scaled up manufacturing of remdesivir to increase available supply as rapidly as possible in anticipation of potential future supply needs. In August 2020, Gilead announced that it had increased supply more than 50-fold since January, and was likely able to meet real-time global demand starting in October. The company is planning to produce more than two million treatment courses by the end of 2020, and several million more in 2021, if needed.

To further expand global supply, Gilead is in discussions with leading chemical and pharmaceutical manufacturing companies about their ability, under voluntary licenses, to produce remdesivir for Europe, Asia and the developing world at least through 2022. Gilead also negotiated long-term voluntary licenses with several generic drugmakers in India and Pakistan and is in active discussions with the Medicines Patent Pool to license remdesivir, and with UNICEF to deliver the drug using its established distribution networks.

As of August 2020, Gilead’s manufacturing network for remdesivir includes more than 40 companies in North America, Europe and Asia.

Gilead also reached an agreement with the EU Commission to secure sufficient doses of remdesivir for 30,000 patients presenting severe COVID-19 symptoms. In addition, the company also signed a JPA with the EU Commission that will enable rapid and equitable access to remdesivir.

Pfizer Pfizer announced a multi-year agreement with Gilead to manufacture and supply Gilead’s remdesivir.
Roche Roche and Regeneron joined forces to significantly increase global supply of REGN-COV2, Regeneron’s investigational antiviral antibody combination, to at least three and a half times the current capacity, with the potential for even further expansion.

Roche confirmed that the U.S. HHS and DOD will purchase additional supply of Regeneron’s casirivimab and imdevimab antibody cocktail for use in non-hospitalised COVID-19 patients as part of Operation Warp Speed.

Sanofi Sanofi increased production capacity of hydroxychloroquine by 50% and is on track to further increase production over the coming months.
Teva Teva is assessing additional production of hydroxychloroquine sulfate tablets with materials that are being sent to Teva from its ingredient supplier.

Teva’s global manufacturing network has been working tirelessly on securing and scaling production of both API and finished doses for potential treatments that my prove essential in treating COVID-19 everywhere Teva does business.

Support Global healthcare systems in the fight against COVID-19

Use our medical expertise to support global healthcare systems to manage the unprecedented increase in the pressure they are experiencing.

IFPMA member companies are committed to helping to boost healthcare system capacities and protect healthcare workers, particularly in the hardest-hit and vulnerable countries that are ill prepared to cope with an accelerating outbreak of COVID-19. When the novel coronavirus first emerged in Wuhan, China, IFPMA and its member companies started working with their teams on the ground, and with the Chinese authorities to ensure people gain access to necessary health care services. This experience has since repeated around the world as the virus spreaded with increased efforts by member companies donating PPE and money to ease burdens on hard-pressed health services.

Support to affected countries worldwide (on-going)

AbbVie AbbVie donated $35 million to COVID-19 relief efforts. In the US, it supported healthcare capacity for hospitals and secured access to food and essential supplies for vulnerable populations. In Europe, it provided critical equipment and supplies to patients and front-line healthcare workers in hard-hit countries.

AbbVie made donations to 26 community non-profit organizations to support COVID-19 relief efforts, totaling $5 million. The AbbVie COVID-19 Community Resilience Fund helped these organizations to support front-line healthcare workers and vulnerable populations in hard-hit communities.

AFIDRO AFIDRO donated medical equipment to the Central Military Hospital of Bogota (Colombia) to strengthen the COVID-19 pandemic response.
Almirall Almirall donated topical cream to healthcare professionals in Spain and the UK, repurposed production facilities in Germany to manufacture antibacterial gels, and donated PPE to healthcare workers in Spain.
Amgen Amgen and the Amgen Foundation donated $12.5 million to support US and global relief efforts for communities with critical needs impacted by COVID-19.

Amgen donated $1 million to support AHA’s COVID-19 rapid response efforts in the cardiovascular health community.

APCRG APCRG donated 35,000 Georgian lari to the STOPCOV fund (State Treasury Fund) created by the Government of Georgia to fight COVID-19.
APIFARMA APIFARMA and associated pharmaceutical companies supported the fight against the COVID-19 pandemic and donated more than €3 million to Portuguese organisations and institutions.
Astellas Astellas and the Astellas Global Health Foundation donated up to $2 million of financial assistance to meet the urgent demand for resources to help US patients, healthcare workers, and first responders in the fight against COVID-19.

Astellas also donated €150,000 euros worth of necessary supplies to public medical institutions and civil society organizations in Italy, and €200,000 to Spain’s health ministry to secure the supply of goods to medical institutions.

Astellas authorized paid leave (in accordance with each country’s provision) to employees who are medically qualified and wish to volunteer within their community.

AstraZeneca AstraZeneca donated 9 million face masks to healthcare workers around the world and partnered with WEF’s COVID Action Platform to identify countries in greatest need.
Bayer Bayer made financial donations to Lombardy, Brazil (€1 million), and France (€1 million) to support COVID-19 relief efforts. The company also donated 1 million chloroquine tablets to Italy; and another 3 million tablets to the US.

Bayer produced hand sanitizers in Indonesia based on their expertise from their plants in Germany.

Bayer supplied German hospitals with ventilators, provided health care workers with masks, provided the German Army with 600,000 chloroquine tablets, and supported employees wishing to volunteer in the local health system by offering 4 weeks paid leave.

Biogen The Biogen Foundation has committed $10 million to support global response efforts and communities around the world.

Biogen employees donated more than $300,000 to NPOs and volunteered in their communities.

Boehringer Ingelheim Boehringer Ingelheim contributed €5.8 million from their Global Support Program donations fund, provided paid leave for its 51,000 employees to volunteer for COVID-19 relief, donated over $1 million to protect health care professionals, and established a €580,000 relief fund for social entrepreneurs and their communities in Kenya and India via its Making More Health program.
Bristol-Myers Squibb Bristol Myers Squibb (BMS)  and the BMS Foundation have contributed more than $31 million in financial support and needed products (e.g. PPE and medical equipment) to relief efforts in 43 countries. The BMS Foundation has supported nearly 50 organizations in the U.S. and more than 150 organizations globally that care for patients and that support those on the frontlines of the COVID-19 response. In addition, it has contributed funding to support the work of more than 40 patient advocacy groups and professional societies. Also, to support research, education, and a wide range of efforts to benefit patients in need, BMS is engaging with more than 250 patient and professional organizations.

BMS partnered with GRYT Health to develop the COVID Advocacy Exchange, a virtual platform to unite patient advocacy organizations, patients, policy makers, healthcare practitioners and industry in the exchange of information.

Chiesi Chiesi donated €3 million to COVID-19 relief efforts in Italy, donated 50,000 units of sanitizing hand gel to public transport operators and PPE to hospitals, partnered with associations of general practitioners providing advice and guidance, and supported the purchase of respiratory equipment in hospitals.
Chugai Chugai donated JPY 50 million to support healthcare professionals fighting COVID-19 in Japan.
Daiichi-Sankyo Daiichi-Sankyo donated $1 million to the WHO COVID-19 Solidarity Response Fund through the Japan Center for International Exchange, supporting COVID-19 relief efforts.
Eisai Eisai provided $250,000 in funding to US civil society organisations, and provided PPE to local healthcare providers in the US.

Eisai provided €945,000 to professional organizations such as the WHO, as well as healthcare providers and vulnerable communities in the UK, Italy, Germany, Spain, Belgium, France, Portugal, and Slovakia.

Eisai donated 11.8 million rupees to federal emergency funding in India, and donated funding and supplies in Indonesia, Thailand, the Philippines, Malaysia, and Vietnam.

Eisai announced that it has committed the equivalent of 1 million USD in aid towards various activities in response to the spread of the novel coronavirus infection in Africa.

Eli Lilly Eli Lilly deployed medical professionals to staff a free drive-through COVID-19 testing facility at its corporate headquarters in Indianapolis.

Eli Lilly and Company Foundation contributed $500,000 to the Central Indiana COVID-19 Community Economic Relief Fund.

Eli Lilly partnered with local health systems to launch dedicated infusion center locations serving central, northern, and now southern Indiana that are intended to provide Hoosiers with access to important COVID-19 treatments.

Farmindustria Farmindustria and member companies donated over €9.4 million worth of medicines to Italian hospitals, €21.8 million of financial and medical equipment donations, and 4 members modified their production lines to meet health needs during the pandemic.
Gilead Gilead  provided remdesivir to physicians for compassionate use to treat hundreds of severely ill COVID-19 patients. Gilead committed another 1.5 million individual doses of remdesivir for donation, representing 140,000 treatment courses based on a 10-day treatment duration.

Gilead announced the $20 million Gilead CARES (COVID-19 Acute Relief and Emergency Support) Grantee Fund to support civil society organisations impacted by the COVID-19 pandemic.

Gilead partnered with Satcher Health Leadership Institute at Morehouse School of Medicine to study racial health inequities associated with COVID-19.

GSK GSK donated $10 million to the WHO COVID-19 Solidarity Response Fund to enable distribution of essential supplies to frontline health workers.

GSK donated lab equipment, instruments, and scientific kits to support government testing and donated over 700,000 PPE units to frontline health workers in 29 countries.

GSK donated more than 660,000 GSK products to more than 24 countries in Asia, Americas and EU.

HKAPI HKAPI delivered 17,000 surgical face masks to patient organizations together with the continued support of their member companies in sourcing PPE.
Johnson & Johnson Johnson & Johnson committed $50 million to support frontline health workers during the COVID-19 pandemic.

Johnson & Johnson encouraged medically trained employees worldwide to take paid leave and volunteer within their community. Financial donations made by employees or retirees to the Covid-19 Solidarity Response Fund or the CDC Foundation’s All of Us Campaign were matched, dollar for dollar, up to a total of $1 million for each organization.

LEO Pharma LEO Pharma made donations supporting local hospitals and communities in Northern Italy, Spain and New Jersey (US) in fighting COVID-19.
Lundbeck Lundbeck supported fundraising activities in Italy, donated PPE to France and the US, committed $1 million to COVID-19 relief efforts in North America, and donated to the COVID Response Funds in regions where the company is present.
Medicines Australia Medicines Australia joined forces with 15 healthcare organisations in the Continuity of Care Collaboration to stress the importance for people to continue monitoring their health and maintaining regular medical care.
Menarini Menarini converted a topical pharmaceutical producing plant in Florence into a antibacterial gels producing plant, donated products across Italy and increased production from 20 to 100 tons per month.
MSD MSD committed more than $30 million to COVID-19 relief efforts, including donations of medicines, PPE and funding to relief organizations, and pledged another $10 million to support disparately impacted patients and communities in the US and globally.

Through MSD for Mothers, MSD committed $3 million to address critical maternal health needs during COVID-19.

MSD encouraged medically trained employees to volunteer in local communities, providing paid leave.

MSD announced it was taking a number of new steps to support patients in the US who may have lost their jobs and health insurance coverage.

Merck Merck donated 150,000 liters of disinfectant to the German state of Hesse.
Novartis Novartis donated up to 130 million doses of hydroxychloroquine.

Novartis’ COVID-19 Response Fund provided $20 million in support to the most impacted communities around the world.

Novartis and the Novartis US Foundation established a $5 million US COVID-19 Community Response Fund.

Novartis Canada and Sandoz Canada donated $500,000 to community and patient groups via the Community Strong COVID-19 response program.

Novartis contributed $1 million to the International Rescue Committee to support the COVID-19 response in East Africa.

Novartis and its subsidiary Sandoz launched a not-for-profit portfolio of medicines for symptomatic treatment of COVID-19, which were made available to governments, NGOs and other institutional customers in up to 79 eligible countries.

Novo Nordisk Novo Nordisk donated PPE, provided 20 tons of hand sanitizer to hospitals, and through its Novo Nordisk Foundation donated more than $7 million to fight COVID-19 in Denmark.
Pfizer Pfizer created a Global COVID-19 Medical Service Program to empower medical colleagues to provide diagnostic, treatment, and public health support.

Pfizer and the Pfizer Foundation provided $40 million in medical and charitable cash grants to combat the COVID-19 pandemic.

Roche Roche’s subsidiary, Genentech and the Genentech Foundation, provided $42 million to address the devastating impact of the COVID-19 pandemic.
Sanofi Sanofi made a charitable gift of 100 million euros to help tackle the coronavirus crisis in France, with the money going to hospitals, care homes and other initiatives.

Sanofi also donated 100 million doses of hydroxychloroquine across 50 countries globally.

Servier Servier provided PPE to hospitals in affected countries, donated to foundations and NGOs, and encouraged medically-trained staff to volunteer in the French healthcare system to combat COVID-19.
Sumitomo Dainippon Pharma Sumitomo Dainippon Pharma (SDP) manufactured 20,000 face shields and procured PPE through its Chinese subsidiary for use in the worst affected Japanese prefectures.

SDP subsidiary Sunovion Pharmaceuticals provided a monetary donation to the US CDP COVID-19 Response Fund, donated PPE, delivered food donations to a food bank and sent out volunteers to support the activities of the NHS in the UK, and provided further financial support to several organizations.

SDP also joined forces with Innovative Medicines Canada to set up a Canadian COVID-19 fund.

Takeda Takeda donated $6.25 million to the American Red Cross, the city of Cambridge, and the town of Lexington to fight COVID-19.
Teva Teva donated more than 10 million hydroxychloroquine doses to hospitals in the US, and another 2 million hydroxychloroquine units to the Israeli Ministry of Health. The company also donated hydroxychloroquine as well as PPE to Spain and allowed UK employees to volunteer with the NHS, providing paid leave.

Teva provided PPE, kits and food to populations in need in India.

UCB UCB donated hydro-alcoholic solutions to the Belgian and Swiss authorities which it started producing at its own manufacturing sites.

UCB encouraged healthcare professionals to volunteer in line with local government needs and guidance.

UCB donated PPE to Belgian healthcare authorities and local hospitals.

Support to China during the start of the outbreak (Jan/ Feb 2020)

AbbVie AbbVie donated older antiviral drugs upon request from the Chinese government as an experimental option to support the growing public health crisis.
Astellas Astellas Pharma China donated 1 million yuan to the Red Cross Society of China for purchasing PPE and procuring medical treatment equipment and donated 300,000 yuan worth of PPE to hospitals in Wuhan, China.
Bayer Bayer made financial contributions and donations of several medicines to the Chinese Red Cross.
Boehringer Ingelheim Boehringer Ingelheim made financial donations to the Chinese Red Cross to purchase PPE and made donations of medicines.
Bristol-Myers Squibb Bristol Myers Squibb (BMS) and the BMS Foundation provided more than $5 million in financial support and essential products to COVID-19 relief efforts.
CSL Group/ Seqirus CSL Group donated 1 million RMB to the China Red Cross in support of COVID-19 relief efforts.
Eisai Eisai donated 1 million yuan to the Wuhan Charity Federation and provided local healthcare providers with medicines and medical relief supplies.
Johnson & Johnson Johnson & Johnson donated 300 boxes of HIV medication to the Shanghai Public Health Clinical Centre and Zhongnan Hospital of Wuhan University. The company also provided drug-screening for antiviral properties against SARS-CoV-2 to assist laboratory-based investigations of the Chinese CDC.
Eli Lilly Eli Lilly China donated 1 million yuan to the Chinese Red Cross. The Lilly Foundation donated $100,000 to Direct Relief, and $150,000 to Project HOPE to support their COVID-19 relief efforts.
Lundbeck Lundbeck supported local communities and societies with monetary and medicine donations to Wuhan, China.
MSD MSD donated 1 million RMB to the Chinese Red Cross Foundation and supported the construction of a second specialty hospital (Leishenshan Hospital) to treat COVID-19 patients in Wuhan.

MSD launched online campaigns to educate the public about respiratory disease and helped provide up-to-date articles on treatment guidelines for health care professionals.

Otsuka Otsuka donated 1 million RMB to the Red Cross located in Jinnan Community Hangzhou Lin’an Area for medical supplies and PPE, 500,000 RMB to the Sichuan Red Cross, medical supplies to the Hubei Charity Federation, and provided supportive nutritional products to medical staff, the Tianjin Red Cross and designated hospitals in Beijing.
Pfizer Pfizer made cash contributions to its global NGO partners who shipped supplies to hospitals in China. The Pfizer Foundation provided $500,000 in grants for direct COVID-19 relief efforts of Direct Relief and Project HOPE.
Roche Roche donated diagnostics tests, medical supplies and financial support, including a donation of $2 million worth of tocilizumab to China to help manage the COVID-19 outbreak. Roche subsidiary Genentech also worked with Chinese government and health authorities to provide screening and health care.
Sumitomo Dainippon Pharma SDP subsidiary Sumitomo Pharmaceuticals donated  1 million RMB to the Chinese Red Cross Foundation for prevention and containment efforts.
Teva Teva donated 9,600 packs of azithromycin to 15 hospitals in Hubei.
Abbreviations
  • Abbreviated Term
    Full name
  • ACT Accelerator
    The Access to COVID-19 Tools Accelerator
  • ACIP
    Advisory Committee on Immunization Practices
  • ACTIV
    Accelerating COVID-19 Therapeutic Interventions and Vaccines
  • AHA
    American Hospital Association
  • AMED
    Agency for Medical Research and Development (Japan)
  • AMSP
    Africa Medical Supplies Platform
  • anti-GM-CSF
    anti-granulocyte macrophage colony-stimulating factor
  • AU
    African Union
  • BARDA
    Biomedical Advanced Research and Development Authority
  • CDC
    Centers for Disease Control
  • CEPI
    Coalition for Epidemic Preparedness Innovations
  • CHMP
    Committee for Medicinal Products for Human Use
  • CMA
    Conditional Marketing Authorisation
  • cMAA
    conditional Marketing Authorisation Application
  • COMET-ICE
    COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early
  • CRS
    Cytokine Release Syndrome “cytokine storm”
  • CoVax
    Vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator
  • DARPA
    The Defense Advanced Research Projects Agency (US)
  • DSMB
    data safety monitoring board
  • DZIF
    German Center for Infection Research
  • EFPIA
    European Federation of Pharmaceutical Industries Associations
  • EMA
    European Medicines Agency
  • EUA
    Emergency Use Authorization
  • GISAID
    The Global Initiative on Sharing All Influenza Data
  • HHS
    U.S. Department of Health and Human Services
  • H-IG
    Hyperimmune globulin
  • IAVI
    International AIDS Vaccine Initiative
  • IDMC
    Independent Data Monitoring Committee
  • IMI
    Innovative Medicines Initiative
  • INSERM
    Institut National de la Santé et de la Recherche Médicale (France)
  • ISB
    Institute for Systems Biology (US)
  • ITAC
    Inpatient Treatment with Anti-Coronavirus Immunoglobulin
  • JPA
    Joint Procurement Agreement
  • LAAB
    long-acting antibody
  • LSTM
    Liverpool School of Tropical Medicine
  • mAbs
    Monoclonal antibodies
  • MIT
    Massachusetts Institute of Technology
  • MHRA
    Medicines & Healthcare Products Regulatory Agency
  • MoH
    Ministry of Health
  • mRNA
    Messenger ribonucleuc acid
  • NEJM
    New England Journal of Medicine
  • NHS
    National Health Service (UK)
  • NIAID
    National Institute of Allergy and Infectious Diseases (US)
  • NIH
    National Institutes of Health (US)
  • NIID
    National Institute of Infectious Diseases (Japan)
  • OSCAR
    Otilimab in Severe COVID-19 Related Disease
  • PHRI
    Population Health Research Institute
  • PPE
    Personal Protection Equipment
  • UKK
    Cologne University Hospital
  • UMR
    University of Marburg
  • US CDC
    United States Centre for Disease Control and Prevention
  • US DOJ
    United States Department of Justice
  • US FDA
    United States Food and Drug Administration
  • UTMB
    University of Texas Medical Branch
  • WHO
    World Health Organisation
Key Facts & Figures
  • <12

    Months of COVID-19 vaccine development

    until WHO EUL
  • 3

    WHO approved or authorized COVID-19 vaccines

    from IFPMA members
  • 6

    COVID-19 vaccines in clinical development

    from IFPMA members
  • 263

    Manufacturing and production deals for COVID-19 vaccines

    around the globe
  • 76.8M

    COVID-19 vaccines delivered

    to LMICs and LICs
  • 2

    Approved or authorized COVID-19 therapeutics

    from IFPMA members
  • 60

    Manufacturing and production deals for COVID-19 therapeutics

    around the globe