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FDA Issues Guidance for Coronavirus Vaccine Developers

Kinjel Shah

The FDA has issued guidance documents for companies that are developing a vaccine to prevent COVID-19 in order to get approval for the same. The guidance specifies the data that the companies need to submit in order to get approval for their COVID-19 vaccines. The disease has infected more than 10 million people globally.

Around a dozen companies are working on developing a vaccine for the deadly coronavirus disease using different technologies such as DNA, RNA, protein and viral vectored vaccines. Of these, Moderna MRNA, Novavax NVAX, Pfizer PFE and its Germany-based partner BioNTech, AstraZeneca AZN in partnership with Oxford University and Inovio Pharmaceuticals have initiated human/clinical studies on a coronavirus vaccine. J&J JNJ expects to begin a human study this month. In fact, Moderna expects to initiate a pivotal phase III study in July. AstraZeneca/Oxford University partnership also expects to begin late-stage studies with 30,000 participants in a number of countries if data from the phase I/II study, expected to be released shortly, is successful.

In fact, per a New York Times report, published last month, the Trump administration has picked five companies as part of the Operation Warp Speed (OWS) initiative to rapidly develop a vaccine for COVID-19. The five companies are J&J, Moderna, the Oxford University/AstraZeneca, Merck MRK and Pfizer. The report mentioned that the five companies will get extra federal funds, and help to run their clinical studies and manufacturing assistance.

With the pandemic being labelled one of the biggest global health hazards and severely denting economic growth, it is inevitable that companies are rushing to develop a safe and effective vaccine to prevent COVID-19 and will try to quickly generate data from vaccine clinical trials.

Though the FDA is looking to expedite the development of a vaccine, it made it clear that it “will not cut corners” and sacrifice its standards for quality, safety, and efficacy while giving its decision for approval. The guidance released clearly specifies the requirements for chemistry, manufacturing and control, nonclinical and clinical data through development and licensure. The FDA encourages that the studies should demonstrate the safety and efficacy of the potential vaccine against SARS-CoV-2 infection and should include diverse patient populations including children and elderly. The guidance mentioned that the primary efficacy endpoint point of a placebo-controlled efficacy trial should be at least 50%, which means the vaccine should be able to lower the risk of the disease caused by the SARS-CoV-2 virus in at-least 50% of the people who are vaccinated.

The agency did not rule out granting Emergency Use Authorization (EUA) to a COVID-19 vaccine in development stage. However, the FDA clarified the decision will be made on a case-by-case basis depending on the target population, the characteristics of the vaccine and available scientific data, which proves the vaccine’s effectiveness and safety. 

All eyes are on these pharma/biotech companies to find a vaccine for COVID-19 as they are being considered the key to bring stalled global economies back on track.

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Johnson Johnson (JNJ) : Free Stock Analysis Report
 
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Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Merck Co., Inc. (MRK) : Free Stock Analysis Report
 
Moderna, Inc. (MRNA) : Free Stock Analysis Report
 
Novavax, Inc. (NVAX) : Free Stock Analysis Report
 
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