Vaccine Covid

Two Potential Covid-19 Vaccines Could Meet The FDA’s Authorization Guidelines By 2021

Over 190 countries have joined the effort to create some sort of Covid-19 vaccine or drug treatment. According to the World Health Organization, of those trials 42 are being evaluated in clinical studies and 10 have already reached the late-stage of clinical testing. 

For America, however, there are only two coronavirus vaccines that could potentially meet the US Food and Drug Administration’s (FDA) Emergency Use Authorization guidelines by the end of 2020. In normal circumstances, new vaccines have to undergo a very long process to secure FDA approval for public use, however, in emergent situations the FDA can approve of a vaccine to be used; such as during a global pandemic that’s killing hundreds of thousands. 

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The Covid-19 pandemic qualifies as a “biological threat” under FDA guidelines, meaning the administration can grant emergency use authorization. Emergency Use Authorization (EUA), doesn’t mean that the FDA will just approve of the first vaccine to appear, but instead means they won’t be as stringent as they normally are when working to approve of a vaccine. 

The FDA recently claimed that it “does not expect to be able to make a favorable benefit-risk determination that would support an EUA without phase 3 data that included, among other factors, a high proportion of enrolled subjects (numbering well over 3,000 vaccine recipients) followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.”

The FDA would also want to see late-stage clinical data on the subjects who received the vaccine at least two months after they completed the full vaccine regimen. What will happen now is an advisory committee that consists of infectious disease experts not working for the FDA will review the two vaccine options and determine if it’s eligible for EUA. 

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Drug-makers would need to file for EUA of a Covid-19 vaccine by the end of November in order for it to have any chance at receiving FDA approval by the end of 2020. So far, Pfizer and BioNTech’s joint vaccine and Moderna’s RNA vaccine are the only two viable options to potentially receive EUA. 

Moderna’s CEO claimed in September that her company would have enough data to submit a request for EUA by November 25th, while Pfizer and BioNTech claim they’ll be receiving initial data from their Phase 3 trial this month. The only other vaccines that had a chance at receiving EUA by the end of 2020 were AstraZeneca’s and Johnson & Johnson’s vaccine candidates, however, both vaccine trials were recently put on pause in the US due to unexplained illnesses appearing in some of the volunteers. 

Of course, the number one priority for the FDA is how safe and effective a vaccine is, this is why there’s such an emphasis on late-stage data when it comes to vaccine development. A vaccine could completely eradicate the virus it was meant to kill but still have adverse side effects months down the line that are completely unrelated to the virus. 

As of right now, however, it’s most imperative that you as an individual are making conscious choices every day to best protect yourself, and those who you are quarantined with, by always wearing a mask in public, social distancing whenever you can, washing your hands frequently, and staying home unless absolutely necessary. 

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