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“Why EUA, Why Not Approval?” EUAs Fuel Vaccine Hesitancy
(Thursday, May 13, 2021) Even though both Pfizer and Moderna Covid vaccines have been administered to almost 200 million people in the US and many more worldwide, some populations have hesitated to get vaccinated due to them being only authorized under EUAs and not formally “approved”. There are two sides of the story; on one side, some people may be genuinely concerned about the safety of the vaccines since after more than 6 months of the EUA, regulators have not yet formally approved the vaccines. On the other hand, the regulators and the companies may have treated the approval more as a formality than a necessity since these vaccines have been administered at a pace and scale unparalleled in human history without any major adverse events and with unprecedented effectiveness. More importantly, so far, the demand far outpaced the supply. The EUAs were necessary for the quick release of the vaccines and thereafter the attention was focused on supply, distribution, and pharmacovigilance, while the BLAs seemed to be of secondary importance. But now after 6 months, the EUAs are fueling vaccine hesitancy and tying the hands of employers, leaders at educational institutions, event organizers, and government bodies from mandating their constituencies to get vaccinated. An EUA is for an experimental treatment since technically information sufficient for full approval was not available at the time of authorization. So, by law, it is not possible to “require” an unwilling person to take an experimental treatment. About 25% of the US population is unwilling to be vaccinated and most of those attribute their unwillingness to the lack of FDA approval. This is a significant fraction of the population that could continue the spread of the infection and potentially lead to new more infectious variants, as has been seen in India. The irony of this situation is that both Pfizer and Moderna vaccines seem to have the data needed for a BLA. Both vaccines underwent extensive clinical testing, were reviewed and cleared by FDA’s advisory committees, have manufactured hundreds of large batches of vaccines under GMP, have been administered to tens of millions of people with remarkable short- and long-term safety and effectiveness profile. So, the BLA should be a gimme for them. And they are working on it. Pfizer announced last week that it is planning to file a BLA for its Covid vaccine, and Moderna is close behind. Technically, it could take a few months after filing the BLA for FDA to decide on it but if there ever was a case where FDA can approve an application in days and weeks rather than months, this is it. Not to say that all the people hesitant to get vaccinate would suddenly line-up to get vaccinated then, but it will be a good start. More importantly, it will give the administrators the tool they need to mandate vaccine, and hopefully ease pandemic-related restrictions and normalize life. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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