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Has The FDA Approved The COVID Vaccines Or Not?

As SARS-CoV-2 and its more virulent variants continue to spread around the world, it becomes even more critical to get the vaccines to unvaccinated people. The slow pace of vaccination in Africa, parts of Asia, and South America is largely due to lack of vaccine access or poor healthcare infrastructure. However, slowing vaccination rates in the US and Europe are now mostly due to vaccine hesitancy. Earlier in these pages, I addressed several of the most common anti-vax myths that people invoke as reasons to avoid the vaccine. These are largely fears based on mis- or even dis-information about the vaccines and COVID-19.

However, there also are people who are not necessarily anti-vaxers, but who hesitate to be vaccinated because of the perception that the current vaccines are not FDA approved.

The vaccines are FDA approved. An FDA panel gave them Emergency Use Authorization (EUA), which is not much different from full approval.

What is EUA? EUA comes from an expedited review process that is used to approve new medicines during public health emergencies, like a pandemic, in order to lessen roadblocks to get needed therapies to the public as soon as possible. EUA also puts significant limits on the medicine’s manufacturers. Many people do not understanding what the EUA entails and assume that the vaccines are not fully vetted.

That is not the case.

When people hear “Emergency Use Authorization,” they focus on the word emergency, and jump to the conclusion that the vaccines have not been fully tested, and are not known to be safe or effective. However, the reality is that a vaccine given EUA has gone through the same clinical tests as a vaccine given Full Approval, and all the clinical trial data have gone through the same rigorous review by the same large FDA science panel that also confers Full Approval.

How does EUA differ from Full Approval? For full vaccine approval, a large panel of FDA scientists reviews all the clinical trial data, including data collected six months following the end of the trial. The FDA also uses a fine tooth comb to examine the vaccine’s manufacturing plans to ensure the quality and consistency of the vaccines that are produced. This also includes extended negotiations with manufacturers to determine how the vaccines will be labeled (i.e., what claims and warnings will be placed on the informational insert and on the bottle). It is the review of the manufacturing processes and the negotiations over labeling that draws out the approval process.

In order to streamline the whole approval process during a time of emergency, the FDA allows temporary emergency use after carefully vetting the medicine. As with Full Approval, for EUA the FDA panel reviews all the clinical trial data. However, the post-trial data review is shortened to two, rather than six months. (Note that after either EUA or Full Approval, data continue to be collected and reviewed in order to identify extremely rare side effects that would not be picked up in a study of 30-40,000 participants). Both full and EUA reviews assess the relative risk of receiving the vaccine vs the risk of catching the disease the vaccine is designed to prevent. If that risk calculus is favorable, the vaccine is approved. I repeat, if the risk/benefit ratio of the vaccine outweigh the risk of the disease, the vaccine is approved. This is FDA approval and it is why it is disingenuous to claim that the CoV-2 vaccines have not been approved by the FDA.

More than 180 million doses of the Pfizer and 133 million of the Moderna vaccines have been distributed in the US, with millions more worldwide. Data from all of these recipients continue to be collected making these vaccines the most scrutinized for efficacy and safety in the history of biologics medicine. To summarize: clinical trials on about 70,000 volunteers showed both vaccines to be 95% effective and extremely safe; since then, a number of peer reviewed reports in leading journals have confirmed this using real-life data from vaccine recipients collected in Israel, Qatar, the UK, US and other countries. In other words, the mRNA vaccines have been proven safe and effective in clinical trials, and by independent research examining the real life experiences of hundreds of millions of people who have been vaccinated.

But, that is not enough for some people. Many claim that they want the full imprimatur of the FDA before they will get the vaccine. A survey by the Kaiser Family Foundation found that 32% of unvaccinated adults in the US said that they would be more likely to get the “Fauci Ouchie” if it had full FDA approval. They do not realize that the EUA is very similar to Full Approval. So, their hesitation is based on not understanding the approval processes and focusing on the word emergency in the EUA approval.

Pfizer filed for full approval on May 7, and Moderna followed with its own application on June 1. It will be 3-5 months before the full approval is granted, on which I would bet my house. But, the vaccine delay in hesitant people will lead to preventable mortality and morbidity. That is why I have written this blog post. Hopefully, it will convince some vax hesitators that they can be confident in the EUA approval status of the vaccines and will be vaccinated in order to avoid significant health consequences of the aggressive Delta variant that is overtaking many countries, including the US.

If EUA is almost as good as Full Approval, why would a vax company ever go for full approval after they have EUA? There are several reasons for doing so, which mostly have to do with marketing and sales. Without Full Approval vaccine companies cannot give the vaccine a brand name and market it directly to consumers on TV, radio, and other media. With EUA, the companies can also have price restrictions on their vaccines that could be lifted after Full Approval. Also, without Full Approval, law-suit averse employers and schools are often reluctant to mandate the vaccines like they have with other fully approved vaccines. Sure, a few colleges and hospitals already have mandated CoV-2 vaccinations, but others, like the University of California and California State University systems said that they will only mandate a fully approved vaccine. The US military also is waiting for full FDA approval before mandating the vaccine.

Bottom line. All of this shows that having Full Approval for the vaccines makes little difference for assuring the safety and efficacy of the vaccines. However, having Full Approval mostly means that you will see commercials and posters advertising the shots, may be required to get the shots, and will pay more for them.

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