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Consult with almost any health care professional about this third decision, and the answer you will likely receive overwhelmingly is: yes, get your shot, and now. (And trust me, that’s good advice.)
But many are still hesitant to receive a vaccine that does not carry the familiar label “approved by the United States Food and Drug Administration.” So what exactly does it mean that vaccines have Emergency Use Authorization (EUA)?
How does this differ from traditional FDA approval? Should we be confident that each of these labels has been awarded with the safety of the public in mind? And with these vaccines deemed safe and effective, can the federal and state governments, or any institution, – or will they – compel the public to be vaccinated?
We’re already starting to learn the answer to the last question with news earlier this week that the Department of Veterans Affairs will require doctors to be vaccinated, and an early announcement from the Biden administration on Thursday that all federal employees and contractors must receive. vaccines or subject to regular testing and mitigation.
Although there has been some backlash on the idea of mandatory vaccinations, the data shows that the widespread administration of these vaccines – even if they are only allowed in emergencies – is in the best possible way. public interest. The reality is that while there is a higher bar to be crossed for full FDA approval, there are many overlapping requirements that ensure the safety and necessity of vaccines.
Both require that a certain number of people be treated with the vaccine or a placebo in a clinical trial (in this case, 3,000 people in each group).
They also require proof that the vaccine reduces the frequency and severity of infection, and proof that it is made with consistent purity and potency. Each undergoes laboratory testing, early clinical and large-scale clinical testing, as well as a review of the manufacturing process.
The main differences between these two processes are the length of time after vaccination that study participants are observed and the standard set for evaluating clinical data. For EUA, observation of study participants should continue for an average of two months after complete vaccination, while for FDA approval, all subjects should be observed for at least six months.
The bar of evidence for granting an EUA requires that the FDA “determine that the known and potential benefits outweigh the known and potential risks of the vaccine.” For approval, the FDA requires “substantial evidence,” which essentially means that clinical trials are large enough to determine whether the potential benefits and potential risks are real, thus providing greater public confidence.
The bottom line is that these vaccines were carefully evaluated before receiving EUA, and the additional evaluation done before FDA approval is just icing on the cake. Additionally, Pfizer, Moderna, and Johnson & Johnson each performed clinical trials five to seven times larger than the required sample size of 3,000 subjects – and each was designed to continue follow-up for at least six months.
However, we probably won’t have to wrestle with the distinction between EUA and FDA approval soon, at least for a few of the vaccines. In late spring, Pfizer and Moderna launched the FDA approval application process. While this process typically requires six months for a priority review, a decision could be announced sooner given the US FDA’s prior review.
Ideally, the FDA has already completed many of the activities that would be required to reach an approval decision prior to vaccine manufacturer submissions, such as performing audits of manufacturing facilities and clinical sites, preparing for analyzes. statistics and drafting documents such as product labels. This could reduce the exam time from a few months to a few weeks.
As a former employee of the FDA, I have the utmost confidence in the review process by its scientists, engineers, doctors and safety officers. But recent events have raised questions about political influence over his actions, including the commissioner participating in a political event, the agency granting an EUA under political pressure for hydroxychloroquine to treat some Covid-19 patients – followed by his revocation from the EUA within three months – and a recent decision to approve an Alzheimer’s drug despite several irregularities in his testing and exam.
This is made worse by an administration that does not prioritize the FDA enough to have yet appointed a commissioner, unlike the last two presidents, each of whom had a commissioner in place in March of their first term.
To restore confidence in the FDA as it approaches its decision whether or not to approve Covid-19 vaccines, the administration must appoint a commissioner who has a proven track record of acting independently of politics. And using established authority, the commissioner must initiate a transparent investigation into irregularities in his processes.
In the meantime, whether by institutional requirement or by their own choice, anyone who is eligible must be vaccinated. This reduces the possibility of the emergence of a new viral variant that is more dangerous or resistant to current vaccines and offers us a chance to beat this pandemic.
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