The US FDA is now tightening its regulatory policy around COVID vaccines by setting up a new framework that raises the bar for certain approvals.
Marty Makary, MD, the FDA Commissioner, and Vinay Prasad, MD, the Center for Biologics Evaluation and Research head, have already laid out the agency’s evidence-based approach when it comes to COVID-19 vaccination in one of the articles in the New England Journal of Medicine.
As per the officials, for people who happen to be under the age of 65 and have no risk factors, the FDA will need vaccine makers to gather all sorts of clinical trial data so as to warrant the future approvals. For people who happen to be 65 years or older and have the risk factors for severe outcomes, the agency anticipates that with the data showcasing the antibody titers production in people, the officials are going to be able to make a favorable benefit-risk finding when it comes to COVID-19 vaccines.
It is well to be noted that the new stance taken by the agency for COVID-19 vaccine approvals mostly reflects the restrictions that are imposed in the very recent approval for the protein-based COVID vaccine by Novavax. The approval happens to limit the vaccine’s usage to those over 65 years old and also to people between the ages of 12 and 64 who have at least one underlying health condition that puts them at high risk for even severe COVID outcomes. So as to explain the shift, both Makary and Prasad have cited poor uptake of annual COVID boosters and also declining public trust when it comes to vaccines across the board. The agency leaders want to contend that the new approach can still offer timely approval when it comes to a broader set of the population because the range of diseases that qualify as risk factors for severe COVID happens to be pretty vast.
The FDI leaders wrote that their policy also balances the requirement for evidence. According to them, they don’t simply know whether a healthy 52-year-old woman who has a normal BMI and who has had COVID-19 at least three times despite having received six previous doses of COVID-19 vaccine is going to benefit from the seventh dose.
To put it plainly, the guidance goes on to stipulate that the FDA is going to clear the new vaccines when it comes to high-risk people while at the same time demanding robust and gold-standard data for those who are at risk for severe COVID outcomes. The new approach is going to point out vaccine recommendations that are used across other countries, thereby rejecting the prior stance taken by the US, which upheld the decision of a one-size-fits-all regulatory framework.
This kind of guidance goes on to represent the clearest explanation when it comes to the new administration’s approach as far as policy around COVID vaccines are concerned.
The Department of Health and Human Services earlier in May went on to adhere to a stricter approach in a statement that declared that all the new vaccines are going to undergo safety testing within placebo-controlled trials prior to them getting the license.
While placebo testing already happens to be a standard practice for novel vaccines, annual updates when it comes to flu and COVID shots have not been required in order to showcase the new efficacy data. Both Makary and Prasad have clarified that in their new framework, the COVID policy happens to be separate from that of flu vaccines because of differences between the mutational revolution of viruses, which goes on to suggest that immunity from COVID vaccines may not need yearly updates.
However, it still remains unclear as to how exactly the new COVID standard is going to pan out with the updated vaccines since the FDA is going to opt to let the science tell us policy rather than continuing with the typical practice of yearly updates, says Prasad. In its briefing document, the FDA has already noted that the updating of the current vaccines to better match the new strains may as well offer added benefits for the expected rise in viral spread in winter and fall.
