Moving

The FDA’s mRNA vaccine full approval opinions are transferring lots quick. Begin the mandates now – Endpoints Information

As the US continues to have a surplus of protective Covid vaccines, some experts hope that a transition from the EEA to full approval status for the two mRNA vaccines will boost public confidence in them and, in turn, just increase the country’s vaccination rates It’s time to block the resurgence of Covid we’re seeing elsewhere, powered by the Delta variant.

While such a rapid upward shift can have this immediate effect, we shouldn’t lose sight of the fact that the FDA will likely review the Pfizer / BioNTech and Moderna vaccines in record time. And their huge pool of real safety and manufacturing data doesn’t make that easy. Even so, the FDA plans to have its Covid vaccine regulatory exams take about half the time (3-4 months) it currently takes the agency to sign a priority drug / vaccine application (6 months) and only a fraction of that the time for a new application that is not accelerated (12 months).

There is no question that the agency should pick up the pace on both Pfizer and Moderna’s filings. Employers may be more willing to push for mandates once vaccines are fully approved. Let’s not forget the reason we find ourselves in this enviable position, with nearly 160 million people fully vaccinated in just over a year and a half since the pandemic began in the US: the FDA was able to quickly improve the outstanding effectiveness of both data To provide vaccines and to ensure that the manufacturing process was robust enough and could be replicated in such a way that all of these hundreds of millions of doses could be made safely and efficiently.

A push from the EUA to full approval does not help the millions of Americans who are still not vaccinated, they may hesitate or be completely against the idea because of the EUA status. And with the EEA transitioning to full approval, employers across the country need to be strong and require vaccinations so we can stay protected. As lawyers have indicated, it is not illegal to require vaccines to be administered under EUAs.

Eric Topol, Professor of Molecular Medicine at Scripps Research, recently penned a comment in the New York Times urging the FDA to now fully approve the mRNA vaccines. independent research and the experience of millions of people around the world who have received it. “

However, FDA reviews of Pfizer and Moderna vaccines have taken less than 3 months to complete. And there is nothing in the EEA or real world data for the Moderna or the Pfizer / BioNTech vaccine that should initiate a pause or in any way suggest that the vaccine’s clinical data package is not comparable to other mandatory vaccines that already have the have received full approval.

And while some seem to suggest that the FDA is stretching its feet, the size (thousands of pages long) and complexity of a full package of approvals shouldn’t be taken lightly. If the FDA takes longer to make sure the vaccines are made properly enough to get full approval, so be it.

Peter Marks

As FDA Chief Vaccine Officer Peter Marks made it clear from the start, vaccines were released at a higher bar than the other treatments EUAs received, and the American public should trust vaccines under EUAs as much as under full approvals.

For those who remain unvaccinated, in a stakeholder call last week, Marks and Janet Woodcock reiterated the urgent need to move now, even with the very rare risk of myocarditis in mostly younger men. The CDC also made it clear on Tuesday evening that now more than half of all cases in the USA can be traced back to the Delta variant from India.

“The delta variant is increasing in this country and its incidence could double about every week, and experts expect it to be the dominant variant within a month or so,” said Woodcock. The time for vaccination is now, with or without permission.

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