FDA Fully Authorizes Pfizer COVID-19 Vaccine

By: Michael Mandarino, Follow South Jersey Managing Editor

WASHINGTON, D.C. — On Monday, the Food and Drug Administration issued full approval for the Pfizer-BioNTech COVID-19 vaccine model. The decision elevates the vaccine from emergency use authorization and could have a number of ramifications throughout the United States.

Fully authorizing the Pfizer vaccine will pave the way for employers, universities, hospitals, and other organizations to require people to be inoculated. Some entities have already instituted vaccine requirements for certain groups of people.

In New Jersey, Governor Phil Murphy previously announced that healthcare workers and employees in high-risk, congregate settings must be vaccinated against the pandemic or be subject to multiple COVID-19 tests per week. Gov. Murphy is also expected to announce a vaccine requirement for teachers during his regularly-scheduled COVID-19 briefing on Monday afternoon.

Additionally, the FDA’s decision to fully authorize the Pfizer vaccine could help combat vaccine hesitancy in the United States. More than 85 million eligible Americans remain unvaccinated, and polling data from the Kaiser Family Foundation showed that three out of 10 unvaccinated Americans would be inclined to get inoculated if the FDA fully approved one of the existing models.

Previously, the Pfizer vaccine model only had emergency use authorization. This was a common argument used by the unvaccinated in the past, so government officials are hopeful today’s announcement will encourage some to finally get vaccinated.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

As part of its approval process, Pfizer presented data that showed its vaccine was 91% effective in preventing COVID-19 infection among a group of 44,000 clinical trial participants from different continents. This number is down four percent from data shown to the U.S. when Pfizer was granted emergency use authorization in December — a drop that the medical giant attributes to researchers having more time to find people who had been infected with the virus.

The FDA’s decision to fully authorize Pfizer’s vaccine model applies to community members aged 16 and older. The vaccine can still be administered to those aged 12-15 under its emergency use authorization, but full approval for younger Americans may not come for months.

The COVID-19 vaccines are safe and effective at stopping the virus’ spread. Though breakthrough cases are possible, the vaccines are still highly effective at stopping the most serious COVID-19-related consequences, including severe illness and death.

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