The Food and Drug Administration granted final approval of the Pfizer COVID-19 for people 16 and older Aug. 23, sparking hopes that a new wave of Americans who were wary of the vaccine will now get the shots.
One consistent criticism of the vaccine was that it had only received emergency use authorization, which provides access to medical products that may be effective in preventing or treating a disease, provided the FDA determines its potential benefits outweigh the potential risks.
Full approval came after FDA scientists examined hundreds of thousands of pages of vaccine data from 40,000 trial participants.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of (the vaccine’s) safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.
That key approval is expected to trigger government, education, employers and other institutions to start requiring vaccinations.
COVID-19, now largely a pandemic of the unvaccinated, has killed more than 625,000 Americans. And the approval comes as hospitals begin to fill with yet another surge that is straining capacity across the U.S.
“Vaccines are the only way we have at this time to end this pandemic,” said Dr. David Priest, Novant Health senior vice president and chief safety, quality, and epidemiology officer, “and the only way to ensure that we do not give a deadly virus to those who trust us.”
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Younger children still not eligible
Children under 12 are not yet eligible for the vaccine. The best way to protect them is for the unvaccinated to get the shots, said Dr. Catherine Ohmstede, a Novant Health pediatrician. “It’s time for us all to do our part to keep our friends and family safe, end this latest pandemic surge, and provide the life we want for our children,” she said.
The vaccine will continue to carry the “emergency” status for children 12-15 as research continues. Pediatricians, public health experts and scientific community stress the vaccine is safe for this age group and by far the best way to protect them.
Nearly 5 billion doses of COVID-19 vaccines have been administered worldwide and has been declared safe and highly effective at preventing serious illness. Though data varies by state, more than 90 percent of hospitalized patients in the U.S. are unvaccinated, according to press and public health reports.
According to The New York Times, some 85 million of Americans eligible for the vaccine are still unvaccinated.
The vaccine has also been declared safe for pregnant women, nursing mothers, and women trying to get pregnant. There is no harm to fertility for adults and no plausible mechanism by which an mRNA vaccine could affect the fertility of children. Ohmstede said. Physicians at Novant Health also note that pregnant women who don’t get vaccinated face higher risks of:
- Being admitted to the ICU and intubated.
- Having complicated pregnancies that lead to longer hospital stays.
- Having to deliver early for their health and the baby’s, which in turns can lead to great complications.
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