The Food and Drug Administration granted final approval for the Pfizer COVID-19 vaccine for people 16 and older in August, 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 from those who were hesitant 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.

The full approval means the vaccine has now cleared a higher bar of review and that it is safe and effective.

While millions of people have safely received the COVID-19 vaccines, a June poll from the Kaiser Family Foundation found that a third of unvaccinated people said they would be more likely to get vaccinated once it received full FDA approval.

"It's really a moment to celebrate," said Dr. David Priest, Novant Health senior vice president and chief safety, quality, and epidemiology officer. After reviewing hundreds of thousands of documents related to the clinical trial with 44,000 patients and other data related to millions of doses around the world, "the FDA said enough time had gone by and they were confident this was a safe product."

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 patients from yet another surge that is straining capacity across the U.S.

Novant Health is requiring team members to get vaccinated, as are multiple other large health care systems across North Carolina and the U.S. Patient safety drove the decision at Novant Health. “Vaccines are the only way we have at this time to end this pandemic,” Priest said, “and the only way to ensure that we do not give a deadly virus to those who trust us.”

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Guidance for children ages 5 and older

Novant Health is also administering Pfizer's vaccine to children ages 5 to 11, following emergency authorization. Vaccinations in this age group – the first U.S. children under 12 to become eligible for a COVID vaccine – began Nov. 4.

The vaccine already carried “emergency” status for children 12-15. 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.

The best way to protect children who are not yet eligible 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.

Nearly 5 billion doses of COVID-19 vaccines have been administered worldwide and the vaccine has been proven 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.

Novant Health resources

  • Nearly 100 Novant Health clinics are administering vaccines to their patients. Established patients can call their primary care clinic to see if it is offering the vaccine.
  • Novant Health still has mass vaccination clinics in Winston-Salem, Charlotte and Salisbury. For more information or to schedule an appointment, visit GetVaccinated.org. Walk-ins are also accepted.

Those seeking a COVID-19 test can please visit NovantHealth.org/coronavirus for a list of COVID-19 testing locations. Please don’t go to the emergency room for a test.