FDA

WASHINGTON, D.C. — The U.S. Food and Drug Administration fully approved the Pfizer-BioNTech COVID-19 vaccine on Aug. 23 for those 16 and older.

Previously, the Pfizer vaccine was under emergency use authorization — which is used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product outweigh the known and potential risks of the product.

The Pfizer vaccine is still under emergency use authorization for those between the ages of 12 to 15 years old. The vaccine will be marketed as Comirnaty.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock in a press release. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product. 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.”

The Pfizer COVID-19 vaccine was first granted EUA on Dec. 11. FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.

“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 Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in a press release. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements, according to the FDA.

“Vaccines are our most important tool in the fight against COVID-19,” said NC Department of Health and Human Services Secretary Mandy Cohen in a press release. “All authorized vaccines have met rigorous testing and scientific standards. Millions of North Carolinians have been safely vaccinated, but for some people full FDA approval provides additional confidence. If you are not vaccinated, we urge you: please don’t wait to vaccinate.”

To support the FDA’s approval decision, the FDA stated it reviewed updated data from the clinical trial, which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.

The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older. The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

“Today’s announcement of the FDA approval of the Pfizer vaccine affirms that the vaccines are safe and effective,” said AppHealthCare spokesperson Melissa Bracey. “We have continued to see data and information that supports the COVID-19 vaccines are very effective at preventing severe illness, hospitalization and death. We urge anyone who is unvaccinated to get a vaccine today.”

Bracey said the agency has ample supply of the Pfizer vaccine and has the ability to order more as needed.

AppHealthCare offers COVID-19 vaccines by walk-in or appointment Monday through Friday. Walk-in hours for vaccines are 1-4 p.m. If a community member chooses to walk-in for a vaccine, they may have to wait. In order to lessen they wait time, they can schedule an appointment by calling (828) 795-1970. More information can be found at www.apphealthcare.com/covid-19-vaccinations.

“In order for us to be in a better place as a community, we need everyone,” Bracey said. “We need everyone to do their part and practice prevention measures like getting a vaccine, wearing a mask and getting tested if they feel sick or have been around someone who has COVID-19. This is a pandemic and a serious public health issue, so we are calling on everyone to help us, and that’s what it is going to take — everyone doing their part and taking care of each other. We are all tired of COVID-19 but we need to keep pushing forward to a better place.”

Bracey said the agency is seeing increasing trends of COVID-19 in the community and are concerned at where the community is at with the virus.

“We are continuing to see a strain on our health care system and hospitals filling up with COVID-19 patients,” Bracey said. “This is particularly important in our hospitals because we need to maintain capacity for other emergent issues that someone may need care for such as a heart attack, car accident, stroke and others.”

After the FDA gave full approval, President Joe Biden said private sector companies should step up vaccine requirements to reach more people.

“If you’re a business leader, a nonprofit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that,” Biden said in televised remarks. “Do what I did last month. Require your employees to get vaccinated or face strict requirements.”

Vaccine requirements have been around for years with students, health care workers and even military personnel required to get vaccines for such viruses like smallpox and polio, Biden said.

Appalachian State spokesperson Megan Hayes said Aug. 23 that as a state government entity, App State cannot unilaterally mandate vaccines for students or employees. Students and employees who are unvaccinated or who have not uploaded their vaccine status are required to participate in regular, randomized COVID-19 testing.

When students, faculty or staff become fully vaccinated, they can submit their vaccine status to be removed from the COVID-19 testing pool, exempted from other requirements and entered to win prizes, including $1,000 scholarships, campus parking passes and more.

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