The Food and Drug Administration granted full approval to the Pfizer-BioNTech vaccine for protection against the spread of COVID-19 in people 16 and above. The FDA has not yet approved the vaccine for kids under the age of 12.
The Pfizer-BioNTech vaccine is now called Comirnaty (Koe-mir’-na-tee) and remains available under the Emergency Use Authorization (EUA) for children 12-15, along with the other EUA vaccines needed to help prevent the spread of COVID-19. It is the first vaccine to get full approval by U.S. regulators.
The vaccine went through a rigorous approval process to establish safety, quality, and effectiveness. In a news release, the FDA Commissioner, Dr. Janet Woodcock, tried to reassure the public.
“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,” Woodcock said.
The decision makes it easier for businesses and various government agencies to mandate the vaccine, which is precisely what the University of Utah, Utah State and Weber University have done after hearing word of the approval.
On August 27, President Deneece Huftalin sent a letter to students that said Salt Lake Community College may join the other institutions and colleges in making vaccines mandatory.
“Pfizer COVID-19 vaccine received full FDA approval, and with that, state leaders have granted Utah System of Higher Education institutions more flexibility in the decisions regarding vaccine requirements,” Huftalin wrote.
When asked for a comment, Huftalin’s office said, “SLCC’s Executive Cabinet is discussing vaccination details this week” and promised to relay any new details after they have made a concrete decision.
Health officials also anticipate the approval will increase vaccination rates.
“We hope the FDA approval of the vaccine may now instill additional confidence to get vaccinated,” Woodcock said.
In a poll conducted by the Kaiser Family Foundation, only 30 percent of unvaccinated people said the government agency’s approval would make them more likely to get the vaccine.
Rickelle Zucker, a student at SLCC who was vaccinated earlier in the year, explained how she feels about the FDA’s decision.
“I am glad the vaccine I got was the one that got approved,” Zucker said.
According to the Centers for Disease Control and Prevention, the most common side effects from the Pfizer vaccine include pain, swelling, and redness at the injection site as well as fatigue, headache, fever, joint pain, and nausea.
“I think everyone is different,” Zucker said. “After the first shot, my arm hurt a little, and I got a minor headache which was gone the next day. I had no side effects at all from the second shot.”
The CDC claims that severe reactions have only been experienced in 0.4 percent of the people who have received the vaccine. They have also found that those who receive the vaccine are less likely to become seriously ill from the disease and recommend that everyone gets the vaccine to stop the spread of COVID-19.