FDA grants full approval for Pfizer COVID-19 vaccine
September 9, 2021
The FDA granted full approval to the Pfizer-BionNTech vaccine for individuals 16 and over on Aug. 30, following almost nine months of approval under Emergency Use Authorization.
The Pfizer vaccine has been renamed “Comirnaty,” its official FDA drug name.
“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,” acting FDA Commissioner Janet Woodcock said in a statement by the agency.
Health care providers can now order a third dose of Comirnaty for immunocompromised individuals as a booster shot in addition to the current two-doses given for standard immunization.
“It is our hope that the full authorization will make people who previously didn’t want to get the vaccine get it now,” said Awais Vaid, deputy administrator and epidemiologist of the Champaign-Urbana Public Health District. “After all, when more people take the vaccine, (it) becomes more effective.”
Full approval by the FDA is a promising sign for other vaccines such as the Moderna and Janssen vaccines which are currently under EUA but not fully approved, said Vaid.
The Moderna COVID-19 vaccine is currently approved by the European Medicines Agency, the United Kingdom and Australia for full usage under the name Spikevax.
Full FDA approval for the Moderna vaccine is forecasted to come at least a month later than Pfizer’s approval, with Moderna submitting its approval request approximately a month later to the FDA.
Individuals between the ages of 12-15 are currently allowed to receive the vaccine under the EUA. This lack of full authorization has restricted certain school districts from mandating that children get vaccinated.
“Parents who are enthusiastic about (the vaccine) understandably still are holding out for full authorization for their children, which is forcing us to do the same and wait for the FDA to approve the vaccine for youth before we make any requirements,” said Kathy Shannon, board vice president of Champaign Unit 4 School District.
Vaccine hesitancy is a major factor to the slower than anticipated rollout of COVID-19 vaccines with only 53% of the population fully vaccinated, according to the Centers for Disease Control and Prevention. This is well below the commonly cited number of 70% for herd immunity to occur.
“We hope that the FDA’s official approval of Pfizer’s vaccine erases some of the fears that people have in getting vaccinated,” Vaid said. “This authorization is further proof of how safe the vaccines are.”