The U.S. Food and Drug Administration on Monday approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
“Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” said Acting FDA Commissioner Janet Woodcock, M.D.
Gov. Gavin Newsom added, “The FDA’s full approval further confirms that the Pfizer vaccine meets a rigorous, scientific standard for safety and efficacy, protecting against serious illness, hospitalization and death. With COVID-19 cases rising across the nation due to the Delta variant, I encourage all Californians to trust the science and protect themselves and their community by getting vaccinated.”
Since Dec. 11, 2020, the Pfizer vaccine has been available under emergency use authorization (EUA) in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be 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, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
Los Angeles County Board of Supervisors Chair Hilda Solis expressed hope Monday that the FDA’s approval of the Pfizer vaccine will encourage people who have been hesitant about vaccination to finally get the shot.
“Although millions of people across the country and the county have already received this vaccine and the data has overwhelmingly shown that it is safe and effective, I know that for some who remain hesitant full approval was a key factor,” Solis said. “With this step, it is my hope that those who are still unvaccinated see that the safety and effectiveness of these vaccines have been proven yet again.
“I also encourage businesses, healthcare facilities, schools, and other sectors who had been waiting for full FDA approval to follow the county’s lead and begin implementing vaccine requirements,” Solis said. “Only by further increasing vaccinations can we slow the spread of the Delta variant, prevent severe hospitalization and death from this virus, and finally put an end to this pandemic. Today’s full approval is another key milestone in that process.”
All three vaccines — Pfizer, Moderna and Johnson & Johnson — have been in circulation under emergency use authorization from the FDA. Pfizer is the first to be granted full approval.
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. For Comirnaty [Pfizer], the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
For more information, visit: https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine