Monday, November 28, 2022

FDA Gives Final Approval for COVID-19 Vaccine

The FDA has announced that the Pfizer-BioNTech vaccine has been fully approved by the administration. (Mat Napo/Courtesy of USplash)

NATIONWIDE — On Monday, Aug. 23, the Food and Drug Administration (FDA) gave final approval for the Pfizer-BioNTech vaccination to be administered in persons ages 16 years and older.

The vaccine, which will be marketed as Comirnaty (koe-mir’-na-tee), has been fully approved for this age group. It is currently available through an Emergency Use Authorization (EUA) for individuals 12 years and older as well as a third booster vaccine for those with certain immunocompromising conditions.

While the EUA was put into place as a result of the ongoing public health emergency (the COVID-19 pandemic), the three vaccines still needed final approval from the FDA.

“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, M.D. “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.”

According to an Aug. 23 release from the Virginia Department of Health (VDH), over 200 million doses of the Pfizer-BioNTech vaccine (now called Comirnaty) have been administered in the United States, with 5,479,907 in Virginia as of the date of the release.

The Virginia State Vaccination Coordinator, Danny Avula, M.D., M.Ph., said, “We at the Virginia Department of Health (VDH) are pleased that the Food and Drug Administration (FDA) decided to grant full licensure to the Pfizer-BioNTech COVID-19 vaccine for persons ages 16 years and older. This action comes after rigorous review and study by scientists and other researchers at the FDA and the Centers for Disease Control and Prevention (CDC).”

According to the FDA, Comirnaty contains messenger RNA (mRNA), a kind of genetic material. This is used by a body to create a mimic protein in the virus which causes COVID-19. As a result, the body of a person who receives the vaccine will react defensively to the virus that causes COVID-19. The FDA also notes that the mRNA in the Comirnaty vaccine is only in a person’s body for a short period of time. Therefore, it does not incorporate itself nor alter a person’s genetic material.

The FDA will continue to work with the Centers for Disease Control and Prevention (CDC) to monitor the systems put into place in order to address any safety concerns that may arise. The FDA is also requiring Pfizer-BioNTech to continue post-market studies on Comirnaty to assess risks such as myocarditis and pericarditis following vaccination.

“The science is clear that this is a safe and effective vaccine that is highly effective in preventing infection by the SARS-CoV-2 [COVID-19] virus and subsequent variants, and in preventing serious illness that could result in hospitalization and/or death,” said Dr. Avula.

The Johnson & Johnson single dose and the Moderna two-dose COVID-19 vaccines are still available through an EUA, but have not received final approval from the FDA.

To learn more or to schedule your appointment to receive the COVID-19 vaccine, visit the website for Vaccinate Virginia.

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