Upon the Food and Drug Administration’s (FDA) approval of the Pfizer-BioNTech COVID-19 vaccine Monday, Virginia State Vaccination Coordinator Dr. Danny Avula quickly voiced his support. The vaccine was granted full licensure for people aged 16 and older, and continues to be authorized for emergency use for people aged 12-15, according to Avula.
Avula said in a statement:
“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).”
VDH reported 5,479,907 Pfizer doses have been administered in Virginia since December 2020. Avula noted:
“The science is clear that this is a safe and effective vaccine that is highly effective in preventing infection by the SARS-CoV-2 virus and subsequent variants, and in preventing serious illness that could result in hospitalization and/or death.”
The FDA first authorized the Pfizer vaccine for emergency use on Dec. 11, 2020 for individuals 16 years and older after reviewing data from an ongoing clinical trial of thousands of people. The FDA reviewed updated data from the trial, following approximately 20,000 vaccine recipients, over half of which were followed for at least four months following the second dose.
Although information on long-term health outcomes is not yet available, the FDA said the vaccine was 91% effective in preventing COVID, according to results from the clinical trial.
The vaccine’s manufacturer, BioNTech Manufacturing GmbH, submitted a biologics license application (BLA) as part of the FDA’s standard quality and safety review process. The BLA evaluates data on the vaccine such as clinical information, details of the manufacturing process, and site inspections.
On Aug. 13, VDH announced that Virginia would begin making third doses of the Pfizer and Moderna COVID vaccines available to moderately and severely immunocompromised Virginians, starting Aug. 14. VDH estimates 3% of Americans fall under this category. State data showed a similar percentage of eligible immunocompromised individuals.
The FDA has not recommended additional doses of the Johnson and Johnson vaccine, nor additional doses for the general public. The FDA advised eligible recipients to wait at least 28 days after their second dose before receiving their third dose.