San Juan Basin Public Health sent out a press release yesterday, August 23, to alert its constituents that the Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech COVID-19 vaccine today for individuals ages 16 and up.
The Pfizer vaccine continues to be available under emergency use authorization (EUA) for individuals ages 12 to 15. It is also available under EUA for the administration of a third dose for moderately to severely immunocompromised individuals. Booster shots for anyone other than immunocompromised people are not approved or being offered at this time.
San Juan Basin Public Health (SJBPH) is awaiting federal guidance regarding boosters for additional populations and is preparing to distribute boosters, alongside local partners, when authorized.
SJBPH emphasizes that full FDA approval for the Pfizer vaccine is a positive step forward for vaccinating the community. While the Pfizer, Moderna, and Johnson & Johnson vaccines all met the rigorous scientific and safety standards for EUA, the FDA’s full approval today demonstrates that the Pfizer vaccine meets the highest standards for safety, efficacy, and manufacturing quality that a vaccine can receive from the FDA.
The Pfizer vaccine has been available under EUA since December 11, 2020. 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 disease. FDA approved vaccines undergo additional review processes for quality, safety and effectiveness. Full approval for the Moderna vaccine is currently under review. Johnson & Johnson is also expected to apply for full review by the FDA.
“Full approval by the FDA is a positive step forward in vaccinating our community and limiting the spread of COVID-19. We’ve been looking forward to this milestone,” said Liane Jollon, Executive Director of SJBPH. “For anyone who has been hesitant or putting off their vaccine, the full approval of the Pfizer-BioNTech vaccine by the FDA should give you the utmost confidence that the vaccine is extremely safe and effective. All three authorized vaccines are highly effective at preventing hospitalization and death and we urge you to protect yourself and your family right away, especially with the new school year starting. People who are not yet fully vaccinated remain at high risk of falling ill with the more transmissible Delta variant of COVID-19. The majority of transmission is occurring in the unvaccinated population.”
Full approval by the FDA for the Pfizer vaccine may provide additional support for employers or institutions who have been considering mandating the COVID-19 vaccine for their staff.