FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine
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.
Full approval for the Pfizer vaccine comes on the heels of authorization by the FDA and Centers for Disease Control and Prevention (CDC) for a third dose of mRNA vaccine for moderately to severely immunocompromised Americans ages 12 and older. For immunocompromised people, booster shots should be administered at least four weeks after the second dose of the Pfizer or Moderna vaccine. Vaccine recipients are advised to seek the same mRNA vaccine that they originally received. If the matching vaccine type is not available, immunocompromised individuals may receive the alternative mRNA vaccine.
According to the CDC and FDA, individuals who are fully vaccinated and not immunocompromised do not need a booster shot at this time. SJBPH is continuing to monitor any new guidance as it becomes available and will keep the public informed.
At this time, the amended EUA and updated CDC guidance for boosters only refers to the mRNA vaccines. There is not enough data yet to determine if a mRNA booster shot is beneficial for people who originally received a Johnson & Johnson vaccine. Boosters have not been recommended yet for immunocompromised people who originally received the Johnson & Johnson vaccine.
Research demonstrates immunocompromised individuals may not build as much immunity when vaccinated as non-immunocompromised people do, and benefit from receiving a third dose of mRNA vaccine. Immunocompromised people have a higher risk of becoming seriously ill from COVID-19. Public health experts estimate this vulnerable group is approximately 3% of the total U.S. population.
You should seek a COVID-19 booster shot if you have:
- Been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking immune-suppressing medications
- Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress the immune system
Consult with your primary care provider to discuss if a booster shot is recommended for you. SJBPH recommends immunocompromised individuals seek a booster through an enrolled vaccine provider or existing vaccine clinic of their choosing. Immunocompromised individuals will be asked to self-attest for eligibility at the time of vaccination for the additional dose.
SJBPH is urging all community members to maintain their practice of the following critical public health precautions to prevent the spread of COVID-19:
- Get vaccinated for COVID-19. Vaccine clinics and providers are available on the SJBPH website.
- Stay at home when feeling unwell.
- Follow the local public health advisory that is in effect.
- Employees and guests are strongly advised to wear a mask in public indoor settings, regardless of vaccination status. Masks are recommended for anyone two years and older.
- Physical distancing (staying at least six feet away from another person) is strongly advised while in a public indoor setting.
- Businesses should assume that some customers are unvaccinated and err on the side of caution, maintaining face coverings and physical distancing in indoor settings (i.e., grocery stores, gyms, restaurants).
- Wear a face covering while using public transportation and when travelling by air, train, or bus, as required by federal orders.
- Practice good hygiene: wash hands frequently, cover coughs and sneezes.
- Get tested if you have symptoms or if you are unvaccinated and believe you were exposed through a known contact or community interaction, testing sites are listed on the SJBPH website.
The COVID-19 vaccine is now widely available to all residents ages 12 and up. Youth ages 12 to 17 are only eligible for the Pfizer vaccine. Minors must have a signed parental consent form which can be completed online when registering or at the clinic.
Although advance registration is preferred, walk-ins are also welcome at upcoming clinics. The vaccine is free, and no ID is required. Additional clinics and information about the COVID vaccine can be found on SJBPH’s website.