Which vaccines have been FDA approved for COVID-19?
The FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. As of August 23, 2021, the FDA has issued full approval of the Pfizer-BioNTech vaccine for ages 16+.
The previously issued Emergency Use Authorizations (EUA) for the Pfizer-BioNTech vaccine for those ages 12 to 15 and third doses for the immunocompromised, as well as EUAs for COVID-19 vaccines manufactured by Moderna and Johnson & Johnson’s Janssen, remain in effect. An EUA gives the FDA authority to allow unapproved medical products to be used in emergencies when no approved alternatives are available. Other COVID-19 vaccines are in development and will be reviewed by the FDA under EUA.
Who qualifies for a booster shot?
Following guidelines set by ACIP and the CDC all individuals who are over the age of 18 are eligible to receive a Moderna or Pfizer-BioNTech COVID-19 booster shot at least six months after their primary two-dose vaccination series.
The FDA and CDC also authorized the administration of a booster dose of the Pfizer-BioNTech vaccine for patients ages 16-17 years, six months after receiving the second dose of their primary COVID-19 vaccination series.
Eligible individuals do not need to receive a booster shot that matches the formulation of their primary series. If individuals choose a booster dose that differs from their primary vaccine series, the manufacturers recommend individuals should check with their health care provider regarding the timing of the booster dose.
Additionally, individuals who are 18 years and old and received the Johnson & Johnson (Janssen) COVID- 19 vaccine may receive a single booster does of Johnson & Johnson (Janssen), Moderna, or Pfizer-BioNTech COVID-19 vaccine at least two months after receiving their primary vaccination.
Patients who received a Johnson & Johnson (Janssen) COVID-19 vaccine and prefer to receive a Johnson & Johnson (Janssen) booster are encouraged to contact their primary care provider for best next steps or refer to vaccines.gov for more information.