FDA Amends Authorization for Second Booster Dose for mRNA COVID-19 Vaccines
The new action by the federal agency now means the additional booster shot can be administered to people 50 years and older.
The Food and Drug Administration (FDA) has amended its Emergency Use Authorizations (EUA) for both mRNA vaccines to now include a second booster dose allowing adults 50 years and older the ability to receive the additional shot.
The federal agency says this action now makes a second booster dose available to populations at higher risk for severe disease, hospitalization, and death.
FDA amended the EUAs as follows:
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
- A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.
"Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
FDA made it clear in its statement this is only applicable to the Moderna and Pfizer-BioNTech vaccines, and the agency also reiterated the recommendation to get a booster shot for those who have not had one yet.
“Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19,” Marks also stated. “So, those who have not received their initial booster dose are strongly encouraged to do so.”