FDA Authorizes Second COVID-19 Booster Dose
By Angelle Cortes
On Mar. 29, the Food and Drug Administration authorized a second booster shot for those older and immunocompromised.
The authorization now makes the second booster available to other populations at higher risks for severe disease, hospitalization and death Evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.
A second booster dose of Pfizer or Moderna may be administered to individuals 50 years of age and older at least four months after the first booster dose.
The second booster dose may be given to those 12 years old and older that are immunocompromised at least four months after the first booster dose. Those who have undergone solid organ transplantation or living in equivalent immunocompromised conditions.
"Current evidence suggest 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," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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. So, those who have not received their initial booster dose are strongly encouraged to do so.”
The FDA has only applied the authorization to the Pfizer and Moderna vaccine. Data and information will continue to be evaluated as it becomes available when considering the potential use of a second booster dose in other age groups.
It has been determined by the FDA that the known and potential benefits of a second COVID-19 vaccine booster with either of these vaccines outweigh their known and potential risks in these populations.
Photo Courtesy of The Associated Press