Second booster dose of Pfizer, Moderna COVID-19 vaccines authorized by FDA
Those with severely weakened immune systems can get a fifth shot
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The Food and Drug Administration (FDA) on Tuesday authorized another COVID-19 booster shot for emergency use in people ages 50 and older.
The regulators' decision opens a fourth dose of the Pfizer-BioNTech or Moderna vaccines to those people at least four months after their previous booster.
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"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," Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "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."
A Jackson, Miss., resident receives a Pfizer booster shot from Linda Glenn, Jackson-Hinds Comprehensive Health Center nurse, at a vaccination station next to Jackson State University in Jackson, Miss., Tuesday, Feb. 8, 2022. (AP Photo/Rogelio V. Solis)
Previously, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems.
The agency said this group also can get a fifth shot of the Pfizer vaccine.
A second booster dose of the Moderna vaccine can now also be given to individuals 18 years of age and older who are similarly immunocompromised.
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The FDA said emerging 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."
Citing data from the Ministry of Health of Israel, the FDA said that the benefits of a second COVID-19 vaccine booster dose with either of the vaccines outweigh the known and potential risks in these populations.
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It said data and information would continue to be evaluated as it becomes available when considering the potential use of a second booster dose in other age groups.
The move was made without input from its independent advisory panel, which is set to meet to discuss vaccination on April 6.
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The Centers for Disease Control and Prevention (CDC) is also expected to weigh in on the decision.
Pfizer and Moderna had both previously requested an additional dose, though Moderna's was for all adults and Pfizer's was for people 65 and older.
The Associated Press contributed to this report.