Authorization for another round of COVID-19 booster shots from Pfizer BioNTech and Moderna was announced Tuesday by the U.S. Food and Drug Administration for “older people and certain immunocompromised individuals.”
For most of these individuals, this shot would be their fifth dose of a COVID-19 vaccine. Previously, the FDA authorized a three-dose primary series of shots as well as one booster dose for seniors and those who are immunocompromised.
“This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death,” said the FDA. “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.”
According to the administration, second booster doses 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.
Additionally, second booster doses of the Pfizer BioNTech vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after their first booster dose. A second booster of the Moderna vaccine will be available to people with the same immunocompromise who are at least 18-years-old.
Conditions that qualify individuals for the shot include recent solid organ transplantation or “conditions that are considered to have an equivalent level of immunocompromise,” said the FDA.
Two primary doses and a third booster shot are recommended for individuals who do not fall under those categories.
“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,” 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.”
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