“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 Dr. Peter Marks, 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 agency said its approval of the new uses for the vaccines came as a result of safety surveillance data provided to the FDA. The Ministry of Health of Israel immunized approximately 700,000 people with second booster doses of the Pfizer-BioNTech COVID-19 vaccine. A second booster dose of the Moderna COVID-19 vaccine was tested on 120 participants over the age of 18 years old in a separate study.
“No new safety concerns were reported during up to three weeks of follow up after the second booster dose,” the agency reported.
What older and immunocompromised individuals need to know
The agency has provided the following additional information on the emergency use authorizations:
Older individuals: 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.
Immunocompromised individuals: 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.
As for the Moderna COVID-19 vaccine and immunocompromised individuals, a second booster dose of the 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 certain kinds of immunocompromise.
The FDA previously authorized a single booster dose for certain immunocompromised individuals following the completion of a three-dose primary vaccination series.