The U.S. Food and Drug Administration. (FDA) gave the green light for a second booster dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines in people over 50 years of age and certain immunocompromised individuals.
The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series, and will now make available a second booster dose of these vaccines for other populations at increased risk of severe illness, hospitalization and death.
Emerging evidence suggests that a second booster dose of an mRNA vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.
The agency modified the emergency use authorizations as follows:
A second booster dose of Pfizer-BioNTech or Moderna COVID-19 vaccine may be administered to persons 50 years of age and older at least 4 months after receiving a first booster dose of any licensed or approved COVID-19 vaccine, as well as to persons 18 years of age and older who are immunosuppressed.
While those between 12 and 17 years of age with certain types of immunosuppression may be given a second booster dose at least 4 months after receiving a first dose of any licensed or approved vaccine.
Immunocompromised individuals are those who have undergone solid organ transplantation or are living with conditions that are considered to have an equivalent level of immune compromise.
"Current evidence suggests some decline in protection over time against severe COVID-19 outcomes in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase levels of protection for these higher-risk individuals," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
The expert added that the data show that an initial booster dose is critical to help protect all adults from potentially serious COVID-19 outcomes. "Therefore, those who have not received their initial booster dose are strongly encouraged to do so."
It should be noted that the FDA action applies only to the Pfizer-BioNTech and Moderna vaccines, and the authorization of a single booster dose for other age groups remains unchanged.
He detailed that he will continue to evaluate the data and information as it becomes available to consider a second booster dose in other sectors.
The FDA has determined that the known and potential benefits of a second dose with any of these vaccines outweigh the known and potential risks in these populations. They have been shown to be safe.
A summary of safety surveillance data provided to the FDA by the Israeli Ministry of Health showed that the administration of 700,000 second booster doses of Pfizer-BioNTech and Moderna vaccine 4 months after the third dose in adults 18 years of age and older, of whom 600,000 were 60 years of age or older, is reliable and safe.
Similarly, it detailed that the evidence considered for the authorization of a second booster dose after primary vaccination and the first booster dose included information on safety and immune response provided to the agency, as well as additional information on efficacy submitted by the companies.
Meanwhile, immunogenicity data from an ongoing, open-label, non-randomized clinical study in health care workers at a single center in Israel revealed that individuals 18 years of age and older who had received primary vaccination and a first booster dose of Pfizer-BioNTech COVID-19 vaccine and were given a second booster dose of the same vaccine - 154 individuals - or Moderna - 120 individuals - at least four months after the first booster dose of the same vaccine - 154 individuals - showed increased levels of neutralizing antibodies to SARS-CoV-2 virus, including delta and omicron variants, at least two weeks after the first booster dose, at least four months after the first booster dose, showed increased levels of neutralizing antibodies to SARS-CoV-2 virus, including delta and omicron variants, two weeks after the second booster compared to 5 months after the first booster dose.
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