FDA Authorized 4th COVID-19 vaccine for those 50 and older
A second booster offers additional protection for older individuals and those who are immunocompromised
Today, the FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. 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.
How do we know this is safe? Safety surveillance data provided by the Ministry of Health of Israel on the administration of approximately 700,000 fourth (second booster) doses of the Pfizer vaccine given at least 4 months after the third dose in adults 18 years of age and older (~600,000 of whom were 60 years of age or older) revealed no new safety concerns.
The safety of a second booster dose of the Moderna COVID-19 vaccine is also informed by an independently conducted study in which the Moderna vaccine was administered as a second booster dose to 120 participants 18 years and older who had received a two-dose primary series and a first booster dose of Pfizer vaccine at least 4 months prior. No new safety concerns were reported.
Immunogenicity data were reviewed from ongoing study in healthcare workers in Israel; individuals 18 years and older who had received primary vaccination and a first booster dose with Pfizer vaccine were administered a second booster dose of Pfizer (n=154) or Moderna vaccine (n=120) at least four months after the first booster dose. Increases in neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants, were reported two weeks after the second booster as compared to 5 months after the first booster dose. This signals that the second booster is both safe and effective at bolstering our protection against severe illness and death due to COVID-19.
Is this “necessary”? Currently, COVID-19 cases have dropped to low levels after the winter Omicron surge. Two vaccine doses plus a booster still provide strong protection against severe disease and death, CDC data show. But, the Omicron subvariant BA.2 has caused a rise in infections in Europe and is now the dominant strain in the US causing concern about another possible surge.
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