FDA, WHO: Covid Boosters Not Needed for General Population

“Any decisions about the need for boosting or timing of boosting should be based on careful analyses of adequately controlled clinical or epidemiological data, or both, indicating a persistent and meaningful reduction in severe disease,” the scientists wrote in the Lancet medical journal.

The risk-benefit evaluation should consider the number of severe COVID-19 cases that boosting would be expected to prevent, and whether it is safe and effective against the current variants, they said.

“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” the scientists wrote.

Some countries have begun COVID-19 booster campaigns, including Israel, providing some of the data on which the Biden administration has made its case for additional shots.

The article’s authors included the FDA Office of Vaccines Research and Review Director Marion Gruber and Deputy Director Phil Krause, both of whom plan to leave the agency in the next several months.

They acknowledged that some individuals, such as those who are immunocompromised, could benefit from an additional dose.