Even though the U.S. Department of Health and Human Services has already announced a plan to roll out booster shots this fall, two outgoing Food and Drug Administration officials say the shots might not be necessary.
In a review published Monday in the Lancet Journal, Dr. Phillip Krause and Dr.
Marion Gruber of the FDA – along with other health experts – said that current evidence does not “appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.”
According to the New York Times, Krause and Gruber lead the F.D.A.’s vaccine office and “are likely to be crucial to any decisions the agency makes about boosters.” Gruber is eventually expected to formally sign off on official FDA approval of the vaccines before she is expected to leave the agency next month.
Krause will leave the agency in November. Both doctors left in part because they were upset about the Biden administration’s recent announcement that adults should get booster shots eight months after they become fully vaccinated, said the New York Times.
Apart from saying the booster shots might not be necessary, the Lancet article said there could be risks associated with wide distribution of booster shots too soon or too frequently. This is especially true for immune-mediated side effects already associated with some vaccines as myocarditis or Guillain-Barre syndrome
“If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines,” said the review. “Thus, widespread boosting should be undertaken only if there is clear