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 evidence that it is appropriate.”
They did say that booster shots may be useful for some vulnerable populations, a use they have already been approved for by the FDA.
Views expressed in the paper do not reflect the views of the FDA, only Krause and Gruber.
Pfizer BioNTech’s application for approval of a booster dose is expect to come before an FDA advisory panel during a meeting Friday.
“We are in the middle of a deliberative process of reviewing Pfizer’s booster shot supplemental approval submission, and FDA as a matter of practice does not comment on pending matters before the agency,” said and FDA spokesperson. “We look forward to a robust and transparent discussion on Friday about that application.”
While Krause and Gruber do still have authority at the FDA, Dr.
Janet Woodcock, the acting agency commissioner, and Dr. Peter Marks, a career regulator who oversees the vaccine office that Dr. Gruber and Dr. Krause lead, could overrule them, said the New York Times.
According to the outlet, Krause, Gruber and other contributors to the piece are critical of Israeli data that federal health officials such as Dr. Anthony Fauci, the president’s chief medical advisor, believe shows that the initial vaccines have waning efficacy over time. They think more study and discussion is needed to determine if boosters are needed.
The researchers also questioned whether it would be better to use vaccines to provide more initial doses around the world as a way to prevent more mutation of the virus, the New York Times said.
This summer, the World Health Organization recommended halting booster programs in an effort to get more of the world vaccinated. As of July, Doctors Without Borders said in a press release that only 1 percent of people in low income countries had received a vaccine dose.
Widespread vaccination can cut down the risk of mutation and prevent severe illness from taking hold even when breakthrough infections occur.
“Immunity conferred by vaccines relies on protection both from antibodies and from immune cells,” said the New York Times. “Although the levels of antibodies may wane and raise the risk of infection, the body’s memory of the virus is long-lived.”
Additionally, it will take weeks before regulators can decid