Two Departing FDA Leaders Say ‘Not Need For Booster Shots’ Right Now

Two departing United States Food and Drug Administration (FDA) leaders have said that the current COVID-19 vaccines do not show a need for booster shots. Their statements echo the ones made by an international group of vaccine scientists and the World Health Organization (WHO).

“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 write in a new opinion piece, published Monday in the medical journal The Lancet.

The FDA leaders stated: “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 FDA leaders’ remarks come after they reviewed randomized trials and observational studies on COVID-19 vaccines and consistently found that the current vaccine efficacy remains substantially great against severe disease and even against all the main viral variants. The opinion added, “Although the efficacy of most vaccines against symptomatic disease is somewhat less for the delta variant than for the alpha variant, there is still high vaccine efficacy against both symptomatic and severe disease due to the delta variant.”

The FDA officials also said that the limited supply of the available vaccines should be used as an opportunity to save more lives by giving them to the unvaccinated population rather than being used as boosters.

They noted, “Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated. If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants.”

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The opinion came out a month before the U.S. federal health officials announced plans for booster doses of the COVID-19 vaccines. They said they wanted to offer the booster shots starting this fall subject to authorization from the FDA and sign-off from the U.S. Centers for Disease Control and Prevention (CDC). The FDA is yet to comment on the opinion piece.

WHO Director-General Tedros Adhanom Ghebreyesus also called for wealthy nations to wait to boost their COVID-19 vaccinations until more supplies are available to other countries. Ghebreyesus encouraged countries to wait until the end of the year to decide on giving booster shots.