FDA and CDC Urge White House to Downsize Sept. 20 Booster Vaccine Rollout Plan

The Biden administration’s plan for a Sept. 20 rollout of vaccine booster shots may be delayed as the FDA and the Centers for Disease Control and Prevention (CDC) consider the available data for the Pfizer/BioNTech, Moderna and Johnson & Johnson (J&J) boosters.

Acting FDA Commissioner Janet Woodcock and CDC Director Rochelle Walensky told the White House last week that they may need more time to review the data and may initially only recommend boosters of the Pfizer vaccine – and only for some at-risk populations.

The Biden administration has frequently said that it will abide by the science-based decisions of the regulatory authorities, so a partial or delayed rollout of boosters seems likely.

The FDA, which has scheduled a Sept. 17 meeting of its vaccine advisory committee to discuss the matter, has received full data on the Pfizer-BioNTech and the Moderna booster vaccines and is awaiting data from J&J on a booster for its single-dose vaccine.

In a Sept. 2 news briefing, Anthony Fauci, Biden’s chief medical adviser and the director of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, spoke in favor of boosters and cited the detailed Israeli data on their efficacy. “There’s no doubt, from the dramatic data from the Israeli study, that the boosts that are being done there and contemplated here support very strongly the rationale for such an approach,” he said.

According to the CDC, 94.6 million people in the U.S. have been fully vaccinated with the Pfizer-BioNTech vaccine, 65.8 million with Moderna’s vaccine and 14.2 million with the single-dose J&J vaccine.

In Europe, which appears to be taking a more cautious approach to boosters, the European Centre for Disease Prevention and Control (ECDC) has said there is no immediate need to give booster shots to the general population.

Vaccine effectiveness against severe disease should be “the primary outcome of interest for assessing when there is a clear need for an additional vaccine dose in specific groups,” the ECDC said, in a new report, adding that “[c]lose monitoring of vaccine effectiveness data, particularly among vulnerable groups at risk of severe COVID-19 and among those living in closed settings, should be continued, and decisions adapted accordingly, should a substantial decrease in effectiveness be noted in one or more population groups.”

However, the EMA has not ruled out boosters and said that member states are free to administer them as they see fit.

Read the ECDC report here: www.fdanews.com/09-03-21-report.pdf. ― Jason Scott