Enlarge / A vial containing Moderna COVID-19 booster vaccine at a vaccination center. (credit: Getty | SOPA Images )

A vaccine advisory group for the World Health Organization said Tuesday that, at this point, it does not recommend additional, let alone annual COVID-19 booster shots for people at low to medium risk of severe disease. It advised countries to focus on boosting those at high risk—including older people, pregnant people, and those with underlying medical conditions—every six to 12 months for the near- to mid-term.

The new advice contrasts with proposed plans by US Food and Drug Administration , which has suggested treating COVID-19 boosters like annual flu shots for the foreseeable future. That is, agency officials have floated the idea of offering updated formulations each fall, possibly to everyone, including the young and healthy.

In a viewpoint published last May in JAMA , the FDA's top vaccine regulator, Peter Marks, along with FDA Commissioner Robert Califf and Principal Deputy Commissioner Janet Woodcock, argued that annual COVID booster campaigns in the fall, ahead of winter waves of respiratory infections—such as flu, COVID-19, and RSV—would protect health care systems from becoming overwhelmed. And they specifically addressed the possibility of vaccinating those at low risk.

Enlarge / The US Food and Drug Administration in Silver Spring, Maryland. (credit: Getty | Xinhua News Agency )

Two top vaccine regulators have resigned from the Food and Drug Administration, revealing anger, frustration, and turmoil at the federal agency as it faces intensifying pressure to authorize COVID-19 vaccine booster shots and doses for children under the age of 12.

The two regulators leaving are Marion Gruber, director of the FDA’s Office of Vaccines Research and Review (OVRR), and OVRR Deputy Director Phil Krause. Gruber has been with the FDA for more than 30 years, and Krause has been at the agency for more than a decade.

Their resignations, first reported by pharmaceutical trade publication BioCentury , were apparently sparked by frustration that the Biden administration had overstepped the FDA in announcing plans to offer COVID-19 booster shots beginning on September 20. The pair also clashed with higher-up Peter Marks, who reportedly went along with the administration's plans. Marks is the director of the FDA's Center for Biologics Evaluation and Research (CBER), which includes the OVRR.

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