US: FDA panel endorses half-dose Moderna COVID jabs for booster

As a key step forward, the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) advisors panel has unanimously approved  Emergency Use Authorisation (EUA) of 'half-dose' of Moderna as booster jabs to enhance protection against COVID-19. On 14 October, the health advisors said that Americans, who have completed six months since the primary series of Moderna vaccines, will be eligible for a low-dose of its booster jabs, the Associated Press reported. The panel comprising of 19 members recommended 50 micrograms (50 µg) from a 100 microgram (100 µg) vial for a certain age group.

As a part of the expansion of the US booster vaccine campaign against COVID-19, senior citizens (65 and older); 18 to 64 at-risk adults; and people aged between 18 and 64 constantly exposed to COVID-19 risk zones like hospitals, will be eligible for the shot, CNN reported. Moderna took to Twitter to announce its successful approval of EUA from the FDA. 

According to CNBC, Moderna now awaits approval from the Center for Disease Control and Prevention (CDC) to begin bolstering immunocompromised people among those who received their vaccine earlier. The CDC committee is expected to discuss the proposal next week. Once the CDC endorses the booster shots, they will be available for those who comply with the CDC-advised guidelines for booster shots.

Moderna data clinical trial not convincing enough: FDA panel

Despite the unanimous endorsement of the booster shot, some members of the panel were not satisfied with the clinical trials data presented by Moderna. "The data are not perfect but these are extraordinary times and we have to work with imperfect data," CNN reported quoting Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and a professor at the Harvard T.H. Chan School of Public Health.

However, the panel could not "afford to have health care workers, even if not sick, be positive and infected and have to stay home from work because in parts of the country there's a shortage of health care workers and there's burnout everywhere," CNN reported quoting Dr. Stanley Perlman, a professor of pediatrics at the University of California San Diego.

On the other hand, the advisory panel meeting consisting of members of FDA's VRBPAC will resume on Friday to discuss the need for Johnson and Johnson COVID booster shots. Meanwhile, British-Swedish biopharmaceuticals company AstraZeneca has also intended to seek full regulatory approval of COVID-19 vaccines from the FDA after concerns emerged over its side effects.

(With inputs from AP)

(Image: AP)