Moderna seeks FDA approval for booster shots of its COVID-19 vaccine

Photo by Alexandru Pavalache/Getty Images

Moderna, the maker of one of the COVID-19 vaccines available under emergency use authorization, has submitted data to the U.S. Food and Drug Administration for the evaluation of a booster shot of its COVID-19 mRNA vaccine.

The yet-to-be peer-reviewed data comes from a study of 344 individuals who received a third dose of the Moderna vaccine six months after their second shot. Moderna found that their antibodies had "waned significantly" before getting the booster shot, but the additional jab increased antibodies to an even higher level than the previous round.

Heightened protection was observed across age groups, but particularly in adults over the age of 65, according to Moderna. It also offered protection against "all variants of concern," including the Delta variant.

Moderna is submitting the data to be peer-reviewed as well as to other regulatory authorities around the world in the coming days.

WHY THIS MATTERS

Pfizer has already scored full approval for its vaccine, which is now marketed as Comirnaty. Pfizer also submitted data of its own to the FDA to support a booster dose of its COVID-19 vaccine.

Having emergency use authorization and not full approval is one reason given for those who choose not to be vaccinated. As of September 1, the U.S. had vaccinated nearly 53% of its total population, according to the Centers for Disease Control and Prevention.

Despite having more than half of the country fully vaccinated, CDC data shows that COVID-19 cases, hospitalizations and deaths are on the rise. The increase has been largely attributed to the highly contagious Delta variant, which currently makes up 99.1% of COVID-19 cases in the U.S., according to the CDC.

Although the CDC says that breakthrough infections of the Delta variant happen, its largest concern is for unvaccinated individuals. It points to data showing patients infected with the Delta variant were more likely to have severe illness than patients infected with other strains of COVID-19.

THE LARGER TREND

Moderna's vaccine received emergency use authorization last December and showed to be 94.1% effective in preventing symptomatic COVID-19 in its clinical trial.

The prospect of COVID-19 booster shots has been a hot topic recently. Earlier this month officials from the CDC and the Department of Health and Human Services said they will begin offering booster shots for all Americans after eight months since their second dose beginning the week of September 20.

Johnson & Johnson recently released data suggesting a second dose of its vaccine could rapidly increase antibody levels in recipients.

Despite these measures, the World Health Organization has called for a halt on COVID-19 vaccine booster shots until at least the end of September. It cites a growing vaccination rate gap between wealthy and poor countries for its desired moratorium.

For example, while countries like Canada, Spain and Belgium inch their way towards having 100% of their population fully vaccinated, there are countries such as Nigeria, Syria and Haiti that have 1% or less of their population fully vaccinated, according to data from Reuters.

Twitter: @HackettMallory
Email the writer: mhackett@himss.org