Washington, DC—Decisions on booster doses for the Moderna and Janssen (Johnson & Johnson) vaccines should be made shortly after the middle of the month.
The FDA announced that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on October 14 and 15 to discuss newly available data for the currently available COVID-19 vaccines.
Both the Moderna and Janssen vaccines are currently authorized for emergency use to prevent COVID-19 in persons aged 18 years and older. The FDA stated that the committee also will hear presentations and discuss the available data on the using a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster).
“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic. It’s critical that as many eligible individuals as possible get vaccinated as soon as possible. Once vaccinated, we want to ensure that individuals continue to be protected against the adverse effects of COVID-19. The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
On October 14, the committee will discuss an amendment to the emergency-use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose in individuals aged 18 years and older.
At the beginning of September, Moderna announced that it was submitting data to the FDA about a booster dose of its COVID-19 vaccine (mRNA-1273) at the 50-µg dose level, essentially a half-dose.
“Our submission is supported by data generated with the 50-µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant,” said Stéphane Bancel, chief executive officer of Moderna. “We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies.”
Moderna stated that its phase II study of mRNA-1273 was amended to offer a booster dose of mRNA-1273 at the 50-µg dose level to 344 participants 6 months following their second dose. The company said that neutralizing antibody titers had waned significantly prior to boosting at approximately 6 months but that the booster dose of mRNA-1273 at the 50-µg dose level “boosted neutralizing titers significantly above the Phase 3 benchmark.”
“After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults (ages 65 and above),” Moderna stated in a press release. “The safety profile following dose 3 was similar to that observed previously for dose 2 of mRNA-1273.”
In addition, analysis indicated that a “booster dose of mRNA-1273 at the 50 µg dose level induced robust antibody responses and significantly increased geometric mean titers (GMT) for all variants of concern including Beta (B.1.351) by 32-fold, Gamma (P.1) by 43.6-fold, and Delta (B.1.617.2) by 42.3-fold,” according to the press release.
On October 15, the VRBPAC will discuss amending the emergency-use authorization of the one-dose Johnson and Johnson’s Janssen COVID-19 vaccine for the administration of an additional booster dose in individuals aged 18 years and older.
Also on October 15, the committee will hear a presentation from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases on the heterologous use of booster doses following the primary series of the three currently authorized or approved COVID-19 vaccines.
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