FDA Authorizes Moderna, J&J Booster COVID-19 Vaccine Dose

FDA recently granted emergency use authorization to both the Moderna and Johnson & Johnson respective COVID-19 vaccine booster doses. 

The agency specifically approved Moderna’s booster dose at the 50 microgram dose level for individuals 65 years of age and older and individuals aged 18 to 64 who are at high risk of severe COVID-19 or who have frequent exposure to SARS-CoV-2.

FDA also authorized a single booster dose of the vaccine for individuals who have completed a primary vaccination with other authorized or approved COVID-19 vaccines.

Providers should administer the booster dose at least six months after completing the primary series for both doses. 

“This emergency use authorization is supported by robust clinical evidence that a 50 µg booster dose induces a strong immune response against COVID-19. We thank the FDA for their review and for this EUA including for those people who have completed a primary vaccination with a different COVID-19 vaccine,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

FDA based its decision on a totality of scientific data. For example, a Phase 2 clinical study found that the vaccine neutralized antibody titers significantly above the Phase 3 benchmark. The safety profile for the vaccine was also positive. 

At the same time, FDA also authorized Johnson & Johnson’s COVID-19 vaccine booster dose for adults aged 18 years and older at least two months following primary vaccination.

The booster dose is the same formulation and dosage as the primary vaccination. 

“We welcome the FDA’s decision to authorize emergency use of our COVID-19 vaccine as a booster,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer of Johnson & Johnson, said in the announcement. 

“Our data support a schedule that provides benefit to individuals based on their risks associated with COVID-19, whether administered as a single dose for an efficient response to the pandemic, or as a booster dose after at least two months – to protect against symptomatic COVID-19,” Stoffels continued. 

FDA based its decision on efficacy, safety, and immunogenicity data from Johnson & Johnson’s clinical trials and real-world evidence data. In the trials, a booster dose of the vaccine protected against the virus and was generally well-tolerated across all age groups. 

Additionally, providers may also administer a single booster dose of the vaccine as a heterologous booster after completing the primary vaccination with another authorized or approved COVID-19 vaccine. 

The CDC Advisory Committee of Immunization Practices will meet to discuss a potential recommendation to roll out all COVID-19 booster doses to Americans.