FDA Authorizes Johnson & Johnson And Moderna Booster Shots

(RTTNews) - The U.S. Food and Drug Administration has granted emergency use authorization for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine.

Johnson & Johnson said its booster shot will be the same formulation and dosage as the primary shot.

The authorization follows a unanimous recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee based on data provided by the company, including efficacy, safety and immunogenicity data from its clinical trials and real-world evidence data.

The company noted that the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will provide a potential recommendation on October 21.

In a separate press release, Moderna Inc. (MRNA) said that the U.S. Food and Drug Administration as authorized for emergency use a booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.

Moderna stated that its booster dose will be administered at least six months after completion of the primary series.

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

The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet to discuss a potential recommendation for the use and rollout of COVID-19 boosters to Americans.

The FDA last month had authorized booster shots of the Pfizer-BioNTech vaccine for older people and high risk workers at least six months after the second dose.