FDA Amends EUA to Allow Booster Shots for Moderna, J&J COVID-19 Vaccines
In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.
FDA announced on Oct. 20, 2021, that it had amended its Emergency Use Authorization (EUA) for various COVID-19 vaccines. The Moderna and Johnson & Johnson (J&J) vaccines can both be administered as booster doses under certain conditions. Additionally, the amendment allows for heterologous booster shots, which use boosters of vaccines different from what the recipient received for their base vaccination.
Similar to Pfizer’s vaccine, which received limited booster approval last month, a booster of Moderna’s COVID-9 vaccine is authorized for the following populations six months after their original vaccination:
- Individuals aged 65 and older
- Individuals aged 18 through 64 at high risk of severe COVID-19
- Individuals aged 18 through 64 with frequent institutional or occupational exposure to SARS-CoV-2.
J&J’s product, a single-shot vaccine, received more broad usage. Any individuals aged 18 or older can receive a booster dose of this vaccine two months after their first shot.
FDA also chose to allow for heterologous booster shots following a presentation of clinical trial data from the National Institute of Allergy and Infectious Diseases, the Vaccines and Related Biological Products Advisory Committee’s discussion of information submitted for consideration, and the agency’s own evaluation of available data. Eligibility requirements are the same as those authorized for the individual’s primary vaccination.
“The amendments to the [E]mergency [U]se [A]uthorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in an agency press release. “We are also taking action today to include the use of mix and match boosters to address this public health need. We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”
Source: FDA
