The Food and Drug Administration (FDA) has amended the Emergency Use Authorizations (EUA) for the Moderna COVID-19 vaccine and the Janssen COVID-19 vaccine to include use of a booster dose.
The decision comes following the results of 2 FDA advisory committee meetings, where members of the panel unanimously voted to include boosters in the EUAs for the Moderna and Janssen COVID-19 vaccines. The Pfizer-BioNTech COVID-19 vaccine booster dose was previously authorized in September 2021 for certain groups.
For the Moderna COVID-19 vaccine, a single booster dose at the 50µg dose level (0.25mL) may be administered at least 6 months after completion of the primary series to individuals 65 years of age and older, as well as to people 18 to 64 years old at high risk of severe COVID-19 or to those with frequent institutional or occupational exposure to SARS-CoV-2.
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“This [EUA] is supported by robust clinical evidence that a 50µg booster dose induces a strong immune response against COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna.
Additional information about the booster dose can be found in the updated Moderna COVID-19 EUA fact sheet.
For the Janssen COVID-19 vaccine, a single booster dose may be administered at least 2 months after completion of the single-dose primary regimen in individuals 18 years of age and older. The Janssen COVID-19 vaccine booster dose level is the same as the one administered for the primary vaccination (0.5mL).
“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 2 months, to protect against symptomatic COVID-19,” said Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
The updated Janssen COVID-19 EUA fact sheet can be found here.
The Agency has also authorized the use of a heterologous (or “mix and match”) booster dose for all currently authorized and approved COVID-19 vaccines following the completion of primary vaccination. After a review of available data, the FDA found that the benefits of a single heterologous booster dose outweighed the known or potential risks.
Authorized boosters following primary vaccination*
| Primary vaccination | Booster dose |
|---|---|
| Janssen COVID-19 vaccine | At least 2 months after primary vaccination: |
| Janssen COVID-19 vaccine (0.5mL) | |
| Moderna COVID-19 vaccine (0.25mL) | |
| Pfizer-BioNTech COVID-19 vaccine (0.3mL) | |
| . | |
| Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine | At least 6 months after primary vaccination: |
| Moderna COVID-19 vaccine (0.25mL) | |
| Pfizer-BioNTech COVID-19 vaccine (0.3mL) | |
| Janssen COVID-19 vaccine (0.5mL) |
*Eligible populations and dosing interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for the primary vaccination.
“The amendments to the [EUAs] 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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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 health care community and public with our determination in the coming weeks.”
References
- FDA takes additional actions on the use of a booster dose for COVID-19 vaccines. News release. October 20, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines.
- Moderna announces FDA authorization of a booster dose of Moderna’s COVID-19 vaccine in the US. October 20, 2021. https://www.businesswire.com/news/home/20211020006110/en/Moderna-Announces-FDA-Authorization-of-a-Booster-Dose-of-Moderna%E2%80%99s-COVID-19-Vaccine-in-the-U.S.
- Johnson & Johnson COVID-19 vaccine booster shot authorized for emergency use by US FDA. October 20, 2021. https://www.jnj.com/johnson-johnson-covid-19-vaccine-booster-shot-authorized-for-emergency-use-by-u-s-fda.
This article originally appeared on MPR
