FDA takes additional actions on use of booster dose for COVID-19 vaccines

The US Food and Drug Administration (FDA) yesterday took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. In a statement, FDA said that the agency is amending the Emergency Use Authorisations (EUAs) for COVID-19 vaccines to allow for the use of a single booster dose as follows:

• The use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older, 18 through 64 years of age at high risk of severe COVID-19 and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
• The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
• The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
• To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

Speaking in this regard, Peter Marks, MD, PhD and Director, Center for Biologics Evaluation and Research, FDA, said, “The amendments to the Emergency Use Authorisations 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.”