Recently, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. The authorization allows the use of a single booster shot for certain populations, provided the booster is administered at least six months after the completion of an individual’s first two doses of the Pfizer-BioNTech COVID-19 vaccine.

This authorization comes after the FDA’s advisory committee of independent experts unanimously recommended that the FDA allow a booster dose of Pfizer-BioNTech vaccine for vulnerable populations. This authorization is a scaled-back version of the Biden administration’s objective to allow all American adults to receive a booster shot.

According to the FDA, this authorization applies to:

• Individuals 65 years of age or older;
• Individuals aged 18-64 who have a high risk of getting a severe COVID-19 infection; or
• Individuals aged 18-64 whose frequent institutional or occupational exposure to COVID-19 puts them at high risk of serious complications (these populations include health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others).

To support the authorization for emergency use of a single booster dose, the FDA analyzed safety and immune response data from a subset of participants from the original clinical trial of the Pfizer-BioNTech vaccine.

What’s Next?

This authorization is expected to be followed by a vote from a Centers for Disease Control and Prevention (CDC) panel of experts, who will issue a recommendation on who should receive vaccine doses. Generally, the CDC follows the guidance of the panel. Likely, booster doses for eligible individuals will be available in the coming days.

Notably, this authorization for a booster shot only applies to the Pfizer-BioNTech COVID-19 vaccine. Individuals that have received a Modera or Johnson & Johnson vaccine are not approved for a booster shot under this authorization. However, the FDA is expected to review booster shots for recipients of these vaccines. However, some immunocompromised Moderna vaccine recipients may be eligible to receive a third vaccine dose due to a previous authorization from the FDA.

Individuals should continue to monitor the FDA for updates. To learn more about booster eligibility and vaccines in general, contact your health care provider.

The content of this News Brief is of general interest and is not intended to apply to specific circumstances. It should not be regarded as legal advice and not be relied upon as such. In relation to any particular problem which they may have, readers are advised to seek specific advice. © 2021 Zywave, Inc. All rights reserved.