On April 18, 2023, the United States Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) updated the COVID-19 vaccine regulations. Attached is a fact sheet and vaccine eligibility guide.
Key takeaways are as follows:
- CDC’s new recommendations allow an additional updated (bivalent) vaccine dose for adults ages 65 years and older and additional doses for people who are immunocompromised. This allows more flexibility for healthcare providers to administer additional doses to immunocompromised patients as needed.
- Monovalent (original) mRNA COVID-19 vaccines will no longer be recommended for use in the United States.
- CDC recommends that everyone ages 6 years and older receive an updated (bivalent) mRNA COVID-19 vaccine, regardless of whether they previously completed their (monovalent) primary series.
- Individuals ages 6 years and older who have already received an updated mRNA vaccine do not need to take any action unless they are 65 years or older or immunocompromised.
- For young children, multiple doses continue to be recommended and will vary by age, vaccine, and which vaccines were previously received.
On April 14, 2023, HHS released a fact sheet about the upcoming amendment to the COVID-19 PREP Act declaration, which will be the 11th amendment to the declaration.
Key changes include:
- Extending coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests. PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines (to those individuals three and over, consistent with other requirements), and COVID-19 tests, regardless of any USG agreement or emergency declaration.
- Extending coverage through December 2024 for Federal agreements. This includes all activities related to the provision of COVID-19 countermeasures that are 1) provided based on a Federal agreement (including the vaccines and treatments purchased and provided by the USG), or 2) directly conducted by the USG, including by Federal employees, contractors or volunteers.
- Ending of coverage for certain activities. Once products are no longer distributed under a USG agreement, PREP Act coverage will no longer extend to the following activities:
- COVID-19 vaccination by non-traditional providers (e.g., recently retired providers and students); and
- COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.
- Ending of coverage for routine childhood vaccinations. Once there is no emergency in effect, PREP Act coverage will no longer extend to all routine childhood vaccinations by pharmacists, pharmacy interns, and pharmacy technicians.