President Perspectives (September 2025)

Dear Colleagues,

If you are anything like me, you may be asking yourself what the current approval status for COVID-19 vaccines really means for our patients, pharmacies, and healthcare teams. These are questions we all share, and we want to be sure you feel supported as the landscape evolves. With that in mind, we would like to share what is currently known about providing updated COVID-19 vaccinations in post-acute and long-term care and give you an update on what PALTmed is working on to support you during respiratory virus season.

The typical vaccine recommendation process

• Manufacturers submit a biologics license application to FDA for a specific vaccine, including all data on age groups or people with specific conditions that could receive the vaccine.
• The FDA reviews the data for safety and efficacy and can approve the vaccine for all ages or conditions they believe meet the thresholds.
• Next, the ACIP examines safety, efficacy, epidemiology, risk of illness, and cost benefit to recommend which populations should routinely receive the vaccine or should receive it after shared clinical decision making with their provider.
• Payment may be tied to either FDA licensure, ACIP recommendations, or other groups’ recommendations based on payer policies.
• The ability for pharmacies to administer vaccines also depends on ACIP recommendations in some states. Without an ACIP recommendation, individuals may need prescriptions from their providers to access vaccines at the pharmacy.
• For influenza and COVID-19 vaccines, this process usually takes place in July and August.

What We Know Now

FDA licensure

• On August 27, 2025, the FDA approved the license of 3 COVID-19 vaccines (Moderna’s mRNA vaccine for those 6 months and older, Pfizer-BioNTech’s mRNA vaccine for those ages 5 and older, and the Novavax vaccine for those ages 12 and older).
• However, the FDA has restricted use of these vaccines to those 65 years or older and children or younger adults who have a high risk condition. 

ACIP recommendations

• The ACIP is expected to meet to discuss this season’s recommendations for the COVID-19 vaccine on September 18 and 19.
• It is anticipated that ACIP will continue to recommend that those ages 65 and older receive a vaccine.
• ACIP has not issued healthcare worker specific recommendations for past COVID seasons and is not anticipated to do so this time. Based on the FDA licensing, this would mean that staff who have a high-risk condition could access the vaccine while healthy staff could not. 

CMS payment

• COVID-19 vaccine is covered under Part B for Medicare and will continue to be paid for those on Medicare. 

What We Are Watching and Doing

• The ACIP meeting on September 18-19 should set forth the recommendations for the upcoming respiratory virus season with COVID-19 vaccination. This will allow pharmacies, including consultant pharmacies serving post-acute and long-term care facilities, in some states to administer vaccination.
• In places that tie pharmacy administration to ACIP recommendations, a physician’s order may be necessary until those recommendations are published.
• In addition to ACIP recommendations, this year, the American College of Physicians is making recommendations for healthy adults and the Infectious Disease Society of America is making recommendations for  immunocompromised adults.  These should be released in the coming weeks.
• PALTmed is working on an evidence review and recommendations specific to 2025/2026 COVID-19, influenza, and RSV vaccines in the post-acute and long-term care population.
• PALTmed is also working with several other medical associations and partners to discuss how best to ensure scientific and evidence-based vaccine recommendations are used moving forward, including considerations to provide COVID-19 vaccination as an option for health-care workers.

What You Can Do Now

• Plan your COVID-19 vaccine clinic to vaccinate your residents who are over 65 and/or high risk
• Ask if your vaccine clinic can also offer a COVID-19 vaccine to any staff who are over 65 or high risk
• Consider giving both the COVID-19 vaccine and flu vaccine to patients and staff on the same day (it is just as effective and saves time and energy)
• Several States have issued orders, including Washington and Colorado that people in their states can receive the updated COVID vaccines from pharmacies and medical clinics without a prescriptions. If your state does not have such an order in place yet, advocate with your Health Department to:
  • Issue an order to have pharmacies and medical clinics administer the updated COVID -19 vaccine without a prescription
  • Consider providing COVID-19 vaccination as an option for health-care workers
• Use the Moving Needles Implementation Guide to identify actions that support efficient and effective vaccination practices this season.

Should you have any questions, please contact movingneedles@paltmed.org.