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Expert: With New COVID-19 Vaccine Approvals, Pharmacists Should Remain Vigilant

Allison Hill, PharmD, RPh, emphasized that pharmacists must stay updated on ACIP and state-level guidance following HHS’s changes to COVID-19 vaccine authorizations.

In an interview with Pharmacy Times®, Allison Hill, PharmD, RPh, director of professional affairs at the American Pharmacists Association, discussed how the Department of Health and Human Services' (HHS) decision to end emergency use authorizations for COVID-19 vaccines places greater reliance on FDA approvals but still requires pharmacists to look to the Advisory Committee on Immunization Practices (ACIP) and CDC recommendations for authority. Hill stressed the importance of pharmacists checking state regulations to remain compliant, ensuring vaccine access for patients, and navigating coverage issues effectively.

The conversation centered on the recent news that the FDA was approving 3 COVID-19 vaccines updated to target the LP.8.1 strain of SARS-CoV-2. The vaccines were approved with age restrictions, contrary to the indications allowed for under their emergency use authorizations. The FDA also revoked the emergency use authorizations for the 3 vaccines. You can read coverage here.

Pharmacy Times: What are your thoughts on the recent announcement from HHS ending emergency use authorizations for COVID-19 vaccines? How will this impact pharmacists?

Key Takeaways

  1. Pharmacists must follow ACIP and CDC recommendations for vaccine authority, as only a few states rely solely on FDA approvals.
  2. Ensuring patient access and coverage for vaccines remains a critical responsibility for pharmacists.
  3. Hill expressed concern over the absence of ACIP recommendations for pregnant women, emphasizing the need to protect this population while staying alert to evolving federal guidance.

Allison Hill, PharmD, RPh: Well, today is August 27, and I don’t want anything to be misconstrued, because what we’ve learned in the past few months is that vaccine information changes quite frequently. Today, the HHS Secretary announced that COVID-19 vaccine approvals are now strictly under the FDA.

Unfortunately—or fortunately—we could be in a better space, but we still need to wait and see what ACIP says about these recommendations. As pharmacists, we know our vaccine authority really relies on ACIP and CDC recommendations. Only a couple of states follow FDA approvals alone.

So, I suggest pharmacists check with their state regulatory bodies and make sure they are up to date on what their vaccine authority includes. That way, they know exactly what to follow. Ultimately, we need to continue encouraging patient health, ensuring those who need vaccines are able to access them. If there are issues with coverage, we must know the steps to take to make sure vaccines are covered for our patients.

Pharmacy Times: Do you expect further announcements from HHS that will stand to impact pharmacists?

Hill: I think we already received a couple of blows earlier this year. For example, ACIP announced there is no recommendation for pregnant women. It’s hard to think that we don’t need to protect pregnant women. APHA’s position—and I’m sure ACOG’s as well—is that pregnant women, pediatrics, and women who have recently given birth should be protected.

So, while we follow federal agency announcements, we also need to make sure we’re following the science. I do expect things may continue to change, but we don’t know what will happen, given how often guidance has shifted.

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