On 1 December 2020, the CDC’s Advisory Committee on Immunization Practices (ACIP) COVID-19 vaccine priority recommendations were discussed. As I have written recently, Pfizer, Moderna, and AstraZeneca all have announced that their vaccines exhibited high effectiveness and safety during phase 3 clinical trials, while both the Pfizer and Moderna vaccines are seeking emergency use authorizations (EUA) from the US Food and Drug Administration (FDA), so these vaccines may become available within a few weeks.
This is a brief review of the ACIP and CDC COVID-19 vaccine priority lists for the first tranches of vaccines.
ACIP COVID-19 vaccine priority
As I reported previously, and similar to my thoughts on the matter, the ACIP COVID-19 vaccine recommended priorities for the first shipments of vaccines (Phase 1a, not to be confused with clinical trial phases) will be:
- healthcare personnel
- residents of long-term healthcare facilities (LTHF)
ACIP has defined healthcare workers as paid and unpaid individuals serving in healthcare settings who have the potential for direct or indirect exposure to COVID-19 patients or infectious materials. This could include physicians, nurses, auxiliary personnel, volunteers, and many others who interact with COVID-19 patients.
ACIP has defined long-term care residents as adults who reside in facilities that provide a variety of services, including medical and personal care.
ACIP has also decided that Phase 1a would not include children who live in LTHF locations.
As of November 6, 2020, LTCF residents and staff have accounted for nearly 6% of COVID-19 cases. Furthermore, they represent 40% of mortalities in the USA.
The vote was 13-1 in favor of the proposal, which has now gone to CDC Director Robert Redfield for final approval. The one vote against the proposal was from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tennessee.
Dr. Talbot voted against putting long-term care residents into the 1a phase and stated:
We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘We hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine.
She stated that neither of the COVID-19 mRNA vaccines was studied in seniors who were living in these long-term facilities. However, she stated she had no issue with healthcare workers being included in the Phase 1a.
As a reminder, neither the Pfizer nor Moderna COVID-19 vaccines have been approved at this time. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 10 December 2020 to review the EUA for the Pfizer/BioNTech mRNA vaccine. VRBPAC will review the safety and efficacy data for Moderna EUA on December 17. It is possible that the EUA will be approved for specific groups in line with the ACIP COVID-19 vaccine priority recommendations.