Advisory Committee on Immunization Practices October 2020 Meeting and COVID-19 Vaccines
Stefanie Cole, BSN, RN, MPH, Immunization Nurse Educator
The Advisory Committee on Immunization Practices (ACIP) met on October 28-30 to discuss numerous vaccines and immunization recommendations and to vote on the 2021 immunization schedules. ACIP voted in favor to approve the proposed changes to both the childhood/adolescent and adult immunization schedules. The new schedules usually get released in February each year. The immunization schedules can be found at www.cdc.gov/vaccines/schedules/index.html.
In addition to the votes, the ACIP heard presentations on numerous other vaccines, including influenza, pneumococcal, zoster, smallpox and monkeypox, rabies, and COVID-19. The last day of the ACIP meeting was dedicated to discussing COVID-19 topics such as vaccine development and regulation, implementation, safety, allocation and epidemiology, and summarizing the ACIP COVID-19 work group’s interpretation of data and current policy questions.
As of October 30, 2020, there were over 200 COVID-19 vaccines currently under development globally. In the United States, four COVID-19 vaccines are in active phase III clinical trials, and five are in active phase I/II clinical trials. The update on the four COVID-19 vaccines in phase III clinical trials in the U.S. was as follows: AstraZeneca and Janssen both resumed Phase III trials in late October (both were previously paused/on hold, for more information about this visit www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html), Pfizer/BioNTech had over 42,000 participants enrolled in their phase III trial as of late October and more than 35,000 had received their second vaccination, and Moderna’s trial enrollment was complete with more than 30,000 participants enrolled and more than 25,000 who had received their second vaccination.
Most of the U.S. COVID-19 vaccines in human clinical trials are 2-dose vaccines, most of which have an interval of either 21 or 28 days, dependent on the product. The U.S. vaccines currently undergoing human trials are being tested in the adult population, beginning at age 18 years. The Food and Drug Administration (FDA) gave a presentation summarizing their recent Vaccines and Related Biologics Products Advisory Committee (VRBPAC) Meeting. This committee reviews and evaluates data concerning safety, effectiveness, and appropriate use of vaccines and related biological products and recently met to discuss the development, authorization, and/or licensure of COVID-19 vaccines.
When COVID-19 vaccine is first released, it is anticipated there will be limited doses available. Because of the constrained supply, vaccine administration will be highly targeted to achieve coverage in the populations that ACIP deems highest priority (e.g., healthcare personnel). There are several post-authorization/post-licensure safety surveillance systems in place to continue to monitor vaccine safety data once COVID-19 vaccines are being administered outside of clinical trials to the general population. COVID-19 vaccine effectiveness surveillance and studies are already being planned.
As of the October ACIP meeting, ACIP has not yet voted on any COVID-19 vaccine or allocation recommendations. The committee will do so once a COVID-19 vaccine has been approved by the FDA. The two policy questions for ACIP will be 1.) Should the approved COVID-19 vaccine be recommended for adults in the U.S., and 2.) Who should be recommended to receive COVID-19 vaccine during phase 1 of the vaccine roll out (i.e., which group(s) should receive early allocation of vaccine while there is constrained supply in the early stages of vaccine manufacture and distribution)?
Meeting information and materials for the ACIP meetings can be found at www.cdc.gov/vaccines/acip/meetings/index.html.