Regulatory Focus™ > News Articles > 2020 > 12 > Updated: Redfield endorses ACIP's first-wave COVID-19 vaccine priorities

Updated: Redfield endorses ACIP's first-wave COVID-19 vaccine priorities

Posted 04 December 2020 | By Kari Oakes 

Updated: Redfield endorses ACIP's first-wave COVID-19 vaccine priorities

Meeting the week before an FDA advisory committee convenes to consider the first application for emergency use authorization of a COVID-19 vaccine, an advisory committee of the Centers for Disease Control and Prevention (CDC) voted 13-1 to allocate the first vaccine rounds to health care workers and residents of long-term care facilities.
“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over finally,” said CDC’s Nancy Messonier, MD, director of the National Center for Immunization and Respiratory Diseases, as she thanked the committee at the meeting’s close on the afternoon of 1 December.
In a 3 December press release, CDC director Robert Redfield, MD, announced his support for the recommendations.  Redfield signed the memo endorsing the committee’s recommendations, but added that he “looks forward to future recommendations that, based on vaccine availability, demonstrate that we as a Nation also prioritize the elderly (>70 yo) who reside in multi-generation households.”
Equity considerations were a factor in Redfield’s further proposal, which would put elderly people living in intergenerational households high up on the priority list for who should receive COVID-19 vaccines. “Often our Hispanic, Black and Tribal Nations families care for their elderly in multigenerational households and they are also at significant risk,” according to the press release. “This framework, in addition to the ACIP guidance, will ensure a more equitable distribution to those most at risk for hospitalizations and fatalities.”
The initial set of recommendations from ACIP will help guide any deployment of vaccines before the end of 2020, though final allocation decisions are left to individual states. Another set of recommendations for vaccine allocation has been developed by the National Academy of Sciences, Engineering and Medicine (NASEM) and endorsed by the American College of Physicians.
NASEM’s framework for equitable allocation of COVID-19 vaccines proposes vaccinating “high-risk” health workers and first responders, followed by individuals of all ages who have comorbidities that significantly elevate risk of poor outcomes with COVID-19, as well as older adults who live in congregate housing, or in “overcrowded settings.” These groups collectively make up those who would be vaccinated under NASEM’s Phase 1.
Phase 2 in the NASEM framework would see a specified list of individuals who are critical workers or teachers, along with non-elderly individuals living in congregate settings, people with moderately elevated risk from comorbidities, and older adults not included in phase 1.
For NASEM, “equity is a crosscutting consideration,” meaning that vaccine access in each specified group should go first to geographic areas identified by CDC’s Social Vulnerability Index, or another similar or more specific index.
The early phases of the proposed ACIP priority scheme were outlined in CDC’s Morbidity and Mortality Weekly Report on 3 December. In material presented at the 1 December meeting, ACIP saw the full proposed scheme from the committee’s COVID-19 vaccines working group.
This proposal would have essential workers vaccinated after healthcare workers and older adults in congregate living situations, followed by adults aged 65 and older and those with significant comorbidities. Equity considerations played into the decision to prioritize essential workers; several committee members pointed to the high representation of vulnerable populations among grocery store and agriculture workers and those in the transportation industry, for example. Vaccinating those workers also helps protect vulnerable households in communities at risk, said some on the committee.
The CDC committee also weighed, but did not vote on, considerations for which health care workers should be first in line to receive authorized vaccines in early days when supplies may be limited and supply chains tenuous. Here, those who have the ability to tele-work or who do not have ongoing direct patient contact should perhaps end up standing in line behind those most at risk, according to materials presented by CDC staff and presented to ACIP.
The lone dissenting vote on the committee came from Vanderbilt University’s Helen Keipp Talbot, MD, MPH. In remarks after the vote, she made clear that her “no” vote was driven solely by concerns about insufficient safety data and the possibility of fragmented followup for the medically fragile population who reside in skilled nursing facilities and other long-term care facilities. “I will also want to say out loud that I have no reservations for health care workers taking the vaccine,” said Talbot.
The vote from ACIP comes a little over a week before the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (FDA’s VRBPAC) will hear an application for emergency use authorization (EUA) for a COVID-19 vaccine developed by Pfizer and BioNTech. If that vaccine is authorized, ACIP plans to reconvene soon after the 10 December VRBPAC meeting to consider its recommendations for that specific vaccine. However, the committee’s recommendations regarding allocation will not shift according to individual vaccines at this point, ACIP chair Jose Romero, MD, made clear.
“You know, we all would like to know more, but there comes a time when we go through a process. We evaluate carefully every bit of information that we have access to, and then we need to act,” said the University of Washington’s Beth Bell, MD, in commentary that fell in line with the sentiments of many of her fellow committee members. Bell co-chairs the ACIP panel along with Romero, who is the chief medical officer for the Arkansas Department of Health.  
Presentations from CDC staff emphasized the critical importance of safety monitoring for all populations receiving vaccinations in the first wave, dubbed Phase 1a, especially those residing in long-term care facilities.
In contrast to the practice for vaccines approved under usual procedures, patients who receive vaccines via EUA will be given an EUA Fact Sheet particular to that vaccine, rather than a blanket Vaccine Information Statement (VIS). The EUA Fact Sheets will not be subject to a period of public commentary, since the details are ironed out as part of the fast-tracked EUA process.
The committee also heard detailed updates on plans for post-authorization safety monitoring of COVID-19 vaccines. Tom Shimabukuro, MD, of the CDC’s vaccine safety team, presented an array of data sources for active and passive surveillance that include large federal data warehouses as well as existing mechanisms such as the Vaccine Adverse Event Reporting System (VAERS) maintained jointly by CDC and FDA.
In early days, said Shimabukuro, VAERS and the new COVID-19-specific V-safe system will be used for safety surveillance. As time passes and data accrues in large databases and data warehouses, FDA and CDC will fold these new signal assessment capacities into their surveillance programs.
The CDC has made ACIP meeting materials available online for public viewing.

This article was updated on 4 December 2020 to add information about NASEM's vaccine priorities and to add Redfield's comments and links to ACIP's MMWR publication.


© 2021 Regulatory Affairs Professionals Society.

Tags: CDC, coronavirus, US

Regulatory Focus newsletters

All the biggest regulatory news and happenings.