Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.
A federal advisory panel recommends that healthcare workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the US Food and Drug Administration (FDA).
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.
The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.
“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,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.
Healthcare workers are defined as paid and unpaid individuals serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.
“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panellist Grace Lee, MD, MPH, professor of paediatrics at Stanford University School of Medicine in California. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff, she said.
“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University School of Medicine in Missouri. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities,” she said.
CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.
But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tennessee, voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults,” she said. “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 said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.
She added, “I have no reservations for health care workers taking this vaccine.”
Prioritization Could Change
The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff November 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.
“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.
He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.
A second vaccine, made by Moderna, is not far behind. The company reported on November 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on December 17.
“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine in Houston, Texas.
ACIP will meet again after the December 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
Staggered Immunization Subprioritization Urged
The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that healthcare organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among healthcare workers.
“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post-vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.
The CDC will soon be issuing guidance on how to handle systemic symptoms with healthcare workers, Oliver noted.
Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 to 10 million a week coming online after that, Cohn said. That means not all healthcare workers will be vaccinated immediately. That may require “sub-prioritization, but for a limited period of time,” she said.
Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their healthcare workers within 3 weeks — some in less time.
The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that healthcare workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.
ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.