The committee in charge of recommending vaccines for use in the United States voted Tuesday to give the first limited doses of a future approved COVID-19 vaccine to front-line health care personnel and residents of long-term care facilities.
The vote comes as the United States reports 13.6 million COVID-19 cases and 269,234 deaths — nearly one death a minute, Dr. Beth Bell, chair of the COVID-19 Vaccines Work Group for the Advisory Committee on Immunization Practices said at Tuesday’s emergency meeting.
“So in the time it takes us to have this ACIP meeting, 180 people will have died from COVID-19,” she said. “So we are acting none too soon.”
While it was a vote on the allocation process — not a specific vaccine recommendation — the “hope is that this vote gets us all one step closer to the day when we can all feel safe again, when this pandemic is over,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention.
The CDC expects one or more COVID-19 vaccines to be authorized by the FDA for emergency use in December, but with only 40 million doses (enough for 20 million people as both of the current candidates require two doses) prioritization and even sub-prioritization is crucial.
The group had concurred at previous meetings that health care personnel should be first in line, and on Tuesday, clarified that workers who have direct contact with patients and are unable to telework should be sub-prioritized, as well as those who handle infectious materials in both inpatient and outpatient settings. Residents in skilled nursing facilities will also be prioritized over those in assisted living or other community care settings.
While appreciative of the thoughtful recommendations, several committee members also asked for additional CDC guidance that provides clarity but also allows and encourages flexibility “because the health systems know their own people the best,” said Dr. Peter Szilagyi, a professor of pediatrics at UCLA and voting ACIP member.
Those health systems will have to determine how to distribute vaccine to staff quickly and efficiently, yet also space out vaccines in such a way that if workers experience fatigue, fever or other physical impacts following the vaccine, the entire unit isn’t calling in sick on the same day.
There’s also the fact that 75% of the health care workforce are women, meaning that there could be as many as 330,000 health care personnel who are pregnant or breastfeeding, said Dr. Sara Oliver, an epidemic intelligence service officer with the CDC.
While pregnant women with COVID-19 are at higher risk for severe illness and may be at risk for preterm birth, there are no data yet on the use of mRNA vaccines in pregnant or breastfeeding women. (Both of the leading vaccine candidates are mRNA vaccines.)
The group also recommended that if health care workers have had COVID-19 in the past 90 days, they not be considered at the very top of the list, as “reinfection appears uncommon” within the next three months.
Outside of the hospital setting, outpatient providers, private providers and community clinics form the “backbone of the health care system,” said Dr. Jason Goldman, a liaison from the American College of Physicians, and as such, he asked that they be prioritized just as much as large hospitals or health care systems.
Even where sub-prioritization is needed, it’s likely to play out over weeks, not months, as most of the jurisdictions across the country have told the CDC they can vaccinate all of their health care workers within three weeks, said Messonnier.
Several national pharmacy chains will also play a major role in vaccinating long-term care facility residents and staff.
In Utah, health care personnel and long-term care facility staff and residents were already a “top priority,” said Rich Lakin, immunization program manager for the Utah Department of Health. He said he’ll be reviewing all forthcoming information from CDC to determine the best order for subsequent priority groups.
Once someone is vaccinated, there will be multiple safety checks to monitor for vaccine safety and long-term effects. The main system is VAERS, which since 1990 has been the nation’s “early warning system” for vaccine safety, explained Dr. Tom Shimabukuro with the CDC’s COVID-19 Vaccine Task Force Vaccine Safety Team.
The CDC has also rolled out a new text-message program specifically for COVID-19 vaccines: V-SAFE, which connects vaccine recipients directly to the CDC via daily texts for the first week post vaccination, plus weekly thereafter for 6 weeks.
Despite some public hesitancy surrounding vaccines, Messonnier emphasized that the FDA will not authorize a vaccine, nor will the advisory committee recommend a vaccine, unless the phase III clinical trials show that the vaccine is safe. Phase III data is expected soon.
“But we all also know that the vaccine safety doesn’t stop there,” said Messonnier. “We do need to ask, especially in this initial phase, for everybody in the community to be rowing together.”
That means medical providers quickly reporting any concerns to the CDC, and individuals choosing to enroll in V-SAFE and report any negative reactions, even if they’re not sure they were the result of the vaccine.