- If COVID-19 vaccines are approved by the FDA, limited doses will be available initially.
- The Advisory Committee for Immunization Practices (ACIP) voted that healthcare workers and residents of long-term care facilities like nursing homes should be given the COVID-19 vaccine first.
- The vaccine may be approved and released as early as next week.
Healthcare workers and residents of long-term care facilities should be first in line for any COVID-19 vaccines that get emergency approval, recommended an independent vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) on Tuesday.
The Advisory Committee for Immunization Practices (ACIP) voted to include both groups in phase 1a of the CDC’s COVID-19 vaccine distribution plan because they are at high risk.
“Healthcare personnel have high exposure to COVID-19, and need to be available to meet the increasing health needs of all Americans,” said committee member Dr. Katherine A. Poehling, a pediatrician at Wake Forest Baptist Health.
More than 244,000 healthcare workers have developed COVID-19 and 864 have died, reports the CDC. Although according to some reports, this number may be vastly undercounted.
The nurses union National Nurses United estimates that over 1,700 healthcare workers have died during the pandemic.
“As to the long-term care facility residents, they have high risk,” added Poehling, pointing out that they represent 1 percent of the U.S. population, but account for 6 percent of coronavirus cases and 40 percent of COVID-19-related deaths.
ACIP group members also felt that it makes sense logistically to vaccinate staff and residents of long-term care facilities at the same time.
The recommendations from the committee now go to CDC Director Robert Redfield for final approval.
Prioritization is needed because vaccines are expected to be in limited supply early on.
“Healthcare personnel and long-term care residents should be at the front of the line,” said Angela K. Shen, ScD, MPH, a visiting research scientist at the Vaccine Education Center at Children’s Hospital of Philadelphia, who was not part of the advisory group.
“However, there will not be enough doses,” she added. “So tough decisions at healthcare institutions on sub-prioritization will have to be made for a limited period of time until doses catch up to demand.”
Hospitals will likely have limited doses in the beginning, so they may choose to only vaccinate staff who have direct contact with patients with COVID-19.
Two groups — Pfizer-BioNTech and Moderna — have submitted applications for emergency use authorization to the Food and Drug Administration (FDA).
The CDC advisory committee expects that if both applications are approved, there could be about 40 million doses of vaccine available by the end of December.
Both vaccines require two doses for full protection, so this would be enough to vaccinate about 20 million people.
Going forward, the committee anticipates that an additional 5 to 10 million doses would be available each week as vaccine makers ramp up manufacturing.
The ACIP’s vote was nearly unanimous: 13-1 in favor.
The one vote against the recommendation came from Dr. Helen Keipp Talbot, an infectious disease physician at Vanderbilt University Medical Center.
She stressed that she had no reservations about healthcare workers taking an approved COVID-19 vaccine, but wanted to see more data on the safety and efficacy of the vaccines for older adults in long-term care facilities.
The phase 3 clinical trials for these vaccines included older adults, but not long-term care residents, who tend to be frailer with multiple chronic health problems.
Older adults are often
“Skilled nursing facilities are a population that needs lots of vaccines, not just COVID,” said Talbot. “We really need to start finding ways of developing and testing these vaccines to prolong the quality of life for our long-term care facility residents.”
Committee member Dr. Robert L. Atmar, an infectious disease physician at Baylor College of Medicine, shared some of Talbot’s concerns.
However, “Ultimately I was persuaded by the tremendous burden,” he said, “in terms of [COVID-19] mortality and hospitalization that the residents of these facilities bear.”
He was also moved by the high efficacy of the vaccines based on preliminary data, and plans for ongoing monitoring of vaccine safety in long-term care facilities.
Early data for the Pfizer-BioNTech and Moderna vaccines suggest they are safe and have high efficacy. Both vaccines protected over 90 percent of people from symptomatic coronavirus infection.
The committee will meet again after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets on Dec. 10 to review Pfizer’s application for emergency use authorization of its vaccine.
At that point, the ACIP will review data from the phase 3 trials and vote on whether any FDA-authorized vaccine should be given to people in the United States.
Tuesday’s meeting focused only on the highest priority groups for vaccine distribution. The committee will vote later on which high-priority groups should receive the vaccine next as more doses become available.
It will likely include police, firefighters, food and agriculture workers, and other essential workers.
“That is, vaccinating people who are important to maximizing benefit to society and keeping society running,” said Shen. “It’s analogous to putting on the oxygen mask first and then helping others.”
Other adults over age 65 and adults with high-risk medical conditions will likely be next in line for the vaccine.
Shen says the committee will discuss whether to recommend the use of the COVID-19 vaccine in older children when data from the phase 3 trials for this population is available.
Pfizer-BioNTech’s started enrolling 16- and 17-year-olds in its trial in October, and later received approval to enroll children as young as 12. No study currently includes children younger than that.
It will take many months for the country to reach community immunity, or herd immunity, for the coronavirus. At this point, enough people have been vaccinated in order to keep the virus from easily spreading.
Scientists estimate that
Adm. Brett Giroir, the White House’s coronavirus testing czar, told CNBC on Sunday that lower risk people will not receive the COVID-19 vaccine until the “second quarter, third quarter of 2021.”
So, public health measures will be needed until then — and likely longer — to slow the spread of the virus and protect those most at risk.
”People should remember that wearing masks and social distancing are still critical,” said Shen. “We do not know the duration protection of these vaccines, and we have yet to vaccinate a critical proportion of the population.”