Enlarge /. Vials with COVID-19 vaccine labels with logos of the pharmaceutical company Pfizer and the German biotechnology company d BioNTech.
View more stories
The very first doses of an approved COVID-19 vaccine should go to both frontline health workers and residents of long-term care facilities, a committee of expert advisors from the Centers for Disease Control and Prevention recommended in an emergency meeting Tuesday evening.
The committee's recommendation will now be presented to CDC director Robert Redfield for approval before it becomes official federal guideline. And ultimately, states will make their own final decisions on how to distribute the first coveted shipments of vaccine bottles.
Still, the committee – the Advisory Committee on Immunization Practices (ACIP) – has made such recommendations for vaccination policy for decades, and states are likely to be eager to set their guidelines as they attempt to finalize their plans. States only have until next Friday, December 4th to place their first vaccine orders with the federal government. The orders determine which facilities in each state receive vaccine shipments and how much vaccine each facility receives from their state's limited allotment.
The hasty planning assumes that the Food and Drug Administration is only a few days away from issuing an emergency permit for the front-runner COVID-19 vaccine, developed by pharmaceutical giant Pfizer and German biotech company BioNTech. The FDA is currently reviewing the companies' EEA application and will hold an advisory committee meeting to review the application on December 10th. If the application is approved, deliveries of vaccine doses could be in the States as early as December 11th or 12th. Moderna has also requested an EEA for its COVID-19 vaccine, which will be reviewed in a meeting on December 17th. The federal government is assuming that by the end of December enough vaccine doses will be available to vaccinate around 20 million people with five to ten vaccines. Million doses are distributed weekly.
In a press conference last week, top officials from Operation Warp Speed - the federal government's program to rapidly develop and deliver COVID-19 vaccines and therapies – said the first 6.4 million doses of COVID-19 vaccine per Year to be distributed to states head-based – to keep this simple. The decision was a reverse of Warp Speed, which had previously suggested assigning the vaccine based on each state's risk group – per ACIP recommendations. Officials on the program had also previously announced that they would wait for final guidelines from ACIP before deciding how to distribute vaccines.
ACIP planned to finalize its guidelines only after the FDA approved a vaccine. With Warp Speed's abrupt distribution decision last week, the committee convened an emergency meeting on Tuesday to finalize its recommendation and aid states.
In a 13-to-1 vote after a nearly four-hour session, the committee finalized its recommendation for the earliest phase of vaccine distribution, known as Phase 1a. The final wording of the recommendation is as follows:
If a COVID-19 vaccine is approved by the FDA and recommended by ACIP, vaccination should be offered to both 1) healthcare workers and 2) long-term care residents in the initial stages of the COVID-19 vaccination program (Stage 1a).
The committee defined healthcare workers as paid or unpaid individuals who work in the healthcare sector and who have the potential to be directly or indirectly exposed to patients or infectious materials. Long-term care facility residents have been defined as adults living in facilities that provide a variety of services, including medical and personal care, to people who are unable to live independently. The definition is primarily intended to include qualified nursing homes, but also assisted living facilities, nursing homes and other residential facilities that offer medical care.
The committee found that an estimated 21 million frontline health workers and approximately 3 million long-term care facility residents will be included in the Phase 1a distribution. The total number of people insured is just above the estimated 20 million vaccine doses expected to be available this month.
Due to the limited early access to vaccines, the committee went a step further and recommended prioritizing subgroups. For health workers, priority should be given to those who have direct contact with patients who work in long-term care facilities and who have not been infected with the pandemic coronavirus in the past 90 days (re-infection appears uncommon within 90 days, the committee argued .)
For residents of long-term care facilities, priority should be given to those in qualified care facilities who usually look after the residents who are most medically at risk. After these facilities are provided with vaccines, state officials can extend the distribution to other types of facilities, including assisted living facilities and veterans' homes.
The decision to have health workers on the front lines for vaccines was an easy one. Frontline workers are putting their own health and lives at risk to care for patients amid the devastating pandemic. In addition, their health and ability to work are critical to saving the lives of others. As of November 30, at least 243,000 health care workers were infected with the novel coronavirus and 858 had died, the committee said.
A more difficult decision was to prioritize residents of long-term care facilities alongside health workers. Overall, the committee was shaped by the overwhelming impact of the pandemic on the residents of these facilities. Residents and employees account for 6 percent of all US cases and a staggering 40 percent of all US deaths. Of those 85 years and older who were hospitalized with COVID-19, nearly 66 percent were from long-term care facilities.
However, the data were not enough to influence the entire committee. The only member of the committee who voted against the phase 1a recommendation did so out of concern about the involvement of residents of long-term care facilities. Helen Talbot, an infectious disease expert at Vanderbilt University, feared that the COVID-19 vaccines developed so far had not been adequately tested in people specifically living in these facilities.
Although her committee colleagues pointed to data showing that older adults tended to have milder vaccine side effects than younger age groups, Talbot was not convinced. In addition, she noted that weaker side effects could also indicate weaker immunity, raising the question of whether vaccinating these residents would maximize public health benefits. (Early vaccine data suggest high effectiveness in older age groups). The lack of certainty that the vaccine will work and be safe in this group "affects me on many levels," Talbot said. Instead, she advocated vaccinating only long-term care workers.
Nonetheless, the other 13 members of the committee were unaffected by their concerns and found that the disease had a huge impact on the residents of the facilities.
Tuesday's recommendation maximizes benefits, minimizes harm, promotes equity and reduces health inequalities, the committee chairman José Romero stressed in the final statements after the vote.
After completing phase 1a, the committee proposed vaccinating key workers in phase 1b, and people over 65 years of age and people with high-risk diseases in phase 1c.