乌鸦传媒

The CDC's Advisory Committee on Immunization Practices (ACIP) cleared the way for healthcare personnel (HCPs) and nursing home residents to receive a COVID-19 vaccine first, once one is authorized, the committee said on Tuesday.

ACIP voted 13-1 for an interim recommendation for COVID-19 vaccination for HCPs and long-term care facility residents once a vaccine is authorized by FDA and recommended by ACIP. There was no preferential recommendation given to one group over the other.

"I believe my vote reflects maximum benefit, minimum harm, promoting justice and mitigating inequalities," said ACIP chair, José Romero, MD, who voted yes.

Committee member Peter Szilagyi, MD, of the University of California Los Angeles, quoted Mahatma Gandhi in his endorsement, saying, "a nation's greatness is how it treats its weakest members."

Other committee members expressed reservations about including long-term care facility residents, but ultimately voted yes. The one dissent was Helen Keipp Talbot, MD, of Vanderbilt University in Nashville. She reiterated her concerns about lack of data, as well as potentially lower immunogenicity, among long-term care facility residents, but expressed how she has "no reservations" about HCPs receiving the vaccine.

"I still struggle with this, this is not an easy vote," Talbot said.

With 40 million vaccine doses expected at the rate of 5-10 million doses per week, sub-prioritization, or who gets the vaccine first for the first couple weeks, took on new importance. For HCPs, those with direct patient contact unable to telework, and those who handle infectious materials in inpatient or outpatient settings should get the vaccine first, CDC researchers said.

However, both committee members and liaison members urged that vaccination should not be limited to hospitals, advocating for outpatient providers, small community clinics and primary care physicians in small practices.

"Transmission dynamics of COVID-19 also suggest those providers who care for patients earlier in their course of illness may be at higher risk, and that would include outpatient healthcare providers," said liaison member Jeff Duchin, MD, representing the Infectious Diseases Society of America (IDSA).

For long-term care facility residents, CDC researchers noted skilled nursing facility residents are the most "medically vulnerable," ahead of assisted living facilities. In addition, consent or assent to vaccination would be obtained from residents or patients' families/medical proxies and documented in the patients' charts.

Reactogenicity to the vaccine was another issue, with CDC researchers noting that within the limited available data, systemic symptoms were more common after the second dose. They suggested staggering vaccinations for HCPs in similar units or positions, in case they have reactions to the vaccine.

CDC noted they will have additional post-vaccination guidance available for HCPs about systemic symptoms after vaccination. Moreover, federal pharmacy partners that support the long-term care facility vaccination program must provide fact sheets to vaccine recipients.

Safety will also be rigorously monitored in phase 1a, with Tom Shimabukuro, MD, of the CDC, encouraging public health and HCPs to participate in , CDC's new smartphone-based health checker for people who receive COVID-19 vaccines, and to promote reporting of any clinically significant adverse events to the (VAERS).

Nancy Messonnier, MD, director of CDC's National Center for Immunization and Respiratory Diseases, emphasized how neither CDC nor FDA will recommend a vaccine unless they are convinced the vaccine is safe, and will hold themselves to an "extremely high standard" for safety following authorization.

"We're enhancing our existing vaccine safety system to meet this challenge," she said, adding that in the initial phase, reporting safety data "may mean extra work for some groups."

While this meeting addressed COVID-19 vaccines in general, the committee will next meet shortly after the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Dec. 10 to discuss data and recommend products.

Pfizer and BioNTech applied for FDA emergency use authorization for their mRNA vaccine candidate, and VRBPAC is slated to discuss that application on Dec. 10.

In her presentation, committee member Beth Bell, MD, of the University of Washington, set the tone about the importance of vaccination in fighting the pandemic in the U.S.:

"We are averaging one COVID death per minute. In the time it takes us to have this ACIP meeting, 180 people will have died from COVID-19," she said.

Comment