The Pfizer/BioNTech COVID-19 vaccine should be offered to adults ages 16 and older under the FDA’s emergency use authorization (EUA), said the CDC Advisory Committee on Immunization Practices (ACIP) in an emergency meeting on Saturday.
In a 11-0-3 vote (with three members recusing themselves due to conflicts of interest), the committee voted for this interim recommendation. They also voted 14-0 to amend the adult and child/adolescent immunization schedule to recommend COVID-19 vaccination under the scope of use for an EUA.
CDC staff noted that insurance carriers will have 15 business days after the vote and adoption until they will be mandated to cover COVID-19 vaccine administration fees. They said the generic language about COVID-19 vaccines, rather than the Pfizer vaccine, is to ensure there is no delay in coverage as additional vaccines are added.
This planned 2-day emergency meeting took place Friday, with a last minute schedule change. The second day of the meeting shifted from Sunday to Saturday following the FDA authorizing the vaccine late Friday night.
“I know you share with me with burden of the responsibility of this moment,” said Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases. “We look to this committee to be scientifically driven and transparent and you have certainly fulfilled that responsibility.”
Indeed, consumer representative Veronica McNally, JD, of Franny Strong Foundation in West Bloomfield, Michigan, pointed out ACIP members listened to over 70 presentations and have had nine meetings since February.
Similar to the FDA advisory committee on Thursday, there was little intense debate about the recommendation. In addition to the relative lack of data for individuals ages 16-17, the issue arose about vaccinating pregnant women. This will be addressed in the clinical guidance, CDC staff said, although current language states there are no data on the safety of COVID-19 in pregnant women, but women should discuss vaccination with their healthcare providers, to make an informed decision about whether the benefits outweigh the risks.
The guidance also suggests that if a woman experiences fever following a vaccine, she should take acetaminophen, as “fever has been associated with adverse pregnancy outcomes.”
Committee members were further assured by comments from liaison member Linda Eckert, MD, of the American College of Obstetricians and Gynecologists (ACOG), who said both ACOG and CDC came to an “overall complete consensus” that there was no biological plausibility at this time for placental transfer.
“Clearly, we are waiting for data … we look forward to studies in pregnant women, but at this point, we are very supportive of the permissive recommendation,” she said.
There was similar guidance for lactating women, where there is also a lack of data.
While the issue of lack of data in individuals ages 16-17 arose again, most members were persuaded by the need to vaccinate this population due to potential transmission of SARS-CoV-2 to close contacts and to the community, recognizing some 16 and 17-year-olds are essential workers or even work in healthcare settings.
Committee member Henry Bernstein, MD, of Zucker School of Medicine at Hofstra/Northwell Cohen in Hempstead, New York, expressed reservations about this data, but ultimately voted to recommend the vaccine, including this population.
However, he proposed this age group be treated as a special population, given the limited data available at the time.
“Child health providers will benefit from specific detail in discussing” the COVID-19 vaccine with their patients and communities, Bernstein said.
Messonnier said there will be additional clarifying language about the interim recommendation in an upcoming edition of the Morbidity and Mortality Report, noting it is tied to ACIP’s interim recommendation about allocation of limited vaccine supply. As of this point, healthcare workers and residents of long-term care facilities are recommended to receive the vaccine when available.
In the midst of the optimistic mood about the vaccine as a viable tool to combat the COVID-19 pandemic, liaison member Jeffrey Duchin, MD, of the Infectious Diseases Society of America, reminded the committee about the continued programmatic challenges facing public health departments as they attempt to roll out vaccination on a larger scale.
“The funding necessary for state and local health departments to carry out this program has been put in a deep freeze along with the vaccine,” he said.
ACIP recommendations are not considered final until they are published in the Morbidity and Mortality Weekly Report.