CDC headquarters in Atlanta
Elijah Nouvelage | Bloomberg via Getty Images
A key U.S. Centers for Disease Control and Prevention panel voted unanimously to recommend Pfizer–BioNTech‘s Covid-19 vaccine for people 16 years and older on Saturday, clearing another pivotal hurdle for the drug before vaccinations begin in the coming days.
The CDC’s Advisory Committee on Immunization Practices, an outside group of medical experts that advises the agency, voted 11 to 0 recommend the vaccine for use in people 16 and older under the Food and Drug Administrations emergency authorization. Three members recused themselves due to conflicts.
The recommendation will now be sent to CDC Director Dr. Robert Redfield, who will need to sign off before vaccinations can begin. A CDC spokesperson was not immediately available for comment regarding when Redfield would sign off on the recommendation.
“This Covid-19 vaccine offers us hope,” said Veronica McNally, an ACIP member and assistant dean for experiential education at Michigan State University College of Law. “It’s important to remember that while this vaccine has been developed at an incredible pace and involves new technology, it’s gone through all the appropriate regulatory channels and the approval processes have been transparent.”
Dr. Beth Bell, an ACIP member and a clinical professor of global health at the University of Washington, said that she recognizes people’s concern about this vaccine and new vaccines in general, but added that she “certainly” will take this vaccine when it’s her turn.
“I do believe that the process that we have used here in the ACIP to reach this decision is transparent, is science based, keeps equity in mind and is, for this moment, the absolute best that we can do,” Bell said.
Dr. Peter Szilagyi, a member of the committee and a pediatrician at the University of California Los Angeles, added that he wanted to emphasize the need “for substantially increased government funding to actually implement the recommendation” following the vote. Several trade groups that represent state health agencies have placed the price tag for the vaccine distribution plans at more than $8 billion.
“I know we’re going to have very tough and sad times ahead because of the surge and a limited vaccine supply, but I am really hopeful that this is the beginning of the end of the coronavirus pandemic,” Szilagyi said.
The vote marked the end of an hours-long meeting where ACIP members heard presentations from officers at the CDC regarding clinical considerations for people who are vaccinated under the emergency authorization. The ACIP’s emergency meeting, which was pushed from Sunday to Saturday, followed the FDA’s decision to issue Pfizer’s vaccine an emergency use authorization Friday evening.
Dr. Sarah Mbaeyi, a CDC medical officer, told the agency during a presentation that vaccines should be offered to people “regardless of history of prior symptomatic or asymptomatic” coronavirus infection. Mbaeyi told the panel, however, that a diagnostic or antibody test isn’t recommended to decide whether someone should get the vaccine.
Further studies regarding the safety of the vaccine in pregnant women are still ongoing, Mbaeyi said. However, if a pregnant woman is part of a group prioritized for the vaccine, Mbaeyi said they could choose to be vaccinated following an informed decision with a health-care provider.
Members of the public were also invited to share comments and concerns about the vaccine and its distribution. Claire Hannan, the executive director of Association of Immunization Managers, told the committee that there needs to be more defined guidance regarding who’s considered an essential worker since states across the U.S. differ on their definitions.
On Dec. 1, the group voted 13-1 to give health-care workers and long-term care facility residents the first vaccine doses once cleared for public use.
“Guidance on subsequent priority groups is needed immediately,” Hannan said. “Jurisdictions are working now to plan for vaccine allocation coming in the next month. They need to work closely with providers and communicate clearly with consumers about what to expect.”
Following the meeting, California Gov. Gavin Newsom said in a tweet that a panel arranged by a coalition of west coast states to independently review the safety and efficacy data from Covid-19 vaccines will examine Pfizer’s data on Saturday following the ACIP recommendation. Newsom said the state expects vaccine “distribution as early as tomorrow.”