CDC panel recommends Pfizer Covid vaccine for individuals 16 years and older, clearing pivotal hurdle
Vail Health Hospital nurse Diane Schmidt (left) gives Caitlyn Ngam (right), a hospital infection preventer, a sham vaccine for Covid-19 on December 8, 2020 in Vail, Colorado.
Helen H. Richardson | MediaNews Group | The Denver Post via Getty Images
A key panel from the U.S. Centers for Disease Control and Prevention unanimously voted on Saturday to recommend Pfizer-BioNTech’s Covid-19 vaccine for people aged 16 and over. This cleared another crucial hurdle for the drug before the vaccinations begin in the coming days.
The CDC’s Advisory Committee on Immunization Practices, an external group of medical experts advising the agency, voted 11-0 in favor of recommending the vaccine for use in people aged 16 and over under the Food and Drug Administration’s emergency clearance. Three members withdrew due to conflicts.
The recommendation will now be sent to CDC Director Dr. Robert Redfield who must sign out before vaccinations can begin. A CDC spokesman was not immediately available for comment on when Redfield would sign the recommendation.
“This Covid-19 vaccine gives us hope,” said Veronica McNally, ACIP member and assistant dean of experiential education at Michigan State University College of Law. “It’s important to remember that while this vaccine was being developed at an incredible pace and incorporating new technologies, it went through all appropriate channels of regulation and the approval process was transparent.”
Dr. Beth Bell, an ACIP member and clinical professor of global health at the University of Washington, said she recognized people’s concern about this vaccine and new vaccines in general, but added that they were “safely” taking this vaccine when it is she will turn.
“I believe the process we have used here at ACIP to make this decision is transparent, science-based, fair-minded, and for this moment the absolute best we can do,” said Bell .
Dr. Peter Szilagyi, a committee member and pediatrician at the University of California at Los Angeles, added that he wanted to emphasize the need to “increase government funding significantly” after the vote to actually implement the recommendation. Several trade groups representing state health officials have price the vaccine distribution plans at more than $ 8 billion.
“I know we will have very difficult and sad times ahead of us due to the surge and limited vaccine supply, but I am really confident that this is the beginning of the end of the coronavirus pandemic,” Szilagyi said.
The vote marked the end of an hour-long meeting during which ACIP members heard presentations from CDC officials on clinical considerations for those vaccinated under the emergency license. The ACIP emergency meeting, postponed from Sunday to Saturday, followed the FDA’s decision to give Pfizer’s vaccine emergency approval on Friday evening.
Dr. Sarah Mbaeyi, a CDC doctor, told the agency during a presentation that vaccines should be offered to people “regardless of a history of previous symptomatic or asymptomatic” coronavirus infection. However, Mbaeyi told the panel that a diagnostic or antibody test is not recommended to help decide whether someone should receive the vaccine.
More studies on the vaccine’s safety in pregnant women are ongoing, Mbaeyi said. However, if a pregnant woman is part of a group that is prioritized for the vaccine, Mbaeyi said she could opt for vaccination after making an informed decision with a health care provider.
The public was also asked to share comments and concerns about the vaccine and its dissemination. Claire Hannan, the executive director of the Association of Immunization Managers, told the committee that there needs to be more precise guidance on who is considered an essential worker, as definitions differ across the US.
On December 1, the group voted 13-1 for healthcare workers and residents of long-term care facilities to receive the first doses of vaccine once released for public use.
“Guidelines for subsequent priority groups are needed immediately,” said Hannan. “The jurisdictions are currently working on planning the vaccine allotment for the next month. They need to work closely with providers and communicate clearly with consumers about what to expect.”
Following the meeting, California Governor Gavin Newsom said in a tweet that a panel set up by a coalition of West Coast states to independently review the safety and efficacy data of Covid-19 vaccines would review Pfizer’s data on Saturday, according to the ACIP recommendation will investigate. Newsom said the state expects to “distribute the vaccine tomorrow”.