A federal advisory panel voted overwhelmingly Saturday to recommend the nation’s first coronavirus vaccine for people 16 and older, paving the way for inoculations to begin as shipments of vaccine arrive at hospitals and state health departments Monday.
The vote was 11 in favor, with three members not voting because of conflicts of interest.
CDC Director Robert Redfield approved the recommendation from the Advisory Committee on Immunization Practices Saturday night, making it official CDC recommendation for the United States. “As covid-19 cases continue to surge throughout the United States, CDC’s recommendation comes at a critical time, Redfield said in a statement Sunday. “Initial COVID-19 vaccination is set to start as early as Monday, and this is the next step in our efforts to protect Americans, reduce the impact of the covid-19 pandemic, and help restore some normalcy to our lives and our country.”
Advisory group members said the nation was on the cusp of a historic moment.
“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,” said Peter G. Szilagyi, a professor of pediatrics at the University of California at Los Angeles.
The panel’s recommendation is “a hugely important step,” said Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases.
Beth Bell, a global health expert at the University of Washington who leads the panel’s coronavirus vaccine work group, referred to public concerns about the new vaccine and said she would get a shot when it is her turn and would recommend it for her family. Several members said they would do the same.
While Bell applauded the huge scientific achievement of developing a vaccine, she and others noted the stark imbalance between the $10 billion of taxpayer money used to fund vaccine development and the lack of funding — only “hundreds of millions” — for the enormously complicated and challenging distribution and vaccination effort rolling out across the country during the next year.
“The imbalance between that kind of money and funding provided for the vaccination program is really shocking and needs to be corrected,” Bell said. “We are not going to be able to protect Americans if we don’t have a way to deliver the vaccine to them.”
Jeffrey Duchin, a top health official for Seattle and King County, Wash., noted that the funding necessary for state and local health departments “has been put in the deep freeze with the vaccine,” referring to the vaccine’s ultracold storage and handling requirements.
Because the vaccine initially will be in extremely limited supply, the CDC recommended last week that about 21 million health-care workers and about 3 million residents of long-term care facilities be first to receive it.
Health-care personnel are a priority because of their potential exposure to the virus and their role in keeping the nation’s hospitals and clinics functioning. Residents and employees of long-term care facilities were prioritized because those sites account for nearly 40 percent of deaths from covid-19, the disease caused by the virus.
Authorization from the FDA means that the Pfizer vaccine is permitted to be administered, but an endorsement by the CDC immunization panel signals that the vaccine should be administered to the populations included in its guidance.
Recommendations from the group, an independent body of experts, have been the gold standard for evidence-based guidance on vaccine use in the United States for decades. Health-care providers rely on the group’s recommendations because of the committee’s reputation for rigor and attention to detail, said Jason L. Schwartz, a professor of health policy at the Yale School of Public Health. The committee has been planning for its recommendations for coronavirus vaccines since the spring.
The committee’s review of safety and efficacy data Friday and Saturday reached the same conclusions as the FDA and its advisory committee, including appropriateness of use in 16- and 17-year-olds. One member noted that teenagers can actively spread the virus to family members.
Committee members said pregnant women who are part of a group recommended to receive the shot may talk with their medical providers and choose to get vaccinated, even in the absence of data on the safety of coronavirus vaccines in pregnant women.
Many health-care workers are women, and a significant percentage are likely to become pregnant or to have recently had babies, noted physician Sandra Fryhofer, a liaison representative speaking on behalf of the American Medical Association.
Pregnant women have been excluded from coronavirus vaccine trials. A Pfizer official said Saturday that the company plans to report to the FDA this month on a developmental and reproductive toxicity study in animals that could help clarify any risks.
On Sunday, the CDC is expected to provide briefings for clinicians and provide additional detailed clinical considerations for health-care providers and patients on its website, including guidance on possible severe allergic reactions. Peter Marks, director of the FDA’s division that regulates vaccines, said Saturday that officials had looked carefully at such side effects and concluded that people should receive the vaccine unless they “have had a severe reaction to the vaccine or one of its components.”
Two health-care workers in Britain had severe anaphylactic reactions after receiving the vaccine, according to authorities. Both had a history of serious allergic reactions and carry epinephrine auto injectors, known as EpiPens, for such emergencies. A third health-care worker, with no history of allergies, developed a rapid heartbeat and skin reddening. The CDC is following up with British health officials on the cases and has convened experts in vaccine safety, immunology and allergy to investigate possible causes, officials said.
The weekend meeting was not devoted to deciding on allocation of finite vaccine supplies but whether to recommend its use.
But there was a preview of the jockeying certain to take place over who will be next after health-care workers and long-term care facility residents and staff, who constitute the first phase, known as Phase 1a. Members of the advisory group heard from industry representatives and other advocates about why workers in certain sectors or particularly vulnerable people should have priority access.
John T. Allan III, vice president of regulatory affairs and international standards for the International Dairy Foods Association, warned that if food workers did not get immunized soon, “Our supply chains could eventually fall apart, creating widespread disruptions to our economy.”
Julie Russell, a representative of a school district in San Diego County, said teachers and other front-line education staff required attention because of “how many young lives each of them touch.”
And Charles Lee, president-elect of the American College of Correctional Physicians, said incarcerated people are of paramount concern because of the outbreaks that have torn through prisons.
There were also concerns about access in the first phase. A rural health advocate in Wisconsin said ultracold storage requirements and the batch size of the Pfizer vaccine, which is shipped in 975-dose allocations, threatens access beyond densely populated metropolitan areas.
Several members of the public warned about the pernicious effects of misinformation, asking the committee to develop a plan to combat false narratives about vaccination, particularly those targeting communities of color.
Laurie McGinley contributed to this report.
