Last night, the Food and Drug Administration announced that it has granted emergency use authorization for administering the Pfizer-BioNTech COVID-19 vaccine to people aged 16 and older in our country.
The Wall Street Journal reports that
Initial supplies will be limited. Pfizer projects it will deliver 25 million doses to the U.S. this year, including 2.9 million doses the first week. Inoculation requires two doses three weeks apart, so only half that many people will be vaccinated. States will decide where many doses go.
Gen. Gustave Perna, chief operating officer of the federal government’s Operation Warp Speed vaccine effort, said Saturday the initial supplies will be distributed among 636 locations nationwide, with 145 sites expected to get the doses Monday.
Another 425 sites should receive deliveries Tuesday, while the remaining 66 sites are slated to get their supplies Wednesday, Gen. Perna said.
The U.S. government is dividing up the supply among states, territories and jurisdictions based on their adult populations.
First in line will largely be the nation’s 21 million health-care workers such as doctors and nurses treating Covid-19 patients, as well as residents of nursing homes and other long-term care facilities.
The Centers for Disease Control’s Advisory Committee for Immunization Practices (“ACIP”) made this phase 1A distribution recommendation earlier this month. Medscape reports that at a meeting held today,
ACIP voted 11-0, with three recusals, to recommend use of the Pfizer-BioNTech mRNA vaccine in individuals 16 years or older according to the guidelines of the Food and Drug Administration’s (FDA’s) emergency use authorization issued on Friday.
The panel also voted unanimously to include the vaccine in 2021 immunization schedules. All panel members said the recommendation should go hand-in-hand with ACIP’s previous recommendation on December 1 that allocation of the vaccine be phased-in, with health care workers and residents and staff of long-term care facilities in phase 1a, as reported by Medscape Medical News.
Of course, more medical guidance will be forthcoming as the vaccine is rolled out to the general public. To that end,
Peter Marks, MD, PhD, director of the FDA’s Center for Biologic Evaluation and Research (CBER) clarified this in a briefing on December 12, noting that women who are pregnant or lactating can make the decision in consultation with their physician. And, he said, patients with any other history of allergy should be able to safely get the vaccine.
The bottom line is that
Committee members breathed a sigh of relief at the end of the 2-day meeting, saying that although the Pfizer vaccine is not perfect, it represents a scientific milestone and a significant advance against the continuing march of the SARS-CoV-2 pandemic.
“This vaccine and future vaccines do provide a promise for a lot of progress in the future,” said panelist Beth P. Bell, MD, MPH, clinical professor of global health at the University of Washington School of Public Health in Seattle.
Peter Szilagyi, MD, MPH, executive vice-chair and vice-chair for research at the University of California, Los Angeles pediatrics department, said, “I’m really hopeful that this is the beginning of the end of the coronavirus pandemic.”
Pursuant to the CARES Act, health plans, including FEHB plans, become obligated to cover administration of this vaccine to its members with no cost sharing fifteen days from now, December 27, 2020.