Committee: Pfizer shot should be authorized
First doses of vaccine could arrive in New York over the weekend
A U.S. government vaccine advisory committee recommended Thursday that the Pfizer-biontech COVID -19 vaccine should be authorized for use, an endorsement that makes it likely an immunization against coronavirus will soon be available in the U.S. and New York for the first time.
The U.S. Food and Drug Administration is now expected to swiftly authorize the vaccine for emergency use. The first doses of the Pfizer vaccine could arrive in New York over the weekend.
The FDA advisory panel of
scientists, convening for a day-long virtual public meeting, considered data on whether the Pfizer vaccine was safe and effective for emergency use by Americans, questioned Pfizer representatives, and cast a vote on whether to endorse it for emergency use.
The 23-member panel overwhelmingly voted that the benefits of the Pfizer vaccine outweigh the risks for individuals ages 16 and older based on available scientific evidence.
FDA scientists released
their first scientific analysis of Pfizer’s clinical trials Tuesday and found the vaccine appears safe and more than 90 percent effective across different patient populations.
New York will receive a first batch of 170,000 vaccines. The Capital Region will get 7,850, or a little less than 5 percent.
The first vaccinations will go to nursing home residents and staff, as well as front-line health care workers who are treating patients. Members of the New York National Guard working on COVID -19 response will be among the first in the U.S. military to get the vaccine as soon as next week.
The Pfizer vaccine requires each patient receive two doses three weeks apart.
The authorization would approve the use of the vaccine in individuals age 16 and older. The panel of doctors had a heated debate Thursday about whether 16- and 17-year-olds should be authorized to get the vaccine, with some doctors raising concerns that there was not enough study of this age group.
The authorization is a statement from the FDA that the benefits of the vaccine outweigh the risks, although the study needed for the more rigorous FDA licensing process is not complete.
The Pfizer vaccine has previously been approved by Britain and Canada. Britain began mass vaccinations on Tuesday.
British officials are investigating reports that two people experienced allergic reactions to the Pfizer shot to determine if their reactions were linked to the vaccine. For now, British regulators have told people with a history of severe allergic reactions to hold off on the Pfizer vaccine.
Doctors on the panel raised concerns about these allergic reactions, and questioned Pfizer representatives about their study of the vaccine in individuals with severe allergies.
Marion Gruber, director of the FDA Office of Vaccine Research and Review, told the panel the FDA has already decided to advise vaccinators to not administer the shot to people with a history of severe allergic reactions to any components of the vaccine.
The FDA is also expected to soon review and authorize a similarly effective vaccine from the pharmaceutical company Moderna. Johnson & Johnson and Astrazeneca also have developed vaccine candidates.
Gov. Andrew M. Cuomo announced in late September that New York would have an independent panel review the efficacy before allowing vaccinations to proceed. New York’s independent panel has already been studying the Pfizer vaccine concurrently with the FDA process, and Cuomo said Wednesday that the panel would convene immediately after the FDA approves the vaccine.
U.S. Health and Human Services Secretary Alex Azar has said this step could undermine public confidence in the vaccine. Cuomo also spent weeks publicly asserting that the federal vaccine approval process under Trump was politicized and could not be trusted.
“Frankly, I’m not going to trust the federal government’s opinion, and I wouldn’t recommend to New Yorkers based on the federal government’s opinion,” the governor said when the panel was announced.
Cuomo has said in recent weeks that public skepticism of the vaccine is a major problem, and that he believes New York’s independent process will bolster faith in the vaccine. The FDA’S approval process, however, is internationally recognized as the gold standard, and no specific evidence has been offered to suggest the process for approving the Pfizer vaccine has not met that standard.
The members of the state’s panel are Charles M. Rice of The Rockefeller University, Dr. Scott M. Hammer of Columbia University Medical Center, Adolfo Garcia- Sastre from Mount Sinai, Sharon Nachman from Stony Brook University, Dr. Kelvin Lee from Roswell Park, Dr. Bruce Farber from Northwell Health and Shawneequa Callier from George Washington University.
There’s also a New Yorker involved directly in the federal approval process: Dr. Stephen Thomas of SUNY Upstate Medical University was tapped by Pfizer — a New York company — to help usher its vaccine through the FDA approval process as the lead investigator.