Panel urges FDA to OK vaccine
Pfizer’s COVID-19 immunization could arrive in Conn. in next few days
WASHINGTON — A U.S. government vaccine advisory committee recommended the PfizerBioNTech COVID-19 vaccine Thursday should be authorized for use, an endorsement that makes it likely an immunization against coronavirus will soon be available in the U.S. and Connecticut for the first time.
The U.S. Food and Drug Administration is expected to swiftly authorize the vaccine for emergency use. The first doses of the Pfizer vaccine could arrive in Connecticut in the next few days.
The FDA advisory panel of scientists convened for a daylong, virtual public meeting Thursday. They 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 authorize it.
The 23-member panel overwhelmingly voted that the benefits of the Pfizer vaccine outweigh the risks for individuals ages 16 years and up 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.
Connecticut is expected to receive 31,200 doses of the Pfizer vaccine next week, according to Gov. Ned Lamont’s office. More doses of the vaccine will arrive each week.
The first doses will go to health care workers, nursing home residents and medical first responders. Hospital clinics vaccinating
employees could start Tuesday, Lamont said Thursday. Nursing home clinics will start the following week, he said.
The West Haven Veterans Affairs Healthcare system will be among the first to get Pfizer doses, U.S. Sen. Richard Blumenthal, D-Conn., said.
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.
An emergency use authorization is a statement from the FDA that the benefits of the vaccine outweigh the risks, although study is not complete as would be needed for the more rigorous FDA licensing process.
The Pfizer vaccine has been approved by the United Kingdom and Canada. The U.K. began mass vaccinations on Tuesday.
British officials are investigating reports that two people experienced allergic reactions to the Pfizer 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 pharmacists and doctors not administer the vaccine to people with a history of severe allergic reactions to any components of the vaccine.
The FDA is expected to review and authorize a similarly effective vaccine from the pharmaceutical company Moderna. Johnson & Johnson and AstraZeneca also have developed vaccine candidates.
A committee of scientists on Connecticut’s vaccine advisory group have been charged with reviewing and affirming the integrity of the FDA authorization and approval processes.
“Our science subcommittee has been monitoring and discussing the development of COVID vaccine candidates, including the Pfizer-BioNTech vaccine, since our group was established earlier this fall,” said Jason Schwartz, an assistant professor of public health at Yale and co-chair of the committee.
The subcommittee will meet Friday to discuss the panel’s recommendations and possible FDA authorization. The subcommittee will make a recommendation to the larger vaccine group and Gov. Ned Lamont about the vaccine.
Vaccine distribution in Connecticut can start before the subcommittee finishes its work.