FDA authorizes Pfizer vaccine
Conn. health care workers can receive inoculations as soon as Monday
WASHINGTON — The federal government approved the first coronavirus vaccine for use in the U.S. Friday night, a pivotal decision that immediately kicks off distribution of the Pfizer-BioNTech shot to Connecticut and other states.
Health care workers in Connecticut will begin receiving their shots as soon as Monday. Nursing home residents and staff will start vaccination before Christmas.
In the near term, the arrival of the nation’s first COVID-19 vaccine will help
Connecticut combat staffing shortages in hospitals and other medical settings as the state sees more new cases of the infectious virus each day than it ever has during the pandemic.
Connecticut recorded
3,782 new infections Friday, and 36 more deaths brought the death toll to 5,363.
The daily positivity rate, found from 54,269 new tests, hovered just below 7 percent. Statewide, four more hospitalizations were reported, bringing the total number of patients hospitalized for the illness to 1,210.
The vaccine should also tamp down cases and deaths among some of the state’s most vulnerable residents: the elderly in congregate settings.
For the general public, these early vaccinations do not eliminate the need to wear masks, social distance, wash hands and limit gatherings during the holidays. It’s expected most Connecticut residents will not have access to a vaccine until late spring or summer.
The authorization marks a record-breaking accomplishment for Pfizer, the Trump administration and Congress: the fastest a vaccine has ever moved from conception to dissemination to the U.S. public, fueled by billions in federal investment, scientific ingenuity and overwhelming need. Vaccine development normally takes about a decade.
The U.S. Food and Drug Administration announced
its approval of the Pfizer vaccine for emergency use just after 9:30 p.m. Friday.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”
President Donald Trump had criticized the FDA Friday morning for not acting more quickly after the panel’s recommendation, calling the agency “a big, old slow turtle.”
“Stop playing games and start saving lives!” he tweeted, directing his comment at the FDA Commissioner Stephen Hahn.
An outside advisory panel of doctors recommended the FDA authorize the vaccine on Thursday. The doctors overwhelmingly decided that the benefits of the
vaccine outweigh the risks and individuals 16 years and older should be able to get it now.
The Pfizer vaccine has been approved by the United Kingdom and Canada. The U.K. began mass vaccinations on Tuesday.
U.S. Sen. Richard Blumenthal, D-Conn., praised the work of Pfizer, which has a research and development laboratory in Groton, Connecticut.
“I am extraordinarily proud of Pfizer’s scientists and entire workforce in Connecticut who helped achieve what seemed impossible: developing a safe, effective COVID-19 vaccine in less than a year,” he said. “The historic challenge now is to scale up manufacturing, strengthen supply chains, spur trust and confidence, as well as continue developing additional versions of vaccine — all of which demands massive federal investment.”
FDA scientists released their first scientific analysis of Pfizer’s clinical trials earlier this week and found the vaccine appears safe and more than 90 percent effective across different patient populations.
British authorities are investigating two cases in which people who received the Pfizer shot had allergic reactions. The FDA is receiving information from
U.K. health officials about the cases and 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.
Connecticut doctors serving on the governor’s vaccine advisory group met Friday afternoon to discuss the expected authorization and the analysis of Pfizer’s clinical trials now available. They applauded the scrutiny of the FDA and its panel and generally concurred with its decision to authorize the vaccine.
“I was really impressed with the rigor of the process,” said Albert Ko, department chair and professor of epidemiology and medicine at Yale.
The doctors also expressed interest in more information about the impact of the vaccine on 16and 17-year-olds, pregnant women and individuals with hypersensitive reactions like allergies.
The FDA is expected to review and authorize a similarly effective vaccine from the pharmaceutical company Moderna as soon as next week. Johnson & Johnson and AstraZeneca also have developed vaccine candidates.