FDA OKS Pf izer vaccine
New Yorkers most vulnerable to COVID-19 in line to receive first shots
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 PfizerBiontech shot to New York and other states.
Health care workers in New York will receive the first shots starting in a matter of days. Nursing home residents and staff will start vaccination soon after.
In the near term, the arrival of the nation’s first COVID -19 vaccine will help New York deal with staffing shortages in hospitals and other medical settings as the state combats more new cases of the infectious virus each day than it ever has during the pandemic. 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 New York 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: It is 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 authorized the Pfizer vaccine for emergency use by individuals 16 years and older.
“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 J. Trump criticized the FDA on 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 Hahn.
An outside advisory panel of doctors on Thursday recommended the FDA authorize the vaccine.
The doctors overwhelmingly decided that the benefits of the vaccine outweigh the risks, and said 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.
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.
The doctors also expressed interest in more information about the impact of the vaccine on 16- and 17-year-olds, pregnant women and individuals with hypersensitive reactions like allergies.
The approval and the state’s preparations to receive the first doses of the vaccine came as coronavirus cases climbed higher in New York and Gov. Andrew M. Cuomo took new steps to preserve hospital capacity.
Cuomo established a separate state review panel to analyze results from the vaccine’s clinical trials.
State Commissioner of Health Howard Zucker “met with the New York State panel yesterday, last night, and the New York State clinical advisory task force has approved unanimously the FDA decision to go forward with the vaccine, so that’s good news, and we notified the FDA of that,” Cuomo said Friday. “Obviously there was no delay whatsoever in the timing, and New Yorkers will have more confidence.”
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.
The authorization marks a record-breaking accomplishment for Pfizer, the Trump administration and Congress.