... we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated. [Today’s] milestone puts us one step closer to altering the course of this pandemic in the U.S. — Dr. Janet Woodcock, the acting F.D.A. commissioner
... we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated. [Today’s] milestone puts us one step closer to altering the course of this pandemic in the U.S. — Dr. Janet Woodcock, the acting F.D.A. commissioner

The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S. — Dr. Peter Marks, the F.D.A.’s top vaccine regulator
The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S. — Dr. Peter Marks, the F.D.A.’s top vaccine regulator

This is a pivotal moment for our country in the fight against the pandemic. The public can be confident that this vaccine meets the F.D.A.’s gold standard for safety, effectiveness, and manufacturing quality that we require for an approved product. — Dr. Janet Woodcock, the acting F.D.A. commissioner
This is a pivotal moment for our country in the fight against the pandemic. The public can be confident that this vaccine meets the F.D.A.’s gold standard for safety, effectiveness, and manufacturing quality that we require for an approved product. — Dr. Janet Woodcock, the acting F.D.A. commissioner

F.D.A. Approves Pfizer-BioNTech Covid Vaccine
The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first to move beyond emergency use status in the United States.

The decision will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations. Defense Secretary Lloyd J. Austin III will be sending guidelines to the country’s 1.4 million active duty service members mandating that they be vaccinated, the Pentagon announced on Monday
.

... The approval comes as the nation’s fight against the pandemic has intensified again, with the highly infectious Delta variant dramatically slowing the progress that the country had made over the first half of the year. In a nine-minute speech Monday afternoon, President Biden he said he hopes the development will motivate many of the roughly 85 million unvaccinated Americans who are eligible for shots to get them. He told corporate, state and local leaders: “Do what I did last month. Require your employees to get vaccinated or face strict requirements” such as frequent testing.

He cast Pfizer’s approval as a sign of the overall progress he said his administration is making against the pandemic. While he acknowledged that the death rate, now averaging about 1,000 new deaths a day, has been climbing, he said the toll is still far lower what it was last winter because the vast majority of elderly people are vaccinated.

Mr. Biden also tried to reassure anxious parents about the growing numbers of children who are getting infected with the Delta variant, saying that severe Covid cases among children are still “very, very rare.” He promised to soon address “how we get our kids back to school safely.”

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Pfizer said it presented the F.D.A. with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine was 91 percent effective in preventing infection — a slight drop from the 95 percent efficacy rate that the data showed when the F.D.A. decided to authorize the vaccine for emergency use in December. Pfizer said the decrease reflected the fact that researchers had more time to catch people who became infected.

... So far, more than 92 million Americans — 54 percent of those fully inoculated — have gotten Pfizer shots. Most of the rest received Moderna’s vaccine.

Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said that the Pfizer vaccine’s licensure followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is produced. The agency, which has been under pressure to work ever faster on vaccine decisions, finished its review 97 days after Pfizer filed the required data — or in about two-fifths the normal time for such an evaluation, he said.

“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” he said.

Dr. Marks said that federal health agencies would continue to monitor the vaccine’s safety and that the F.D.A. would require Pfizer to continue to study the risks of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, including the long-term outcomes for recipients. The F.D.A. in June attached warnings to the Pfizer-BioNTech and Moderna vaccines noting possible increased risk of those conditions after the second dose.
Read the full article: https://www.nytimes.com/2021/08/23/us/politics/fda-approval-pfizer-vaccine.html

See also: F.D.A. Fully Approves Pfizer-BioNTech’s Vaccine, a First for a Covid-19 Shot