In Major Scientific Feat, Pfizer Is First To Win FDA Approval Of Covid Vaccine

Stat: FDA Grants Full Approval To Covid-19 Vaccine Developed By Pfizer
The Food and Drug Administration on Monday granted full approval to the Covid-19 vaccine developed by Pfizer and its partner BioNTech, a long-awaited development that public health officials hope will persuade some people who remain hesitant about the vaccine to get the shot. The vaccine is the first of the pandemic vaccines used in the United States to transition from emergency use status to full licensure, a major victory for a partnership that decided to forgo funding through the government’s Operation Warp Speed program on the belief that the development project could move faster without being part of the government fast-tracking program. (Branswell and Joseph, 8/23)

AP: US Regulators Give Full Approval To Pfizer COVID-19 Vaccine
Pfizer CEO Albert Bourla called the FDA’s action “an important milestone that I think will unlock some of the more skeptical minds.” Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot’s safety. The formula, jointly developed with Germany’s BioNTech, will be marketed under the brand name Comirnaty. (Neergaard and Perrone, 8/23)

The Wall Street Journal: FDA Gives Pfizer-BioNTech Covid-19 Vaccine Full Approval
Of the three authorized vaccines in the U.S., only Pfizer had submitted all the required information to the FDA for full approval, according to the companies, and analysts expected it to be the first to receive clearance. Moderna, whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech vaccine, has said it is still completing rolling data submissions. Johnson & Johnson, whose shot was authorized in February, has said it plans to file for full approval later this year. (Hopkins and Armour, 8/23)

The Washington Post: Pfizer’s Full FDA Approval Likely To Boost Vaccinations Among The 90 Million Hesitant
Top public health officials are optimistic that a large swath of vaccine-hesitant Americans will be swayed by the full approval by the Food and Drug Administration of the Pfizer-BioNTech coronavirus vaccine — which had previously received emergency use authorization — and resulting mandates for the public and private sector. Anthony S. Fauci, the nation’s top infectious disease expert, said he estimates that about 20 percent of the U.S. population that is eligible for a shot but has yet to get one — a group of about 90 million — may be nudged by the approval. “I believe that those people will now step forward and get vaccinated,” he told NPR’s “All Things Considered.” (Pietsch and Suliman, 8/24)

Why approval took so long, and what the vaccine's not approved for —

The Atlantic: Pfizer Vaccine Full Approval: Why The FDA Took So Long
After months of anticipation, Americans have a fully licensed COVID-19 vaccine. Today, the FDA announced the approval of Pfizer-BioNTech’s shot for people 16 and older—the first complete thumbs-up among the three vaccines available in the U.S. The pervasive mood has been: Finally. Pfizer’s shot was given its emergency use authorization—the vaccine’s training wheels—back in December, and the company submitted its application for full approval in May. While America’s emergency-use vaccination rollout has saved an untold number of lives, many institutions, including some universities and hospitals, have been waiting for formal approval to mandate vaccinations. Health officials have expressed hope that approval will help convince people who are vaccine-hesitant to get a shot. (Bastian, 8/23)

ABC News: FDA-Approved Pfizer Vaccine Not OK For Off-Label Use In Kids, Official Says 
When the Food and Drug Administration (FDA) granted full approval of the Pfizer COVID-19 vaccine for people ages 16 and older Monday, it did so with a warning to parents and medical providers. The vaccine -- the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval -- should not be given to young children as off-label use, according to FDA commissioner Janet Woodcock. (Kindelan, 8/23)

On what the approval could mean —

CNN: America Could Enter Spring Of 2022 With Covid Under Control If Enough People Get Vaccinated, Fauci Says 
As the first full FDA approval is granted to a Covid-19 vaccine, Dr. Anthony Fauci urged the public to take part, saying if the "overwhelming majority" of the population gets vaccinated, the US could have the pandemic under control by spring of 2022. "We hope we'll be there ... but there's no guarantee because it's up to us," Fauci, director of the National Institute of Allergy and Infectious Diseases and the President's chief medical adviser, told CNN's Anderson Cooper Monday. (Holcombe, 8/24)

AP: What Does Full Approval Of Pfizer’s COVID-19 Vaccine Mean?
What does full approval of Pfizer’s COVID-19 vaccine mean? It means Pfizer’s shot for people 16 and older has now undergone the same rigorous testing and regulatory review as dozens of other long-established vaccines. COVID-19 vaccines in the U.S. were initially rolled out under the Food and Drug Administration’s emergency use authorization, which allows the agency to speed the availability of medical products during public health emergencies. (Perrone, 8/24)

NBC News: FDA Vaccine Approval Is Good News For Markets, Employment, Economy
The Food and Drug Administration’s decision Monday to grant full approval to Pfizer-BioNTech's two-dose Covid-19 vaccine pushed markets higher, boosting the Dow Jones Industrial Average by 300 points and propelling the S&P 500 and the Nasdaq to new highs. Investors appeared to express confidence that the move could be an inflection point for the economic recovery. ... “I think some companies and state and local governments will all be feeling more comfortable in issuing vaccine mandates,” said Eric Diton, president and managing director of The Wealth Alliance, an investment advisory firm. “All of that is going to contribute to a higher vaccination percentage, which means a reduced impact of Covid and the delta variant, which should ultimately lead to a strengthening of the economy.” (White, 8/23)

Also —

NBC News: After FDA Approves Pfizer Vaccine, Several Steps Remain Before Kids Under 12 Can Be Vaccinated
The Food and Drug Administration’s decision to grant full approval to Pfizer-BioNTech’s two-dose Covid-19 vaccine Monday for people ages 16 and up is a pandemic milestone, but parents may wonder what it means for their young children who still aren’t authorized to get vaccinated. ... Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a video news conference Monday that trials for vaccines for children continue and that the agency “has to wait for the company to submit the data from those trials so that we have a good safety dataset, because we certainly want to make sure that we get it right in the children ages 5 through 11 and then even in younger children after that.” (Silva, 8/23)