“Today I call on more countries (I should say, more private sector companies) to step up vaccine requirements that will reach millions more people,” Biden said. “If you’re a business leader, a nonprofit leader, a state or local leader, who’s been waiting for full FDA approval to demand vaccinations, now I’m asking you to do it, to require it.”
Full approval will give legal coverage to many organizations that want to require vaccines for their employees, as the delta variant increases nationwide. The United States has so far vaccinated 71% of the eligible population, but poorly vaccinated areas such as the southeast have shown that the virus will continue to spread where there is insufficient protection.
“Let me say it out loud and clear, if you’re one of the millions of Americans who said they won’t get fired until you have full and final FDA approval, it’s over now,” he said. Biden during statements at the White House. “The moment you’ve been waiting for is here.”
The approval came a week ahead of previous estimates by federal health officials that the agency would complete its review on Labor Day.
It indicates that Pfizer has shown sufficient efficacy and safety data to meet the strict requirements of the Biology License Application (BLA), which includes at least six months of safety data from most volunteers in a large clinical trial in final phase.
“Based on the long-term monitoring data we presented, today’s approval for those over 16 states the efficacy and safety profile of our vaccine at a time when it is urgently needed.” , said Albert Bourla, CEO of Pfizer. statement to ABC News. “Since December 2020, hundreds of millions of doses of our vaccine have been administered in the United States and we look forward to continuing to work with the U.S. government to reach more Americans.”
This prioritized review involved government scientists pouring hundreds of thousands of pages of safety and efficiency data at a rapid fire rate, conducting thorough inspections of Pfizer’s manufacturing process.
“This is a crucial time for our country in the fight against the pandemic,” FDA Acting Commissioner Janet Woodcock said in a briefing with reporters after announcing full approval.
“Working 24 hours a day, FDA staff was able to complete the evaluation of this organic product license application in just over three months,” Woodcock said. “This is an unprecedented chronology given the amount of revision and meticulous manner in which it was done, but we want to stress that our efforts to move forward as quickly as possible have in no way sacrificed scientific standards for integrity. of our process “.
As Biden said in his speech, there will be growing pressure for Pfizer’s full and formal approval to pave the way for new vaccine mandates in both the public and private sectors, similar to existing vaccine mandates for other vaccines. FDA approved. Some companies and state leaders have held out so far, indicating they would wait for full approval before imposing stricter requirements.
However, at a press conference in Capitol Hill, several Republicans withdrew their vaccination warrants.
Rep. Chip Roy, R-Texas, a cancer survivor, announced the vaccine, but said it should be up to the Americans and their doctors to decide whether to get vaccinated and Rep. Bob Good, R- Va, he also attacked the Biden administration. for having required the vaccine in the army.
“What we shouldn’t do is order anyone to get the vaccine and certainly not our military,” he said.
Federal, state, and local health officials have expressed optimism that full approval will help dissolve some of the persistent hesitation when firing when only authorized for emergency use; it has also been reflected in a recent survey.
Similar to the president, Dr. Peter Marks, director of the Center for Biological Assessment and Research and supervisor of the approval process, urged people waiting at this time to get vaccinated to do so.
“Following our rigorous processes to evaluate this application, we hope that those who have waited so far to make the decision to protect themselves and therefore also help protect their communities by reducing the spread of COVID-19, will to get vaccinated, ”Mark said at Monday’s briefing with reporters alongside Woodcock.
Marks said the agency worked “tirelessly” 24 hours a day to approve the vaccine in such a short time. The whole process took about half the time it would under normal circumstances, Marks said, though the FDA was under pressure in recent weeks to move faster because more people could use full approval as a reason. to be vaccinated.
“People have wondered what it has taken so long. Well, the FDA, when we do a review of the license application for organic products, we are very rigorous in what we do and we don’t just look at what the data summaries are. : We go up to the level of individual patients, ”Marks said.
In this case, that meant 20,000 patients who received a vaccine and 20,000 who received a placebo. The FDA visited clinical trial sites, inspected vaccine manufacturers, and combed thousands of pages of patient data for their own analysis, as well as for risk-benefit analysis of data that emerged after finish the clinical trials, when hundreds of millions of people arrived they were shot.
“We reviewed hundreds of thousands of pages of data and information on the safety, efficacy and quality of vaccine manufacturing, and concluded and conducted inspections of various facilities for the vaccine manufacturer,” he said. Marks.
The team “worked night and day to do it,” he said.
Former CDC Acting Director Dr. Rich Besser, president of the Robert Wood Johnson Foundation, said the timing “could not come at a more important time, as the highly contagious variant of Delta continues to increase case loads and deaths in the United States.”
“I hope the full approval will address the remaining concerns and move many people to the‘ yes ’about vaccination,” Besser said in an interview with ABC News.
Pfizer was the first to apply for full approval in the United States; other COVID vaccine manufacturers are likely to follow suit. The three authorized vaccines received an emergency authorization based on massive clinical trials that included tens of thousands of volunteers.
Federal health officials have received immense political pressure from all parties to get approval as soon as possible, as much of the country is facing a further rise, and the delta variant threatens hard-fought victories in the fight against the virus.
In private calls with the team obtained by ABC News at the White House COVID, some governors of the nation have recently expressed their lack of patience and frustration over the wait for full approval of the vaccine, saying the FDA must to act or be transparent about how much longer to wait, as the lack of total approval was a recurring motive they had heard from doubters who had not yet taken the shot.
The FDA had made it clear that the Pfizer vaccine at the finish line of approval was a priority, with a “practical approach to the deck” and “advancing as quickly as possible.”
ABC News learned in late July that the agency would re-prioritize some of its “agency-wide” staffing and technology resources and remodel other existing work, in order to complete the review more quickly, devoting those resources additional to speed up the process for Pfizer approval.
“We recognize that for some, FDA approval of COVID-19 vaccines can provide additional confidence and encourage them to get vaccinated,” an agency spokesman told ABC in late July, promising that any approved vaccine would meet “strict safety, efficacy, and quality standards.”
Cheyenne Haslett, Ben Gittleson, Justin Gomez, Benjamin Siegel and Briana Stewart collaborated on this report.