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FILE – In this file photo from March 2, 2021, pharmacy technician Hollie Maloney loads a syringe with Pfizer’s COVID-19 vaccine at the Portland Expo in Portland, Maine. The United States gave full approval to Pfizer’s COVID-19 vaccine on Monday, August 23, 2021. (AP Photo / Robert F. Bukaty, File)
WASHINGTON (AP) – The United States gave full approval to Pfizer’s COVID-19 vaccine on Monday, potentially boosting public confidence in the shots and instantly paving the way for more universities, businesses and local governments to make vaccinations mandatory.
The Pentagon was quick to announce that it would continue plans to force members of the military to get vaccinated as part of the battle against the extra-contagious delta variant. The University of Minnesota has also said it will require its students to be vaccinated, as do major public universities in Louisiana, including LSU, although state law allows wide exemptions.
More than 200 million doses of Pfizer have been administered in the United States under emergency arrangements – and hundreds of millions more around the world – since December. Going one step further and granting full approval, the Food and Drug Administration cited months of real evidence that serious side effects are extremely rare.
President Joe Biden said that for those who were hesitant to get the vaccine until he received what he has dubbed the “gold standard” FDA approval, “the moment you’ve been waiting for is here.”
“Please get vaccinated today” he said.
Pfizer CEO Albert Bourla called for FDA action “An important step which I think will unlock some of the most skeptical minds. “
Pfizer said the United States is the first country to grant full approval for its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA had so much evidence to judge the safety of a shot.
The formula, developed jointly with the German BioNTech, will be marketed under the brand Comirnaty.
Moderna has also asked the FDA for full approval of its vaccine. Johnson & Johnson, maker of the third option in the United States, said it hopes to do so later this year.
Just over half of the American population is fully vaccinated. Vaccinations in that country hit a low in July with an average of around half a million vaccines per day, up from a peak of 3.4 million per day in mid-April. As the Delta variant fills hospital beds, shots are on the rise again, with one million a day given Thursday, Friday and Saturday.
Pfizer’s full COVID-19 vaccine approval means it meets the same “Very high standards demanded of all approved vaccines we rely on every day”, said Dr Jesse Goodman of Georgetown University, a former FDA vaccine chief. that should help “Anyone who still has concerns gains confidence” in the blows.
Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s approval to make the vaccine mandatory by mid-September or once the FDA grants final approval, whichever comes first. On Monday, after the FDA acted, the Pentagon said guidelines on vaccinations would be developed and a schedule would be provided in the coming days.
The approval also paved the way for rapid action by colleges to demand vaccines and solidified the legal foundation for hundreds of universities that have already issued warrants for students and staff.
The public university systems in Louisiana and Minnesota were awaiting action from the FDA before making vaccinations mandatory. Louisiana has become a hotspot for COVID-19, repeatedly breaking records for the number of people hospitalized with the virus. But some other states prohibit universities from requiring injections, including Texas and Florida.
“The mandate becomes much easier when you have full approval” said Dr Carlos del Rio of Emory University. “I think a lot of companies were waiting for him.”
On the same day the FDA decision fell, New York City announced that all public school teachers and other staff will need to be vaccinated.
The delta variant has skyrocketed cases, deaths and hospitalizations in recent weeks in the United States, erasing months of progress. Deaths are around 1,000 per day on average for the first time since mid-March, and new cases are on average 147,000 per day, a level last seen in late January.
Elizabeth Nichols, 18, of Akron, Ohio, said she felt “A burst of relief” after hearing the news of the FDA approval. She was already on her way to be vaccinated Monday morning after months of hesitation.
“I had an internal battle over whether to shoot or not” Nichols said in an email. “It can be scary to submit to something that is not approved. “ But she added: “The clearance proves how safe it is.”
The FDA, like regulators in Europe and much of the rest of the world, initially cleared the emergency use of Pfizer’s vaccine based on a study that followed 44,000 people aged 16 and over for at least two months – the period during which severe side effects usually occur.
This is shorter than the six months of data security normally required for full approval. So Pfizer continued this study, and the FDA also looked at the actual safety evidence.
Pfizer’s vaccine will continue to be distributed to 12 to 15 year olds under emergency use authorization until the company files its full approval application.
Normally, doctors can prescribe products approved by the FDA for reasons other than their initial use. But Acting FDA Commissioner Dr Janet Woodcock has strongly warned that the Pfizer vaccine should not be used “without label” for children under 12 – a warning echoed by the American Academy of Pediatrics.
Pfizer and Moderna both have ongoing vaccine studies in young people, and they use lower doses than those available for people 12 years of age and older.
Bourla of Pfizer said he expects the results of the study for children aged 5 to 11 to be by the end of September, but data for those under 5 will take a few months.
Additionally, Woodcock said healthcare providers are offering COVID-19 vaccines as part of deals with the government that should prevent using Monday’s approval as a pretext to offer booster shots to the public. general.
Currently, the FDA has authorized third doses of Pfizer’s or Moderna’s vaccine only for certain people with severely weakened immune systems, such as organ transplant recipients. For everyone else, the Biden administration is planning boosters starting in the fall. But the FDA is evaluating this issue separately.
Making the decision on Monday, the FDA said serious side effects remain very rare, such as chest pain and heart inflammation a few days after the second dose, mostly in young men.
Regarding efficacy, six months after the start of the original Pfizer study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infections decreased slightly, from a peak of 96% two months after the second dose to 84% in six months.
These findings came before the delta variant began to spread, but other data from the Centers for Disease Control and Prevention shows that the vaccine still does a good job of preventing serious illness.
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Associated Press Reporter Jonathan Lemire contributed to this report.
The Associated Press’s Department of Health and Science receives support from the Department of Science Education at Howard Hughes Medical Institute. The AP is solely responsible for all content.
Copyright 2021 The Associated Press.
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