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The Pentagon immediately announced that it would continue its plan to require members of the military to get vaccinated as the United States and the world battle the extra-contagious delta variant.
The formula developed by Pfizer and its German partner BioNTech now enjoys the strongest approval of the Food and Drug Administration, which has never had so much evidence to judge the safety of a shot. More than 200 million doses of Pfizer have been administered in the United States – and hundreds of millions more around the world – under special emergency arrangements since December.
“Vaccines are one of our best weapons against the virus,” said Acting FDA Commissioner Janet Woodcock. “We hope this approval will boost the confidence of those who hesitated.”
Pfizer said the United States is the first country to grant full approval for the company’s vaccine. The shot will be marketed in the United States under the brand name 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.
The full approval of Pfizer’s COVID-19 vaccine means it meets the same “very high standards required of all approved vaccines we rely on every day,” said Dr Jesse Goodman of Georgetown University, a former chief of vaccines for the FDA. This should help “anyone who still has concerns to gain confidence” in the shots.
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 FDA’s action could also lead to more vaccination mandates covering students, employees and customers.
“The tenure becomes a lot easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of companies were waiting for him.”
This month, New York City, New Orleans and San Francisco all imposed proof of vaccination requirements in restaurants, bars and other indoor locations. At the federal level, President Joe Biden is requiring officials to sign forms certifying that they have been vaccinated or to submit to regular tests and other requirements.
Anxious Americans are increasingly on board: Nearly 6 in 10 support requiring people to be fully immunized to get on planes or attend crowded public events, according to a recent Associated Press poll -NORC Center for Public Affairs Research.
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.
“For weeks we have seen cases increase at an alarming rate among individuals who are not vaccinated while the vaccinated are largely protected,” said Dr. Tomas J. Aragon, director of the California Department of Public Health. “If you are not vaccinated, then this is the step that gets you there.”
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 real-world safety evidence in deciding whether to fully authorize the vaccine for people 16 years of age and older, those who have been studied the longest. The Pfizer injection is still distributed to young people aged 12 to 15 in an emergency.
Normally, doctors can prescribe products approved by the FDA for reasons other than their initial use. But Woodcock strongly warned that the Pfizer vaccine should not be used “off-label” for children under 12.
Pfizer and Moderna both have ongoing vaccine studies in young people, and they use different doses than those available for ages 12 and older. The results are expected in the fall.
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 Monday’s decision, the FDA said the safety monitoring of millions of doses found that serious side effects remain extremely rare, such as chest pain and heart inflammation within days of 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 illnesses caused by this mutant.
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Associated Press Reporter Jonathan Lemire contributed to this report.
Copyright © 2021 by The Associated Press. All rights reserved.
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