[ad_1]
By LAURAN NEERGAARD and MATTHEW PERRONE from AP NEWS
WASHINGTON (AP) – The United States gave full approval to Pfizer’s COVID-19 vaccine on Monday, a milestone that could help boost public confidence in the gunfire as the nation battles the most contagious coronavirus mutant nowadays.
The vaccine made by Pfizer and its partner BioNTech now enjoys the strongest approval from the Food and Drug Administration, which has never had so much evidence to judge the safety of a vaccine. More than 200 million doses of Pfizer have already been administered in the United States – and hundreds of millions more around the world – since emergency use began in December.
“The public can be very confident that this vaccine meets the high standards of safety, efficacy and manufacturing quality that the FDA demands of an approved product,” said Acting FDA Commissioner Janet Woodcock. “Today’s milestone brings us one step closer to changing the course of this pandemic in the United States”
The United States becomes the first country to fully approve the vaccine, according to Pfizer, and CEO Albert Bourla said in a statement he hoped the decision “will help increase confidence in our vaccine, because the vaccine remains the best.” tool we have to help protect lives. “
US vaccinations hit their lowest point in July. As delta fills hospital beds, the shots are on the rise again – with one million a day given Thursday, Friday and Saturday. Just over half of the American population is fully vaccinated with one of the country’s three options, from Pfizer, Moderna, or Johnson & Johnson.
The FDA’s action could also push companies, universities and local governments to demand more vaccines. 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 travel on planes or attend crowded public events, according to a recent Associated Press poll. NORC Center for Public Affairs Research.
“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.”
The FDA, like regulators in Europe and much 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 with this study, and the FDA also looked at the actual safety evidence in deciding to fully authorize the vaccine for people 16 years of age and older, those who have been studied the longest. Pfizer’s shot still has an emergency clearance for 12-15 year olds.
Even after hundreds of millions of injections, serious side effects, such as chest pain and heart inflammation in adolescents and young adults, remain extremely rare, the FDA said.
Regarding efficacy, the six-month follow-up of the original Pfizer study showed that 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.
This data came before the extra-contagious 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.
As with all discussions of booster doses, FDA licensure does not cover them. The agency will decide this separately.
The FDA is already authorizing the emergency use of a third dose of the Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients who do not respond as strongly to the usual two injections. For anyone who has received these vaccines, the Biden administration is planning a booster starting in the fall – if the FDA and CDC agree.
It also remains to decide on the vaccination of children under 12 years of age. Pfizer and Moderna are studying young people, with data expected in the fall.
___
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.
[ad_2]
Source link