The Food and Drug Administration plans to approve Pfizer-BioNTech’s COVID-19 vaccine in adolescents by early next week, according to federal health officials who are aware of the agency’s plans.
This move allows many American middle and high school students to be vaccinated with COVID-19 long before the start of their next school year. Pfizer claims to have shown “100% effectiveness” to a 12-year-old child. Side effects similar to those seen in young adults.
An FDA spokesperson declined to comment on the expected approval of Pfizer’s amendment to the Emergency Use Authorization, stating that regulators “strive to consider this request as quickly and transparently as possible.” It was.
The New York Times first reported the FDA’s plans to extend Pfizer’s vaccine approval to adolescents.Pfizer will be the first COVID vaccine approved for adolescents in the United States
The FDA has previously stated that it has no plans to convene an advisory board to consider amendments, as it did before the vaccine was approved by Pfizer, Moderna and Johnson & Johnson.
However, the US Centers for Disease Control and Prevention should revise the recommendations for using Pfizer shots before most healthcare providers begin their first dose to adolescents. CDC officials said they would promptly convene an advisory committee meeting on the implementation of vaccination following the FDA amendment.
CDC officials told a webinar hosted by the Infectious Diseases Society of America over the weekend that they are actively preparing to present data from Pfizer’s trials to a panel of vaccine advisors.
Opening Pfizer’s shots to youth could lead to a surge in demand for national vaccine campaigns that have begun to slow in recent weeks.
According to CDC figures released on Monday, more than 21% of the dose given to the jurisdiction has not yet been reported, and many states are no longer ordering the full amount of the allotted dose. It states that it is not.
However, deploying shots in the summer can also pose some challenges for providers.
The CDC currently recommends that the vaccine be given alone, in most cases at least 14 days before and after other injections. Federal health officials have repeatedly warned that vaccinations for adolescents plunged during last year’s pandemic and pose a risk as students expect to return to school in the fall.
“We will be in the summer when many adolescents come to the office to get regular vaccines, so if you miss them, you may not be able to catch up with them in the near future,” Sean Oh said. The doctor says. Really, a pediatric infectious disease specialist at the University of Colorado.
O’Leary acknowledged that deploying to young recipients could also pose some logistical challenges, but many pediatricians have already decided to administer the COVID-19 vaccine. He said he was successful. Pfizer shots are currently allowed for recipients up to the age of 16.
“I don’t know if I’ve given it thousands of times at this point, but I’m ready. I don’t know where I’m giving birth to my 16 and 17 year olds.” From 12 to 15 years old I think starting delivery is that important point, “O’Leary predicted.
Pfizer COVID vaccine may be approved in adolescence by early next week
Source link Pfizer COVID vaccine may be approved in adolescence by early next week