WASHINGTON – The Food and Drug Administration is preparing to authorize the use of the Pfizer-BioNTech coronavirus vaccine in adolescents aged 12 to 15 by early next week, according to federal officials familiar with the agency’s plans by launching a U.S. vaccination campaign. millions more.
Some parents are counting down the weeks since Pfizer announced the results of its study in adolescents, showing that the vaccine is at least as effective in this age group as in adults. Vaccination of children is key to raising the level of immunity in the population and reducing the number of hospitalizations and deaths.
The enlargement will be a major development in the country’s vaccination campaign and would welcome news for some parents who want to protect their children during summer activities and before the start of the next school year. This is also another challenge for politicians struggling to vaccinate a large percentage of adults who are hesitant to get shot. Many more could refuse to inoculate their children.
Pfizer reported a few weeks ago that none of the adolescents in the clinical trial who received the vaccine developed symptomatic infections, a sign of significant protection. The company said the volunteers produced strong antibody reactions and experienced roughly the same side effects seen in people between the ages of 16 and 25.
Stephanie Kakomo, a spokeswoman for the Food and Drug Administration, said she could not comment on the moment of the agency’s decision.
“We can assure the public that we are working to review this request as quickly and transparently as possible,” she said.
More than 100 million adults in the United States are fully vaccinated. But the resolution will arrive in the midst of a delicate and complex push to reach 44 percent of adults who have not yet received a single shot.
As much of the world insists on a surplus of vaccines produced in the United States, the use of Pfizer-BioNTech in adolescents will also raise questions about whether delivery should be targeted at an age group that appears to be spared heavy Covid19.
“I think we need to have a national and global conversation about the ethics of our vaccinated children who are at low risk of serious complications from the virus when there are not enough vaccines in the world to protect adults at high risk of death,” said Jennifer B. Nuzzo, an epidemiologist at the John Hopkins Center for Health Security.
President Biden is under increasing pressure to distribute some of the country’s vaccine supplies. Some federal officials have also called on the administration to decide soon how much vaccine is needed so that doses do not run out or are sent to the states and remain unused. The federal government has purchased 700 million doses of three authorized federal vaccines to be delivered before the end of July, far above what is needed to cover every American.
White House officials said last week that they intend to make up to 60 million doses of AstraZeneca available to other countries, as long as federal regulators consider the doses safe. The vaccine has not yet been approved by US regulators. But global health groups and public health experts have said commitment is not enough.
Dr. Rupali J. Limaye, a researcher at Johns Hopkins University who studies vaccine use and fluctuations, said the United States should donate redundant photos to Pfizer-BioNTech – and any surpluses from other manufacturers – to India and other countries that have had severe outbreaks and asked for help.
“From an ethical point of view, we should not give priority to people like them over people in countries like India,” Dr. Limaye said of the adolescents.
If the United States withholds its supplies to Pfizer-BioNTech, she said, it should be reserved for adults as health officials struggle with the vaccination campaign phase, which requires a more personalized, local scope.
“We still need to examine hesitant adults, while we can start at the age of 14 or 15 at the same time,” said Dr. Limaye. “But the priority still has to be adult.”
The current supply of vaccines in the United States is significant. As of Monday, about 65 million doses have been delivered but not delivered, including 31 million doses of Pfizer-BioNTech vaccine, nearly 25 million doses of Moderna and 10 million doses of Johnson & Johnson’s, according to data collected by the CDC.
Both Pfizer and Moderna vaccines require two doses. Pfizer is allowed for people over 16, while Moderna is allowed for people over 18.
Tens of millions more doses of Pfizer-BioNTech – worth about three weeks, according to one federal official – have been produced and are in various stages of readiness, awaiting final testing before being sent.
Moderna expects results soon from its own clinical trial involving adolescents aged 12 to 17, followed by results for children aged 6 months to 12 years later this year.
The permission of the Food and Drug Administration is likely to significantly ease concerns among high school and high school administrators planning for the fall. If students can be vaccinated by then, this may allow for more normal gatherings and allow administrators to plan further during the school year.