FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Subsequent Week

WASHINGTON – The Food and Drug Administration is preparing to approve the use of the Pfizer BioNTech coronavirus vaccine in adolescents ages 12-15 by early next week, according to federal officials familiar with the agency’s plans, and opens the US vaccination campaign to millions more people.

Some parents have counted down the weeks since Pfizer announced results of its teenage study showing the vaccine was at least as effective in this age group as it was in adults. Vaccinating children is key to increasing immunity in the population and reducing hospital stays and deaths.

The approval in the form of an amendment to the existing emergency approval for the Pfizer vaccine could come as early as later this week. If so, the Centers for Disease Control and Prevention’s vaccine advisory panel is expected to meet the following day to review the clinical trial data and make recommendations on the use of the vaccine in adolescents.

The enlargement would be a major development in the country’s vaccination campaign and welcome news for some parents looking to protect their children during summer activities and before the start of the next school year. This is also another challenge for policy makers who have difficulty vaccinating a large percentage of adults who are reluctant to get the shot. Many more may refuse to vaccinate 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 volunteers produced strong antibody responses and had roughly the same side effects seen in people aged 16-25.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, said she was unable to comment at the time the agency made the decision.

“We can assure the public that we are working to look into this request as quickly and transparently as possible,” she said.

Over 100 million adults in the US have been fully vaccinated. However, approval would come in the middle of a delicate and complex push to reach the 44 percent of adults who have not yet received a single shot.

With much of the world demanding the surplus of US-made vaccines, the use of the Pfizer BioNTech shot in adolescents will also raise questions about whether care should be targeted at an age group largely spared heavy vaccines seems 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 high-risk adults from dying “Said Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.


May 3, 2021, 8:53 p.m. ET

President Biden has come under increasing pressure to shed some of the country’s vaccine supplies. Some federal officials have also urged the government to decide soon how much vaccine is needed so that doses don’t expire or are shipped to states and not used. The federal government has bought 700 million doses of three state-approved vaccines to be dispensed before the end of July, well in excess of what would be required for any American.

White House officials said last week that the intention is to make up to 60 million doses of the AstraZeneca vaccine available to other countries as long as federal regulators deem the doses to be safe. The vaccine has not yet been approved by American regulators. However, global health groups and public health experts said engagement was not enough.

Dr. Rupali J. Limaye, a Johns Hopkins University researcher who studies vaccine use and reluctance, said the United States should donate any surplus Pfizer BioNTech shots – and any surpluses from other manufacturers – to India and other countries that are had severe outbreaks and asked for help.

“From an ethical point of view, we shouldn’t give people like them priority over people in countries like India,” said Dr. Limaye about teenagers.

If the United States continues its supply of Pfizer-BioNTech, it should be reserved for adults while health officials grapple with the phase of the vaccination campaign that requires more individualized local contact.

“We still have to move on to reluctant adults and start at the same time maybe 14 or 15,” said Dr. Limaye. “But the priority should still be adults.”

The current vaccine supply in the United States is substantial. As of Monday, about 65 million doses had been dispensed but not given, according to the CDC, including 31 million doses of the vaccine from Pfizer-BioNTech, nearly 25 million doses from Moderna, and 10 million doses from Johnson & Johnson

The Pfizer and Moderna vaccines each require two doses. Pfizer is approved for ages 16 and up, Moderna for ages 18 and over.

Dozens of millions more Pfizer BioNTech cans – about three weeks long, according to a federal official – have been made and are in various stages of readiness pending final testing before shipping.

Moderna expects results from its own clinical study in adolescents ages 12 to 17 years old soon, followed by results in children ages 6 months to 12 years old later this year.

The approval of the Food and Drug Administration should ease the concerns of middle and high school administrators scheduled for the fall. If students can be vaccinated by then, it could lead to more normal gatherings and allow administrators to plan further ahead into the academic year.

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