FDA Set to Authorize Pfizer Vaccine for Adolescents by Subsequent Week

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FDA Set to Authorize Pfizer Vaccine for Adolescents by Next Week

The Food and Drug Administration is preparing to approve the use of the Pfizer-BioNTech Covid-19 vaccine in adolescents ages 12-15 by early next week, according to federal officials familiar with the agency's plans opens the country's vaccination campaign to millions more Americans.

The news is eagerly awaited: Eager parents have been counting down the weeks since Pfizer announced the results of the study in adolescents. This shows that the vaccine is at least as effective in this age group as it is in adults. Vaccinating children is also key to increasing immunity in the population and reducing hospital stays and deaths.

The approval could come as early as the end of this week, according to federal officials, who did not reveal their names because they were not allowed to speak publicly. If so, the Centers for Disease Control and Prevention Advisory Board will likely meet the following day to review the clinical trial data and make recommendations on the use of the vaccine in adolescents.

The clearance would be a major development in the country's vaccination campaign and welcome news for parents looking to protect their children during summer activities and before the start of the next school year.

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 announced in late March that volunteers produced strong antibody responses and had roughly the same side effects 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 moved.

"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 country have already been fully vaccinated. However, approval would come in the middle of a delicate and complex venture to reach the 44 percent of adults who previously hesitated or had no access to a shot.

With much of the world demanding an oversupply of US-made vaccines, the use of the Pfizer BioNTech shot in adolescents could also raise questions about whether care should be targeted at an age group that appears to have largely spared a tough battle remains from Covid-19.

"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 aren't enough vaccines in the world to protect high-risk adults from dying "he said to Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

President Biden has come under increasing pressure to give away some of the country's vaccine supply, and even within the federal government, some officials have urged the government to decide soon how much vaccine is needed so the doses don't expire or get shipped to the states and not used. The federal government has bought 700 million doses of three federally approved vaccines to be dispensed before the end of July – well in excess of what would be required for any American.

The country's current vaccine supply is substantial. As of Monday, around 65 million doses had been dispensed but not administered, including 31 million doses of the vaccine from Pfizer-BioNTech, nearly 25 million doses from Moderna, and 10 million doses from Johnson & Johnson, according to the Centers for Disease Control and Prevention. Both Pfizer and Moderna vaccines require two doses.

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. They're waiting to go through the final testing before shipping.

Moderna expects results from its own clinical study in adolescents aged 12 to 17 years old soon, followed by results in children aged 6 months to 12 years in the second half of this year.

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