FDA to approve Pfizer vaccine for teens by early next week

WASHINGTON – The Food and Drug Administration is preparing to authorize the use of Pfizer-BioNTech coronavirus vaccine among teens ages 12 to 15 early next week, according to federal officials familiar with the agency’s plans, opening the U.S. vaccination campaign to millions more.

Some parents have been counting the weeks since Pfizer announced the results of its trial in adolescents showing that the vaccine is at least as effective in this age group as in adults. Immunization of children is essential to raise the level of immunity of the population and to lower the number of hospitalizations and deaths.

The authorization, in the form of an amendment to the existing emergency use authorization for the Pfizer vaccine, could come as soon as the end of this week. If granted, the Centers for Disease Control and Prevention’s vaccine advisory committee will likely meet the next day to review clinical trial data and make recommendations on vaccine use in adolescents.

The expansion would be a major development in the country’s vaccination campaign and good news for some parents keen to protect their children during summer activities and before the start of the next school year. It also poses another challenge for policy makers who struggle to immunize a large percentage of adults. hesitant to take the picture. Many others may refuse to immunize their children.

Pfizer reported Several weeks ago, 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 responses and had roughly the same side effects seen in people aged 16 to 25.

Food and Drug Administration spokeswoman Stephanie Caccomo said she couldn’t comment on the timing of the agency’s decision.

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

Over 100 million adults in the United States have been fully vaccinated. But clearance would come in the midst of a delicate and complex push to reach the 44% of adults who have yet to receive a single injection.

With much of the world claiming the surplus vaccines manufactured in the United States, the use of the Pfizer-BioNTech vaccine in adolescents will also raise the question of whether the offer should be targeted at an age group that, so far, appears to be mostly spared from severe 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 are not enough vaccines in the world to protect them. adults at high risk of death. Said Jennifer B. Nuzzo, epidemiologist at the Johns Hopkins Center for Health Security.

President Biden has fallen increased pressure to donate part of the country’s vaccine supply. Some federal officials have also urged the administration to decide quickly on how much vaccine is needed, lest doses expire or be shipped to states and not be used. The federal government purchased 700 million doses of three vaccines authorized by the federal government to be delivered by the end of July, well in excess of what would be needed to cover all Americans.

White House officials said last week he intended to do up to 60 million doses of AstraZeneca vaccine available in other countries, provided federal regulators deem the doses safe. The vaccine has yet to receive clearance from US regulators. But global health groups and public health experts said the commitment was not enough.

Dr Rupali J. Limaye, a researcher at Johns Hopkins University who studies vaccine use and reluctance, said the United States should donate excess doses of Pfizer-BioNTech – and any excess of it. other manufacturers – India and other countries that have experienced severe outbreaks and have pleaded for help.

“From an ethical standpoint, we shouldn’t prioritize people like them over people in countries like India,” Dr Limaye said of adolescents.

If the United States maintains its supply of Pfizer-BioNTech, she said, it should be reserved for adults while health officials grapple with the phase of the vaccination campaign that demands more. personalized and local influence.

“We still have to go through hesitant adults, while possibly starting simultaneously at 14 or 15,” said Dr Limaye. “But the priority should always be adults.”

The current vaccine supply in the United States is substantial. As of Monday, around 65 million doses had been delivered but not administered, including 31 million doses of Pfizer-BioNTech vaccine, nearly 25 million doses of Moderna and 10 million doses of Johnson & Johnson, according to figures collected by the CDC

Both Pfizer and Moderna vaccines require two doses. Pfizer is licensed for ages 16 and over, while Moderna is licensed for ages 18 and over.

Tens of millions of additional doses of Pfizer-BioNTech – worth about three weeks, according to a federal official – have been manufactured and are in various stages of preparation, awaiting final testing before shipping.

Moderna is soon awaiting the results of its own clinical trial involving adolescents aged 12 to 17, followed by results for children 6 months to 12 years later this year.

The clearance from the Food and Drug Administration is likely to greatly allay the concerns of middle and high school administrators planning the fall. If students can be vaccinated by then, it could allow for more normal gatherings and allow administrators to plan further into the school year.

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