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The FDA is set to approve the Pfizer vaccine for adolescents by next week



The Food and Drug Administration is preparing to allow the use of Pfizer-BioNTech Covid-19 in adolescents aged 12 to 15 until early next week, according to federal officials familiar with the agency’s plans, opening the country’s vaccination campaign for millions more Americans.

The news is eagerly awaited: impatient parents are counting down the weeks since Pfizer announced the results of its experience in adolescents, showing that the vaccine is at least as effective in this age group as in adults. Vaccination of children is also key to raising the level of immunity in the population and reducing the number of hospitalizations and deaths.

The permit could come as early as the end of this week, according to federal officials, who did not give their names because they were not authorized to speak in public. If granted, the vaccine advisory committee of the Centers for Disease Control and Prevention is likely to meet the next day to review clinical trial data and make recommendations for the use of the vaccine in adolescents.

The permit will be a major development in the national vaccination campaign and would welcome news for parents seeking 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. In late March, the company announced that the volunteers were producing strong antibody reactions and experiencing 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 agency’s move.

“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 country have already been fully vaccinated. But the resolution would arrive in the midst of a delicate and complex push to reach 44 percent of adults who have so far been reluctant to receive a shot or do not have access to one.

As much of the world claims an oversupply of US-made vaccines, the use of Pfizer-BioNTech in adolescents may also raise questions about whether supplies should be targeted at an age group that appears to be spared a severe attack of 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 high-risk adults from dying,” said Jennifer Nutzo. , an epidemiologist at the John Hopkins Center for Health Security.

President Biden is under increasing pressure to cut off part of the country’s vaccine supply, and even in the federal government, some officials are urging 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 beyond what is needed to cover every American.

The current supply of vaccines in the country is significant. As of Monday, about 65 million doses had been delivered but not received, including 31 million doses of Pfizer-BioNTech, nearly 25 million doses of Moderna and 10 million doses of Johnson & Johnson’s, according to data collected by the Centers for Disease Control and Prevention. Both Pfizer and Moderna vaccines require two doses.

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, waiting to pass final tests 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 in the second half of this year.


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