FDA to approve Pfizer’s vaccine for teens ages 12 to 15 next week

The Food and drug administration of the United States (FDA for its acronym in English) would be prepared to authorize the use of the Pfizer-BioNTech vaccine against COVID-19 in adolescents aged 12 to 15 years early next week, according to federal officials familiar with plans for the agency, which will expand the North American country’s vaccination campaign, which has already applied more than 245.5 million doses, according to figures from the British tracker Our World In Data.

The news is eagerly awaited: anxious parents had been counting the weeks since Pfizer announced the results of its trial in adolescents, which shows that the vaccine is at least as effective in this age group as in adults. Vaccination of children is also essential to increase the level of herd immunity in the population and reduce the number of hospitalizations and deaths.

The long-awaited clearance could arrive at the end of this week, as reported by reporters Noah Weiland, Sharon LaFraniere and Apoorva Mandavilli of The New York Times. The next step would be that an advisory group of vaccine experts from the United States Centers for Disease Control and Prevention (CDC) meet to review clinical trial data and make appropriate recommendationss for the use of this vaccine in adolescents.

BioNTech and Pfizer laboratories announced at the end of March that their vaccine against the coronavirus showed 100% effectiveness in young people between 12 and 15 years old. and they hoped to start vaccinating them before the next school year, which begins in the United States at the end of August.

Phase III clinical trials conducted in 2,260 adolescents in the United States “showed 100% efficiency Yes a robust response in the form of antibodies “the companies said in a statement.

As detailed, volunteers produced strong antibody responses and experienced roughly the same side effects as in people aged 16 to 25.

“We plan to send this data to the FDA (the US regulator) as a Proposal for an amendment to our emergency use authorization in the coming weeks and to other regulators around the world, Hope that start vaccinating this age group before the next school year ”, said the CEO of Pfizer, Albert Bourla.

The CEO of German company BioNTech said the results showing high protection for adolescents are “very encouraging given the trends we have observed in recent weeks con the distribution of the British variant B.1.1.7 ”.

Stephanie Caccomo, a spokesperson for the Food and Drug Administration, warned he could not comment on the timing of the agency’s decision, but stressed: “We can assure the public that we are working to consider this request as quickly and transparently as possible.“.

104.7 million adults in the United States have already been fully vaccinated against COVID-19, according to Our World In Data. But the authorization would come as part of a delicate and complex process to reach 44% of adults who have so far hesitated to be vaccinated or have not had access to it.

The BioNTech / Pfizer injection is based on new mRNA technology and was the first COVID-19 vaccine approved in the West late last year. The United States and the European Union have approved its use for people over 16 years of age. Since, has been used in millions of adults in over 65 countries.

A study of 1.2 million people inoculated with the Pfizer BioNTech vaccine in Israel found that this antidote had a 94 percent effective. As the world struggles to vaccinate, BioNTech said in late March that was on track to manufacture 2.5 billion doses of its vaccine this year.

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