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United States: drug agency gives green light to Pfizer to vaccinate teens


The American Medicines Agency has just authorized the use of this vaccine against the coronavirus for adolescents aged 12 to 15 years

After Canada, it is the turn of the United States to extend the vaccination to adolescents with the Pfizer-BioNTech serum to young people.

In a press release, which was expected, the American Medicines Agency (the FDA) announced on Monday evening "the extension of the authorization for emergency use of the Pfizer vaccine for the prevention of Covid-19".

If the original clearance was for those 16 and over, all Americans aged 12 and over will now be eligible.

This is "an important step in the fight against the Covid-19 pandemic," Janet Woodcock, the acting chief of the FDA, said in a statement. “Our action today allows a younger population to be protected against Covid-19. It brings us closer to a sense of normalcy and the end of the pandemic. Parents and guardians can rest assured that the agency has undertaken a rigorous and in-depth review of all available data, as we have done with all of our emergency vaccine use authorizations, ”she said. added.

The FDA also recalls that from March 1, 2020 to April 30, 2021, approximately 1.5 million cases of coronavirus in people aged 11 to 17 were reported to the Centers for Disease Control and Prevention (CDC), the American health agency.

Most of the time, minors suffered from milder forms than adults.

100% efficiency from the second injection

Pfizer said in late March that a clinical trial involving 2,260 young people aged 12 to 15 had shown that it was 100% effective and was well tolerated.

"The data from the clinical trial showed that after the second dose, the prevention effectiveness of Covid-19 in this younger age group was 100%", compared to more than 90% in adults, had assured the Canadian Ministry of Health.

To read also Covid-19: "To hope to stop the epidemic, it is necessary to vaccinate the children and the teenagers"

However, the FDA warns that “the most common side effects reported in adolescents participating in clinical trials generally lasted one to three days.

They were mainly fatigue, headache, chills, muscle pain, fever, and joint pain.

More adolescents reported these side effects after the second dose than after the first dose.


President Biden last week underlined the crucial role of adolescent vaccination in the continuation of the American immunization campaign.

After the announcement of the authorization by the FDA, "we will be ready to act immediately," he said.

These are 20,000 pharmacies which should thus be able to vaccinate adolescents in the coming days, and doses will subsequently be sent to pediatricians, he had detailed.

Soon in Europe?

A big week ago, Pfizer announced that it planned to submit an emergency use authorization from the FDA for children aged 2 to 11 in September.

The study of the safety and efficacy of the vaccine in children aged 6 months to 11 years is ongoing.

Moderna is also working on vaccine trials for children from six months old and could apply at the end of the summer.

Read alsoCovid-19: adolescents, soon allowed to be vaccinated?

Almost half of Americans have received at least one dose of the vaccine, twice as much as in France.

It is even triple for people who are fully vaccinated (more than 33% in the United States, 11% in France).

The American authorities are struggling to convince new volunteers and all means, some very original, are being implemented to achieve this.

Pfizer will "imminently" file a request with the European Medicines Agency. For their part, infectiologists and pediatricians say that it will be essential to vaccinate the youngest if we want to achieve collective immunity and regain a more normal life.

Source: leparis

All life articles on 2021-05-14

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