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EMA evaluates Pfizer’s request for a booster dose in adolescents aged 12 to 17

The European Medicines Agency (EMA) on Tuesday began studying a request from Pfizer/BioNTech for the use of its booster doses in adolescents aged 12 to 15 years, which adds to another request that it was analyzing to authorize the third dose against COVID-19 in young people aged 16 and 17.

The booster injection of this mRNA vaccine is recommended by the EMA for all adults over 18 years of age who have already received their primary two-dose regimen at least three months earlier, with the goal of “restoring protection after it has waned” over time and after SARS- CoV-2.

The agency’s Committee for Human Medicines (CHMP) will expeditiously assess the data submitted by the pharmaceutical companies that developed the vaccine, including data on evidence generated from experience in Israel, to determine the need for and efficacy of a third dose in people ages 12 to 17 with a healthy immune system.

There is no date yet for the announcement of the recommendations of the EMA in this sense.

Although the agency issues recommendations based on scientific evidence on vaccination strategies against COVID-19decisions on how to administer the vaccines remain the prerogative of the technical advisers of each European country, who are the ones who guide the campaigns in each EU Member State.

The EMA underlines that it is not for this agency but for the national public health agencies to issue official recommendations on the use of booster doses and on the associated travel certification requirements, such as the expiration date of the covid passport or the intervals of time between the full pattern or contagion and reinforcement.

Pfizer It was the first vaccine to receive approval from the EMA in this pandemic, in December 2020, but since then the agency has given the green light to the use of four other preparations: Moderna, AstraZeneca, Janssen and Novavax.


Pharmaceutical giant Pfizer and its partner BioNTech are preparing to ask US health authorities to authorize their COVID-19 vaccine for children under 5, US media reported on Tuesday. (Source: AFP)

Source: Gestion

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