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EU approves Pfizer-BioNTech COVID-19 vaccine for adolescents

NEW YORK (Reuters): Pfizer Inc (PFE.N) has planned to ask US regulators to authorize a booster dose of its COVID-19 vaccine within the next month based on evidence of greater risk of reinfection six months after inoculation and the spread of the highly contagious Delta variant.

BRUSSELS: The European Commission has authorised Pfizer and partner BioNTech’s COVID-19 vaccine for use in children as young as 12, paving the way for a broader rollout in the bloc after similar clearances in the United States and Canada.

The decision comes after European Medicines Agency (EMA) backed the use of the vaccine in 12- to 15-year olds earlier in the day. The agency’s endorsement came weeks after it began evaluating extending use of the vaccine to include that age group. The vaccine is already being used in the European Union for those aged 16 and above.

The EMA said two doses of the vaccine, branded as Comirnaty, were required in the 12-15 age group and should be administered with an interval of at least three weeks, the same as for adults, adding that it was up to individual EU states to decide if and when to offer the vaccine to teenagers.

Distribution and administration of the vaccine by the EU member states will continue to be determined according to the populations identified in the EU and as per national guidance, Pfizer and BioNTech said.

Earlier Germany laid out plans to offer shots to 12-year-olds from June 7, pending the EMA’s verdict. Italy has also said it is preparing to extend its campaign to over 12-year olds.

Youngsters have been much less likely to suffer severe disease, with many experiencing no symptoms, allowing them to unwittingly transmit COVID-19 to others. However, giving vaccines to younger people in affluent countries while many parts of the world await doses for older and more vulnerable people has raised concerns.

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Pfizer and BioNTech in March unveiled trial data showing their vaccine offered 100% protection against the infectious disease in a trial with 2,260 adolescents aged 12 to 15. The pair marched ahead of other drugmakers, including AstraZeneca, Moderna, and Johnson & Johnson, who are working on vaccines for children, some as young as six months.

The shorter duration of safety monitoring in trials so far in the 12-15 age group compared with older cohorts was not a concern, said Marco Cavaleri, EMA’s head of health threats and vaccines strategy.

“Based on the experience that we’ve gathered with many other vaccines throughout the years is that … what we see with young adults is also seen in adolescents,” he told a news briefing, when asked about side effects. He added that monitoring would intensify as vaccine recipients become younger in future.

EMA also said that reports of cases of an inflammation of heart muscles following vaccination with Comirnaty were no cause for concern as they continued to happen at a rate that typically affected the general population.