MOSCOW (Pakistan Point News / Sputnik - 29th May, 2021) The European Medicines Agency (EMA) has approved the use of the COVID-19 vaccine developed by Pfizer/BioNTech in adolescents aged 12-15, Marco Caveleri, the head of EMA's Biological Health Threats and Vaccines Strategy, said on Friday.
"The EMA scientific committee for human medicines, that is the CHMP, has today approved the use of the vaccine from Pfizer/BioNTech, which is called Comirnaty, in adolescents from 12 to 15 years. The vaccine, as you know, was already authorized in people from the age of 16 and above, and now we have data that would show that the vaccine is safe also in the ages of 12 and 15 years and that has allowed the scientific committee to indeed conclude today," Caveleri told a briefing.
The committee concluded that the benefits of the vaccine in this age group outweighed the risks, although it said that the small size of the test group (1,005 children) meant that the trial could not detect rare side effects.
Caveleri said that EMA was looking to receiving an application for emergency use authorization from Moderna, which "hopefully we will able to evaluate in the coming weeks and come up with an opinion as soon as possible."
"At the moment there are no other pediatric plans ongoing, at least for the vaccines that are authorized in the EU," he added.
The United States and Canada have fast-tracked the approval of the Pfizer vaccine for the use in those aged 12 through 15. Italian and German drug regulators said earlier that they would approve the use of the vaccine in teens in the coming days. Germany plans to start immunizing teens from the age of 12 from June 7.
