The European Medicines Agency authorizes the Comirnaty COVID-19 vaccine in children ages 12 to 15
02/06/2021
On 28 May 2021, the Committee for Medicinal Products for Human Use, of the European Medicines
Agency (EMA/CHMP), recommended granting an extension of indication for the Pfizer COVID-19 vaccine Comirnaty to include use in children ages 12 to 15. This vaccine had initially been approved for use in adults and in adolescents age 16 and older. The vaccination schedule for children ages 12 to 15 will be the same: two injections in the muscles of the upper arm, given three weeks apart.
The effects of the Comirnaty vaccine in children were studied in 2,260 children ages 12 to 15; the trial showed that the immune response to the Comirnaty vaccine in this group was comparable to the immune response in the 16 to 25 age group (as measured by the level of antibodies against SARS-CoV2). The efficacy of the Comirnaty vaccine was assessed in nearly 2,000 children ages 12 to 15; of the 1,005 children who received the vaccine, none developed COVID-19, compared to 16 of the 978 children in the placebo group who contracted the disease. Thus, in this study the vaccine was 100% effective in preventing COVID-19 (although the actual rate could be between 75% and 100%).
Source: https://www.ema.europa.eu/en/news/first-covid-19-vaccine-approved-children-aged-12-15-eu