Filenews 3 May 2021
The EMA will deliver an opinion in June on extending the use of Pfizer's vaccine to the ages of 12-15, the European Medicines Agency announced today from Amsterdam.
In particular, ema announced that it has started evaluating an application to extend the use of the COVID-19 Comirnaty vaccine to include young people aged 12 to 15 years.
"The EMA's Human Medicines Committee (CHMP) will carry out a rapid evaluation of the data submitted by the comirnaty trading company, including the results of a large ongoing clinical trial involving adolescents as young as 12, in order to decide whether to recommend the expansion."
"The CHMP's opinion will then be forwarded to the Commission, which will issue a final legally binding decision valid in all EU Member States," he explains.
"The EMA will communicate on the outcome of its assessment, which is expected in June, unless additional information is required," it notes.
As the EMA reports, "Comirnaty is a vaccine for the prevention of COVID-19, currently approved for use in people aged 16 years and over".
"It contains a molecule called messenger RNA (mRNA) with instructions for the production of a protein, known as the protein spike, naturally found in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2," he says.
Source: KYPE
