EU drug regulator approves first COVID shot for 5-11 year olds -Breaking
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(Reuters) – The European Union drug regulator has approved Thursday’s use of Pfizer BioNTech’s COVID-19 vaccine in children aged 5-11 years. It will allow them to get a shot at fighting the growing infections.
Comirnaty is a vaccine that’s administered as an injection to the upper arm. It will be given three times a week in doses of 10 mg each.
Adult doses contain 30 micrograms.
“The benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19,” the EMA said https://www.ema.europa.eu/en/news/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11.
According to the companies, their vaccine was 90.7% effective against coronaviruses in clinical trials with children aged 5-11 years old.
Pfizer BioNTech has approved the vaccine to be used in Europe for adolescents aged between 12-17 since May.
Final approval of the European Commission is at the discretion of the Commission. However, it usually follows EMA recommendations.
There is no indication when other countries will begin to offer the shots for younger children. Jens Spahn (the outgoing German Health Minister) stated that EU-wide distributions of low-dose paediatric versions would begin Dec. 20.
The bloc joins a growing number of countries https://reut.rs/3COxM1t, including the United States, Canada, Israel, China and Saudi Arabia, which have cleared vaccines for children in the 5-11 year age group and younger.
The shot will be available to tens or millions of European children aged between 13 and 24.
A new vaccine version was approved by the U.S. regulator for paediatric shots. It uses a different buffer, and can be kept in the refrigerator up to 10 days.
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