European regulator says yes to BioNTech / Pfizer coronavirus vaccine for young children – POLITICO

EU countries may soon start vaccinating children as young as five against COVID-19 after European Medicines Agency noted the BioNTech / Pfizer COVID-19 vaccine was safe and effective in young children.

The EMA’s Medicines Committee, the CHMP, on Thursday recommended that the vaccine be given in two doses three weeks apart to people aged five to 11. The dose in this age group is one-third of the amount given to people aged 12 and older, the EMA said.

A study in this age group showed that this lower dose elicited an antibody response similar to that seen in adults aged 16 to 25 years.

A placebo-controlled study of nearly 2,000 children aged five to 11 without previous coronavirus infection found the vaccine to be 90.7% effective in preventing symptomatic COVID-19.

Side effects seen in the study were similar to those seen in adults, such as pain at the injection site, headache, and chills.

Since the Delta variant dominated in Europe, infection rates have skyrocketed, especially among young people. Although they are less likely to suffer from serious illness, they bring the highly transmissible virus back to their homes.

In Austria, which has just entered a full lockdown and is planning a general vaccine mandate from February, the latest weekly impact among 5-14 year olds is 2,249 cases per 100,000 people, more than double the national figure.

The World Health Organization also changed tack and supported immunizing children on Wednesday, depending on local situations, but said global vaccine sharing should come first.

Once the EMA decision is approved by the European Commission, EU countries will decide whether and when to extend the jab to young children.

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