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EMA Gives Green Light for Pfizer-BioNTech Vaccine from Five Years

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The European medicines agency EMA has given the green light to the Pfizer-BioNTech vaccine against the coronavirus for children aged five to eleven. The EMA announced this on Thursday.

 

The dose of vaccine that children can receive would be lower than has hitherto been the case in older age groups. However, two injections will still be needed. The EMA concludes that the benefits of the vaccine in children aged five to 11 “outweigh” the risks, “particularly in children who are at higher risk for severe COVID-19”.

A study in children aged 5 to 11 showed that at a lower dose, they had a similar amount of antibodies as the age group of 16 to 25 year olds at a higher dose. The study also shows effectiveness that, statistically speaking, is between 68 and 98 percent, with a probability bordering on certainty. In this one study itself, the effectiveness was 91 percent.

Specifically, nearly 2,000 children took part in the study. Some received the vaccine, others a placebo Of the more than 1,300 children who received the vaccine, 3 developed covid. Of the more than 660 children who received a placebo, 16 developed Covid.

“The most common side effects in children aged five to 11 years are similar to those seen in children aged 12 years or older. These include pain at the injection site, fatigue, headache, redness and swelling at the injection site, muscle aches and chills. However, these effects are usually mild or moderate and improve after a few days,” the EMA said in the press release.

The safety and effectiveness, in both children and adults, will be further monitored. Now that the EMA has prepared its advice, it is up to the European Commission to make a final decision, but that is considered a formality.

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