The Pfizer-BioNTech vaccine is 90.7% effective in preventing symptomatic forms of the coronavirus in children aged five to 11, Pfizer announced on Friday.
The company made the announcement in a document supporting its application for emergency use authorisation (EUA) for that age group in the United States, which was posted on the US Federal Drug Agency (FDA) website.
The FDA found that, in almost every scenario, the vaccine’s effectiveness in preventing hospitalisations and deaths from the virus outweighed any potential side effects in children.
According to Pfizer, the vaccine’s effectiveness against symptomatic forms of the virus at least seven days after the second dose was 90.7%, based on the results of a study among 2,250 children aged 5 to 11, of whom 1,500 had received the vaccine while 750 were given a placebo.
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The results showed that the risk of falling ill from Covid-19 was more than 90% lower in the vaccinated group.
Pfizer also stated that no severe illnesses and no cases of multi-inflammatory syndrome or myocarditis (inflammation of the cardiac muscle) were observed after vaccination.
The dose has been adapted to 10 microgrammes per injection for children, down from the 30 microgrammes dose that is given to older groups.
These results follow the announcement made by Pfizer one month ago that its vaccine is “safe and effective” for use in children between the ages of five and 11, which included results on the immune response but not on the effectiveness of its remedy.
Road to approval
An FDA consultative committee of the US Federal Drug Agency comprising external vaccine experts is scheduled to meet on Tuesday to study Pfizer’s EUA application.
If the US health authorities give Pfizer the green light, the injections could begin in early November since the White House announced early this week that it planned to fast-track the distribution of millions of doses throughout the country.
The European Medicines Agency (EMA) also started evaluating an application to extend the use of the Pfizer/BioNTech coronavirus vaccine for children aged over five on Monday.
Whether Belgium will decide to vaccinate children under 12 years old will depend on the EMA’s evaluation, according to Gudrun Briat, spokesperson for Belgium’s Vaccination Taskforce.
“Should this file be approved, it will also become accessible to the EU Member States,” she told The Brussels Times.
“In our case, the Superior Health Council will then look at the results of the study and issue an opinion based on them,” Briat added. “Then, based on that advice, the policymakers will see what will happen in Belgium.”