The German laboratory Bioentech and its American partner Pfizer have applied for the authorization of their anti-covid vaccine for children aged 12-15 years, paving the way for approval in the European Union in June, Bioentech announced on Friday.
Based on a clinical study showing that this age group has a “100% effect”, Bioentech and its American partner Pfizer said in a press release that the “extension” of authority is currently valid for adults over 16 years of age. Such a procedure usually takes between four and six weeks.
In the United States, two companies had already filed a similar request in early April to extend the emergency powers granted by the FDA.
These requests are based on data from a 3rd phase clinical study published in late March, showing the “100% effectiveness” of the vaccine in preventing disease at this age. It is “generally well tolerated”.
Pfizer and Bioemtech reported in late March that side effects “correspond to what is commonly observed” in 16- to 25-year-olds.
Currently children do not have the vaccine, less exposure to severe cases of the disease, and whose vaccines have not yet been prioritized.
But they represent a large part of the population, so immunity is also needed to prevent the spread of the disease, experts argue.
German Health Minister Jens Spann on Thursday ruled that 12-15 year olds should be vaccinated as “fresh during the summer holidays”.
For children aged 5 to 12, biotech director Ugur Sahin continues to rely on clinical study results in July, considering himself a “track” for authority in early September.
The results of a study of young children will be available from September, the German newspaper Spiegel told Thursday.
For these requests, “certification takes between four and six weeks,” Mr Sahin said.
The German-American alliance plans to make similar requests to children aged 12 to 15 to “other regulatory authorities in the world.”
The Pfizer / BioMTech vaccine, based on the latest messenger RNA technology, is the first COVID-19 vaccine to be approved in the West by the end of 2020.
Clinical trials of other vaccines in children are underway.
On Wednesday, the co-founder of the Mainz Laboratory told Variant Indian about the coronavirus, which was considered “mass immunity” in Europe “in August” in July and confirmed his “confidence” in the effectiveness of the vaccine.