Pfizer/BioNTech stated Friday they’ve requested European regulators to authorise their Covid-19 vaccine for 12- to 15-year-olds, a transfer seen as an important step towards attaining herd immunity.
The firms already filed an analogous request with US authorities earlier this month. Their vaccine is presently solely authorised for use in individuals aged 16 and over.
In a joint assertion, Pfizer and BioNTech stated that they had submitted a request with the Amsterdam-based European Medicines Agency (EMA) to increase the usage of their jab to incorporate “adolescents 12 to fifteen years of age”.
Ugur Sahin, co-founder and CEO of Germany’s BioNTech, on Thursday said the jab could be available for those age groups from June if EU approval is granted.
The move comes after phase 3 trial data showed that the vaccine provided “robust antibody responses” and was one hundred pc efficient in fending off the illness amongst these aged 12 to fifteen.
“The vaccine additionally was typically properly tolerated,” the statement added.
In an interview with Der Spiegel weekly, Sahin said he expected regulators’ evaluation of the data to take four to six weeks.
If approved, the green light would apply to all 27 European Union member states.
Pfizer and BioNTech added that they also plan to seek authorisations “with other regulatory authorities worldwide”.
No coronavirus vaccines are presently authorised for use on youngsters.
While youngsters and youngsters are much less prone to develop extreme Covid, they make up a big a part of the inhabitants and inoculating them is taken into account key to ending the pandemic.
The prospect of getting older youngsters jabbed earlier than the following college yr begins would additionally ease the pressure on mother and father who’re juggling the calls for of homeschooling whereas maintaining with jobs.
“It’s essential to allow youngsters a return to their regular college lives and permit them to fulfill with household and associates,” Sahin informed Spiegel.
BioNTech and Pfizer are also racing to get their jab approved for younger kids, from six months upwards.
“In July, the first results for five- to 12-year-olds could be available, and those for younger children in September,” Sahin stated.
Ongoing trials thus far are “very encouraging”, Sahin said, suggesting that “children are very well protected by the vaccine”.
The BioNTech/Pfizer shot is predicated on mRNA know-how and was the primary Covid-19 jab to be authorised in the West late final yr.
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