Coronavirus: Global situation

Pfizer, BioNTech seek EU approval for use of vaccine in young teens

Staff working on the production of the Pfizer-BioNTech Covid-19 vaccine at a plant near Hamburg, Germany. The companies have submitted a request to the European Medicines Agency to expand the use of their vaccine to those aged 12 to 15 years.
Staff working on the production of the Pfizer-BioNTech Covid-19 vaccine at a plant near Hamburg, Germany. The companies have submitted a request to the European Medicines Agency to expand the use of their vaccine to those aged 12 to 15 years. PHOTO: AGENCE FRANCE-PRESSE

FRANKFURT • Pfizer and BioNTech said they have asked European regulators to authorise their Covid-19 vaccine for those aged 12 to 15, a move seen as a crucial step towards achieving herd immunity.

The companies filed a similar request with United States authorities earlier this month. Their vaccine is currently approved for use only in people aged 16 and over.

In a joint statement released yesterday, Pfizer and BioNTech said they had submitted a request to the Amsterdam-based European Medicines Agency (EMA) to expand the use of their jab to include "adolescents 12 to 15 years of age".

Mr Ugur Sahin, co-founder and chief executive of Germany's BioNTech, on Thursday said the jab could be available for those age groups from next month if European Union approval is granted.

The move comes after phase three trial data showed the vaccine provided "robust antibody responses" and was 100 per cent effective in warding off the disease among those aged 12 to 15.

"The vaccine also was generally well tolerated," the statement said.

In an interview with Der Spiegel weekly, Mr 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 EU member states.

Pfizer and BioNTech added that they also plan to seek authorisations "with other regulatory authorities worldwide".

No coronavirus vaccine is currently authorised for use on children.

While children and teenagers are less likely to develop severe Covid-19 symptoms, they make up a large part of the population and inoculating them is considered key to ending the pandemic.

The prospect of getting older children vaccinated before the next school year begins would also ease the strain on parents who are juggling the demands of homeschooling while keeping up with jobs.

"It's very important to enable children a return to their normal school lives and allow them to meet with family and friends," Mr Sahin told Der Spiegel.

BioNTech and Pfizer are also racing to get their vaccine approved for younger children, 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," Mr Sahin said.

Ongoing trials so far are "very encouraging", he added, suggesting that "children are very well protected by the vaccine".

The BioNTech-Pfizer shot is based on mRNA technology and was the first Covid-19 jab to be approved in the West late last year.

AGENCE FRANCE-PRESSE

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A version of this article appeared in the print edition of The Straits Times on May 01, 2021, with the headline Pfizer, BioNTech seek EU approval for use of vaccine in young teens. Subscribe