EU drug agency starts evaluating Pfizer vaccine for 12- to 15-year olds

Europe’s medicines watchdog said Monday that it had begun evaluating the use of the Pfizer-BioNTech COVID-19 vaccine for 12- to 15-year-olds, after a similar request in the United States.

Its possible authorization for children is seen as a crucial step toward achieving herd immunity.

The European Medicines Agency’s human medicines committee “will carry out an accelerated assessment of data submitted by the company that markets Comirnaty,” said an EMA statement — referring to vaccine’s brand name.

This included results from a large ongoing clinical study involving adolescents from 12 years of age, the Amsterdam-based agency said.

The agency would announce its findings in June “unless supplementary information is needed,” the statement added.

Pfizer and BioNTech on Friday asked the European regulator to authorize their COVID-19 vaccine, after filing a similar request with the US authorities earlier in April.

Their vaccine is currently only approved for use on people aged 16 and over.

The move comes after phase 3 trial data showed the vaccine provided “robust antibody responses” and was 100-percent effective in warding off the disease among those aged 12 to 15, the companies said.

If approved, the green light would apply to all 27 European Union member states.

Pfizer and BioNTech added that they also planned to seek clearance from “other regulatory authorities worldwide.”

No coronavirus vaccines are currently authorized for use by children.

While children and teenagers are less likely to develop severe COVID, they make up a large part of the population, and inoculating them — to prevent them from infecting others — is considered key to ending the pandemic.

Getting older children vaccinated before the next school year begins would also ease the strain on parents juggling the demands of homeschooling and work.

“It’s very important to enable children (to make) a return to their normal school lives and allow them to meet with family and friends,” Ugur Sahin, co-founder and CEO Germany’s BioNTech told German weekly Der Spiegel last week.

BioNTech and Pfizer are also racing to get their shot approved for younger kids, from six months upwards.

The BioNTech/Pfizer shot, based on mRNA technology, was the first COVID-19 jab to be approved in the West late last year.

Israel is already making preparations to launch a vaccination drive of 12- to 15-year-olds following its adult inoculation campaign, which has given the Pfizer-BioNTech shots to over half the population. Health officials have said the program will start as soon as US authorities approve the vaccines for use with children.

Last month, Israel signed deals to purchase millions of Pfizer-BioNTech and Moderna vaccine doses to ready the country for another campaign that would also include young adolescences.

The Israeli Pediatric Associated has called for parents and family doctors to vaccinate their children when the Pfizer-BioNTech vaccine is approved for those children. Currently, the vaccine has emergency authorization for use in people 16 and older.

Source Link: https://www.timesofisrael.com/eu-drug-agency-starts-evaluating-pfizer-vaccine-for-12-to-15-year-olds/

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