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BioNTech, Pfizer seek EU approval for kid's COVID vaccines

April 30, 2021

If approved by EU regulators, children over the age of 12 would be allowed to receive the BioNTech-Pfizer coronavirus vaccine — extending a level of protection to younger populations.

A doctor vaccinates a child
Image: Julian Stratenschulte/dpa/picture alliance

German vaccine manufacturer BioNtech and US pharma giant Pfizer officially requested European Union regulators to widen approval of their coronavirus vaccine to include adolescents.

The companies asked for approval for their jab to be extended to children ages 12 to 15, after trials showed the jab was safe and effective.

How long could approval take?

The European Medicines Agency (EMA) will now review the request.

On Thursday, BioNTech's CEO Ugur Sahin told the news magazine Der Spiegel that the evaluation "takes four to six weeks on average." 

He added that the vaccine should be available to 12- to 15-year-olds in Europe by June.

Is it really necessary to vaccinate kids?

While young people are less likely to suffer severe cases of COVID-19, they are more likely to have an asymptomatic infection, unwittingly transmitting the virus to others.

The vaccination of children is seen as the next important step in achieving herd immunity and ending the pandemic.

Having older children vaccinated before the start of the next school year would also relieve the pressure on parents struggling with the demands of homeschooling.

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

The manufacturers announced in March that the final phase clinical trials of their vaccine for 12 to 15-year-olds showed it was 100% effective at preventing the disease.

US teens can get COVID vaccines

Timeline for more vaccines

BioNTech and its partner Pfizer have already applied for authorization for the vaccine for 12 to 15 year-olds in the United States. Teenagers over the age of 16 can already take the two-shot vaccine that is available for adults.

However, the companies are also keen to obtain approval for a vaccine for younger children.

Results from clinical tests should be available on a vaccine for children aged 5 to 12 by July. Figures for a jab for younger children, aged 6 months and upwards, should be on hand by September.

"If all goes well, as soon as the data is evaluated, we will be able to submit the application for approval of the vaccine for all children in the respective age group in different countries," BioNTech's Sahin told Der Spiegel.

Sahin said that current trials for younger age groups were "very encouraging" with figures suggesting "children are very well protected by the vaccine."

Easier-to-use version on the way

BioNTech-Pfizer's Comirnaty vaccine uses novel messenger RNA technology to program cells to generate immunity to the virus.

The current version of the vaccine used in adults must be stored at minus 70 degrees Celsius (minus 94 degrees Fahrenheit). This has limited its distribution to specially equipped vaccination centers.

However, Pfizer last week said it was planning a new version of Comirnaty that can be stored in a standard freezer and comes diluted and ready for use.

This article was originally published on April 29, 2021 and has been updated following BioNTech and Pfizer's request for the EMA to approve their vaccine for children 12 and older.

rs, rc/sms (AFP, dpa, AP)