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First coronavirus vaccine for older children could be approved in June, BioNTech founder suggests

Scientist behind Pfizer jab says early trials have produced ‘encouraging results’

Conrad Duncan
Friday 30 April 2021 22:07 BST
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The first coronavirus vaccine for children could be approved for those aged 12 and above by June, according to the chief scientist behind the Pfizer/BioNTech jab.

Professor Ugur Sahin, the co-founder of BioNTech, told the German magazine Der Spiegel that early trials had produced “encouraging results”, showing children over the age of 12 were “particularly well protected by the vaccine”.

Pfizer/BioNTech submitted a request on Friday for EU drug regulators to extend the approval of the companies’ Covid-19 vaccine to include children aged 12 to 15.

The two companies said in a statement that their submission to the European Medicines Agency (EMA) was based on an advanced study in more than 2,000 adolescents that showed the vaccine was safe and effective.

As the evaluation usually takes a few weeks, older children could start to receive the jab in June.

Prof Sahin added that he was hopeful younger children could start to receive the vaccine later this year.

“In July, we could have the first results for the five- to 12-year-olds, and in September for the younger kids. The evaluation will take about four to six weeks,” he told Der Spiegel.

“If everything goes well, once the data has been evaluated, we can submit the request for approval of the vaccine for children in the respective age group in different countries.”

Earlier this month, Pfizer/BioNTech requested an extension to their emergency use authorisation with the US Food and Drug Administration for children aged 12-15.

The Covid-19 jab was previously approved by the EMA in December, when it was licensed for anyone aged 16 and over across the EU’s 27 countries.

It is currently unclear when they will seek approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) but a Pfizer spokesperson told The Guardian in late March that they hoped to submit data “in the next couple of months”.

German health minister Jens Spahn said on Friday that approval could “make a further real difference to our vaccine campaign”.

Although children are at much lower risk from Covid-19 than adults, vaccinating children of all ages will likely be important for stopping the pandemic as some research shows older children may play a role in spreading the virus.

Immunising children may also be important for reopening schools safely without the need for social distancing and other restrictions.

“It’s very important to allow children to return to normal school routine and to make it possible for them to meet with family and friends,” Prof Sahin told Der Spiegel.

Other vaccine manufacturers including AstraZeneca, Moderna and Johnson & Johnson are also studying whether their jabs can safely be used in children.

Additional reporting by AP

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