Pfizer aims to submit trial data for children aged five to 11 ‘this month’

Children as young as five could soon be given the Pfizer coronavirus vaccine, with the company set to submit trial data to regulators “this month”.

The pharmaceutical giant announced in March that it had launched a series of clinical trials to test two doses of its vaccine, developed with the German firm BioNTech, in children as young as six months old. 

According to Pfizer’s chief executive, Dr Albert Bourla, results from the older cohort of participants – aged between five and 11 – are set to be submitted to regulators before the end of September. 

“We know that the vaccine works very well in young kids,” he told journalists on Tuesday. “We are working also to submit data from five to 11 [year olds] this month.”

Reports from the New York Times suggest results for children aged between two and five are expected shortly afterwards, while data on infants aged between six months and two years could be submitted in October or November. 

It is likely that, in line with Pfizer's approach to approval for the booster shots, the data on five to 11 year olds will first be submitted to the US Food and Drug Administration. 

The trial is testing a two shot regimen 21 days apart, but with a slightly smaller dosage – 10 micrograms, rather than the 30 micrograms used in children and adults over 12. 

Dr Bourla’s comments come amid increasingly fraught discussions around whether to vaccinate children in the UK. 

While more than 10 million children over 12 have been given Covid jabs in the United States, the UK’s Joint Committee on Vaccinations and Immunisations (JCVI) has taken a more cautious approach, advising that only “high risk” children with certain underlying conditions receive a vaccine. 

For healthy children, the committee argued, the benefits of a jab only “marginally” outweigh the risks, and the longer term impacts remain hazy. Much of the concern focuses around reports of myocarditis, a very rare but potentially fatal swelling of the heart muscle linked to the mRNA vaccines. 

But during Tuesday’s briefing, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Dr Bourla said the science supports vaccinating children. 

“It is not my role to say who should be receiving doses,” he said. “But what I can say, clearly, is that younger ages are getting sick... the percentage of people that will get severe [Covid] in older ages is higher than in younger, but this [risk] is not zero. 

“The other thing that we need to understand is that kids attend school. And because of that, the kids have much higher probability [of getting] infected, as they socialise in high proximity with other kids.

“We know that the vaccines work very well in young kids,” Dr Bourla said, adding that the Pfizer shot has already been approved in children over 12 in much of the world. 

In the UK, the increasingly fractious debate about whether or not to vaccinate children is expected to reach a conclusion this week. The UK’s chief medical officers are set to make a final decision on whether to follow the JCVI’s advice or overrule it following a broader analysis of the societal impacts of vaccinations.  

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