EU drugs regulator approves Pfizer’s Covid-19 vaccine for use in children aged 12 to 15

The European Medicines Agency (EMA) has approved the Covid-19 vaccine made by the US-German partnership Pfizer-BioNTech for children aged 12 to 15, allowing kids in the bloc to be vaccinated against the virus for the first time.

New data shows that the ‘Comirnaty’ vaccine is safe for the younger cohort, the EMA’s head of Biological Health Threats and Vaccine Strategy, Marco Cavaleri, told a press conference on Friday.

Cominarty is the brand name of the US-German jab. The jab will be administered the same way as it has been so far for people aged 16 and over, with two doses administered at least three weeks apart.

The EMA’s human medicines committee based its decision to approve the vaccine on a US clinical trial of around 2,000 children aged 12 to 15.

Trial data showed that the immune response in this age group was “similar or even better” than that of young adults given the vaccine, Cavaleri said.

He added that the jab was “well-tolerated” and side effects were similar to those already witnessed among older recipients.

A final decision on the vaccine still needs to be made by the EU itself, before it will be up to individual member state governments whether or not they roll out the jab to younger teenagers.

The move follows the US Food and Drug Administration’s decision earlier this month to approve Pfizer’s vaccine for children aged 12 to 15.

The US regulator said clinical trial data showed the vaccine was 100% effective in preventing Covid-19 in children of this age group.

On Friday Cavaleri also said the EU was working to increase production capacity for Pfizer in Europe, saying that further vaccine manufacturing sites would be approved as soon as possible to boost the rollouts of member states.

Earlier in 2021, the bloc was hit by a shortfall in jabs after AstraZeneca fell short of delivery targets to the EU, citing European production issues.

In January Pfizer also shipped fewer doses to some EU nations than had been expected while the company carried out upgrades to boost its production capacity.