Pfizer plans to seek emergency approval for its Covid vaccine in younger people after a US trial found the jab prevented the disease and was “well-tolerated” in 12- to 15-year-olds.
The US pharmaceutical company, which partnered with the German firm BioNTech to manufacture the vaccine, said it would submit the trial data to the US Food and Drug Administration in the coming weeks and to other regulators thereafter.
In a statement, Albert Bourla, Pfizer’s chairman and chief executive, said approval would pave the way for vaccinations to start in the new age group before the next school year. The vaccine is already approved for use in those aged 16 and above.
Researchers in the US examined the use of the Pfizer/BioNTech vaccine in a trial of 2,260 children aged 12 to 15. Half were given the jab and half a placebo. The trial recorded 18 cases of Covid among 1,129 people in the placebo group, and zero cases among the 1,131 who received the vaccine.
“We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Bourla added. A Pfizer spokesperson told the Guardian the company hopes to submit the data to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the next couple of months.
The announcement will lift hopes of getting millions more children safely back into classrooms after more than a year of their education being disrupted by the coronavirus pandemic. The company is ramping up production and distributing its vaccine internationally at an accelerating rate.
According to the Pfizer statement, the vaccine was well-tolerated, with side effects similar to those seen in the 16- to 25-year-olds in the adult trial. The statement does not elaborate on the side effects for the younger group, but those in the adult trial were generally mild to moderate and included injection-site pain, headaches, fever and fatigue.
Pfizer and BioNTech also studied a subset of trial volunteers to measure the level of virus-neutralising antibodies a month after the second dose and found it was comparable to study participants aged 16 to 25 in the pivotal trial in adults.
Last week, the companies gave the first vaccine doses in a series of trials testing the vaccine in even younger children. The aim is to approve the vaccine for much younger children, including toddlers and babies, eventually vaccinating those as young as six months of age.
Adam Finn, a professor of paediatrics at Bristol University who sits on the Joint Committee on Vaccination and Immunisation (JCVI) said it was not yet clear whether children in the UK would need to be vaccinated to keep Covid under control. “However, we definitely do need to put ourselves in a position to be able to do that if it does prove necessary,” he said.
“The questions that comes up is why does that make sense for children given that they very rarely get seriously ill with Covid? I think the best answer to that question is that they all stand to benefit if we can keep schools functioning normally as they suffer disproportionately from the suspension of their normal educational and social activities.”
Other manufacturers have their own vaccines in trials with children. Oxford University announced last month that it was opening up trials of its vaccine, made with AstraZeneca, to those aged six to 17. Meanwhile, the US firm Moderna, which makes an RNA vaccine similar to Pfizer’s, has started enrolling for a trial that will assess the jab in children from six months to 12 years old.
