UK authorises Moderna's COVID-19 vaccine Spikevax for adolescents

The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday extended the conditional authorisation for Moderna's mRNA COVID-19 vaccine Spikevax, allowing it to be given to 12- to 17-year-olds in Great Britain. The agency had initially signed off on the vaccine for use in adults back in January.

The latest decision comes a few weeks after Spikevax obtained backing from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to expand the vaccine's EU authorisation to this age group as well. It also follows an MHRA nod in June allowing children as young as 12 to be vaccinated with Pfizer and BioNTech's Comirnaty.

Spikevax, also known as mRNA-1273, is being investigated in the ongoing Phase II/III TeenCOVE trial involving participants ages 12 to <18 years. In May, Moderna reported that the vaccine had achieved its primary immunogenicity endpoint, triggering immune responses comparable to those seen in a pivotal study of adults last year. Meanwhile, the MHRA has not identified any new side effects with Spikevax and said the safety data in children are similar to what has been seen in young adults, with most side effects being mild-to-moderate in nature.

Experts divided on vaccinating younger teens

It is now up to the UK's Joint Committee on Vaccination and Immunisation (JCVI) to decide whether Spikevax should be given to 12- to 17-year-olds as part of its deployment programme. The JCVI gave the go-ahead earlier this month for healthy 16- and 17-year-olds to get their first dose of Comirnaty ahead of schools reopening in September, adding that advice on when to offer the second dose would "come later."

However, several members of the expert committee remained largely opposed to extending vaccination to younger teens aged 12 to 15, despite lawmakers having signalled they would like to see a shift in the guidance. At the moment, children in that age group are offered Comirnaty only if they are considered clinically vulnerable.

"In the current UK situation, where there is good uptake of the vaccine amongst adults, we can take a more precautionary approach to vaccine rollout in younger people, who are at lower risk of serious harm from COVID-19," the panel said in its August 4 guidance, citing data pointing to a small risk of heart inflammation linked to mRNA COVID-19 shots, particularly in young people.