Spikevax vaccine, previously called Covid-19 Vaccine Moderna, was already approved in the UK, for active immunisation in adults aged 18 years and older

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UK approves Moderna Covid-19 vaccine in children. (Credit: Arek Socha from Pixabay.)

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the approval for Moderna’s Covid-19 vaccine, allowing its use in 12- to 17-year-olds.

Spikevax vaccine, previously called Covid-19 Vaccine Moderna, was already approved in the UK, for active immunisation in adults aged 18 years and older.

The extended Conditional Marketing Authorisation (CMA) is valid only in Great Britain and was granted through the European Commission (EC) Decision Reliance Route.

MHRA noted that Moderna’s marketing authorisation application references the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

MHRA chief executive June Raine said: “I am pleased to confirm that that the Covid-19 vaccine made by Moderna has now been authorised in 12-17-year-olds. The vaccine is safe and effective in this age group.

“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this surveillance will include the 12- to 17-year age group.

“It is for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group should be vaccinated with the Covid-19 vaccine made by Moderna as part of the deployment programme.”

The UK health regulator has said that that Moderna’s mRNA-based Covid-19 vaccine is safe and effective in the approved age group, with no new side effects identified.

Spikevax safety data in the 12 to 17 years age group was collected in an ongoing Phase 2/3 US clinical trial in 3,726 participants, who received at least one dose of Spikevax.

The clinical study demonstrated that safety data in children was comparable with that observed in young adults.

Most of the adverse events in the study were mild to moderate, and are related to reactogenicity, such as a sore arm or tiredness, similar to those seen in young adults.

The most frequent adverse reactions include pain, erythema, swelling at the injection site, headache, fatigue, myalgia, chills, axillary swelling, nausea and fever.

Last month, European Medicines Agency (EMA) has granted an expanded authorisation for Spikevax in children aged 12-17 years in Northern Ireland.