Recommended

Sarepta’s DMD drug Elevidys issued FDA label update
Rare disease gene therapy granted European first approval
Johnson & Johnson agrees $3bn oncology acquisition
European Commission grants EU first for J&J’s Simponi biosimilar
Researchers validate approach that supports animal-based pyrogen test replacement
ON DEMAND webinar: automating QC testing for radiopharmaceutical production
Insmed secures EU approval for Brinsupri (brensocatib)
Moderna invests over $140m to onshore mRNA medicine manufacturing in US
news

MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds

0
SHARES

The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.

COVID-19 Vaccine Moderna

The UK’s Medicines and Healthcare product Regulatory Agency (MHRA) have authorised an extension to the current approval of the Spikevax vaccine, formerly COVID-19 Vaccine Moderna, that allows its use in individuals aged 12-17 years.

 

Reserve your FREE place

 


Address the time-to-result challenge posed by short shelf-life radiopharmaceuticals.

20 November 2025 | 3:00 PM GMT | FREE Virtual Panel Discussion

This webinar showcases the Growth Direct System; an RMM (Rapid Microbial Method) that improves on traditional membrane filtration, delivering increased accuracy, a faster time to result, enhanced data integrity compliance, and more control over the manufacturing process.

Key learning points:

  • Understand the benefits of full workflow microbiology quality control testing automation in radiopharmaceutical production
  • Learn about ITM’s implementation journey and considerations when evaluating the technology
  • Find out how the advanced optics and microcolony detection capabilities of Growth Direct® technology impact time to result (TTR).

Don’t miss your chance to learn from experts in the industry – Register for FREE

 

“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,” said MHRA Chief Executive Dr June Raine. “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.”

According to the MHRA, no new side effects were identified and the safety data in children was comparable with that seen in young adults. As in young adults, the majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness.

The MHRA has stated that this Conditional Marketing Authorisation (CMA) extension granted by the MHRA is valid in Great Britain only. It was approved via the European Commission (EC) Decision Reliance Route, wherein the marketing authorisation application made by the company references the decision made by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP).

Spikevax was previously authorised in children aged 12-17 years in Northern Ireland under the CMA extension granted by the EMA on 23 July 2021 and is already authorised in the UK for adults aged 18 years and over.

Share via
Share via