The U.K. medicines regulator, the MHRA, has approved the Moderna Covid vaccine for six to 11 year olds, describing it as “safe and effective”.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an update to the current U.K. approval of the Moderna COVID-19 Vaccine, or ‘Spikevax’, that allows its use in Great Britain (GB) in six to 11 year-olds.
This approval takes into account the extension to use in children aged six to 11 years already approved by the European Medicines Agency on March 2nd 2022, as the original GB licence for Spikevax in adults was approved by relying on the EU decision.
Spikevax is authorised in children aged six to 11 in Northern Ireland under the update granted by the European Medicines Agency on March 2nd.
Dr June Raine, MHRA Chief Executive, said:
I am pleased to confirm that that the COVID-19 vaccine made by Moderna, ‘Spikevax’, has now been authorised in Great Britain in six to 11 year olds. The vaccine is safe and effective in this age group.
We have in place a comprehensive surveillance strategy for monitoring the safety of all U.K.-approved COVID-19 vaccines and this surveillance includes those aged six to 11.
It is for the Joint Committee on Vaccination and Immunisation (JCVI) to advise in due course on whether six to 11s should be offered vaccination with the COVID-19 vaccine made by Moderna as part of the deployment programme.
How effective really is it against the immune-evading Omicron variant, though, and do the benefits really outweigh the risks in an age group at such low risk from the virus? There has been no assessment of this published by the MHRA, as far as I am aware.
The MHRA also today approved the Valneva Covid vaccine for 18-50 year-olds, which uses more traditional vaccine technology and so may be safer than the novel genetic vaccines.
The U.K.’s independent medicines regulator is the first in the world to approve the Valneva vaccine which becomes the sixth COVID-19 vaccine to be granted an MHRA authorisation.
It is also the first, whole-virus inactivated COVID-19 vaccine to gain MHRA regulatory approval. With this type of vaccine, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response to the COVID-19 virus. This process is widely used already in the production of flu and polio vaccines.