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 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.
June Raine said:
Our approval of the COVID-19 vaccine made by Valneva today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the Government’s independent scientific advisory body, the Commission on Human Medicines.
Professor Sir Munir Pirmohamed, Chair of the independent Commission on Human Medicines, said:
The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence are [sic] pleased to say that we have advised that the benefit risk balance is positive. The vaccine is approved for use in people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.
Interesting choice of words: not “safe and effective” but “the benefit risk balance is positive”. For everyone? Against Omicron? The trial is still ongoing so it’s not possible to review the findings for ourselves, though some information is provided here. Almost all trial participants are under 50, hence the approval being limited to the younger age range.
The U.K. has not actually yet purchased any doses of Valneva and also the approval doesn’t include use as a ‘booster’ so it has little immediate practical effect. In time it means a more traditional vaccine is available for those who wish to avoid experimental gene-based products – and unlike Novavax, not just based on the spike protein.