By James Simons-
Authorisation has today been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a new version of the Moderna ‘bivalent’ Covid vaccine (Spikevax) that targets both the original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants.
The updated vaccine, which can be used as a booster in individuals aged 12 years and above, is the second bivalent vaccine from Moderna to be authorised by the MHRA after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.
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The decision, based on the advice of the Commission on Human Medicines, has been taken after a careful review of the evidence.
In each dose, half of the vaccine targets the original virus strain and the other half targets Omicron (BA.4 and BA.5).
The MHRA’s decision is based on all available evidence on the original Moderna COVID-19 vaccine and its adapted vaccines. This includes extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent Original/Omicron BA.1 vaccine and safety data from an on-going clinical trial. These show that the common side effects observed with the new bivalent vaccine were the same as those seen for other versions of the vaccine. These side-effects were typically mild and self-resolving, with no new safety concerns identified.
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All authorised COVID-19 booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19.
The first bivalent vaccine from Moderna (Spikevax) was authorised by the MHRA on 15 August 2022
This new line extension granted by the MHRA is valid in Great Britain only and was authorised via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due consideration of the EC decision, before making an independent decision on the quality, safety and effectiveness of the vaccine.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is an executive agency of the Department of Health and Social Care.
The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
A few days ago, Health Canada authorized one of Moderna’s Spikevax Omicron-targeting bivalent COVID-19 boosters for use in children and teens aged six to 17 years. The booster targets the Omicron variant BA.1.
The BA.1 booster was previously only approved for people aged 18 and over. Moderna’s Omicron-targeting bivalent booster for variant BA.4/5 has not yet been approved for use in children and teens under 18.
Health Canada approved the booster as safe and effective for use in children and teens under 17, basing its recommendation on data from clinical trials of Moderna’s original Spikevax vaccine. Those trials showed that, beginning two weeks after the second dose, the Spikevax vaccine was 100 per cent effective in trial participants 12 to 17 years old and more than 94 per cent effective in participants aged six to 11 years old. The bivalent COVID-19 vaccine for strain BA.1 was shown in trials to further increase the immune response against the variant.
The vaccine will be administered as a 25-microgram booster dose for children aged six to 11 years and a 50-microgram booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster.
Side effects of Moderna’s Spikevax can include redness, soreness and swelling at the site of injection, as well as more general temporary symptoms including chills, fatigue, joint pain, headache, mild fever, muscle aches, nausea, vomiting, dizziness and enlarged lymph nodes.
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