All licensed COVID-19 booster vaccines help enhance the protection gained from previous doses of the vaccine and help provide long-term protection against becoming seriously ill with COVID-19. Already at the end of 2021, vaccines had been put into circulation that were no longer directed against the original Alpha to Delta strains of the coronavirus. With the advent of the Omicron variant and its subvariants, vaccines directed against these variants were developed, which began their distribution after last summer. Clearance was granted today by the Medicines and Healthcare products Regulatory Agency (MHRA) for a new version of the Moderna ‘bivalent’ vaccine (Spikevax) that targets both the original strain of SARS-CoV2 and Omicron BA.4 and Subvariants BA.5.
This updated vaccine, which can be used as a booster in individuals 12 years of age and older, is Moderna’s second bivalent vaccine to be licensed by the MHRA after it was found to meet the safety, quality and efficacy standards of the UK regulator. The decision, based on the opinion of the Commission for Medicinal Products for Human Use, was taken after a careful examination of the evidence. The MHRA’s decision is based on data from a clinical trial which showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain. In an exploratory analysis the bivalent vaccine was also found to generate a good immune response against Omicron subvariants BA.4 and BA.5.
In each dose, half of the vaccine targets the original virus strain and the other half targets the Omicron variants. Side effects recorded during the clinical trial were generally mild and resolved on their own, with no new safety concerns identified. Professor Munir Pirmohamed, chair of the Commission on Human Medicines, said: “The Commission and its expert working group on COVID-19 vaccines have independently reviewed the data on safety, quality and efficacy and agree with the decision of the MHRA. The virus, SARS-CoV2, is constantly evolving to evade the immunity provided by vaccines. This new bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine.”
The Joint Committee on Vaccination and Immunization (JCVI) will advise on how this vaccine should be offered as part of the distribution programme.
- By Dr. Gianfrancesco Cormaci, PhD, specialist in Clinical Biochemistry.
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– Degree in Medicine and Surgery in 1998 (MD Degree in 1998) – Specialist in Clinical Biochemistry in 2002 (Clinical Biochemistry residency in 2002) – Doctorate in Neurobiology in 2006 (Neurobiology PhD in 2006) – Stayed in the United States, Baltimore (MD ) as a researcher employed by the National Institute on Drug Abuse (NIDA/NIH) and then at Johns Hopkins University, from 2004 to 2008. – Since 2009 he has been involved in Personalized Medicine. – Emergency medical care in private structures since 2010 – Holder of two patents on the preparation of gluten-free products starting from regular enzymatically neutralized wheat flour (owner of patents concerning the production of gluten-free bakery products, starting from regular wheat flour). – Head of the Research and Development department for CoFood srl (Leader of the R&D for the partnership CoFood srl) – Author of articles on medical and health information on the website www.medicomunicare.it (Medical/health information on website) – Author of ECM FAD courses advertised on the website www.salutesicilia.it