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Moderna’s bivalent COVID-19 booster vaccine has today been approved for adult booster doses by the Medicines and Healthcare products Regulatory Agency (MHRA).
Professor Deborah Dunn-Walters, Chair of the British Society for Immunology COVID-19 and Immunology Taskforce and Professor of Immunology at the University of Surrey, said:
“COVID-19 vaccines have had a huge positive impact on our ability to manage the pandemic and return to normal life. However, as we’ve seen, new strains of SARS-CoV-2 continue to emerge which means it’s important that we continue to develop the COVID-19 vaccines to optimise protection against new strains.
“We welcome today’s news that the MHRA has approved the updated version of the Moderna bivalent booster COVID-19 vaccine, which targets both the original SARS-CoV-2 virus and the Omicron strain, which is the leading strain currently circulating in our communities. The MHRA will have carefully analysed the data to ensure this update to the Moderna vaccine is both safe and effective.
“The original strain and the Omicron strain are quite different from each other. By keeping both in the new vaccine it is hoped to provide immunity against any future new strains related to the original as well as protecting against any new strains related to Omicron.
“It is important to know that although the new bivalent vaccine booster may provide a slightly increased level of protection against current known virus strains compared with the original, this difference is small compared with the overall benefit from any type of booster. It is expected that circulating virus levels will rise in winter so it is important to take up the offer of a booster if you are offered it.”
Prof Penny Ward, Independent Pharmaceutical Physician, and Visiting Professor in Pharmaceutical Medicine at King’s College London, said:
“Good news from the MHRA today as they have announced approval of the first bivalent covid vaccine, Spikevax Bivalent/Omicron, which provides a mix of the original covid strain mixed with the omicron B.1.1.529 variant – this is the original omicron strain which hit the UK in January this year. We are now onto the fifth version of the omicron variant family and this temporary authorisation under regulation 174 (the same regulation used to approve the original covid vaccines in the UK) allows use of this bivalent vaccine as a booster shot in adults aged 18 and over. The approval is based on the superior increase in antibody observed following use of the bivalent vaccine, particularly against the various omicron strains including the BA.4 and .5 variants responsible for the most recent waves of illness, in a previously vaccinated population. This approach – known as immunobridging – makes use of the relationship between the immune response and clinical efficacy established in the phase III clinical trials of the original vaccine which was >90% effective in preventing covid in the (then previously unvaccinated) population. As a booster shot of this bivalent vaccine achieved a significant increase in immune response covering not only the initial strain but also covering various omicron variants, it is expected that this vaccine will reduce covid illness caused by newer variants. Now we need to await the JCVIs view on whether the bivalent vaccine should be used for all those for whom the autumn booster has been recommended, or if supply constraints will result in targeting this vaccine form to a subset of that population. In the meantime bivalent boosters of all vaccines are in development with the Pfizer BioNTech version under rolling review by the EMA currently, and immunobridging trials well underway. Well done MHRA for approving and Moderna for being first past the post in achieving the first approval of the world’s first bivalent covid vaccine.”
Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said:
“The early data certainly suggests that the new Moderna vaccine, targeting two different flavours of Sars2 coronavirus spike protein works better against the newly emerged Omicron variants. These variants have been the most able to escape the antibodies raised through infection or vaccination by previous variants. This should provide people with better protection against the Omicron variants.
“However, the virus is unlikely to stand still and Omicron-targeted immunity, might push the virus down other evolutionary paths, in which case we will be like the Red Queen in Alice and the Looking Glass – having to keep running just to stay in the same place. That said, unless there is a major shift in the virus, immunity will continue to protect the vast majority from serious disease caused by emerging variants, and that’s why it’s important to get vaccinated or boosted, especially if you are vulnerable.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“This vaccine contains two components; the first is the original Moderna Covid vaccine for which there is both very large clinical trial data and massive experience following its introduction in many countries including the UK. The second is a modification of that original vaccine targeted at the Omicron variant of SARS-CoV-2 which is a new component. The similarity of that new component to the original has allowed the MHRA to authorise the vaccine based on its antibody response rather than demonstrating it prevents infections. We now know from many studies that this antibody response (neutralising antibodies) is to a degree predictive of the clinical effect in prevention of infection and hence admission to hospital or death. It would take very much larger trials to show such effects conclusively, but we can be confident it is likely to show better clinical efficacy against the Omicron variants than the original vaccine alone. It would be good to have more data available publicly, but the MHRA will have been very carefully checking the submission made to them and the background knowledge on the original provides confidence that this vaccine will be a useful addition. While not quite the same as one of the seasonal flu vaccines which are authorised based on biochemical analyses rather than clinical efficacy, it is a similar process for authorisation.
“Whether this will be used in the UK booster programme will depend on other factors, including cost and what estimates of clinical efficacy are derived from analysis of the antibody response.”
First bivalent COVID-19 booster vaccine approved by UK medicines regulator
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Declared interests
Professor Deborah Dunn-Walters: “No conflict of interests to declare.”
Prof Penny Ward: “I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 an antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”
Prof Jonathan Ball: “Receipt of funding to develop next generation vaccines.”
Prof Stephen Evans: “No conflicts of interest specific to these studies. I am funded (one day per week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them. I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI. I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs. I am a participant in the Oxford/Astra Zeneca trial, and on 13th January 2021 learnt I had received the active vaccine.”