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The pharmaceutical company Moderna have released interim top-line findings looking at antibody responses from their Omicron-containing bivalent COVID-19 vaccine.
This Roundup accompanied an SMC Q&A Briefing with Moderna.
Dr Brian Ferguson, Associate Professor of Immunology, University of Cambridge, said:
“In 2020 we were assured that COVID vaccine updates, should they be required, would be fast and readily available. The emergence of the Omicron variant of SARS-CoV-2, which is able to significantly evade antibodies elicited by vaccines against the original Wuhan strain, has driven several companies to start producing updated vaccine formulations. Moderna has now produced and begun testing a bivalent vaccine that includes mRNAs encoding two Spike proteins from both the Wuhan strain and the Omicron variant. Moderna have released evidence today that this vaccine elicits high levels of neutralising antibodies against Omicron and is therefore predicted to provide better protection against disease caused by Omicron compared with the original vaccines that only used the Wuhan spike. This makes this vaccine a good candidate for an autumn vaccination campaign. There are, however, some question marks. We do not yet have access to the data from Moderna’s studies, only what has been relayed by press release, so we will learn more once a publication is available that includes the relevant data. It is currently unclear what the rationale is for including the original Wuhan spike protein is and why Moderna’s current formulation includes both mRNAs. The inclusion of both spike proteins as a booster may or may not provide broader and more durable protection from Omicron and future variants. There is also little indication here as to how well this vaccine will work against the BA4/5 Omicron sub-variants that are dominating circulation in the UK. Information about this would be desirable and provide an improved case for using this vaccine as a welcome autumn booster in the UK.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“There is little doubt that these data from a randomised trial are encouraging. Using different strains of virus in a single vaccine is very familiar in flu vaccines to try and provide continuing protection when a virus is changing its characteristics as is happening with SARS-Cov-2.
“The trial has 437 participants which is not sufficient to be able to show convincing evidence of clinical protection (looking at infections or hospitalisations) but is an adequate size for looking at antibody results. These antibody measurements provide an indication that is likely to translate into clinical effects, but an element of uncertainty in extrapolating the results to clinical effectiveness must, inevitably, remain. As the company say: “This means bivalent boosters may provide broad protection against several different variants, even ones they weren’t specifically designed to fight against, which is important to ensure broad immunity as we enter the endemic phase of the pandemic”.
““May provide” is a measured way of describing the results. In order to be sure of the claims there will be careful regulatory review, and while it is understandable for financial market reasons that results are given in a press release, a proper scientific paper is required before detailed comment can be made.”
Prof Penny Ward, Independent Pharmaceutical Physician, and Visiting Professor in Pharmaceutical Medicine at King’s College London, said:
“Following data derived from an earlier study of a bivalent vaccine with ancestral and beta covid variants, Moderna today has announced early data from a study of a bivalent booster shot including the ancestral strain and the omicron variant demonstrating superior antibody response against the omicron variants than boosting with the ancestral strain vaccine alone. In the study investigating the first bivalent product, antibody levels were sustained at higher levels and covered more strains for at least 6 months, suggesting that boosting with a bivalent vaccine may confer greater cover against breakthrough infection caused by multiple strains for a longer period than boosting with a monovalent vaccine. Moderna plans to discuss the data with regulators, no doubt with a view to this product becoming the autumn covid vaccine booster shot of choice. The study is of relatively small size but it would be helpful not only to see antibody responses, but also to have information on the incidence and severity of any detected breakthrough infections/covid disease between the mono and bivalent boosted groups in these studies. This is particularly relevant given that we have yet to see an emerging consensus on correlates of protection with the vaccines in current use.”
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Prof Stephen Evans: “No conflicts of interest. 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.”
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 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”
No others received.