UK first country to approve bivalent booster which targets both original COVID-19 as well as the Omicron strain

pharmafile | August 16, 2022 | News story | Manufacturing and Production  

The UK medicines regulator (MHRA) has given the Moderna-made vaccine conditional approval, backed up by the Joint Committee on Vaccination and Immunisation (JCVI). This makes it the first Omicron-specific booster to be approved by a regulatory agency, with its decision being endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines.


Moderna announced in early August that it was amending its current agreement with the European Commission to change the agreed Spikevax doses to those containing the bivalent products. In each 50mg ‘Spikevax bivalent Original/Omicron’ dose, 25mg targets the original COVID-19 strain from 2020 with the other 25mg targeting Omicron.


The MHRA’s decision was based on clinical trial data which showed a ‘strong immune response’ was triggered by the booster against the older BA.1 strain of Omicron, demonstrating an increase in neutralising geometric mean titers against Omicron at about eight-fold above the baseline levels.


A ‘good immune response’ was seen against the currently-dominant BA.4 and BA.5 strains in exploratory analysis.


Dr June Raine, MHRA Chief Executive said: “What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease…”


Vaccines have been the biggest aid in the fight against COVID-19, however their effectiveness has been weakened as the virus has evolved. It is clear that continuous review and approval of new vaccines is needed in order to keep on top of COVID-19.


Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said: “The virus, SARS-CoV-2, is continually evolving in order to evade the immunity provided by vaccines. This novel 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 next step towards having the booster ready for winter is for the European Union to approve the use of COVID-19 variant-adapted vaccines, which the European Medicines Agency (EMA) expects will happen in September. Shots targeting the older BA.1 variant will be ready for this autumn, with ones targeting the BA.4 and BA.5 strains still being clinically developed.

James Spargo

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