Moderna has ‘completed regulatory submissions’ for its new Omicron Covid vaccine, which could be used for autumn boosters in the UK if approved by the MHRA.
Today’s announcement comes as trials had shown that the company’s updated Covid vaccine generates a strong immune response against the Omicron BA.4 and BA.5 variants.
Moderna said that the new booster vaccine candidate has ‘demonstrated a significantly higher neutralising antibody response against Omicron subvariants BA.4/5 compared to the currently authorised booster’.
It added that it has ‘completed regulatory submissions’ for the vaccine in the UK, EU and Australia.
A spokesperson said: ‘If granted authorisation from the MHRA, the vaccine could be offered as a third or fourth booster for adults in the UK.’
According to the company, the booster is ‘the only candidate expected to have demonstrated significantly higher titers against the BA.4/5 strain in a clinical trial before the [autumn] booster season, when compared to the currently authorised booster’.
The vaccine is based on the Omicron BA.1 subvariant, but Moderna is simultaneously developing another vaccine candidate based on Omicron BA.4/5 subvariant, it added.
Moderna CEO Stéphane Bancel said: ‘We are very pleased that our bivalent platform continues to demonstrate better performance than the current booster.
‘Today’s update extends the remarkable performance of mRNA-1273.214, demonstrating significantly higher titers against all tested variants, including the BA.4/5 and BA.1 Omicron subvariants, and adds to the largest body of data confirming the superiority of a bivalent approach.’
He added: ‘This superior breadth and durability of immune response following a bivalent booster has now been shown in multiple Phase 2/3 studies involving thousands of participants.
‘We are working with regulators to advance two bivalent vaccine candidates, mRNA-1273.214 and mRNA-1273.222, based on different market preferences for Omicron subvariants, clinical data requirements, and urgency of starting [autumn] booster campaigns for vulnerable populations.’
In May, the Joint Committee on Vaccination and Immunisation (JCVI) recommended another autumn booster vaccine for some at-risk groups and frontline health and social care workers, under interim guidance.
This includes all those aged 65 and over, residents in a care home for older adults and staff, frontline health and social care workers and adults aged 16 to 64 years who are in a clinical risk group.
However, NHS England has told commissioners to plan for a ‘maximum scenario’ of autumn boosters for all over-50s, as well as care home residents and carers, frontline health and social care workers and those in clinical risk groups – ‘subject to final JCVI advice’.
The ‘minimum scenario’ it told them to prepare for is the same as the JCVI’s interim advice.