MHRA approves Moderna Omicron COVID-19 booster trialled in the South West

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s Omicron-containing bivalent booster vaccine in the UK.

Bivalent vaccines target multiple COVID-19 variants. Results from the NIHR-supported study show the new vaccine produces a significantly higher antibody response against Omicron variants, when compared with Moderna’s original Spikevax vaccine.

The study recruited 472 volunteers across the South West, at University Hospitals Plymouth NHS Trust, the Royal Devon University Healthcare NHS Trust's NIHR Patient Recruitment Centre: Exeter, and Royal Cornwall Hospitals NHS Trust.

The UK has become the first country in the world to receive authorisation for the use of a next-generation bivalent COVID-19 vaccine (mRNA-1273.214).

The study was Moderna’s first UK commercially sponsored vaccine trial. It recruited over 2,800 participants from across 26 sites in the UK.

The MHRA’s decision is based on data from a clinical trial which shows that a booster jab with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain. The bivalent vaccine also produces a good immune response against the Omicron sub-variants BA.4 and BA.5.

Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving, and no serious safety concerns were identified.

Stéphane Bancel, Chief Executive Officer of Moderna, said: “We are delighted with the MHRA’s authorization of Spikevax Bivalent Original/Omicron, our next-generation COVID-19 vaccine. This represents the first authorization of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the COVID-19 pandemic.

“This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months.”

Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme said: “We are very pleased to hear of the MHRA's announcement regarding the approval of Moderna's Omicron bivalent booster vaccine. The booster marks the next step in the UK's defence against coronavirus infections, and provides us with another safe and effective vaccine to stay ahead of the disease.

"It is important that innovative COVID-19 vaccine studies, such as this, continue to run and recruit participants, so we can evolve our knowledge while the virus continues to evolve and spread infection globally."

Dr Catherine Cosgrove, Chief Investigator for the study and Adult Lead at the Vaccine Institute at St George’s, University of London and St George’s University Hospitals NHS Foundation Trust, said: "This is fantastic news for all of the participants and research staff involved in the Moderna Omicron booster study. The efforts from everyone who has taken part have helped provide extremely useful data when it comes to understanding how we can protect people against infections as we look towards the winter.

"Today's approval is a testament to all of the hard work of running the innovative study across the UK this year."

Moderna is working with The Vaccines Taskforce, UK Health Security Agency, and NHS to make Spikevax Bivalent Original/Omicron available to the UK public.