The UK has become the first country to authorise a bivalent COVID-19 booster vaccine effective against both the Omicron variant and original virus strain.
Moderna’s mRNA-1273.214 vaccine, also known as ‘Spikevax Bivalent Original/Omicron’, contains 25 micrograms of Spikevax — Moderna’s original mRNA vaccine — as well as 25 micrograms of vaccine candidate that the manufacturer says targets “the Omicron variant of concern”.
The bivalent vaccine was approved by the Medicines and Healthcare Regulatory products Agency (MHRA) on 15 August 2022. It is authorised as a booster vaccination for people aged 18 years or older.
In a press release, the MHRA said its decision to approve the new bivalent vaccine was “based on data from a clinical trial which showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain”.
“In an exploratory analysis the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.”
June Raine, chief executive of the MHRA, said: “The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives.
“What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.”
In a press release, Stéphane Bancel, chief executive of Moderna, said that the MHRA’s decision “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.
“mRNA-1273.214 has consistently shown superior breadth of immune response over mRNA-1273 [the currently authorised booster] in clinical trials. This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months.”
In its press release, Moderna said that it was working with the Vaccines Taskforce, UK Health Security Agency and NHS to make Spikevax Bivalent Original/Omicron available to the UK public.
The MHRA said that the Joint Committee on Vaccination and Immunisation “will advise on how this vaccine should be offered as part of the [booster] deployment programme”.