MHRA Grants Moderna’s Omicron Bivalent Vaccine Conditional Approval in UK

On August 15, Moderna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom granted conditional authorization for the Omicron-containing bivalent COVID-19 booster vaccine mRNA-1273.214. Adults aged 18 or older will receive the shot as a booster to prior vaccination. This announcement comes after the European Commission (EC) and the United States purchased large quantities of the boosters earlier this year.

Related Article: Moderna to Supply 66 Million COVID-19 Boosters to US

Bivalent Vaccines Show Greater Immunity than Prior Vaccines

mRNA-1273.214 is the codename for Moderna’s bivalent COVID-19 vaccine. Bivalent vaccines simultaneously protect against two different strains of a disease; in this case, the common strain of COVID-19 and the Omicron BA.1 strain. mRNA-1273.214 contains Moderna’s original vaccine, mRNA-1273, and a new dose protecting against Omicron BA.1.

Bivalent vaccines have shown to be an effective countermeasure against the Omicron strain. For example, Pfizer’s bivalent vaccine demonstrated a greater immune response in patients than their current COVID-19 vaccine in a Phase ⅔ clinical trial.

Similarly, Moderna’s mRNA-1273.214 proved effective in its how Phase ⅔ clinical trial. Due to the results, the UK’s MHRA granted conditional approval for the bivalent vaccine. 

MHRA Approval Follows US and EU Vaccine Purchases

In July of this year, Moderna and the US government agreed to the supply of bivalent vaccines. In return for 66 million doses, Moderna would receive up to $1.74 billion. Similarly, Moderna came to another agreement with the EC. This time, the EC purchased 15 million doses as a supplement to a previous deal and switched all other promised doses to the bivalent vaccine. 

The MHRA granted conditional approval for the bivalent vaccine’s use in the UK. This follows the US Food and Drug Administration’s (FDA) approval for the bivalent vaccine. 

On the approval, 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.”

To help make the Omicron bivalent vaccine available to the public as fast as possible, Moderna is working with the Vaccine Taskforce, UK Health Security Agency, and NHS. In addition, Moderna submitted completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the EU. The company hopes other legislative bodies grant similar approvals within the next few weeks. 

Author

Max Heirich