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Moderna’s Omicron booster receives MHRA approval

The booster dose can be used in adults aged 18 years and over to protect against contracting COVID-19

Moderna

Moderna’s COVID-19 booster vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The booster dose can be used in adults aged 18 years and over to protect against contracting COVID-19.

The MHRA’s authorisation is based on data from a phase 2/3 trial, which showed that mRNA- 1273.214 met all primary endpoints. The trial showed a booster dose of mRNA-1273.214 increased neutralising geometric mean titres (GMT) against Omicron approximately eight times above baseline levels.

The booster dose also provided potent neutralising antibody responses against the Omicron subvariants BA.4 and BA.5 when compared against the currently authorised booster – mRNA-1273 – regardless of age or prior infection status.

Commenting on the decision, Stéphane Bancel, chief executive officer of Moderna, said: “We are delighted with the MHRA’s authorisation of Spikevax Bivalent Original/Omicron, our next- generation COVID-19 vaccine. This represents the first authorisation 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.”

He added: “mRNA- 1273.214 has consistently shown superior breadth of immune response over mRNA-1273 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.”

The conditional authorisation is for mRNA-1273.214 – Spikevax Bivalent Original/Omicron – an Omicron-containing bivalent.

The Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine, containing mRNA-1273 – Spikevax – and a vaccine candidate targeting the Omicron subvariant of concern, BA.1.

The company is currently working with the Vaccines Taskforce, the UK Health Security Agency and the NHS to make the Spikevax Bivalent Original/Omicron vaccine available in the UK. Moderna has completed regulatory submissions for mRNA-1273.214 in the EU, Australia and Canada and anticipates further authorisations over the next few weeks.

Article by
Fleur Jeffries

15th August 2022

From: Research, Regulatory

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