UK Approves World's First Omicron-Specific Booster by Moderna

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The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has granted conditional authorization to Moderna's newest vaccine candidate, making it the first Omicron-specific COVID-19 booster vaccine approved by a regulatory agency. 

The decision is based on positive results from a Phase II/III clinical trial in which the vaccine, called mRNA-1273.214 or Spikevax Bivalent Original/Omicron, met all primary endpoints. This includes a superior neutralizing antibody response versus Omicron (BA.1) compared to a 50 microgram booster dose of mRNA-1273 in baseline seronegative participants.

A booster dose of the vaccine demonstrated an increase in neutralizing geometric mean titers against Omicron around eight-fold above the baseline levels. The vaccine also showed potent neutralizing antibody activity versus Omicron subvariants BA.4 and BA.5 compared to the currently authorized mRNA-1273 booster, regardless of age or infection status.

"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 U.K. public health authorities in helping to end the COVID-19 pandemic," Stéphane Bancel, CEO of Moderna, said in a statement. "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 U.K. from COVID-19 as we enter the winter months."

Spikevax (elasomeran mRNA vaccine) has a conditional marketing authorization from the European Commission, as recommended by the EMA. It is indicated for active immunization to prevent COVID-19 in individuals ages six years and up. Booster shots may be given at least three months after the second dose for those 12 years and older.

In early August, the company announced an amendment to its current agreement with the European Commission to convert contractually agreed doses of Spikevax, mRNA-1273, to its Omicron-containing bivalent products for supply in 2022. The EC had decided to buy an additional 15 million doses of the Omicron-containing vaccine booster candidates.

Per its initial contact, Moderna was scheduled to supply doses in July and August, but the amendment moves the delivery to later in the year, pending the European Medicines Agency's approval of the proposed change.

"The European Commission and Moderna have been steadfast partners in the fight against the COVID-19 pandemic. This agreement highlights the EC's trust in our mRNA platform and next-generation bivalent COVID-19 vaccines. Participating member states will now have access to Omicron-containing vaccine booster candidates, and protection against COVID-19, heading into the winter season," noted Bancel in an earlier announcement.

Moderna has two bivalent vaccine candidates: mRNA-1273.214, a booster based on the Omicron subvariant BA.1, and mRNA-1273.222, a booster based on the BA.4/5 strain. Both candidates contain 25 micrograms of the currently authorized booster mRNA-1273 and 25 micrograms of an Omicron-specific subvariant.

In the United States, the FDA authorized an earlier version of Spikevax for in individuals ages 18 years and older. The first booster dose, like the first Moderna COVID-19 vaccine version, is to be given at least five months after completing the first series in the same age group.

A newer booster, mRNA-1273.222, is being developed in accordance with recommendations to Moderna from the FDA, and is currently in rapid development, according to Moderna's Q2 report released in early August. The candidate is being developed specifically for use in the U.S., where the Omicron subvariant BA.1 poses the biggest threat. Moderna expects to submit the candidate to the FDA in late fall. 

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