The booster is designed for immunization against the original wild strain as well as Omicron variant.
The Medicines and Healthcare Products Regulatory Agency (MHRA )in the United Kingdom has granted an authorization for the Moderna bivalent booster, mRNA-1273.214, (Spikvax Bivalent Original/Omicron), for use in immunizing adults 18 years and older. The UK governmental agency becomes the first one to allow for the use of a vaccine designed with neutralizing antibodies for both the original wild strain of COVID-19 as well as the Omicron (BA.1) variant.
"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," Moderna CEO Stéphane Bancel, said in a statement today.
The MHRA decision is based off the data of Moderna’s phase 2/3 trial. The results of that trial were announced about a month ago and demonstrated that the vaccine met all primary endpoints, including superior neutralizing antibody response against Omicron when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants.
A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. According to the company, 1 month after a 50 µg booster dose of mRNA-1273.214 was given to people previously vaccinated and boosted, the new dose resulted in significantly higher neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to Moderna’s authorized booster. And this was regardless of prior infection status or age in adults over 18, greater or less than 65 years old.
In addition, when the bivalent mRNA-1273.214 booster was given to people without previous COVID-19 infections, this also resulted in significantly higher neutralizing titers against BA.4/5 compared to the authorized booster, with a geometric mean ratio of 1.69 (95% CI: 1.51-1.90).
“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," Bancel said in today’s statement.
Moderna has completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the European Union and expects further authorization decisions in the coming weeks.