Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant.
The vaccine, known as mRNA-1273.214 or Spikevax Bivalent Original/Omicron, is a next-generation bivalent vaccine that contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern (BA.1).
The new COVID-19 booster was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a booster dose for “active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older,” Moderna outlined in a news release.
The primary series of Moderna’s COVID vaccine remains at two doses.
According to Dr. Paul Burton, Moderna’s chief medical officer, it is possible that the new bivalent vaccine may only require administration once a year because it can boost antibody levels to such high levels.
Stéphane Bancel, chief executive officer at Moderna, described it as a “next generation Covid-19 vaccine” which will play an “important role in protecting people in the UK from Covid-19” over the winter.
“What this (combination) vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve,” said Dr. June Raine, the head of Britain’s health care and medicines regulator.
The MHRA approval of the next gen COVID-19 booster was based on data from a Phase II/III clinical trial in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants.
A booster dose of mRNA-1273.214 increased neutralizing antibody titers against Omicron by about eight-fold above baseline levels. Additionally, the vaccine elicited robust neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the original booster (mRNA-1273) irrespective of prior infection status or age.
Moderna’s original COVID-19 vaccine (Spikevax) received full approval in the US from the Food and Drug Administration (FDA) in January for individuals ages 18 years and older. It was first authorized for emergency use in November 2020.
Health officials say people should take whichever booster they are offered as all the shots provide protection.
Moderna said it has also completed applications for regulatory approval of the updated booster in Australia, Canada and the EU.