UK becomes 1st country to approve Omicron-specific vaccine
London, Aug 16: The UK has become the first country to authorise a Covid-19 vaccine tailored to the Omicron variant. The move will pave the way for an autumn booster campaign using Moderna's two-strain shot.
The Medicines and Healthcare products Regulatory Authority (MHRA) - which was the first in the world to approve an original Covid-19 jab - has granted conditional authorisation to the vaccine, which targets both the original strain of the virus and Omicron BA.1.
The vaccine is authorised for use in people aged 18 and over but, to prepare for an expected rise in cases over the winter, the UK plans to focus its booster programme on the over-fifties and those at higher clinical risk of developing severe Covid.
Known as mRNA-1273.214, the dose is an updated version of the Moderna vaccine which is already in use for first, second and booster doses, and will be the first dose approved in the UK to target Omicron and the 2020 strain of the virus.
"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," said Stéphane Bancel, Chief Executive Officer of Moderna.
"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 decision from the MHRA is based on clinical trial data from a phase 2/3 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 geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age.