U.K. Approves Covid-19 Booster Vaccine Targeted at Omicron
The U.K. became the first country to approve
Moderna Inc.’s
Omicron-targeting Covid-19 vaccine as a booster shot, paving the way for the variant shot to play a role in a planned fall vaccination campaign to shore up immune defenses against the virus.
The so-called bivalent vaccine is directed against both the original strain of SARS-CoV-2, the virus that causes Covid-19, and the first Omicron variant, also known as BA.1, which drove large waves of infection over the winter.
“What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve,” June Raine, chief executive of Britain’s Medicines and Healthcare Products Regulatory Agency, said Monday.
Variant vaccines are likely to play a role in fall booster campaigns in the hope that they can strengthen immune protection against newer strains of the virus. The Covid-19 vaccines currently available are based on the original strain of SARS-CoV-2. The protection afforded by those shots has been blunted by the rise of successive new variants, although no variant has so far been found to totally evade immune defenses acquired from earlier vaccination or infection.
Britain’s MHRA said the approval was based on clinical trial data showing that a booster with the bivalent Moderna vaccine triggered a strong immune response against both Omicron BA.1 and the original strain. It said exploratory analysis found that the bivalent vaccine also generated a good immune response against Omicron subvariants BA.4 and BA.5 that are driving waves of infection in some parts of the world. The agency has approved the shot for use in adults.
For the U.S. market, Moderna is developing a separate vaccine that targets the BA.4 and BA.5 Omicron variants, after the Food and Drug Administration in late June recommended that vaccine makers pursue new booster shots aimed at those strains. The highly-contagious BA.5 strain now accounts for nearly 90% of all infections in the U.S., according to the latest variant-tracking data from the Centers for Disease Control and Prevention.
In the U.K., Moderna said it is working with U.K. health authorities to make the bivalent vaccine available in Britain in light of its approval. Earlier supply contracts with the U.K. government included access to modified vaccines to contend with potential variants of concern.
The expert committee that advises the U.K. government on vaccination strategy hasn’t yet specified which shots it will recommend for a planned fall booster campaign for adults aged 50 and older, and certain other groups such as front-line healthcare workers and those with weakened immune systems.
Stéphane Bancel,
chief executive of Moderna, said the U.K. approval was the first time any vaccine that targeted Omicron alongside the original strain had been authorized. Moderna has also applied to regulatory authorities in Australia, Canada and the European Union and expects further decisions in the coming weeks, the company said.
Pfizer Inc.
and partner
BioNTech SE
have also developed an Omicron-targeting update to their Covid-19 vaccine that they said elicited a stronger immune response than their original shot and have said they are sharing the data with regulators.
Sanofi SA
and
GSK
PLC said their modified vaccine targeting the Beta variant of Covid-19 elicited a stronger antibody response to Omicron than existing shots.
Moderna began testing the bivalent booster, dubbed mRNA-1273.214, in a continuing trial in March. It said the bivalent shot elicited a greater neutralizing antibody response against Omicron—and boosted antibodies against the original strain to higher levels—when compared with a booster shot of the original vaccine. The study didn’t test how well the modified shot reduced the risk of developing symptomatic Covid-19.
Write to Denise Roland at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Stay connected with us on social media platform for instant update click here to join our Twitter, & Facebook
We are now on Telegram. Click here to join our channel (@TechiUpdate) and stay updated with the latest Technology headlines.
For all the latest Education News Click Here
For the latest news and updates, follow us on Google News.