The UK became the first country to approve Moderna Inc.’s Omicron vaccine, which targets Covid-19, as a booster dose, paving the way for the vaccine variant to play a role in a planned autumn vaccination campaign to boost immunity to the virus to strengthen .
The so-called bivalent vaccine targets 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 arsenal to protect us from this disease as the virus continues to evolve,” June Raine, chief executive of the UK’s Medicines and Healthcare Products Regulatory Agency, said on Monday.
Variant vaccines are likely to play a role in booster campaigns in the fall in hopes they can boost immune protection against newer strains of the virus. The currently available Covid-19 vaccines are based on the original strain of SARS-CoV-2. The protection these vaccines offer has been weakened by the emergence of successive new variants, although studies have shown that boosting can restore immunity. So far, no variant has been found that completely escapes the immune system acquired through previous vaccination or infection.
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Britain’s MHRA said the approval was based on clinical trial data showing that a booster dose of Moderna’s bivalent vaccine elicited a strong immune response against Omicron BA.1 and the original strain. The exploratory analysis revealed that the bivalent vaccine also elicited a good immune response against the Omicron subvariants BA.4 and BA.5, which 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 targeting Omicron variants BA.4 and BA.5 after the Food and Drug Administration recommended in late June that vaccine makers should do new booster shots targeting those strains. The highly contagious BA.5 strain now accounts for nearly 90% of all infections in the United States, according to the latest variant tracking data from the Centers for Disease Control and Prevention.
In the UK, Moderna said it is working with health authorities to make the bivalent vaccine available in the UK in light of its approval. Previous supply deals with the UK government included access to modified vaccines to deal with variants of potential concern.
A panel of experts advising the UK government on vaccination strategy said on Monday it would recommend the bivalent vaccine alongside some existing vaccines for an autumn booster campaign targeting adults aged 50 and over, as well as certain other groups such as staff at the aimed at frontline healthcare workers and people with compromised immune systems.
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The committee said in a written statement that all available booster vaccines provided good protection against severe Covid-19. In addition to Moderna’s bivalent vaccine, it recommended the company’s original vaccine as well as the existing vaccine from Pfizer Inc. and partner BioNTech SE. It also said Novavax Inc.’s vaccine could be used in certain circumstances.
Stéphane Bancel, CEO of Moderna, said the UK approval marks the first time a vaccine targeting Omicron alongside the original strain has been approved. Moderna has also applied to regulators in Australia, Canada and the European Union and expects further decisions in the coming weeks, the company said.
Studies by Moderna and other manufacturers, including Pfizer and BioNTech, have shown that adjusting their original recordings to target new strains of the virus could steer the antibody response towards new variants. However, these studies did not determine whether this broader immune response meant that the variant vaccines reduced the risk of developing symptomatic Covid-19 compared to vaccines based on the original strain.
Pfizer and BioNTech have developed an Omicron targeting update for their Covid-19 vaccine, while Sanofi SA and GSK PLC have a modified vaccine targeting the beta variant of the virus.
Moderna began testing the bivalent booster, dubbed mRNA-1273.214, in an ongoing study in March. Compared to a booster dose of the original vaccine, the bivalent vaccine elicited a stronger neutralizing antibody response against Omicron and raised the level of antibodies against the original strain.
write to Denise Roland at [email protected]
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