LONDON (Reuters) – The United Kingdom, the first country to approve a coronavirus vaccine in late 2020, has given the first green light to shots adapted to variants that target both the original and Omicron versions of the virus.
The United Kingdom’s Medicines Regulatory Authority (MHRA) on Monday conditionally approved a so-called bivalent vaccine made by US drugmaker Moderna as a booster for adults.
Later on Monday, the UK’s Joint Committee on Immunization and Immunization (JCVI) endorsed the use of variant-adapted shots in the country’s booster campaign starting in September.
MHRA’s Moderna decision was based on clinical trial data showing that the booster elicited a “strong immune response” against both Omicron (BA.1) and the original virus, it said.
Moderna said in June that trial data showed that the variant-adapted shot raised virus-neutralizing antibodies to Omicron eight-fold when given as a fourth dose.
The MHRA also cited an exploratory analysis that found SCHOTT to generate a “good immune response” against the currently dominant Omicron subspecies BA.4 and BA.5.
According to Moderna, the trial data showed that the variant-adapted booster generated virus-neutralizing antibody levels to the subvariant that were 1.69 times higher than those given the original booster.
However, the correlation between neutralizing antibody levels and vaccine efficacy against disease, especially severe disease, remains unclear.
The MHRA added on Monday that no serious safety concerns were identified with the new Moderna formulation.
Existing COVID-19 vaccines continue to provide excellent protection against hospitalizations and deaths, but vaccine efficacy has taken a hit as the virus evolves.
MHRA CEO June Lane said in a statement, “This bivalent vaccine gives us a weapon that can help protect us from this disease as the virus continues to evolve. It is an enhanced tool in the warehouse.
But Jonathan Ball, a professor of molecular virology at the University of Nottingham, added that the virus is unlikely to be quiescent, and that omicron-targeted immunity could push the virus down other evolutionary pathways.
“In that case, we have to be like the Red Queen in ‘Alice Through the Looking Glass’ and keep running to stay in the same place.”
Further approval
European Medicines Agency (EMA) officials hope a vaccine adapted to the COVID variant will be approved in the European Union by September, and regulators will launch shots targeting the older BA.1 variant this fall. indicates a willingness to use Further, clinical development is delayed.
In contrast, the U.S. Food and Drug Administration (FDA) has said it will require all new shots for domestic use to specifically include Omicron’s new BA.4 and BA.5 derivatives.
On Monday, the head of the Indian Serum Institute, which manufactures AstraZeneca’s COVID-19 vaccine under the brand name Covishield, said he expects to develop an Omicron-specific vaccine in India within six months. NDTV reported.
Moderna, which signed a £1bn ($1.2bn) contract with the UK government earlier this year to build the UK’s first mRNA vaccine facility, announced on Monday that it will seek further approvals for its adaptive vaccine in Australia, Canada and the EU. He said he expects…the next few weeks.
Pfizer Inc and BioNTech are also testing modified versions of mRNA vaccines to combat Omicron variants.
(Reporting by Natalie Glover, London; Editing by David Goodman, Mark Potter, Margherita Choi)
