Britain, the first country to approve a CVID-19 vaccine in late 2020, has now also given the first green light to an adapted shot that targets both the original and Omicron version of the virus, informs news agency Reuters.
The UK medicines regulator (MHRA) gave the so–called bivalent vaccine made by U.S. drug company Moderna (MRNA.O) conditional approval as a booster for adults on Monday.
Later on Monday,August 15, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) backed the use of the variant–adapted shot in the country’s booster campaign starting September.
The MHRA’s Moderna decision was based on clinical trial data that showed the booster triggered «a strong immune response» against both Omicron (BA.1) and the original virus.
Moderna in June said trial data showed that when given as a fourth dose, the variant–adapted shot raised virus–neutralizing antibodies by eight–fold against Omicron.
However, the correlation between neutralizing antibody levels and vaccine effectiveness against disease,in particular severe disease ,is yet unclear.
No serious safety concerns were identified with the new Moderna formulation, the MHRA added on Monday.
While existing COVID-19 vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved.
It is very unlikely that the virus will stand still and Omicron–targeted immunity might push the virus down other evolutionary paths, said Jonathan Ball, professor of molecular virology at the University of Nottingham.
European Medicines Agency (EMA) officials expect COVID variant–adapted vaccines to be approved in the European Union by September.
In contrast, the U.S. Food and Drug Administration (FDA) has said it will seek the specific inclusion of the newer BA.4 and BA.5 offshoots of Omicron in any new shots used domestically.
On Monday, August 15, the chief of Serum Institute of India, which produces AstraZeneca’s COVID-19 vaccine under the brand name Covishield, said he expects an Omicron–specific vaccine in the country in six months, NDTV reported.
Moderna, which signed a 1 billion pound deal with the British government to build the country’s first mRNA vaccine facility earlier this year, on Monday said it expected further approvals for the adapted vaccine in Australia, Canada, and the EU in the coming weeks.