British health authorities Monday greenlighted the use of a Moderna COVID-19 vaccine with a new formula designed to fight old strains as well as new variations in what has been dubbed a “bivalent” approach and will be used primarily as a booster for people aged 50 and over starting in the fall.
The Medicines and Healthcare Regulatory Agency said the updated Moderna drug protects users against the initial version of SARS-CoV-2 as well as from the more contagious Omicron lineage. It also pointed out the new chemical met British standards of safety, quality, and effectiveness.
The agency said it based its decision on trials that showed a good immune response against Omicron sub-variants BA.4 and BA.5.
The virus ... is continually evolving in order to evade the immunity provided by vaccines, said Munir Pirmohamed, chair of the Commission on Human Medicines in a statement.
“What this (combination) vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve,” said Dr. June Raine, the head of Britain's health care and medicines regulator.
Health Secretary Steve Barclay said the new shot will be part of the country's booster program roll-out from September. “This safe and effective vaccine will broaden immunity and potentially improve protections against some variants as we learn to live with this virus,” Barclay said.
Stephane Bancel, Moderna's Chief Executive, said in a statement that it was the first regulatory authorization for a vaccine aiming to fight the omicron variant, predicting the booster would have an “important role” to play in protecting people against COVID-19 in the winter.
Germany has told the European Medicines Agency it might clear tweaked COVID-19 boosters next month.
According to the US Centers for Disease Control and Prevention, the BA.5 and BA.5 make up about 94% of all new cases in the United States, reaching even President Joseph Biden earlier this month.