JAKARTA - The UK became the first country to allow the use of a COVID-19 vaccine targeting the original virus and Omicron variant, having previously become the first country in the world to approve a COVID-19 vaccine at the end of 2020.
The UK's drug regulator (MHRA) gave conditional approval for the use of US Moderna's bivalent vaccine as a booster for adults starting Monday.
The UK Joint Committee on Vaccination and Immunization (JCVI) is now expected to issue recommendations soon on how vaccines should be used in the country.
The MHRA's decision was based on clinical trial data showing the booster triggered a "strong immune response" against Omicron (BA.1) and the original 2020 virus, he said.
Moderna said in June that experimental data showed when given as a fourth dose, the variant-adjusted vaccine increased virus-neutralizing antibodies eightfold to Omicron.
MHRA also cites exploratory analyses, in which the vaccine was found to produce a "good immune response" against the currently dominant BA.4 and BA.5 Omicron branches.
According to Moderna, experimental data show the variant-adjusted booster resulted in a level of virus-neutralizing antibody against the subvariant that was 1.69 times higher than that given to the original booster.
However, the correlation between levels of neutralizing antibodies and the effectiveness of vaccines against disease, particularly severe disease, remains unclear.
No serious safety concerns were identified with the new Moderna formulation, the MHRA added on Monday.
The UK government said last month a vaccine booster program would start in 'early autumn' and injections would be offered to over 50s, individuals in clinical risk groups, frontline workers and nursing home staff.
While existing COVID-19 vaccines continue to provide good protection against hospitalization and death, vaccine effectiveness has taken a hit as the virus has progressed.
"The first-generation COVID-19 vaccine used in the UK continues to provide critical protection against disease and save lives," MHRA Chief Executive June Raine said in a statement.
"What this bivalent vaccine gives us is a sharp tool in our arsenal, to help protect us from this disease as the virus continues to evolve," he added.
The UK Health and Safety Agency (UKHSA), which oversees vaccine procurement among other responsibilities, did not immediately respond to a request for comment.
Separately, European Medicines Agency (EMA) officials expect vaccines adapted to the COVID variant to be approved in the European Union in September, and have signaled that regulators are open to using injections targeting the older BA.1 variant this fall, given that specifically targeting newer subvariants is far behind in clinical development.
The US Food and Drug Administration (FDA) said it would seek special inclusion of the newer Omicron BA.4 and BA.5 branches in any new vaccine used domestically.
Moderna, which signed a £1 billion deal with the UK government to build the country's first mRNA vaccine facility earlier this year, said it expected further approvals for adapted vaccines in Australia, Canada and the European Union in the coming weeks.
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