Britain’s drug regulator said on Monday it had approved Moderna’s updated Covid-19 vaccine, which targets the Omicron variant as well as the original form of the virus.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said it approved the booster vaccine for adults “after it was found to meet the UK regulator’s safety, quality and effectiveness standards”.
It was the first such “bivalent” Covid-19 vaccine to be approved by the UK regulator.
June Raine, chief executive of the MHRA, said data from clinical trials showed it produced a “robust immune response” against the original virus and Omicron and would be “a sharp tool in our arsenal” as the virus continues to evolve.
Moderna CEO Stefan Bansel said in a statement that the US biotech company was “delighted” by the decision to “first approve a bivalent vaccine containing Omicron”.
While vaccines have helped reduce hospitalizations and deaths from Covid, which first appeared in China in late 2019, current shots mostly target earlier strains of the disease.
In July, the World Health Organization warned that the pandemic was “not over” due to the spread of Omicron subvariants and the lifting of control measures.
Half of Moderna’s vaccine targets the original 2020 virus, and half targets the Omicron variant, which is officially known as BA.1.
– Bivalent vaccines –
The MHRA said the vaccine also produced a “good response” against two sub-variants of Omicron, BA.4 and BA.5, which have partly caused a wave of new cases in Europe and the US.
The vaccine had the same “generally mild” side effects as Moderna’s original shot, he added.
Moderna said in June that its “bivalent” vaccine performed better against both Omicron and the original virus compared to its original Covid vaccine, called Spikevax.
The EU’s medicines watchdog said it began reviewing the new shot that month.
Moderna said it has also submitted the vaccine to regulators in Australia and Canada and expects further approval decisions in the coming weeks.
The European Health Agency is also studying a rival tailored shot developed by Pfizer/BioNTech, which could be approved this fall.
The Pfizer/BioNTech vaccine is adapted for the BA.4 and BA.5 virus subvariants.
They were first detected in South Africa and spread rapidly, despite the high immunity of the population created by previous waves and vaccination.
Like the other Omicron subvariants, they tend to have a milder course of disease as they settle less in the lungs and more in the upper nasal passages, causing symptoms such as fever, fatigue, and loss of smell.