LONDON — British drug regulators have become the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that aims to protect against the original virus and the Omicron variant.
In a statement on Monday, the Medicines and Healthcare Regulatory Agency said it had given the green light to Moderna’s combination “bivalent” vaccine, which will be used as an adult booster shot.
The booster shot targets both the COVID-19 original virus, which was detected first in 2020, and Omicron BA.1 variants that were first discovered in November. British regulators said the side effects were similar to those seen for Moderna’s original booster shot and were typically “mild and self-resolving.”
“What this (combination) vaccine gives us is a sharpened tool in our armoury 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.
Flu shots can be adjusted annually according to the influenza variants. This approach protects against all four strains of influenza.
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.
Britain’s health officials have not yet decided whether or not the tweaked vaccine will be used in its fall strategy. The government announced in July that everyone over 50 would receive a COVID booster for the fall.
On Friday, Germany’s health minister said the European Medicines Agency might clear tweaked COVID-19 boosters next month.
In June, the U.S. Food and Drug Administration told vaccine makers that any booster shots tweaked for the fall would have to include protection against the newest Omicron variants, meaning BA.4 and BA.5, not the BA.1 subvariant included in Moderna’s latest shot.
FDA stated last month it no longer considered authorizing COVID-19 boosters for adults. Instead, they will be focusing on updated vaccines that are tailored for autumn and target viral subvariants.
Continue reading: Why You Shouldn’t Wait for Updated COVID-19 Boosters
Moderna and Pfizer currently produce updated vaccines that include BA.5, in addition to COVID-19.
According to the World Health Organization, the latest global surge of COVID-19 has been driven by Omicron subvariant BA.5, which is responsible for about 70% of the virus samples shared with the world’s largest public virus database. Subvariant BA.5 can be more infective than the original Omicron virus and may have some genetic differences not addressed by earlier vaccines.
Scientists warn that drugmakers may be one step behind COVID-19’s genetic evolution in trying to develop vaccines.
“The virus is unlikely to stand still and Omicron-targeted immunity, might push the virus down other evolutionary paths,” warned Jonathan Ball, a professor of virology at Britain’s University of Nottingham. He said that the Moderna vaccine will likely be still protective.
“Unless there is a major shift in the virus, immunity will continue to protect the vast majority from serious disease caused by emerging variants,” he said in a statement.
Lauran Neergaard, AP Medical Writer, Washington, D.C., contributed.
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