The Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA, for its acronym in English) has approved this Monday the first covid bivalent vaccine–19, effective both against the original variant of SARS-CoV-2 and against omicron.
Specifically, it is a update of the vaccine manufactured by the American company Modernaand has been approved for booster doses in adults “after verifying that it meets safety, quality and efficacy standards,” according to the British regulatory body.
As they explain, in each dose of the booster vaccine, ‘Spikevax bivalent Original/Omicron’, half of the vaccine (25 micrograms) targets the original strain of the virus from 2020 and the other half (25 micrograms ), to omicron.
The MHRA’s decision is based on data from a clinical trial that showed that a booster with the bivalent Moderna vaccine triggers “a strong immune response both against ómicron (BA.1) and against the original strain of 2020″, they detail.
effective against omicron BA.4 and BA.5
Likewise, it was also found that the bivalent vaccine generates a good immune response against subvariants of omicron BA.4 and BA.5.
As far as side effects are concerned, they have been found to be the same as those triggered by Moderna’s original booster dose And they are usually mild. In this sense, no serious security problems have been identified.
“I am pleased to announce the approval of the Moderna bivalent booster vaccine, which in the clinical trial provided a strong immune response against the BA.1 omicron variant, as well as the original 2020 strain,” said MHRA Chief Executive, Dr. June Raine.
Although he acknowledges that the first generation of vaccines against covid-19 “continues to save lives“, assures that this bivalent vaccine provides “a more refined tool” in the protection against this disease “as the virus continues to evolve”.
For his part, the president of the Commission for Medicinal Products for Human Use in the United Kingdom, Professor Munir Pirmohamed, commented that the injection “represents the next step in the development of vaccines to combat the virus, due to its ability to provoke a response broader immune system than the original vaccine.
The British agency is ahead of the EMA
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In this way, the United Kingdom has advanced its decision to the European Medicines Agency (EMA, for its acronym in English), which already announced in mid-June that it had initiated a continuous review of both the version of the bivalent vaccine of Modern like that of Pfizer and BioNTech, which had also shown promising results.
In fact, last week, Pfizer and BioNTech reported that their vaccine adapted to the BA.1 and BA.4/5 variants will arrive in October 2022, “in time for the autumn booster vaccination campaigns”.