British health authorities stated on Monday that the UK has become the first nation to approve a so-called "bivalent" COVID vaccine that targets both the original strain of COVID-19 and the more recent Omicron version.
The Moderna vaccine was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a "sharpened instrument" against the new coronavirus after it was determined to meet its requirements of safety, quality, and effectiveness.
According to the regulator, half of the booster dose of the "Spikevax bivalent Original/Omicron" vaccine (25 micrograms) is directed against the original viral strain from 2020 and the other half is directed at Omicron.
"I am happy to announce that the Moderna bivalent booster vaccination has been approved in the clinical trial to provide a strong immune response against the Omicron BA.1 variant as well as the original 2020 strain,” said MHRA Chief Executive Dr June Raine.
The first generation of COVID-19 vaccinations, which are still in use in the UK, continue to offer vital disease protection and save lives. As the virus continues to develop, this bivalent vaccine gives us a more effective weapon in our arsenal to help defend us against this disease, she said.
The Commission on Human Medicines, an independent, professional scientific advisory body that advises the government, approved the MHRA's decision to approve this booster vaccination in the UK after carefully examining the available data. The regulatory body claimed that the basis for its decision was information from a clinical trial that demonstrated a booster dose of the bivalent Moderna vaccine strongly elicited an immunological response against both Omicron (BA.1) and the original 2020 strain. In an investigation analysis, the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.
"The SARS-CoV-2 virus is constantly changing to circumvent the immunity that vaccinations provide. With its capacity to elicit a broader immune response than the original vaccine, this innovative bivalent vaccine represents the next step in the development of vaccines to thwart the virus, according to Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines.
According to the authorities, safety monitoring revealed that there were no significant safety issues, and that the side effects were generally modest and self-resolving, just like they were with the original Moderna booster dose.
As part of the deployment of booster vaccines across the nation, the independent Joint Committee on Vaccination and Immunization (JCVI) of the UK will now provide recommendations on how this new vaccine should be administered.
Additionally, the vaccine has been requested that the Australian, Canadian, and European Union regulatory bodies approve it (EU). By the end of next month, the dose is anticipated to receive approval from the EU drugs authority.
The new vaccination, dubbed the "next generation COVID-19 vaccine" by Moderna CEO Stephane Bancel, will be crucial in keeping people safe this winter.
"The UK public health authorities' commitment and leadership in assisting in the eradication of the COVID-19 pandemic are further highlighted by the fact that this is the first authorization of an Omicron-containing bivalent vaccination. As we head into the winter months, this bivalent vaccine will be crucial in preventing COVID-19 in the UK "Bancel stated.
Official records show that 126,504,756 vaccination doses have been given in the UK including first and second doses as well as third and fourth booster doses rolled out on an age group basis.
