All about Moderna’s new bivalent vaccine (UK approved)
From this autumn, the UK will also administer Moderna's new bivalent Covid vaccine, which contains both the parent strain of the virus and that of Omicron. All the details
The United Kingdom is the first country to have authorized the use of Moderna's new bivalent anti Covid vaccine designed to combat both the original Sars-CoV-2 virus strain and the Omicron variant.
British ministers said the vaccine will be part of the autumn recall campaign.
WHAT THE UK HEALTH REGULATOR SAID
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK medicines regulatory agency, has granted conditional authorization for the use of the bivalent vaccine containing Omicron, as a booster dose in individuals aged 18 years and older.
Dr June Raine, chief executive of the regulatory body, said, "This bivalent vaccine gives us a sharper tool in our armory to help protect us from this disease as the virus continues to evolve."
HOW THE MODERNA BIVALENT VACCINE IS MADE
Spikevax Bivalent Original / Omicron, the full name of Moderna's new vaccine, is a next-generation bivalent vaccine that contains both mRna-1273 (Spikevax, Moderna's vaccine used so far) and a candidate vaccine targeting the Omicron variant (Ba.1) .
HOW EFFECTIVE IT IS
The MHRA decision, Moderna says in a statement , is based on data from a phase 2/3 clinical trial, in which the bivalent vaccine met all primary endpoints, including a superior neutralizing antibody response against Omicron (Ba .1) versus a booster dose of 50 micrograms (µg) of Spikevax in seronegative participants at baseline.
A booster dose with the newcomer increased the neutralizing titers against Omicron by about 8 times compared to baseline levels. Furthermore, studies show that it elicited potent neutralizing antibody responses even against the sub-variants Ba.4 and Ba.5 (Omicron 4 and 5, respectively) when compared to the currently licensed booster, regardless of previous infection status or age.
THE CEO'S COMMENT
The bivalent vaccine “has consistently demonstrated a higher amplitude of the immune response than mRna-1273 [Spikevax, ed ] in clinical trials. This bivalent vaccine plays an important role in protecting people in the UK from Covid-19 as we enter the winter months, ”said Moderna CEO Stéphane Bancel.
THE NEED TO UPDATE VACCINES
Since the first form of the virus was identified, which emerged in Wuhan at the end of 2019, there have been numerous mutations and, consequently, variants that have made the current vaccines – especially with the arrival of Omicron – less effective because they were studied for train the organism to fight the original strain.
This does not mean, however, that they are no longer useful. Indeed, pending the authorization of the regulatory bodies, many experts advise vaccination even with the vaccines currently available as they continue to maintain strong protection against the risk of serious illness or death.
THE SITUATION IN THE UNITED KINGDOM
The emergence of new variants and the ability of the virus to partially evade our immune defenses have led to a surge in cases around the world.
In the United Kingdom, reports the BBC , after about 2.5 million people tested positive in mid-late July, cases are now on the decline.
THE AUTUMN RECALL CAMPAIGN
The autumn booster, according to the Joint Committee on Vaccinations and Immunizations (JCVI), should be given to: health and social care personnel, all those over 50, caregivers over the age of 16, people over the age of over 5 years of age whose health exposes them to a greater risk (including pregnant women), people over the age of 5 who share a home with someone with a weakened immune system.
WHICH OTHER COUNTRIES MAY AUTHORIZE IT
Moderna has completed applications for authorization for its bivalent vaccine in Australia, Canada, and the European Union and expects further decisions on this in the coming weeks.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/tutto-sul-nuovo-vaccino-bivalente-di-moderna-approvato-dal-regno-unito/ on Tue, 16 Aug 2022 09:12:08 +0000.