The
adapted COVID-19 vaccine made by Moderna targets two different coronavirus
variants – the original virus from 2020 and the Omicron variant
An updated version of the
COVID-19 vaccine made by Moderna that targets two coronavirus variants (known
as a “bivalent” vaccine) has today been approved for adult booster doses by the
Medicines and Healthcare products Regulatory Agency (MHRA) after it was found
to meet the UK regulator’s standards of safety, quality and effectiveness.
The decision to
grant approval for this booster vaccine in the UK was endorsed by the
government’s independent expert scientific advisory body, the Commission on
Human Medicines, after carefully reviewing the evidence.
In each dose of the booster
vaccine, ‘Spikevax bivalent Original/Omicron’, half of the vaccine (25
micrograms) targets the original virus strain from 2020 and the other half (25
micrograms) targets Omicron.
The MHRA’s decision is based on
data from a clinical trial which showed that a booster with the
bivalent Moderna vaccine triggers a strong immune response against both
Omicron (BA.1) and the original 2020 strain. In an exploratory analysis the
bivalent vaccine was also found to generate a good immune response against the
Omicron sub-variants BA.4 and BA.5.
Safety monitoring showed that
the side effects observed were the same as those seen for the original
Moderna booster dose and were typically mild and self-resolving, and no serious
safety concerns were identified.
Dr June Raine, MHRA Chief
Executive said:
“I am pleased to announce the
approval of the Moderna bivalent booster vaccine, which was found in the
clinical trial to provide a strong immune response against the Omicron BA.1
variant as well as the original 2020 strain.
“The first generation of COVID-19
vaccines being used in the UK continue to provide important protection against
the disease and save lives. What this bivalent vaccine gives us is a sharpened
tool in our armoury to help protect us against this disease as the virus
continues to evolve.
“We
have in place a comprehensive safety surveillance strategy for monitoring the
safety of all UK-approved COVID-19 vaccines and this will include the vaccine
approved today.”
Professor Sir Munir Pirmohamed,
Chair of the Commission on Human Medicines said:
“The Commission
on Human Medicines and its COVID-19 Vaccines Expert Working Group has
independently reviewed the data on safety, quality and effectiveness and agrees
with the MHRA’s decision.”
“The virus,
SARS-CoV-2, is continually evolving in order to evade the immunity provided by
vaccines. This novel bivalent vaccine represents the next step in the
development of vaccines to combat the virus, with its ability to lead to a
broader immune response than the original vaccine.”
The Joint
Committee on Vaccination and Immunisation (JCVI) will advise on how
this vaccine should be offered as part of the deployment programme.
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