COVID-19 vaccine targets both the original virus and the Omicron variant
A second, “bivalent” vaccine
has today been approved as a booster 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 updated booster vaccine
made by Pfizer/BioNTech targeting two coronavirus variants has been approved
for use in individuals aged 12 years and above. This decision has been endorsed
by the Commission on Human Medicines, after a careful review of the evidence.
In each dose of the booster
vaccine, ‘Comirnaty bivalent Original/Omicron’, half of the vaccine (15
micrograms) targets the original virus strain and the other half (15
micrograms) targets Omicron (BA.1).
The MHRA’s decision is based
on data from a clinical trial which showed that a booster dose with the
bivalent Pfizer/BioNTech vaccine triggers a strong immune response against both
Omicron and the original strain. Safety monitoring showed that the side effects
observed were the same as those seen for the original Pfizer/BioNTech booster
dose and were typically mild and self-resolving, and no new serious safety concerns
Dr June Raine, MHRA Chief
“I am pleased to announce
that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial
of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against
the Omicron BA.1 variant as well as the original strain.
“Bivalent vaccines are
helping us to meet the challenge of an ever-evolving virus, to help protect people against COVID-19 variants.
“We have in place a
comprehensive safety surveillance strategy for all UK-approved COVID-19
vaccines, and this will include the updated booster we approved today.”
Professor Sir Munir
Pirmohamed, Chair of the Commission on Human Medicines said:
“Following an independent
review of the safety, quality and effectiveness of the vaccine, the Commission
on Human Medicines and its COVID-19 Vaccines Expert Working Group supports the
“As with any medicinal
product, including vaccines, it is important to continually monitor
effectiveness and safety when it is deployed, and we have the relevant
processes and expertise in this country to do that.
“The Joint Committee on
Vaccination and Immunisation (JCVI) will advise on how this vaccine should be
offered as part of the deployment programme.”