Following on from the previous advice on which vaccines should be used in this year’s autumn booster programme, the Joint Committee on Vaccination and Immunisation (JCVI) has updated its published advice to include an additional bivalent vaccine now approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
Studies indicate the Pfizer-BioNTech bivalent vaccine produces a marginally higher immune response against some variants than the Pfizer-BioNTech mRNA Original ‘wild-type’ vaccine. The clinical relevance of these small differences is uncertain.
‘Bivalent’ vaccines have been developed by global manufacturers since the emergence and dominance of the Omicron variant. These vaccines are targeted against antigens (substances that induce an immune response) from 2 different COVID-19 strains, or variants.
All of the available booster vaccines offer very good protection against severe illness from COVID-19. As more vaccines continue to be developed, the committee will consider their use in the autumn programme.
Professor Wei Shen Lim, Chair of COVID-19 immunisation on the JCVI, said: “It is very encouraging that more vaccines continue to become available and we now have another option to add to the vaccines already advised for the autumn booster campaign.
“Winter is typically the time of greatest threat from respiratory infections. We strongly encourage everyone who is eligible to have their booster vaccine this autumn when it is offered. This is our best defence against becoming severely ill from COVID-19.”
Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator
A second, “bivalent” vaccine was yesterday 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 were identified.
Dr June Raine, MHRA Chief Executive said: 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 MHRA’s decision.
“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.”
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