Newly approved Covid vaccine will be offered as part of Wales’ autumn booster programme
Wales’ Health Minister has confirmed that an updated Covid-19 vaccine which was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) earlier today, will be offered to patients as part of the Autumn booster programme.
The second “bivalent” vaccine, made by Pfizer/BioNTech, targets two coronavirus variants and has been approved for use by the MHRA in those aged 12 and above.
The regulator confirmed on Saturday morning that the vaccine had met its standards of safety, quality and effectiveness.
The vaccine targets both the original strain of coronavirus and the Omicron variant that emerged at the end of 2021 and follows a similar booster from Moderna which was approved in August.
The MHRA said its 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.
Booster roll out
The roll-out of the autumn Covid-19 booster got underway in Wales earlier this week with care home residents and staff the first to receive the vaccine on the 1st of September.
The new booster jab will be offered to everyone in Wales aged 50 and over, as well as those with underlying health conditions, to increase protection ahead of the future waves of the virus.
As part of the Welsh Government’s winter respiratory vaccination strategy, people who are eligible for the Covid jab are also being urged to take up the flu vaccine when offered.
Health Minister Eluned Morgan said: “The Welsh Government continues to be guided by the latest clinical and scientific evidence and advice. Therefore, along with my UK counterparts, I have accepted this advice and agreed that the Pfizer mRNA bivalent vaccine will be utilised in the Covid-19 booster vaccination campaign in Wales.
“Our booster campaign will help boost the immunity of those at higher risk from Covid-19, improving their protection against severe illness and helping protect the NHS this coming winter.
Strong immune response
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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