Pfizer/BioNTech Covid-19 booster approved by UK medicines regulator

An updated Covid-19 booster vaccine has been approved for use in the UK.

The second “bivalent” vaccine, made by Pfizer/BioNTech, targets two coronavirus variants and has been approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) in those aged 12 and above.

The regulator confirmed on Saturday 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.

Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants

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.

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.”

Susan Rienow, country president, Pfizer UK, said: “We are delighted with today’s approval by the MHRA of Pfizer-BioNTech’s Omicron BA.1-adapted bivalent Covid-19 vaccine.

“We have been following the science since the beginning of the pandemic and are pleased to be able to provide the National Health Service with another tool in the armoury.

“We have been manufacturing the new vaccine at risk and doses will be shipped immediately for use in the autumn booster programme to help protect people in the UK this winter season.”

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.”

Health Secretary Steve Barclay said: “Our vaccination programme has already saved countless lives, but it is absolutely vital we are not complacent as winter approaches.

“I have therefore accepted the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI) to add a Pfizer bivalent vaccine to our autumn Covid booster rollout.

“Along with the Moderna bivalent vaccine, this safe and effective vaccine will target two different variants – Omicron and the original Covid strain.

“These innovative vaccines will broaden immunity and strengthen our defences against what remains a life-threatening virus.

“If eligible, please come forward for a booster jab as soon as you are contacted by the NHS.”