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Unlicensed US flu jab approved for temporary use in UK

An unlicensed flu vaccine used in the US for the past three winters has been granted temporary authorisation to help ensure more people receive a flu jab this winter.

Flublok, a quadrivalent vaccine manufactured by Sanofi, has been authorised for supply by the MHRA after the agency decided it met the required standards for safety, quality and effectiveness. It has been given to over nine million people in the US since being authorised by the FDA in 2016.

Flublok is described as ‘closely related’ to Supemtek, another Sanofi flu vaccine that the European Medicines Agency recommended for use this September.

The move forms part of the Government’s plan to immunise more than 30 million people against flu this year. Providers are being told to prioritise over-65s and other at-risk groups before vaccinating 50-64-year-olds, who are also eligible for free jabs this winter.

The Department of Health and Social Care told Pharmacy Network News that 2.15 million Flublok vaccines have been procured for England’s vaccination programme, and that it will be made available to all groups eligible for NHS flu jabs this year.

Advice for community pharmacists on obtaining additional flu supplies, including Flublok, will be published “very soon,” a DHSC spokesperson told PNN.

“There will be further communications on when providers can begin ordering or pre-ordering the central stock from manufacturers.”

Deputy chief medical officer Jonathan Van Tam said: “As we approach the winter and cases of Covid-19 continue to rise, it is crucial we double down on efforts to vaccinate as many people as possible from flu.

“Flublok has been in regular use in the United States – and the evidence shows that it is an excellent product.

“I want to reassure everyone that all vaccines have undergone robust clinical trials and rigorous checks by the regulator to ensure they are safe, effective and of a high quality.”




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