Unlicensed flu vaccine will not be available for use until December, MHRA says

An unlicensed flu vaccine that has been given temporary authorisation for use in the UK will not be available until December 2020.

Pharmacists will be able to order supplies of the recombinant quadrivalent vaccine Flublok (Sanofi), but information published by the Medicines and Healthcare products Regulatory Agency (MHRA) says that the vaccine will be used as part of the seasonal flu programme “from December”.

The news comes as the Pharmaceutical Services Negotiating Committee (PSNC) said it was “continuing to stress the urgency” to the government of informing community pharmacies how they can access centrally held flu vaccine stocks, amid reported shortages.

Flublok is suitable for adults aged 18 years and over; it has been licensed for use in the United States since 2016 and has been authorised for temporary supply by the MHRA. 

The Department for Health and Social Care (DHSC) said in a statement that GPs, NHS trusts and community pharmacies would be able to order stock from the government’s centrally procured supply of Flublok to complement their own flu vaccination stocks, ensuring as many people as possible are able to receive the vaccination this winter.

Pharmacists were only recently permitted to supply unlicensed medicines in response to a public health emergency, following amendments made to the Human Medicine Regulations on 16 October 2020.

The supplies of the new Flublok vaccine follow reports of supply issues in community pharmacy, with pharmacy multiples pausing flu vaccinations for those aged under 65 years.

However, details are yet to be published on how pharmacists can order additional stock, with such instructions already provided to GPs on 9 October 2020.

The PSNC said in its daily email update that it was continuing to work with the DHSC on how pharmacies could access the back-up stock.

“We expect this guidance to be released shortly and PSNC is continuing to stress the urgency of the details being confirmed so that contractors can plan and manage their vaccination programmes across November and December,” it said.

The DHSC told The Pharmaceutical Journal on 22 October 2020 that guidance on how pharmacies could access centrally held flu vaccine stocks would be published “very soon”.