Pharmacists will be able to order supplies of an unlicensed recombinant influenza vaccine to support the UK’s expanded flu vaccination scheme, the Department of Health and Social Care (DHSC) has said.
Flublok (Sanofi), which has been licensed for use in the United States since 2016, has been authorised for temporary supply by the Medicines and Healthcare products Regulatory Agency (MHRA) and is suitable for adults aged 18 years and over.
In response to certain public health threats, the MHRA can temporarily authorise the supply of a medicine for use when it is satisfied that there is robust evidence to show the safety, quality and effectiveness of the medicine.
The 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 (HMR) on 16 October 2020.
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 Pharmaceutical Services Negotiating Committee told The Pharmaceutical Journal that it “is continuing to work with DHSC on the details of how the sector will be able to access vaccines from the government’s backup stock when it starts to be delivered in November ”, adding that further information would be released soon.
The supplies of the new vaccine follow reports of supply issues in community pharmacy, with pharmacy multiples pausing flu vaccinations for those aged under 65 years.
Christian Schneider, interim chief scientific officer at the MHRA, said that it had assessed the Flublok vaccine against safety, quality and effectiveness standards, and sought advice from the government’s independent expert scientific advisory body — the Commission on Human Medicines.
“We are satisfied that this vaccine protects against flu and meets high standards of safety and quality,” he said.
At a meeting in June 2020, the Joint Committee on Vaccination and Immunisation agreed that Flublok was suitable for use in the influenza immunisation programme, after DHSC officials said the government had considered using flu vaccines that were not currently licensed in the UK to support demand.
According to the DHSC, a “physically and biologically similar vaccine”, called Supemtek (Sanofi), was recommended for approval by the European Medicines Agency in September 2020.