Millions of people will be given unlicensed flu vaccines this winter, health officials announced last night.
The Department of Health has reached a deal with drugs giant Sanofi to purchase a substantial quantity of its vaccine Flublok –despite the fact it is not licensed for use anywhere in Europe.
Millions of doses are now being imported from the US.
Ministers earlier this year announced emergency measures allowing the UK Medicines and Healthcare products Regulatory Agency to give a vaccine temporary approval before receiving a European licence.
They aim to vaccinate more than 30million this winter against flu in the largest campaign ever undertaken.
Professor Jonathan Van-Tam, the deputy chief medical officer, said: ‘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.
Millions of people will be given unlicensed flu vaccines this winter, health officials announced last night but the Government insists the vaccine has gone through 'robust clinical trials'
'Flublok has been in regular use in the United States - and the evidence shows that it is an excellent product.
'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.
'We have increased the number of people eligible for free flu jabs this year to reduce all avoidable risks and protect people from illness.'
Flu vaccines are available for over-65s, children up to the age of 11, pregnant women, and those with certain pre-existing conditions such as asthma.
Household contacts of those on the NHS 'shielding' list are also eligible this year.
And for the first time eligibility has been extended to those aged 50 to 64, although this will not take place until the other parts of the programme are well underway.
Dr Christian Schneider, interim chief scientific officer at the MHRA, said: 'The MHRA assessed Flublok 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.'
Professor Jonathan Van-Tam says it is crucial the country doubles down on efforts to vaccinate as many people as possible from flu as number of coronavirus cases continue to rise
Hugo Fry, managing director of Sanofi UK and Ireland, added: 'Sanofi has quickly responded to the UK government's requests for increased supply of flu vaccine, bringing in millions of additional doses to help to protect public health, the NHS and key workers.
'Although not yet licensed in the UK, Sanofi has recognised the importance of providing this vaccine and is working closely with UK regulators to accelerate the import of millions of the stocks from the US at this critical time.
'It is important to point out that unlicensed does not mean untested, so any product deployed in clinical practice will have undergone a rigorous testing and development process to ensure high standards of safety, quality and efficacy.'