Source : 'The Pink Sheet'
The UK government has given the go-ahead for the use of an unlicensed flu vaccine from Sanofi to help meet high demand for vaccination amid the coronavirus pandemic and the oncoming northern hemisphere winter.
The vaccine, which is approved in the US as Flublok, has been given an authorization for temporary supply during the UK’s 2020/21 seasonal flu program in adults 18 years and older, starting in December. The authorization was granted by the Department of Health and Social Care and the medicines regulator, the MHRA.
Marketed in the US since 2016, Flublok has been used in more than nine million people, the government said, adding that the US Food and Drug Administration “considers the vaccine safe and acceptable for use.”
The move is part of the UK’s expanded flu vaccination program, which in turn is intended to help prepare the National Health Service “both for the risk of a second peak of coronavirus cases, and to relieve winter pressures on A&E and emergency care,” the government declared. “This winter more than ever, with COVID-19 still circulating, we need to help reduce all avoidable risks. Vaccinating more people will help reduce flu transmission and stop people becoming ill,” it added.
Allowing an unapproved vaccine to be used like this is not unusual. A temporary authorization for the supply of an unlicensed vaccine can be granted under regulation 174 of the UK Human Medicines Regulations in case of public health threats, including the “suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation”.
In granting the authorization, the MHRA assessed the available scientific evidence on Flublok’s safety, quality and effectiveness. Its assessment also took account of data on another “closely related Sanofi flu vaccine, Supemtek,” the government said. Supemtek has been filed for centralized approval in the EU, and last month was given a positive opinion by the European Medicines Agency’s drug evaluation committee, the CHMP. ()
The MHRA assessment showed the two vaccines were “fundamentally similar on the basis of a review of the manufacture, control, quality, non-clinical and clinical evaluation,” the government said.
It is not clear whether Sanofi plans to seek formal marketing authorization of Flublok in the UK, or whether it will wait for a European Commission decision on the approval of Supemtek. The company had not replied to a request for comment at the time of publication.
The move comes amid the ongoing debate about how to balance the earlier availability of medicines and vaccines with the need to ensure that no corners are cut where safety and efficacy are concerned.
Christian Schneider, interim chief scientific officer at the MHRA, said the agency 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,” he declared.
The issue was also raised by Hugo Fry, managing director of Sanofi UK and Ireland, who said it was “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.”
Fry said his company had “quickly responded” to the UK government's requests for increased supply of flu vaccine and that it was “working closely with UK regulators to accelerate the import of millions of the stocks from the US at this critical time.”
Deputy chief medical officer Jonathan Van-Tam said that as winter approached and cases of COVID-19 continued to rise, it was “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.”
The UK has already said that it will use regulation 174 to allow access to future COVID-19 vaccines as soon as possible. On 19 October it announced that it was pressing ahead with plans to make a coronavirus vaccine available before it had been formally licensed, provided the UK licensing authority was “satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine.” ()
The amendments to the medicines regulations also allow for an expansion of the trained workforce who can administer flu vaccines, as well as a COVID-19 vaccine once one becomes available.
By Ian Schofield