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A new influenza vaccine that is particularly effective at protecting people over the age of 65 has been approved for use by the UK’s drug regulatory body and is expected to be available to GP practices from next year.
The type of vaccine that has been approved is an adjuvanted trivalent influenza vaccine (aTIV). The new aTIV approved for use by the Medicines and Healthcare Products Regulatory Agency this month is known as Fluad.
“This adjuvanted vaccine has a well-established safety and tolerability profile through its use in Europe and other parts of the world”
Pauline MacDonald
Studies have shown that the use of an adjuvant – a substance that enhances the body’s immune response to an antigen – in the vaccine increases protection.
This is particularly relevant for older people whose immune systems decline with age and who, therefore, do not respond as well to conventional non-adjuvanted vaccines.
Fluad is being made available for the 2018-19 flu season by Maidenhead-based manufacturers Seqirus, which has said it could supply 10 million doses in the UK for that period.
In June this year, aTIVs gained some support from the Joint Committee on Vaccination and Immunisation, which advises the government, based on evidence from published studies.
“We consider that Fluad can make a major contribution in reducing the burden of influenza on the health services, locally, regionally, and nationally”
Dr Russell Basser
The JCVI said it would bring forward its review of vaccination programmes for over 65s partly in light of the fact that Fluad had been approved.
However, the committee noted that, as part of its review, it would have to consider data from “a number of years, and would wish greater granularity of effectiveness data by age”.
It said that the gradual deterioration of the immune system due to ageing – or immunosenescence – could be “an important factor in the effectiveness being seen”, while the timing of the vaccination could also have played a part.
“Data on incremental benefit and cost-effectiveness would be useful in forming any views on optimisation of the routine over 65 year olds programme, along with use of adjuvanted vaccines,” said recent minutes from a JCVI meeting. The committee agreed to consider this work at its meeting in October.
Independent consultant nurse Pauline MacDonald, who specialises in immunisation and is a former member of the JCVI, said: “This adjuvanted vaccine has a well-established safety and tolerability profile through its use in Europe and other parts of the world.
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Pauline MacDonald
“Its approval in the UK offers a new effective option for healthcare professionals when making decisions about which influenza vaccines might be the most appropriate for their specific patient groups, particularly for those adults aged 65 years and older,” she added.
Dr Russell Basser, chief medical officer at Seqirus, said: “We understand the devastating human impact of influenza infection in adults aged 65 years and older, the substantial societal impact of influenza, as well as the cost to the NHS in preventable GP appointments and preventable hospitalisations.”
“We believe that our strong and robust data on Fluad’s clinical efficacy, real-world effectiveness, and well-established safety profile, built up over 20 years of use, demonstrates convincingly that this adjuvanted influenza vaccine has clear advantages for adults aged 65 years and over when compared to existing conventional non-adjuvanted vaccines,” he said.
“We consider that Fluad can make a major contribution in reducing the burden of influenza on the health services, locally, regionally, and nationally,” he added.
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