Adjuvanted trivalent flu vaccine approved for over 50s

Aujemflu, an adjuvanted trivalent influenza vaccine, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in adults aged 50 years and older.

The vaccine, which is manufactured by Seqirus UK Limited and contains an adjuvant, is designed to enhance immune response in older adults, who tend to garner less protection from standard vaccines than younger people.

Dr Gregg Sylvester, global head of research and development and chief medical officer at Seqirus, said that he welcomes the MHRA approval: ‘Seasonal flu remains a serious health risk, particularly for older adults, and continues to place pressure on the healthcare systems each winter.’

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‘As the immune system weakens with age, it is less able to mount a sufficient protective immune response to standard influenza vaccines, leaving adults as young as 50 years of age more vulnerable to influenza and related complications.’

‘By combining our MF59-adjuvant with cell-based manufacturing, at a higher dose adjuvanted cell-based trivalent influenza vaccine brings together proven technologies designed to elicit a stronger immune response in older adults.’

The adjuvanted trivalent influenza vaccine is prepared in cell culture and, therefore, is egg-free. It is given as a single dose injection into the upper arm by a doctor, nurse or pharmacist.

According to the MHRA, the approval is based on a study of 7,699 participants aged 50 and over, comparing a quadrivalent formulation of Aujemflu against two alternative influenza vaccines.

At four weeks post-vaccination, Aujemflu recipients showed a stronger immune response than those given a quadrivalent adjuvanted egg-based vaccine, and a comparable response to those given a quadrivalent recombinant vaccine across three of the four strains.

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Julian Beach, MHRA executive director, healthcare quality and access, said: ‘Keeping patients safe and enabling their access to high quality, safe, and effective medical products are key priorities for us.

‘The MHRA has assessed that the benefits of adjuvanted trivalent influenza vaccine are greater than its risks and that it can be authorised for use in the UK.

‘As with all products, we will keep the safety and effectiveness of adjuvanted trivalent influenza vaccine under close review.’

The trivalent vaccine targets three strains of flu in line with World Health Organization (WHO) recommendations for the 2025/2026 season.

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The transition from a quadrivalent vaccine comes as the WHO found that B/Yamagata lineages of flu are no longer circulating and are unlikely to cause future epidemics so, therefore, including it is no longer warranted.

A version of this article was first published on our sister title The Pharmacist.