The Medicines and Healthcare products Regulatory Agency (MHRA)
has today (4 June 2026) granted a marketing
authorisation for the adjuvanted trivalent influenza vaccine
(Aujemflu) to protect adults aged 50 and over against flu.
Adjuvanted trivalent influenza vaccine works by stimulating the
immune system to produce its own protection against flu. None of
the ingredients in the vaccine can cause flu.
The vaccine targets three strains of flu in line with World
Health Organisation recommendations for the 2025/2026 season.
It contains an adjuvant to boost the immune system's response and
is prepared in cell culture, making it egg-free.
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.”
Adjuvanted trivalent influenza vaccine is given as a single dose
injection into the upper arm by a doctor, nurse or
pharmacist.
This approval is based on a study of 7,699 participants aged 50
and over. Four weeks after vaccination, participants who received
a quadrivalent version (targeting four strains of influenza
virus) of adjuvanted trivalent influenza vaccine had a stronger
immune response compared with those who received a quadrivalent
adjuvanted egg-based influenza vaccine, and a comparable immune
response to those who received a quadrivalent recombinant
influenza vaccine against three out of four flu strains.
For a full list of side effects of adjuvanted trivalent influenza
vaccine, patients should refer to the Patient Information Leaflet
or speak to their doctor, pharmacist or nurse.
Anyone who suspects they are having a side effect from this
medicine are encouraged to talk to their doctor, pharmacist or
nurse and report it directly to the Yellow Card scheme, either
through the website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
-
The new marketing authorisation was granted on 4 June
2026 to Seqirus UK Limited.
-
More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will
be published on the MHRA
Products website within 7 days of approval.
-
This application was approved under the MHRA's national
assessment procedure.
