Supemtek TIVr

Profile

⁺This study used Supemtek (quadrivalent recombinant influenza vaccine), the efficacy of which is relevant to Supemtek TIVr because both vaccines are manufactured using the same process and have overlapping compositions.¹

^*Recommended for 25/26 flu season

^**Confidence intervals overlapped with the point estimates for aQIV. Results are expected to be published in a peer-reviewed publication.

Clinical Evidence

A joint first-line recommended flu vaccine with head-to-head RCT efficacy data against another flu vaccine

Supemtek has shown proven efficacy against another flu vaccine in a head-to-head RCT study, the gold standard of clinical research^1,3

Types of study design

A phase 3-4 randomised controlled trial of 8,604 patients ≥50 years of age was conducted during the A/H3N2-dominant 2014/15 influenza season, and patients were randomised 1:1 to receive a single dose of Supemtek or SD-QIVe. Result based on attack rate of influenza-like illness confirmed by RT-PCR. This study found that Supemtek showed 30% greater relative risk reduction (1% absolute risk reduction) against influenza-like illness versus standard-dose QIVe.

Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older

Recent real world data

JCVI would like to see more use of Supemtek TIVr to improve estimates of vaccine effectiveness²

Draft data released in the JCVI minutes for June 2024 showed a 34% absolute vaccine effectiveness against hospitalisation when using Supemtek (compared to 22% absolute effectiveness for aQIV) for those aged ≥65 years in the 2023/24 influenza season.⁴ Confidence intervals were noted to be overlapping between the two vaccines, though there is no mention of the specific confidence interval values.

In addition, data published in the JCVI minutes in June 2023 stated that Supemtek demonstrated 39% absolute vaccine effectiveness against hospitalisation for those aged ≥65 years in the 2022/23 influenza season. The lower confidence interval was stated to be above 0 (there is no mention of the upper confidence interval, and no numerical confidence intervals are provided in the minutes).⁵

Usage

With one vaccine for adults for all ages, Supemtek TIVr has the potential to simplify your flu vaccination campaign²

Supemtek TIVr is the only flu vaccine licensed in adults (≥18 years) that is also joint first-line JCVI recommended across all reimbursable adult cohorts.**²

Table of JCVI recommended flu vaccines

Note: there is a limited amount of data on the use of Supemtek TIVr in pregnant women. One animal study performed with trivalent recombinant influenza vaccine did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development. An assessment of the risks and benefits should be performed by a healthcare professional before administering Supemtek TIVr to a pregnant woman.²

**As recommended by the JCVI for the 2025-26 Influenza season.

* Equally suitable options.

Recombinant technology

Supemtek is the first recombinant influenza vaccine in Europe.

Recombinant technology eliminates the possibility of adaptation or mutation by replicating only the haemagglutinin (HA) antigen direct from a genetic sequence. The resulting antigens are an exact genetic match to the target strain HA antigen.^6,7

Increased HA content

Supemtek contains 3x more HA antigen (45 mcg versus 15 mcg) per strain, compared with cell and egg-based standard-dose quadrivalent influenza vaccines.¹

Adverse Events

Supemtek TIVr offers the reassurance of a known immunogenicity and safety profile^1,3

Safety data for Supemtek TIVr are derived from the quadrivalent recombinant influenza vaccine as both vaccines are manufactured using the same process and have overlapping compositions.^1,3 The most common reactions that occurred after Supemtek administration were injection-site reactions: tenderness was reported by 48%, and pain by 37%, in study participants 18–49 years of age. In study participants ≥50 years of age, injection site tenderness was reported by 34% and injection site pain by 19%.^1,3 Safety and efficacy of Supemtek have not been established in people < 18 years of age.¹ The severity of the reactions was mild to moderate. Onset usually occurred within the first 3 days after vaccination. All resolved without sequelae.¹ For the full list of adverse events please refer to the Summary of Product Characteristics.

Other adverse events included:¹

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