This is intended for HCPs practising in Great Britain (England, Scotland and Wales) only.
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Flu just met its genetic match
Supemtek® Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) is the first recombinant influenza vaccine in Europe, indicated for active immunisation for the prevention of influenza disease in adults.1
Supemtek is manufactured to offer an exact genetic match to the WHO-predicted viral strain haemagglutinin (HA) antigen.1,2
Evidence
Supemtek efficacy
Supemtek has shown 30% greater relative efficacy (1% absolute efficacy) against influenza-like illness versus standard-dose egg-based quadrivalent influenza vaccine (QIVe) (2.2% vs 3.2% influenza attack rate) in adults ≥50 years of age (Figure 1).1,2
A randomised, controlled trial of 8,604 adults ≥50 years of age during the 2014/15 influenza season found that Supemtek showed 30% greater relative efficacy (1% absolute efficacy; 2.2% vs 3.2% influenza attack rate) against influenza-like illness (reverse-transcriptase polymerase chain-reaction [RT-PCR] confirmed) versus standard-dose QIVe (95% confidence interval [CI]: 10, 47).1,2
RT-PCR-confirmed influenza-like illness (primary endpoint) attack rates were 3.2% (138 infections/4301) modified per-protocol population and 2.2% (96 infections/4303) modified per-protocol population with standard-dose QIVe and Supemtek, respectively.1,2
Additionally, when considering the secondary endpoint, culture-positive influenza-like illness, Supemtek showed 43% greater relative protection (1% absolute reduction) compared with standard-dose QIVe. Culture-positive influenza-like illness attack rates were 2.3% (101 infections) and 1.3% (58 infections) for standard-dose QIVe and Supemtek, respectively.1,2
Figure 1: Supemtek showed greater relative efficacy against influenza than standard-dose QIVe in adults ≥50 years of age. Supemtek efficacy was driven by response to influenza A (relative vaccine efficacy [rVE] 36%, aVE 1%; influenza attack rates 1.7% and 2.7% for Supemtek and QIVe, respectively; p=0.03), response to influenza B was similar for Supemtek and QIVe.1,2
*rVE of Supemtek vs standard-dose QIVe.
†Lower bound (LB) of 95% CI interval met pre-specified, exploratory criterion for superior relative vaccine efficacy, LB >9%. Relative risk is calculated as percentage of participants with documented flu in the Supemtek group (Supemtek attack rate) divided by percentage of participants with documented flu in the QIVe group (QIVe attack rate). rVE is calculated as 100x (1 - relative risk).
Supemtek Immunogenicity
Supemtek showed comparable immunogenicity to standard-dose QIVe in adults aged 18–49 years of age.1,4
Comparison of immunogenicity with Supemtek or QIVe during the 2014/15 influenza season was tested according to co-primary endpoints, geometric mean antibody titres (GMT) (Table 1) and seroconversion rates (SCR) (Table 2) at Day 28, across influenza strains in a randomised, controlled trial of 1,350 adults.1,2
Supemtek responses to three of the four influenza strains (A/H1N1, A/H3N2 and B/Yamagata) met non-inferiority criteria. Supemtek responses to B/Victoria/60/2008 did not meet non-inferiority criteria; however, responses were low in both groups so comparisons could not be drawn.1,4
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Table 1: Non-inferiority for haemagglutination inhibition (HAI) SCRs and post-vaccination GMT ratios for each antigen were co-primary endpoints. Success in meeting GMT non-inferiority endpoint was predefined as an upper bound (UB) of the two-sided 95% CI of GMT QIVe/GMT Supemtek <1.5.
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Table 2: Non-inferiority for HAI SCRs and post-vaccination GMT ratios for each antigen were co-primary endpoints. Success in meeting SCR non-inferiority endpoint was pre-defined as an UB of the two-sided 95% CI of SCR QIVe/SCR Supemtek ≤10%.
Figure 2: A/H3N2 GMT ratios between vaccines met non-inferiority criteria in both age groups.1,2,4
*Success in meeting GMT endpoint was predefined as an UB of the two-sided 95% CI of GMT standard-dose QIVe/GMT Supemtek <1.5.
People who received Supemtek showed increased antibody titres against A/H3N2 at Day 28 compared with those who received standard-dose QIVe.1,2,4
Usage
Recombinant technology
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.2,3
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.2
Adverse Events
Supemtek safety profile
In two separate studies of adults ≥50 years of age and 18–49 years, Supemtek showed a comparable safety profile to standard-dose QIVe (Figures 3 and 4).2,4
The most commonly reported reactions after vaccine administration were injection-site reactions (tenderness and pain). Severity of reactions were mild to moderate. Onset usually occurred within the first 3 days after vaccination. All reactions resolved without sequelae.1
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AE, adverse event; CI, confidence interval; GMT, geometric mean titre; HAI, haemagglutination inhibition; LB, lower bound; QIVe, quadrivalent inactivated influenza; RT-PCR, reverse-transcriptase polymerase chain-reaction; rVE, relative vaccine efficacy; UB, upper bound.
References
- Supemtek Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/12761/smpc#gref (Accessed October 2023).
- Dunkle LM, et al. N Engl J Med. 2017;376:2427–36.
- Centers for Disease Control and Prevention. How influenza (flu) vaccines are made. https://www.cdc.gov/flu/prevent/how-fluvaccine-made.htm#recombinant (Accessed October 2023).
- Dunkle LM, et al. J Infect Dis. 2017;216:1219–26.
MAT-XU-2301126 (v2.0) Date of preparation: December 2023