22 September 2020 - Positive opinion based on clinical data demonstrating safety and efficacy of Supemtek for adults aged 18 and older demonstrated in two Phase 3 randomised controlled trials involving more than 10,000 patients.
The EMA’s CHMP has adopted a positive opinion for Supemtek (recombinant influenza vaccine) for active immunisation for the prevention of influenza in adults. A final decision is expected in Q4 2020.
In comparison with a standard-dose egg-based quadrivalent influenza vaccine, Supemtek reduced the risk of influenza by an additional 30% for adults aged 50 years and above.