The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has
adopted a positive opinion for Supemtek (recombinant influenza vaccine) for active immunization for the
prevention of influenza in adults. A final decision is expected in Q4 2020.
The recommendation is based on clinical data demonstrating the safety and efficacy of Supemtek
demonstrated in two Phase 3 randomized controlled trials involving more than 10,000 patients. 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.

In the context of the COVID-19 pandemic, preventing influenza remains a public health priority. as health
authorities worldwide seek to prevent what is preventable: influenza and its potentially severe
complications, and the burden this causes on healthcare systems.

The risk factors for influenza and COVID-19 overlap, with cases and complications, predominantly seen
in people above 65 years old, adults with obesity and underlying comorbidities. This led to many national
and international recommending bodies to reinforce the need for influenza vaccination in this season -
including the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization,

Each year, influenza-associated deaths range from 290,000 to 650,000 globally, and the burden on
hospitals are around 10 million of influenza-related hospitalizations.

Recent data also show that influenza can multiply the risk of heart attack by up to 10 times and the risk
of stroke by up to 8 times in the week after influenza infection8, demonstrating that the burden of
influenza goes beyond its well-known respiratory complications.

Supemtek is the first and only influenza vaccine to rely on recombinant manufacturing technology. This
method for producing influenza vaccines differs significantly from the two other production platforms
currently in use (egg-based and cell-based). Recombinant technology ensures an exact match of the
hemagglutinin protein included in the vaccine to the influenza strains recommended seasonally by theWorld Health Organization for vaccines, which is an important factor when considering the vaccine
effectiveness.

Supemtek has been available in the US since 2017 – under Flublok brand name, with over ten million
doses distributed since then.

This established technology is currently used for the development of one of Sanofi’s vaccines against
COVID-19, developed in partnership with GSK and with the support of US Biomedical Advanced
Research and Development Authority (BARDA).