(News Bulletin 247) – CEPI will grant the French biotech company new funding of up to $41.3 million to support clinical trials in vulnerable populations such as children and pregnant women, and to make its vaccine accessible to low- and middle-income countries in Asia.

The good news keeps coming for Valneva’s world-first chikungunya vaccine. In early July, the European Union gave the green light to market Ixchiq, Valneva’s vaccine for the prevention of chikungunya disease in people aged 18 and older.

Let us recall that chikungunya is a viral disease transmitted by mosquitoes, causing headaches, nausea, fatigue and disabling joint pain. This disease has been identified in 110 countries and more than 3.7 million cases have been recorded on the American continent between 2013 and 2023, with a significant economic impact. However, these mosquitoes continue to expand their territory due to global warming.

Increased accessibility in Ixchiq

To make this vaccine against this disease as accessible as possible, the laboratory indicated on Monday that it had strengthened its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI).

Established at the Davos Forum in 2017, CEPI is a partnership between public, private, philanthropic and civil organizations with the ambition of developing vaccines against diseases with high epidemic potential.

As part of this enhanced partnership, CPEI will provide up to $41.3 million in additional funding over the next five years to Valneva to increase the accessibility of its chikungunya vaccine in low- and middle-income countries. This program will be carried out with the support of the European Union under the Horizon Europe program.

The new funding will fund clinical trials in vulnerable populations such as children, adolescents and pregnant women. Valneva says thousands of participants are expected to take part in these clinical trials, which are expected to launch in 2025. These trials are expected to include evaluating the vaccine in children aged 1 to 11 years and in pregnant women who may be affected by a chikungunya outbreak.

The funding will also support the transfer of vaccine technology to another vaccine manufacturer with the aim of accelerating and expanding access to Ixchiq in low- and middle-income countries in Asia vulnerable to chikungunya outbreaks.

On the Paris Stock Exchange, the announcement was welcomed. Valneva shares rose 5.9% to 3.47 euros at around 3:20 p.m.

A first partnership in 2019

In July 2019, Valneva and CEPI had reached an initial agreement to combat chikungunya, with financial support of up to $23.4 million. Ultimately, the grant turned out to be slightly larger than expected, with Valneva reporting $24.6 million in funding in its press release today.

At the time, this vaccine was only in clinical trials. Five years later, Valneva’s vaccine can be used in adults aged 18 in the United States since the end of 2023, in Canada and in the European Union, since a few weeks.

Valneva has also submitted a marketing authorisation application to the UK Medicines and Healthcare products Agency (MHRA). The company also points out that a marketing authorisation dossier is currently under review by the Brazilian health agency Anvisa, with a potential authorisation in 2024.

In terms of financial spin-offs, Invest Securties recalled that Valneva is counting on a target of more than 100 million euros in turnover in year 3 of marketing this vaccine, including the market entry of competing products.

“According to a 2020 market study, the size of the chikungunya vaccine market is estimated at more than $500 million, of which $300-400 million is represented by the travel segment that Valneva is targeting,” the financial intermediary indicated in early July.

Valneva has a portfolio of vaccines and vaccine candidates that extends well beyond chikungunya, including a vaccine candidate against Lyme disease, or against the Zika virus as well as a vaccine already marketed against Japanese encephalitis and another against cholera.