(News Bulletin 247) – The specialist in vaccines against infectious diseases announced on Monday that the American health authority, the FDA, had modified the target date for the completion of this examination, shifting it from the end of August to the end of November. Valneva still expects to obtain marketing authorization for this vaccine this year.

An important catalyst for the action Valneva takes the lead in the wing. The infectious disease vaccine specialist has been thrust into the limelight in recent years due to its Covid-19 vaccine, which suffered several setbacks and whose production was halted by the group.

But Valneva has a portfolio of vaccines and vaccine candidates that goes well beyond just Covid-19, including a vaccine candidate against Lyme disease and a vaccine against Japanese encephalitis.

The group is also betting heavily on its chikungunya vaccine candidate, called “VLA1553”. This vaccine against this virus transmitted by mosquitoes and resulting in particular in acute fevers and joint pain is currently the subject of requests for examination in the United States as well as in Canada.

Allow time to agree on phase 4

However, in the United States, the Food and Drug Administration, that is to say the American health authority, has postponed the target date for the completion of the examination of the candidate vaccine, the company announced this Monday. This target date has therefore been postponed from the end of August to the end of November.

“The FDA made this decision to allow sufficient time for the parties to agree on the Phase 4 trial program (a phase that occurs after marketing authorization and which allows monitoring of the use of the long-term drug) required under the accelerated approval process. The FDA has not requested any additional clinical data for this approval process,” the company said in a statement.

Valneva has nevertheless confirmed that it anticipates the possible approval of its application for authorization of the vaccine this year, as well as its initial launch. This postponement also has no impact on Valneva’s regulatory submission currently underway in Canada or on a future regulatory submission to the European Medicines Agency (EMA), the European health authority, added the business.

A half-billion-dollar market?

The announcement is nevertheless sanctioned by the market. Around 11 a.m., Valneva shares lost 10.81% to 5.998 euros.

As a reminder, Valneva had published in March 2022 positive data on immunogenicity and safety for the phase III study (the last step before potential marketing) evaluating this vaccine candidate VLA-1553. Then, last December, the company reported conclusive new data on the persistence of the vaccine’s antibodies.

“The VLA1553 is the most advanced product under development in this indication and therefore Valneva has a good chance of being the first and only operator on this market”, Mohamed Kaabouni, analyst at Portzamparc, explained to News Bulletin 247. According to a VacZine analytics study cited by Valneva, the global chikungunya vaccine market could exceed $500 million per year by 2032.