(BFM Bourse) – The company communicated on Monday data on the safety of this vaccine while those on immunogenicity will be published in November.
Valneva is taking a step towards the potential extension of its chikungunya vaccine to adolescents. The specialist in vaccines against infectious diseases had already published positive results for a phase 3 study (last step before future marketing) on this vaccine, called “VLA1553”. But this study focused on adults and young adults.
The group is therefore conducting another trial in adolescents, called “VLA1553-321”, with the aim of “being able to request, if successful, an extension of use for this age group if VLA1553 is first authorized in adults by the US Food and Drug Administration (FDA),” Valneva said in a statement.
“The trial could also allow the vaccine to be licensed in Brazil, which would then constitute the first marketing authorization for use in an endemic population. The current safety analysis could also allow the filing of a marketing authorization application to the European Medicines Agency (EMA) later this year,” Valneva continued.
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The company thus published on Monday the safety data (that is to say which show the absence of harmfulness of a treatment) for this trial carried out in Brazil among 754 adolescents aged 12 to 17 years old.
These data were collected up to the 29th day following the administration of this candidate vaccine. And the majority of subsequent adverse events “were mild or moderate and resolved within three days,” Valneva said.
“These new safety data in a younger population and in individuals previously infected with the chikungunya virus confirm the safety profile we have previously observed in adults and the elderly.” Valneva, Juan Carlos Jaramillo, quoted in a press release.
The immunogenicity data (the immune response to treatment) of the vaccine candidate in adolescents should be available in November.
A half-billion-dollar market?
On the Paris Stock Exchange, Valneva shares are gaining ground following this announcement, the title rising by 2% around 10:00 a.m. after having opened up more than 5% at the very start of the session.
The French group is currently awaiting marketing authorization from the FDA for this anti-chikungunya vaccine. Exactly two weeks ago, Valneva said the US health authority had postponed the target date for the end of the treatment review from the end of August to the end of November, which had weighed on its action.
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”, had then explained to BFM Bourse Mohamed Kaabouni, analyst at Portzamparc. According to a VacZine analytics study cited by Valneva, the global chikungunya vaccine market could exceed $500 million per year by 2032.
Julien Marion – ©2023 BFM Bourse