In August 2022 Valneva SE, a speciality vaccine company based in France, announced that it has “initiated rolling submission of the Biologics License Application (BLA)” to the FDA, seeking approval of the “single-shot chikungunya vaccine candidate” in adults. VLA1553 is a live-attenuated, single dose investigational vaccine candidate.
The BLA comes after Phase III data in March 2022 and lot-to-lot consistency results in May 2022. Further studies in adolescents are ongoing in Brazil. The submission is part of the “accelerated approval pathway” that was agreed with the FDA in 2020. VLA1553 was also granted PRIME designation – PRIority MEdicine – by the EMA in 2020. Valneva hopes to make regulatory submissions for VLA1553 in Europe by early 2023.
What is Chikungunya?
Chikungunya is a mosquito-borne viral disease. It is caused by the chikungunya virus (CHIKV) and infection leads to symptomatic disease in 72-92% of humans after up to a week following the bite. Although mortality rates are low, morbidity is high, and Valneva states that the “global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032”. Chikungunya virus-carrying mosquitos are endemic in the Americas, parts of Africa, and South-East Asia. The virus has spread to around 120 countries.
Dr Juan Carlos Jaramillo, CMO of Valneva, said that this development marks an “extremely important milestone for our VLA1553 programme”.
“We are very proud to be the first company worldwide that has begun submission of a BLA for a chikungunya vaccine candidate”.
He described Chikungunya as a “major public health threat” with no specific treatments available.
Access to VLA1553
As ever, access to a successful chikungunya candidate will prove a sticking point in tackling the “debilitating disease”. Valneva is keen to address this head on. Through an agreement with Instituto Butantan in Brazil, aimed at “development, manufacturing, and marketing”, Valneva intends to generate more opportunities for LMIC. This collaboration “falls within the framework of the agreement signed between CEPI and Valneva” in 2019. This provides $23.4 million in funding with support from the EU’s Horizon 2020 programme.
We look forward to hearing from a speaker from Valneva at the World Vaccine Congress in Europe, 2022. If you would like to join us, get your tickets here.
