BAVARIAN NORDIC A/S The accelerated assessment, which is granted based upon CHMP's decision that the vaccine candidate is of major interest for public health and therapeutic innovation, may reduce the timeframe for the review of the MAA from 210 days under the standard review procedure to 150 days, not counting clock stops when applicants must provide additional information[1].
'We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market. With this, we have the ability to accelerate the approval and our launch timelines for the vaccine in
In 2023,
One study (NCT05072080) enrolled 3,254 healthy adults and adolescents aged 12 to 64 years of age, who were randomized to receive either a single intramuscular injection of CHIKV VLP, or placebo. The results up to day 22 post vaccination showed that CHIKV VLP was highly immunogenic, as demonstrated by the strong induction of chikungunya neutralizing antibodies in 98% of vaccinees in the active group.
Importantly, CHIKV VLP induced significant neutralizing antibodies in 47% and 97% of the subjects after 8 days and 15 days post vaccination respectively. These responses were robust and durable, as 86% of the subjects had seroprotective levels of neutralizing antibodies 6 months post vaccination.
A similar study, which enrolled 413 healthy adults 65 years of age (NCT05349617), showed neutralizing antibodies in 87% of the vaccinees 22 days after a single vaccination. Seroprotective antibodies were confirmed in 82% of the individuals at day 15.
CHIKV VLP was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature.
About
Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
Contact:
Tel: +45 61 77 47 43
Email: graham@paddockcircle.com
Tel: +1 781 686 9600
(C) 2024 Electronic News Publishing, source
