French drugmaker Valneva said on Friday the U.S. Food and Drug Administration (FDA) has approved its Chikungunya single-dose vaccine in individuals aged 18 and above.
The U.S. health regulator did not find any misconduct at clinical sites managed by Care Access for Pfizer (PFE.N) and French partner Valneva’s (VLS.PA) trial of a Lyme disease vaccine candidate, the contract research firm stated.
Today French vaccine maker Valneva reported a smaller half-year loss, as a rebound in global tourism boosted sales of its travel vaccines Ixiario and Dukoral.
Valneva’s chikungunya vaccine candidate will have to wait three more months for a decision from the regulator, potentially giving rival Bavarian Nordic additional time to catch up.
The decision could delay the time to approval of a vaccine that Valneva expects could become a blockbuster shot as infections rise globally due to a burgeoning population of ticks, which usually cause Lyme disease.
Vaccines company Valneva said on Friday that it had completed a regulatory submission step with the United States Food & Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553.
France’s Haute Autorite de Sante public health body advised the government not to use Valneva’s VLA2001 COVID-19 vaccine as part of its wider vaccination strategy, although two rival products should be included as booster shots.
Vaccines company Valneva on Monday reported positive 12-month antibody persistence data for its single-shot Chikungunya vaccine candidate.
The French drugmaker is in talks with a potential partner on producing an updated version of its COVID-19 vaccine that targets new variants of the disease, sending its shares up. Valneva has struggled to bring its COVID-19 vaccine to market to compete with rival products from drugmakers such as AstraZeneca, Moderna and BioNTech/Pfizer.
The World Health Organization (WHO) on Thursday recommended the use of French drugmaker Valneva’s COVID-19 vaccine.