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.
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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.