Valneva SE confirmed that the European Medicines Agency accepted the filing of a marketing authorization application (MAA) for the specialty vaccine company’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001.
Valneva said on May 4 the French drugmaker will conduct a trial about the use of the company’s COVID-19 vaccine candidate VLA2001 as a booster jab following a mRNA vaccination or natural infection.
Valneva said on April 25 that the European Medicines Agency (EMA) had asked for more data on the company’s COVID-19 vaccine, precipitating a sharp fall in the French drugmaker’s shares.
Specialty vaccine company Valneva, along with Pfizer, reported positive Phase II data from their clinical trial evaluating a Lyme disease vaccine candidate.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and White House chief medical advisor, said they expect the U.S. Food and Drug Administration will authorize the Pfizer-BioNTech vaccine for children under the age of 5 years in the next month.
Valneva said on January 19 that preliminary studies showed three doses of the French biotech firm’s inactivated COVID-19 vaccine candidate neutralized the Omicron variant of the disease.
Valneva said the speciality vaccines company was keeping its previous timetable on clinical trials and regulatory submissions for the VLA2001 COVID-19 vaccine candidate, with regulatory approvals targeted in the first quarter of 2022.
The Lancet published CanSino Biologics Inc.’s Phase III clinical trial results on the safety and efficacy of the company’s recombinant novel coronavirus vaccine, Convidecia.
Valneva’s share price jumped more than 20 percent on November 10 after the French vaccines company won European Commission approval for a deal under which it would supply up to 60 million doses of the COVID-19 vaccine candidate VLA2001 over two years.
Valneva SE on Oct. 18 said the company’s experimental Covid-19 vaccine demonstrated efficacy “at least as good, if not better” than AstraZeneca’s shot in a late-stage trial comparing the two, with significantly fewer adverse side effects.