Covid-19 roundup: Valneva runs into EMA questions, still expects March authorization; Canada approves first plant-based vaccine
In February 2021, the European Medicines Agency began a rolling review of French biotech Valneva’s Covid-19 vaccine, which is a whole virus, inactivated, adjuvanted vaccine.
About a year later, Valneva says the EMA still has questions, although the company said Friday that it’s “confident that it will be able to respond to these in the coming days. Following the Company’s response, the EMA will provide a timetable towards anticipated conditional approval.”
Valneva, which earlier acknowledged that its vaccine only performed well after a primary series of the Valneva vaccine candidate, also said it anticipates receiving a positive CHMP recommendation for conditional approval of its Covid vaccine candidate for adults 18 to 55 years old by the end of March. Following a conditional approval, the company said it expects to deliver the first shipments of VLA2001 to European countries early in Q2.
The European Commission signed a supply deal with Valneva in early November for up to 60 million doses in 2022 and 2023.
Thomas Lingelbach, CEO of Valneva, said in a statement, “We are pleased with the initial CHMP assessment and look forward to providing our responses as soon as possible. VLA2001 is the only inactivated COVID-19 vaccine in clinical development in Europe, and this brings us closer to our objective of providing a differentiated vaccine option to the population and physicians who need it.”
Canada approves GSK/Medicago’s plant-based Covid-19 vaccine
Quebec-based Medicago and GlaxoSmithKline said Thursday that Health Canada approved its plant-based Covid-19 vaccine.
This is the first approval for the two companies, which paired GSK’s adjuvant with promising antigens to develop the protein-based, refrigerator-stable vaccine. Known commercially as Covifenz, the vaccine is indicated to prevent Covid-19 in individuals 18 to 64 years of age.
The vaccine showed 71% efficacy in a late-stage trial against all variants of SARS-CoV-2 among more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil. In October 2020, the company reached an agreement with Canada to supply up to 76 million doses of its vaccine, and Medicago also received $173 million in funding support from the Government of Canada for its vaccine R&D.
“We’re also grateful for the Government of Canada’s support in the development of this new vaccine, and we are manufacturing doses to start fulfilling its order,” Takashi Nagao, president and CEO at Medicago, said in a statement.