Health Canada Greenlights Novavax Covid Shot
This is also the third clearance in the Western hemisphere for Nuvaxovid’s shot. The EU’s regulator European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have also given the green light. Approval by the US Food and Drug Administration is still outstanding.
To date, the FDA has approved only three vaccines, Comirnaty, Spikevax and the J&J shot. AstraZeneca has never filed for approval, and Novavax only recently filed with the US health regulator for an emergency use application.
Health Canada said the safety and effectiveness of the vaccine in people younger than 18 have not yet been established. The authorization granted in the other countries likewise does not cover the younger age group.
Though Nuvaxovid is not currently authorized for use as a booster dose in Canada, it may be offered as such to people who are unable or unwilling to receive an mRNA vaccine, the country’s chief public health officer Theresa Tam said.
Worldwide, health officials hope that the recombinant protein vaccine will find acceptance among vaccine skeptics who reject the mRNA vaccines made by Pfizer/BioNTech and Moderna. Up to now, this has not been shown to be the case, but the doses are just beginning to enter marketing channels.
Some 80% of Canadians have received two doses of a Covid vaccine and more than 40% a booster. Novavax chief commercial officer John Trizzino said there is still significant demand for vaccination globally especially in view of the threat of more variants, and this could drive sales.
The Canadian government has committed to ordering 52 million doses of Nuvaxovid with an option to buy up to 24 million more. Health Canada said it expects the first shipments in March, around the same time the first were initially due to arrive in Europe. That region, however, is bracing for a shortfall, due to delayed approval of doses from the Serum Institute of India, which is handling all European shipments.
Author: Dede Williams, Freelance Journalist