Federal health officials say they expect to get approval and offer the first doses of the new COVID-19 flu vaccine within weeks.
Dr. Tara Norelli, Canada’s chief public health officer, issued a news release Thursday announcing that the Therapeutics Goods Administration — a division of Health Canada that oversees the approval and use of drugs — had approved the new nasal spray shot by vaccine giant Novartis.
In late March, Health Canada gave Novartis a Type A fast-track designation, which means that the agency has imposed a narrow set of approval and performance expectations on the Swiss drugmaker that falls roughly in the middle of the expectations of a standard Type B designation.
On the Phase 2 clinical trials alone, Novartis presented data indicating it could deliver a flu shot at least twice the efficacy of the current best-selling and most-used form of the flu vaccine, RotaTeq, now available from GlaxoSmithKline (GSK) in three different forms (alphavalent/Rituxan/immunoglobulin) that work in different ways and for different people.
Norelli, chief of the Center for Infectious Disease Epidemiology, noted in a news release that the COVID-19 can also be injected. The spray is marketed by VaxAssure Inc., which holds a National Access to Vaccines License, which allows it to dispense vaccines without a prescription.
Many children of all ages in the United States, in countries around the world, are receiving RotaTeq. Last month, the Centers for Disease Control and Prevention recommended that anyone 65 and older should get two separate flu shots, because of the risk of complications associated with one. The pediatric vaccine, FluMist, also is considered an “inactivated” vaccine — meaning it does not have the known live component. But it is a nasal spray, and a popular one with some easy-to-administer nasal mist-tolerant children.
In its new announcement, Health Canada said that the COVID-19 vaccine would be available in Canada in about three weeks.
When asked about the timing of the Canadian rollout, Norelli said in an email that health officials “remain optimistic about the timeline” for the vaccine rollout.
According to the company, researchers found that COVID-19 had bested the efficacy of the current best-selling and most-used form of the flu vaccine, RotaTeq, by about 40 percent in the Phase 2 trials. Based on that, the company presented promising new data at the American Association for the Advancement of Science annual meeting in April to support its request for fast-track designation.
The company presented data showing that COVID-19 delivered up to 2.7 times the protection effectiveness of RotaTeq in children ages 6 months to 4 years, compared with 0.5 to 1.2 times that with GlaxoSmithKline’s alphavalent/Rituxan/immunoglobulin vaccine. The nasal spray version was also tested in older people aged 65 and older.
Dr. Gregory Poland, the director of the influenza division at the CDC, wrote in April that GSK’s RotaTeq, which is the sole “oral-inactivated” flu vaccine on the market, should be considered an inactivated vaccine even if it contains live viruses, as long as they are grown in eggs. Those older vaccines, he said, have been seen to have weak protection in older people, especially those with compromised immune systems.