“We have submitted all the data, what is needed for…Canadian submission…it’s under active review by Health Canada,” Ocugen chairman and CEO Shankar Musunuri said during an earnings call on Friday but declined to comment on approval timelines.
Ocugen, which inked a deal for the development, manufacture and commercialisation of Covaxin in Canada in June this year after bagging US rights in December 2020, had initiated rolling submission of Covaxin data to Health Canada through affiliate Vaccigen in mid-June.
He said the regulatory submission filed under Canada’s interim order was transitioned into a new drug submission for Covid-19 “in such a short order, especially when urgency is increasing in Canada”.
Pointing out that Covaxin was the first vaccine to evaluate efficacy against the Delta variant in a controlled setting, he said: “Majority of the symptomatic cases identified in aggregate in Covaxin and control arms in phase-3 clinical trial were Covid-19 variants…majority were identified as Delta variant B.1.617.2. Data showed Covaxin achieving a 65.2% efficacy rate against Delta variant.”
“Data from Covid cases demonstrated low viral load…in vaccinated individuals compared to placebo group, showing potential for less transmission of the disease by individuals who received Covaxin…these data on Delta are very suggestive that Covaxin is a valuable tool in our fight against this virus now, especially with this variant now dominating this fourth wave we are experiencing,” he said.
Musunuri said as Covaxin trains the immune system to attack the whole Covid-19 variants based on multi-antigens, including the spike in nucleocapsid proteins, it has the potential to be effective against multiple variants and reduce the possibility of mutant virus escape.