Health Canada is considering approving Covaxin, a COVID vaccine developed in India, after quietly accepting an application from its American distributor.
The application was filed at the end of June by Ocugen, a Pennsylvania-based pharmaceutical company, through its Canadian affiliate, Vaccigen Ltd. Ocugen only announced it was seeking approval in Canada on Thursday.
Ocugen has a partnership with Bharat Biotech, the Indian biotechnology company that developed the vaccine, giving the American company rights to develop Covaxin for American and Canadian markets. Bharat developed Covaxin with the help of the Indian Council of Medical Research and India’s National Institute of Virology.
India’s government approved Covaxin for emergency use early in January. The vaccine has now been approved for emergency use in 13 countries, which have received more than 30 million doses of the vaccine, according to Ocugen. Another 60 countries are considering approving it.
In its first clinical trials, Covaxin was more than 60 per cent effective at preventing asymptomatic COVID infections, almost 80 per cent effective at preventing symptomatic COVID, and more than 90 per cent effective at preventing severe cases of the disease. Following more recent trials, Bharat researchers determined that Covaxin was about 65 per cent effective against the virus’s Delta variant, which has caused major outbreaks in India and the U.K.
“We thank Health Canada for their upcoming review of Covaxin and look forward to working with them, so we can offer the possibility of another safe and effective option to be used in their fight against COVID-19 and its Delta variant,” Shanker Musunuri, Ocugen’s co-founder and CEO, said in a news release.
Health Canada is reviewing treatments and vaccines for COVID through a special “rolling” process that allows it to make regulatory decisions faster; companies submit information in parts, rather than all at once. Health Canada officials must still pore through the information they normally would to make a regulatory determination, which includes examining and verifying data from animal and human trials, and inspecting facilities where an applicant company plans to manufacture its drug.
Covaxin is the seventh COVID vaccine Health Canada has considered for approval.
The federal government has already bought tens of millions of doses of the four vaccines the regulator has approved: Pfizer’s, Moderna’s, AstraZeneca’s, and Johnson & Johnson’s. It’s also agreed to buy tens of millions of doses of the other two vaccines Health Canada is reviewing, which are Medicago’s and Novavax’s.
As in many countries, Canada’s federal government has paid for its COVID vaccines in an effort to inoculate as many of its citizens and residents against the virus as possible. As of Thursday, nearly three-quarters of Canadians had received at least one dose, and almost half had received two. Using doses it’s still expecting, the government plans to have every willing Canadian fully vaccinated by the end of summer. It’s also bought tens of millions of booster shots from Pfizer, in case they’re needed in future years.
For that reason, it seems unlikely the government will need any Covaxin shots.
Right now, however, fully vaccinated Canadian citizens and residents who are allowed to enter the country without quarantining don’t qualify to skip the otherwise-mandatory 14-day isolation period, unless they’ve received shots that are approved by Health Canada.
When asked on Thursday if Ocugen wanted Covaxin approved so that people who’ve received it outside of Canada might eventually qualify for an exemption from the federal quarantine, Dr. Howard Njoo, Canada’s deputy chief public health officer, wouldn’t say.
“Rather than getting into the ins and outs of individual companies making applications to Health Canada, … I would say we’re looking more now at international collaboration, and international consistency” of widely accepted vaccines, such as those approved by the World Health Organization, Njoo said.
This content was originally published here.