The application was filed in late June by Ocugen, a Pennsylvania-based pharmaceutical company, through its Canadian subsidiary, Vaccigen Ltd. Ocugen didn’t announce she was seeking approval in Canada until Thursday.
Ocugen has a partnership with Bharat Biotech, the Indian biotech company that developed the vaccine, giving the US company the rights to develop Covaxin for the US and Canadian markets. Bharat developed Covaxin with the help of the Indian Council for Medical Research and the Indian National Institute of Virology.
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The Indian government approved Covaxin for emergency use in early 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 early clinical trials, Covaxin was over 60% effective in preventing asymptomatic COVID infections, nearly 80% effective in preventing symptomatic COVID, and over 90% effective in preventing severe cases of the disease. Following more recent trials, researchers at Bharat have determined that Covaxin is around 65% effective against the Delta variant of the virus, which has caused major outbreaks in India and the UK.
“We thank Health Canada for their upcoming review of Covaxin and look forward to working with them, so that we can provide the possibility of another safe and effective option to use in their fight against COVID-19 and its Delta variant,” Shanker Musunuri, Ocugen’s co-founder and CEO, said in a press release.
Health Canada is reviewing COVID treatments and vaccines through a special “continuous” process that allows it to make regulatory decisions faster; companies submit information in part rather than all at once. Health Canada officials should always carefully consider the information they would normally have in making a regulatory decision, which includes reviewing and verifying animal and human test data, and inspecting facilities where a candidate company plans to manufacture its drug.
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Covaxin is the seventh COVID vaccine that Health Canada has considered for approval.
The federal government has already purchased tens of millions of doses of the four vaccines approved by the regulator: Pfizer, Moderna, AstraZeneca and Johnson & Johnson. It has also agreed to purchase tens of millions of doses of the other two vaccines Health Canada is reviewing, namely those from Medicago and Novavax.
As in many countries, the federal government of Canada has paid for its COVID vaccines with the goal of vaccinating as many of its citizens and residents as possible against the virus. As of Thursday, nearly three-quarters of Canadians had received at least one dose and nearly half had received two. Using the doses it always expects, the government predicts that all consenting Canadians will be fully immunized by the end of the summer. He also purchased tens of millions of boosters from Pfizer, in case they are needed in the years to come.
For this reason, it seems unlikely that the government will need injections of Covaxin.
Currently, however, fully vaccinated Canadian citizens and residents who are permitted to enter the country without quarantine are not eligible to skip the otherwise mandatory 14-day isolation period unless they have received vaccines approved by Health Canada.
When asked Thursday if Ocugen wanted Covaxin approved so that people who received it outside of Canada could potentially be granted an exemption from federal quarantine, Dr. Howard Njoo, deputy chief administrator Department of Public Health Canada, did not respond.
“Rather than going into the ins and outs of individual companies submitting applications to Health Canada, … I would say we are now looking more at international collaboration and international consistency” of widely accepted vaccines, such as those approved by the ‘World Health Organization. , says Njoo.
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