Bharat Biotech and Ocugen expand their partnership to co-develop, supply and commercialise Covaxin, the Covid-19 vaccine from the Hyderabad-based vaccine maker, in Canada.
Occugen already had the rights to commercialise Covaxin in the US. It will retain 45 per cent of the profits from sales of Covaxin in the US and Canada.
Shankar Musunuri, chairman, chief executive and co-founder of Ocugen, said: “As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorisation under interim order for emergency use in Canada.”
Bharat Biotech said more than 30 million doses have been supplied in India and other countries. “EUAs (emergency use authorisation) are approved in 13 countries and in the process in more than 60 countries,” it said. Krishna Ella, chairman and managing director of Bharat Biotech, said the company was working with Ocugen to bring Covaxin to the US, and now it will work to do so for the Canadian market.
Phase 3 trial analysis data to be submitted to WHO
Bharat Biotech is working with the World Health Organization (WHO) to get Covaxin listed in the WHO-Emergency Use List (EUL). The company has said it expects the EUL between July and September. It had submitted a dossier with the WHO. Some more details have been sought, which is likely to be submitted soon.
Samiran Panda, head of epidemiology and communicable division at the Indian Council of Medical Research, explained the process of getting the WHO approval and the details usually sought by the agency. It is primarily details of the clinical trial protocol, the safety and immunogenicity data, and the final efficacy analysis of the trials.
“Any vaccine trial protocol is to be registered on the Clinical Trials Registry of India, which is maintained by the National Institute of Medical Studies, an institute under the ICMR. This is considered among one of the best clinical trial registry platforms globally. WHO has access to the clinical trial protocol, and therefore, that is not an impediment. It is transparent, Panda said.
The second set of data that the WHO requires is safety data. “This is available and published in peer-reviewed journals. The raw data (on safety) has been submitted by Bharat Biotech to the Drugs Controller General of India (DCGI). Submitting this to WHO is also not an issue,” he said.
Then comes the immunogenicity data, whether Bharat Biotech vaccine has been able to give the desired effect. “This has also been submitted and peer reviewed in international journals. The raw data was also submitted to the DCGI. Along with this, the animal trial data was also published in the Nature Communications. All this publishing has rendered India’s scientific research on the Covid-19 vaccine a lot of respect,” Panda said.
The interim results from phase 3 have been published in The Lancet. “The last few participant data analysis from phase 3, I believe, is ongoing,” he said.
Clinical trials have two arms — vaccine arm and placebo arm. The outcome to be checked here is incidents of symptomatic infection in both arms. “The outcome is examined over a follow-up period. So, the follow-up period needs to be completed. Many of the participants have completed the follow-up period,” he said.
Panda said the WHO approval would mean that anyone who is vaccinated with Covaxin would be acceptable and admissible to any country that recognises the WHO EUL.