The Nepal Health Research Council is preparing to give the green light to third-phase trials of a Covid-19 vaccine developed by Chinese company WestVac Biopharma Co, Ltd after the company submitted nearly all of the documents requested by the council.
Once it gets approval for testing, it will be the third Covid-19 vaccine in total and the second Chinese vaccine to receive approval for testing after a messenger RNA (mRNA) vaccine jointly developed by Suzhou Abogen. Biosciences, China Institute of Military Medicine. under the Academy of Military Sciences, and Walvax Biotechnology Co Ltd.
“WestVac Biopharma Co, Ltd is almost done submitting more or less all of the documents we requested,” said Namita Ghimire, member of the board’s ethics committee. “We have shared his documents with members of the ethics committee for review. If no issues are found, we will recommend that it be allowed to conduct the third phase trials. “
She said the council could send its recommendation to the Department of Health and Population. The proposal should be forwarded to the cabinet of the Ministry of Health and after cabinet approval, the Department of Drug Administration should provide an import license and give approval for the trials by setting the necessary conditions, in accordance with the Guidelines for clinical trials on vaccines.
In addition to the two Chinese vaccines, another Covid-19 vaccine developed by Sanofi Pasteur, a French multinational, in partnership with GlaxoSmithKline (GSK, a British pharmaceutical company) has also received approval to conduct trials.
Indeed, trials have already started for the Covid-19 vaccine developed by Sanofi and GSK. His trial first began at Dhulikhel hospital at the end of September. Likewise, trials have also started at Nepalgunj Medical College.
The French multinational has been authorized to administer its vaccine to 2,000 volunteers at Dhulikhel hospital and 1,000 volunteers at Nepalgunj Medical College.
Sonafi, together with the International Vaccine Institute, a nonprofit initiative of the United Nations Development Program, had asked the council to conduct a third phase trial of the vaccine in Nepal.
“The trials are going smoothly and we have not received any complaints about side effects,” said Ghimire, a member of the board’s ethics committee. “Immediately after the Dashain festival, we will follow up on the field trials. “
But, as for the Chinese mRNA vaccine Covid-19, trials have not yet started. According to Ghimire, the delay in the trial was caused by the delay in the supply of the vaccine candidate.
Chinese mRNA vaccine trials will be conducted on 3,000 volunteers at the BP Koirala Institute of Health Sciences in Dharan, according to the proposal of companies that have partnered with Nepalese pharmaceutical company Deurali-Janta Pharmaceutical Limited, according to the advice.
The Chinese mRNA vaccine and the Sonafi vaccine had received the necessary approval from the Department of Drug Administration in September.
Nepalese officials said conducting trials in the country could pave the way for preferential access to vaccines being tested in Nepal. “The Chinese mRNA vaccine makers have promised to deliver 500,000 doses of the vaccine to Nepal free of charge,” Ghimire told The Post in September. “In the case of the Sonafi vaccine, Nepal will get the vaccine at a lower price from GAVI, a UN-backed vaccine alliance. “