Nepal Health Research Council is preparing to give its nod for the third phase trials to a Covid-19 vaccine developed by China’s WestVac Biopharma Co, Ltd after the company submitted almost all the documents demanded by the council.

Once it gets an approval for the trials, it will be the third Covid-19 vaccine overall and the second Chinese vaccine to receive approval for trial after an messenger RNA (mRNA) vaccine jointly developed by China's Suzhou Abogen Biosciences, the Institute of Military Medicine under the Academy of Military Sciences, and Walvax Biotechnology Co Ltd.

“The WestVac Biopharma Co, Ltd has almost completed submitting more or less all the documents that we had requested for,” said Namita Ghimire, a member of the ethical board at the council. “We have shared its documents with the members of the ethical board for a review. If no issue is found, we will recommend allowing it to conduct the third phase trials.”

She said that the council could send its recommendation to the Ministry of Health and Population. The proposal should move to the cabinet from the Health Ministry and after a cabinet approval, the Department of Drug Administration should provide import license and give approval for the trials by setting necessary conditions, according to the Vaccine Clinical Trial Guidelines.

Besides the two Chinese vaccines, another Covid-19 vaccine developed by Sanofi Pasteur, a French multinational company, in partnership with GlaxoSmithKline (GSK, a British pharma company) has also received approval for conducting trials.

In fact, trials have already begun for the Covid-19 vaccine developed by Sanofi and GSK. Its trial had begun firstly at Dhulikhel Hospital in late September. Likewise, trials have also begun at Nepalgunj Medical College.

The French multinational company has been allowed to administer its vaccine to 2,000 volunteers at Dhulikhel Hospital and 1,000 volunteers at the Nepalgunj Medical College.

Sonafi in collaboration with the International Vaccine Institute, a nonprofit initiative of the United Nations Development Programme, had applied with the council to conduct a third phase trial of the vaccine in Nepal.

“The trials are proceeding smoothly and we have received no complaints of any side effects,” said Ghimire, member of the ethical board at the council. “Immediately after the Dashain festival, we will conduct monitoring of the trials in the field.”

But, when it comes to the Chinese mRNA Covid-19 vaccine, trials are yet to begin. According to Ghimire, the delay in the trial was caused by the delay in getting supply of the vaccine candidate.

The trials for the Chinese mRNA vaccine will be conducted on 3,000 volunteers at the Dharan-based BP Koirala Institute of Health Sciences as per the proposal of the companies which have joined hands with the Nepali pharmaceutical company—Deurali-Janta Pharmaceutical Limited, according to the council.

The Chinese mRNA vaccine and Sonafi vaccine had received necessary approval from the Department of Drug Administration in September.

Nepali officials said that conducting trials in the country could pave the way for preferential access to the trialed vaccines to Nepal. “The Chinese manufacturers of the mRNA vaccine have promised to deliver 500,000 doses of the vaccine to Nepal free of cost,” Ghimire had told the Post in September. “In the case of the Sonafi vaccine, Nepal will get the vaccine at a cheaper rate through GAVI, an UN-backed vaccine alliance.”