Nepal allows Chinese mRNA vaccine candidate to conduct Phase III clinical trials
Source: Xinhua| 2021-08-28 09:27:22
A woman receives a dose of COVID-19 vaccine in Kathmandu, Nepal, June 8, 2021. (Xinhua/Sulav Shrestha)
A Chinese mRNA COVID-19 vaccine candidate, jointly developed by China's Suzhou Abogen Biosciences (AbogenBio), the Institute of Military Medicine under the Academy of Military Sciences, and Walvax Biotechnology Co., Ltd., has gained approval to conduct the third phase of clinical trials in Nepal.
KATHMANDU, Aug. 28 (Xinhua) -- A messenger RNA (mRNA) COVID-19 vaccine candidate developed by Chinese manufacturers has gained approval from the Nepali government to conduct the third phase of clinical trials in the South Asian country, a senior official from Nepal Health Research Council said Friday.
It is the first time that a COVID-19 vaccine candidate has been allowed for clinical trials in the country.
The vaccine ARCoV was jointly developed by China's Suzhou Abogen Biosciences (AbogenBio), the Institute of Military Medicine under the Academy of Military Sciences and Walvax Biotechnology Co., Ltd.
"A cabinet meeting on Thursday decided to allow the Chinese company (Walvax Biotechnology) and its local partner Deurali-Janta Pharmaceutical Pvt. Ltd to conduct the third phase of clinical trials of the vaccine in Nepal," Dr. Pradip Gyanwali, executive chief of the Health Research Council, told Xinhua.
"We received a proposal from the Chinese company about a month ago seeking approval to conduct clinical trials," said Gyanwali. "After finding the vaccine candidate good in terms of safety and efficacy, we forwarded the proposal to the Health Ministry recommending that it be permitted to conduct trials here. The Health Ministry took the proposal to the Cabinet and the Cabinet approved the proposal."
"After the Chinese company comes up with the license from the DDA (Department of Drug Administration), we will issue a letter to the company authorizing it to conduct the third phase of trials," Namita Ghimire, a member of the Ethical Review Board, told Xinhua.
People get the second doses of COVID-19 vaccine in Kathmandu, Nepal on July 6, 2021. (Xinhua/Sulav Shrestha)
According to Gyanwali, Walvax Biotechnology and its Nepali partner have proposed conducting the trials on 3,000 people at BP Koirala Institute of Health Sciences, a government-run facility in the eastern city of Dharan.
Nepal has been gripped by a second wave of the coronavirus outbreak, and relies on an external supply of COVID-19 vaccines to inoculate its 30 million population.
As of Thursday, 4.98 million Nepalis have been administered the first dose, with 3.9 million fully vaccinated with two shots, according to the Health Ministry.
"Access to vaccines will be easier if they are manufactured in Nepal," said Gyanwali.
Early this month, the Nepali government announced a number of incentives for domestic and foreign companies to establish vaccine plants in Nepal to produce vaccines against COVID-19 and other infectious diseases.