The National Ethics Committee in Biomedical Research under the Ministry of Health said it has agreed in principle for the final phase in human trials of the sub-unit vaccine based on recombinant DNA/protein technology developed by Ho Chi Minh City-based biopharmaceutical company Nanogen.
Researchers need to submit some more documents this week for the ministry to review and officially greenlight the trials.
Phase 3 will be divided into smaller segments – with the first involving some 800-1,000 registered volunteers and will gradually expand to larger groups in future segments. The Vietnam Military Academy in Hanoi and Hung Yen province’s health authorities in the north, along with and HCM City Pasteur Institute and Long An province’s health authorities will help administer the vaccines in volunteers and monitor responses.
The optimal dosage for the phase 3 will be 25mcg. All three dosages of 25mcg, 50mcg, and 75mcg of the vaccine trialled in the first two phases provided largely similar level of immune responses against coronavirus (SARS-CoV-2) so the committee chose the lowest dosage to save on materials.
Phase 2 of human trials, involved 554 people including 108 elderly, was completed on April 8 this year but monitoring of the volunteers’ health for effectiveness and potential side effects could last up to a year. So far the results have been quite promising, the committee said.
The immune response increased by 60 times 35 days after the first shot in some volunteers, and the protection level remains at 34 times the normal level after three months.
All volunteers injected with the jabs produced immune response against the virus.
The vaccine has the capacity to generate neutralising antibodies against the original version of coronavirus first found in China’s Wuhan as well as mutant variants first identified in South Africa during phase 2 trials, but more studies in phase 3 are needed to clarify how effective it could be against the Indian variant that is wreaking havoc across the northern region of Vietnam in the fourth wave of infections.
After injection, volunteers exhibited symptoms such as pain at the injection point, light fever, muscle aches, joint pain, and fatigue, which are typical post-injection reactions. However they did not require medical intervention.
If things go well, phase 3 trials could conclude by the end of September and commercial production could start soon after.
There have been talks earlier this week about using Nano Covax on a wider scale in case of severe outbreaks, similar to how Russia’s Spunit V, the world’s earliest COVID-19 vaccine to be approved and still one of the most effective, is administered on general population when data from phase 3 have not been fully available.
Lao dong (Labour) newspaper, citing a ‘reliable source,’ said that Nano Covax has received millions of dollars in financial donations from a domestic conglomerate for the third phase of trials and eventual inoculation of the country of near 100 million-strong population to achieve vaccination goals within this year, helping to open up the economy and re-enable travel and tourism.
The support also extended to ramping up of production capacity in order to meet the domestic demands as well as possible exports of Nano Covax vaccines.
Nguyen Ngo Quang, Deputy Director of the Department of Science, Technology and Training under the health ministry, said if Vietnam could have its own manufacturing technology domestically then it would be easier to evaluate and adjust the vaccines in cases of new variants.
Deputy Prime Minister Vu Duc Dam, 58, head of the National Steering Committee for COVID-19 Prevention and Control, along with Deputy Minister of Science and Technology Pham Cong Tac, 59, received two full doses of Nano Covax as part of the trials.
The price for each dose was projected to be 120,000 VND (5.2 USD). The doses are given intramuscularly with the spacing between each dose about a month (28 days), according to Nanogen.
Another domestic vaccine contender, Covivac by Institute of Vaccines and Biological Medical (IVAC) in Nha Trang city is preparing phase 1 trial’s data to be reviewed by the health ministry and could start phase 2 around late June-early July if the results are deemed acceptable.
Another locally developed COVID-19 vaccine by Vabiotech is in preclinical trials on animals, and another from Polyvac (Centre for Research and Production of Vaccines and Biologicals, under the health ministry) is still researching in labs.
Polyvac said it is in talks with Russia’s relevant parties for technology transfer of Sputnik V (already approved for emergency use in Vietnam) for commercial production domestically later this year./.