Illustrative image (Photo: VNA) Hanoi (VNS/VNA) - Vietnam’s domestically developed COVID-19 vaccine, NanoCovax, will begin Phase 3 of clinical trials in June involving up to 13,000volunteers.
Thisfollows promising results seen in the first two phases.
TheNational Ethics Committee in Biomedical Research under the Ministry of Healthsaid it has agreed in principle for the final phase in human trials of thesub-unit vaccine based on recombinant DNA/proteintechnology developed by Ho Chi Minh City-based biopharmaceutical companyNanogen.
Researchersneed to submit some more documents this week for the ministry to review andofficially greenlight the trials.
Phase3 will be divided into smaller segments – with the first involving some800-1,000 registered volunteers and will gradually expand to larger groups infuture segments. The Vietnam Military Academy in Hanoi and Hung Yen province’shealth authorities in the north, along with and HCM City Pasteur Institute andLong An province’s health authorities will help administer the vaccines involunteers and monitor responses.
Theoptimal 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 providedlargely similar level of immune responses against coronavirus (SARS-CoV-2) sothe committee chose the lowest dosage to save on materials.
Phase2 of human trials, involved 554 people including 108 elderly, wascompleted on April 8 this year but monitoring of the volunteers’ health foreffectiveness and potential side effects could last up to a year. So farthe results have been quite promising, the committee said.
Theimmune response increased by 60 times 35 days after the first shot in somevolunteers, and the protection level remains at 34 times the normal level afterthree months.
Allvolunteers injected with the jabs produced immune response against the virus.
Thevaccine has the capacity to generate neutralising antibodies against theoriginal version of coronavirus first found in China’s Wuhan as well as mutantvariants first identified in South Africa during phase 2 trials, but morestudies in phase 3 are needed to clarify how effective it could be against theIndian variant that is wreaking havoc across the northern region of Vietnam inthe fourth wave of infections.
Afterinjection, volunteers exhibited symptoms such as pain at the injectionpoint, light fever, muscle aches, joint pain, and fatigue, which aretypical post-injection reactions. However they did not require medicalintervention.
Ifthings go well, phase 3 trials could conclude by the end of September andcommercial production could start soon after.
Therehave been talks earlier this week about using Nano Covax on a wider scalein case of severe outbreaks, similar to how Russia's Spunit V, the world'searliest COVID-19 vaccine to be approved and still one of the mosteffective, is administered on general population when data from phase 3have not been fully available.
Laodong (Labour)newspaper, citing a ‘reliable source,’ said that Nano Covax has receivedmillions of dollars in financial donations from a domestic conglomerate for thethird phase of trials and eventual inoculation of the country of near 100million-strong population to achieve vaccination goals within this year,helping to open up the economy and re-enable travel and tourism.
Thesupport also extended to ramping up of production capacity in order to meet thedomestic demands as well as possible exports of Nano Covax vaccines.
NguyenNgo Quang, Deputy Director of the Department of Science, Technology andTraining under the health ministry, said if Vietnam could have its ownmanufacturing technology domestically then it would be easier to evaluate andadjust the vaccines in cases of new variants.
DeputyPrime Minister Vu Duc Dam, 58, head of the National Steering Committee forCOVID-19 Prevention and Control, along with Deputy Minister of Science and TechnologyPham Cong Tac, 59, received two full doses of Nano Covax as part of the trials.
Theprice for each dose was projected to be 120,000 VND (5.2 USD). The doses aregiven intramuscularly with the spacing between each dose about a month (28days), according to Nanogen.
Anotherdomestic vaccine contender, Covivac by Institute of Vaccines and BiologicalMedical (IVAC) in Nha Trang city is preparing phase 1 trial’s data to bereviewed by the health ministry and could start phase 2 around late June-earlyJuly if the results are deemed acceptable.
Anotherlocally developed COVID-19 vaccine by Vabiotech is in preclinical trialson animals, and another from Polyvac (Centre for Research and Productionof Vaccines and Biologicals, under the health ministry) is still researching inlabs.
Polyvacsaid it is in talks with Russia’s relevant parties for technology transfer ofSputnik V (already approved for emergency use in Vietnam) for commercialproduction domestically later this year./.
VNA
