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| Nanocovax's COVID-19 vaccine / Courtesy of HLB |
By Baek Byung-yeul
Nanocovax, a COVID-19 vaccine developed by Vietnamese biotech company Nanogen, has received confirmation of its safety and effectiveness, paving its way to the global biopharmaceutical market, Korean biotech company HLB said Monday.
HLB, which acquired the global sales rights of Nanocovax's COVID-19 vaccine, said that an official from a Vietnamese public health authority told local media that the company's vaccine had exceeded the qualifications set by the World Health Organization (WHO).
"On the 17th of December, Trung Viet Dung, Chairman of Vietnam's National Ethics Committee under the Ministry of Health, stated in an interview with local news outlet PLO that 'Nanocovax's protective effect has exceeded 50%, the minimum protective effect set by the WHO,'" HLB said.
The chairman further elaborated, "Data on the Phase 3 interim results will soon be delivered to the Advisory Council for the Registration of the Circulation of Drugs and Medicinal Ingredients to proceed with Nanocovax's emergency approval procedure," and, "Vietnam's Ministry of Health will formally announce the outcome of the recent meeting in the foreseeable future."
Nanocovax is the only Vietnamese COVID-19 vaccine candidate conducting Phase 3 testing. In August, HLB said that Nanocovax is a recombinant protein subunit vaccine that has succeeded in increasing the antibodies of volunteers in the Phase 2 clinical trials by more than 60 times 35 days after the first injection, and by 34 times after three months.
According to local Vietnamese media, the Ethics Committee in Biomedical Research in Vietnam has reviewed Nanocovax's interim Phase 3 results and the committee unanimously agreed that Nanocovax has verified its safety and protective effects on Dec. 16. They have requested Nanocovax's Clinical Research Organization (CRO) to submit a final report by Dec. 22.
Nanogen had submitted an emergency use application to the Advisory Council earlier this year, but had been instructed to provide supplementary data regarding Nanocovax's protective effects. Approval by the Advisory Council had been placed on hold, due to the lack of direct data on its protective effects, but the data was finally secured recently when symptomatic COVID-19 cases began to emerge amongst participant groups administered with the vaccine and placebo.
"With the confirmation of Nanocovax's protective effects, the emergency approval procedures for the vaccine are expected gain speed," an HLB official said. Once Nanocovax receives approval from the Advisory Council, approval for emergency use will be officially announced by the health ministry.
Nanogen's Phase 3a trial on 1004 participants has confirmed an antibody response of 96.5 percent and a seroconversion rate of 99.2 percent, and Phase 3b trials on 13,000 patients have also been completed. Currently there are no known cases of serious side effects or anaphylaxis
HLB said that it plans to sign a formal agreement with Nanogen once the company's vaccine is officially approved for emergency use. NextScience, an affiliate of HLB, holds around a 10-percent stake in Nanogen and another HLB affiliate, HLB Pharma, and has established a collaboration with Nanogen for the development of pharmaceutical drugs for overseas markets.
