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Cart 19 clinical trial

/ September 30, 2020

Vietnam to conduct COVID-19 vaccine trials on humans in 2021

As one of 42 countries that is capable of producing vaccines, the nation is speeding up its research process in a bid to develop a COVID-19 vaccine, with the Ministry of Health directing manufacturers to step up research activities in order to eventually lead to mass production of a vaccine. The four local manufacturers of a COVID-19 vaccine include the Institute of Vaccines and Medical Biologicals (IVAC), the Company for Vaccine and Biological Production No.1 (VABIOTECH), the Research Center for Vaccine Production and Medical Biologicals (POLYVAC), and Nanogen Pharmaceutical Biotechnology Co. Ltd. At present, the country’s potential COVID-19 vaccines are being trialed in an experimental capacity on mice. Minister Long added that the nation has not recorded any COVID-19 community infection cases since September 3, while the country has stepped up research activities in an effort to develop a suitable COVID-19 vaccine and increase access to vaccines being produced worldwide. Furthermore, Vietnam is also one of 92 countries participating in the "COVID-19 Vaccine Global Access Facility” (COVAX Facility) scheme and it is expected to get early access to vaccines from Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO). Moreover, the nation has recently ordered vaccines from three countries, including Russia, the United States, and the UK, while actively seeking other sources through direct discussions with foreign manufacturers. …

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/ December 26, 2020

Volunteers receive 50mcg dose of Nano Covax to combat COVID-19

The trio are among a group of 20 volunteers who are scheduled to receive the 50mcg dose as part of the ongoing human clinical trial campaign which is being carried out by Nano Covax producer, Nanogen Pharmaceutical Biotechnology JSC, and the Military Medical Academy. The three volunteers will remain under close scrutiny at the Academy over the course of the subsequent 72 hours. Providing that they stay healthy, the group’s remaining 17 volunteers will then receive a similar dose. The first group of 20 volunteers received a 25mcg doze of Nano Covax on December 17 and have so far shown no signs of any negative side effects, with the exception of a mild temperature of less than 37.8 degrees Celsius. “Based on the encouraging results, the Ministry of Health has permitted the Military Medical Academy to continue with the 50mcg injection on a further 20 volunteers,” said Major General, Prof. Dr. Hoang Van Luong, deputy director of the Military Medical Academy. According to Gen. Luong, an additional group of 20 volunteers will subsequently be given a 75mcg dose of Nano Covax over the coming days in an effort to test the vaccine’s safety. The first phase of the testing campaign involves the participation of 60 volunteers and will be finished following a six-week period. The Academy is now recruiting volunteers to take part in the second and third phases which are scheduled to start in March and August, 2021, respectively. In addition to Nanogen, three other Vietnamese firms are in the process of researching and producing COVID-19 vaccines. They are the Company for Vaccine and Biological Production No1 (Vabiotech), the Institute of Vaccines and Biological Medical (Ivac), and the Centre for Immunization Vaccines (Polyvac). It is anticipated that both Ivac and Vabiotech will test their COVID-19 vaccines on humans in March, 2021. …

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/ December 10, 2020

First clinical tests of locally-produced COVID-19 vaccine get underway

According to Minister of Health Prof. Dr. Nguyen Thanh Long,  in the previous research, Nanocovax has undergone all necessary safety tests, with positive results being collected after conducting trials on monkey and mice. Following this, the National Institute of Hygiene and Epidemiology announced on December 7 the test results of Nanocovax, with a vaccinated hamster being exposed to the SARS-CoV-2 virus for a 14-day period but not becoming infected with the virus and remaining negative. This led to the National Ethical Council for Biomedical Research convening a meeting on December 9 in order to evaluate the research documents from the first and second clinical trial phases for local COVID-19 vaccine Nanocovax. The Military Medical Academy is therefore anticipated to launch the next stage of the clinical trial programme for the COVID-19 vaccine on December 10, whilst also announcing the recruitment of volunteers to participate in future research activities. The first vaccine shot is set to be given to volunteers who are eligible to participate in the first phase of research on December 17. To ensure the safety of the volunteers during the trials, the first three people will be injected with a 25 microrgram (mcg) dose of the trial vaccine, with their health conditions being assessed following a period of 72 hours. The next dose of the experimental vaccine, along with the number of participants in the scheme, will be decided after the results of the first dose given to the three people have been reported.  The experimental period for each participant in the programme will be approximately 56 days. Nanogen initially started their COVID-19 vaccine project in January. Immediately after being licensed by the Ministry of Science and Technology, Nanogen moved to invest a sum of roughly VND200 billion to build three factories, whilst also purchasing all necessary materials for research activities. …

[Read more...] about First clinical tests of locally-produced COVID-19 vaccine get underway

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