Department of Labor to test COVID vaccine in humans Phase I with 210 volunteers in March

10 Feb’20 – Government Pharmaceutical Organization (GPO) Krathorn Wongsatharnsuk And Mahidol University Press release on research results for developing a vaccine against COVID-19 “NDV LaSota-S Hexapro COVID-19 vaccine (NDV-HXP-S)” lethal type by incubation technology. That was prepared for clinical trials in humans, Phase 1, March 2021, if all procedures were completed And registered with the FDA, it is expected that 25-30 million doses of the vaccine will be produced per year.

Anutin Charnvirakul, Deputy Prime Minister and Minister of Public Health, said that Thailand has focused on research and development of vaccines for use in the country. For stability, sustainability and being as self-reliant as possible With the progress in research and development of vaccines from hatched egg technology By the Government Pharmaceutical Organization Which is currently the technology used to produce many types of vaccines Including influenza vaccine Over 80 percent of the 1.48 billion doses of influenza vaccine used worldwide in 2019 were produced by hatched egg technology, according to the World Health Organization. Which is safe, high quality and efficient as well as other technology. And in accordance with the World Health Organization standards

Moreover, the production cost is low and the production process is not very complicated. It has also been found that other companies abroad are using this technology for the production of the COVID-19 vaccine as well. Upon completion of the three phases of vaccine development, it will enter the rolling submissions process. The Food and Drug Administration (FDA) is expected to produce 25-30 million doses of vaccine for domestic use per year. The government is ready to support research, development and production of a vaccine against COVID-19. By using this technology of hatching eggs It is another way of building security and self-reliance on vaccines in Thailand.

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“If in the future the vaccine works well Be in high demand Believe that the capacity can be expanded There may also be a network partner to provide additional support. This progress reflects that Thailand is not riding a single horse. But has developed to the extent of being the owner of a stable with all Thai people The goal is to produce vaccines to keep the country safe. As well as being able to take care of neighboring countries Or other countries Who need a vaccine as well, “said Anutin.

Dr. Vitoon Danwiboon, director of the Pharmaceutical Organization, said the organization had sent NDV-HXP-S vaccine to test for toxicity in rats. In india Found that the vaccine is safe And performance testing (Challenge study) in hamsters (Hamsters) in the United States. The preliminary results showed that the vaccine was effective in preventing disease from the 2019 coronavirus infection, in line with the results of the immunogenic ability study. It was found that the vaccine was able to stimulate the immune system against the corona virus thorn protein well. Currently it is awaiting the results of the complete study.

Prof. Pannee Piti Suthitham Head of the Vaccine Center And the head of the research and development of the vaccine against the novel coronavirus infection 2019 provided further information that The research study of the COVID-19 NDV-HXP-S vaccine has the advantage that it is developed with a hatched egg technology that the GPO has expertise. Which can be stored in the temperature 2-8 degrees, which is relatively stable. The key is to make this vaccine. Using a virus that does not cause disease in humans And cause very little disease in birds It’s called the Newcastle virus. Along with adding spike protein fragments and add protein amino acids So that it is stable, stable and has broader immunity. Per species that will have future mutations

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The project leader continued that for the first phase of the human trials, testing will begin in March. The number of volunteers is 210 people and the second phase is about April – November. In the other 250 volunteers, the Phase I and II studies evaluated the safety, tolerability and immunogenicity of the vaccine. In some range of S-antigen levels, CpG 1018 has been used as an adjunct in early clinical trials. In clinical trials, Phase II aims to select a single vaccine to enter Phase III and is expected by 2022 to begin application form applications. And will be produced on an industrial scale at the WHO’s biological production (vaccine) plant in Saraburi, where the plant already has hatched egg technology used to produce influenza vaccine. Ready to be immediately adapted to produce a vaccine against COVID-19

Dr. Weerapong, M.D. Phumirattanapraphin Added that The NDV-HXP-S vaccine in stages 1 and 2 will be tested on Thai volunteers. To produce effective vaccines The test was divided into three groups of volunteers. In phase 1, the subjects were vaccinated. In the pseudo vaccine group And real vaccines And in some groups that will be injectable booster vaccines To assess performance And select the best group into the Phase 2 trial. In the third phase, if the number of cases in the country is low, It may need to be tested abroad.

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