Police announces first test of COVID vaccine in Thailand this March, preparing to accept the first 210 volunteers!
On February 10 at Ministry of Public Health (Ministry of Public Health), Mr. Anutin Charnvirakul, Deputy Prime Minister and Minister of Public Health, along with Dr. Kiattaphum Wongrachit, Permanent Secretary of the Ministry of Public Health, as the Chairman of the Board of the Pharmaceutical Organization, and Dr. Vitoon Danwiboon, Director of the Pharmaceutical Organization ( TISI) announces progress to study COVID-19 vaccine research Dead in humans, Phase 1
Mr. Anutin said that the Police had conducted research and development to produce a vaccine against COVID-19. There is progress in research and development in cooperation with overseas partners. Using hen egg technology Which is the same technology as influenza vaccine Longtime Data from the World Health Organization showed that more than 80 percent of the global influenza vaccine in 2019 was produced using hatched egg technology. Because it is safe, high quality, in line 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 the technology to produce the COVID-19 vaccine.
Mr Anutin said that the Police Department has started this project since mid-2020 and is now testing on laboratory animals. Found that the vaccine to stimulate the immune system is effective and safe. The first phase of clinical trials in humans will be conducted in March with the Faculty of Tropical Medicine. Mahidol University with Prof. Dr. Pannee Pitisutitham Head of the Vaccine Center To be the head of the research project After completing all three research phases and the results of studies showing that the vaccine is safe and able to stimulate the immune system which prevents COVID-19, it is expected to apply for registration with the Food and Drug Administration (FDA). ) In 2022, apply for rolling submissions in parallel with the Phase 3 research study and will produce at the industrial level at the biological production (vaccine) plant of the district district, Saraburi province.
“The production plant of the Ph.D. will be the second of the vaccine production after Siam BioScience. To produce vaccines from AstraZeneca There is already incubated chicken egg technology used to produce influenza vaccine. The COVID-19 vaccine can be deployed immediately, with 25-30 million doses of the vaccine to prevent COVID-19 per year and can expand the production capacity, ”Anutin said.
Anutin said the government is ready to support research, development and production of the vaccine against COVID-19. From all departments If any manufacturer has a high probability of success, the government by the National Vaccine Institute. With full support
Dr. Kiatphum said that research and development of this COVID-19 vaccine is in collaboration with PATH Institute of the United States. This is an organization aimed at developing affordable, good quality vaccines, increasing access to vaccines for people in middle- and low-income countries. By focusing on countries with potential for vaccine production with hatched egg technology Can produce a vaccine against COVID-19 For domestic use and export to needy countries, PATH delivered the original virus, developed by the Mount Sinai School of Medicine in New York and the University of Texas, free of charge. To produce vaccines Caused by genetic modification Newcastle virus. To contain spike protein of virus that does not cause COVID-19 And can increase the number of hatched eggs as well as influenza virus that the AOP has the potential to produce already
Dr. Vitoon said that Ph.D. has sent the vaccine to test the toxicity in rats in India. Found that the vaccine is safe And performance test (Challenge study) in hamsters (Hamsters) in the United States. The preliminary results showed that the vaccine was effective in preventing disease caused by the coronavirus infection in 2019, consistent with the results of the immunogenic ability study. It was found that the vaccine was able to stimulate immunity against the corona virus thorn protein well. Moreover, it can produce large quantities in a short time. And it is very stable during storage and transportation.
Dr. Vitoon said that the technology of the vaccine factory in Saraburi, originally producing 3 strains of influenza vaccine, is going to be expanded to 4 strains soon. More Because it uses the same technique as the flu vaccine, it is a live vaccine Inoculate the eggs Is to bring more viruses into the eggs And kill the virus as a deadly infection Extracted into a vaccine in a tube. By accepting volunteers, they must first join the Human Research Ethics Committee, however, at this time, it has received funding from the National Vaccine Institute and a total budget of approximately 150 million baht to install additional vaccination lines. This will increase the production capacity by approximately 60 million doses per year and if the COVID vaccine is successful. The plant does not need to divide the production of these two vaccines, they can be produced according to the demand. Because the times of need for vaccine are overlapped
“The COVID-19 vaccine May be produced in 1 egg, approximately 10 doses different. Vaccine can only produce 1 dose of cold egg because up to 3 strains are needed. The optimal dose of vaccine was determined in Phase 1 of the trial. There are 3 sizes at 1 microgram, 3 and 10 micrograms, ”said Dr. Vitoon.
Prof. Pannee said that for the trial in people, it will be divided into three phases, the first phase of March or April, with 210 volunteers who are healthy, aged 20 years and over. Have had previous infections Hence, IgG immunity is tested in groups. Is the group who received different doses of the real vaccine Group who received the sham vaccine And the group receiving additional synergistic substances However, it takes 1-2 months to see safety. And the right size Before leading to a phase II human trial, expected to begin in April or May, 250 volunteers will be selected by selecting the appropriate formula. And compare it to the group that received nothing The data is then analyzed and taken to the trial in phase 3. However, phase 1 and phase 2 can be performed in Thailand, but phase 3 must also depend on the number of patients. If there are few cases in Thailand, they may need to be tested abroad.
“The use of synergistic agents to promote immunity against COVID-19 To be wider and different This is in the hope that the vaccine can also cover the mutant COVID, ”said Pannee.