Chula-Covid19 vaccine from Thailand succeeds trial on monkeys, FDA approval awaited for human trials

The experiments on monkeys had been successful but human testing might be possible only by the end of the year. According to Chulalongkorn research team, a research team developing a vaccine against Covid-19. To proceed to human testing they still have to wait for FDA approval while saying that volunteers could be signed up in September.

Photo credit: euronews.com

Chula-Covid19 is an mRNA vaccine produced from the genetic material of some new strains of the coronavirus. When parts of this genetic material are injected into the body, they will be transformed into proteins to stimulate the creation of antibodies that would help fight the virus. 

Blood test results after the second vaccination of Chula-Covid19 at the National Primate Research Center, Chulalongkorn University, for two weeks found that every monkey that received the vaccine had an increased level of immunity to a very high level of immunity, exceeding the expected level.

However, injections in humans might not have the same result, and it may cause the auto-immune action to be approximately 70 times lower than in monkeys, they added.

The first stage of Thai clinical trials will enroll about 100 volunteers separated in two groups, one for people aged 18 to 60 and the other for 60- to 80-year-old. The focus of the first stage, which will take about two months, is on determining the safety and appropriate dosage for human use. 

The second stage, likely to begin in December, will involve 500 to 1,000 people. The vaccine may get emergency-use authorization from the Food and Drug Administration and skip the third and final stage, which would use more than 10,000 volunteers in countries with an ongoing outbreak.

We have prepared about 10,000 doses for the volunteers, for an estimated 5,000 people. If the test is successful, the vaccine would be ready for use in people around the third or fourth quarter of next year.

Currently, there are around 18 mRNA vaccine developers around the world, but four of them are six months ahead of Thailand. Therefore, it is expected that one research will be successful at the beginning of next year and will be certified by the Food and Drug Administration of America and Europe. By then, the Thai FDA would pass the human trial in phase 3, it will reduce the time required for this phase by 9-12 months, speeding up availability of the vaccine. However, he said the government should be prepared to purchase vaccines from foreign countries as well.