The Phase 1 trial of Thailand’s homegrown mRNA Covid-19 vaccine ChulaCOV-19, suggests the candidate vaccine can help the body elicit the same level of antibody response as the Pfizer-BioNTech, along with much easier storage requirements.
The researchers are aiming for this Thai-made vaccine to be available next year as a booster shot for Thai people.
King Chulalongkorn Memorial Hospital and the Faculty of Medicine at Chulalongkorn University, today announced a promising preliminary result from the Phase 1 clinical trial of the ChulaCOV-19 vaccine, Thailand’s homegrown Covid-19 vaccine developed using the much anticipated mRNA technology.
Dr. Kiat Ruxrungtham, director of the Chula Vaccine Research Center (Chula VRC), said today the Phase 1 trial conducted with 36 volunteers aged 18-55 years old, showed the trial vaccine can help the body build a level of antibody response similar to the Pfizer-BioNTech vaccine, developed using the same mRNA technology.
The volunteers have been constantly monitored and tested for their antibody responses after receiving two doses of ChulaCOV-19 from world-class laboratories. Preliminary results from this study show the vaccine candidate is 94% efficacious in preventing SARS-CoV-2 attachment to human cells, the same level as the Pfizer-BioNTech vaccine.
In comparison, the viral vector vaccine from AstraZeneca has this particular efficacy rate at 84%, while the inactivated vaccine from Sinovac is at 75%. The minimum threshold of research was only 68%.
In terms of safety, all 36 volunteers reported no adverse events following vaccination. Mild to moderate side effects similar to those of other vaccines were observed, with most of the symptoms improving after 1-3 days.
The researchers have concluded that data from the Phase 1 study shows the ChulaCOV-19 candidate vaccine can help the body in eliciting a high level of antibody response effective in preventing illnesses from the wild type SARS-CoV-2, as well as the Alpha, Beta, Gamma, and Delta variants of concern.
With performance expected to be similar to the Pfizer-BioNTech vaccine, this Thai-made mRNA vaccine does not come with ultra cold storage and transportation requirements. The vaccine has been designed to remain potent and stable at a normal refrigerator temperature of 2-8 degree celsius for three months, or at the regular temperature of an air conditioned room for 14 days.
With promising results from the initial trial stage, the researchers are now going ahead with a Phase 2 trial involving more volunteers. The team will be selecting the appropriate dosage for Phase 2 at the end of this week, while the actual study is expected to commence on 25th August.
In this phase, researchers will be making a head-to-head comparison between volunteers receiving ChulaCOV-19, and volunteers receiving Pfizer-BioNTech vaccine supplied by the Ministry of Public Health.
If all goes well, the team expects to have this Thai-made mRNA vaccine available to the general public by April 2022, mainly as a booster shot for fully vaccinated people. The researchers are also working on a second-generation and third-generation vaccine in response to newer variants.
Prof Dr Kiat said the vaccine project still needs more fluid funding from related agencies, while urging the government, private sector, and the general public to consider a new protocol for vaccine authorization to determine at what stage of the study the candidate vaccine could receive emergency regulatory approval.
The Thai Food and Drugs Administration is now brainstorming this new protocol, which is expected to be released next month.
The vaccine project still needs to rely on a capable manufacturer which can produce doses in bulk before the end of this year, as well as a clarified advance vaccine procurement policy from the government.