Thai vaccine to enter third phase of trials
published : 18 Nov 2021 at 19:10
writer: Post Reporters
Chulalongkorn University’s Centre of Excellence in Vaccine Research and Development expects to register its mRNA Covid-19 vaccine, known as ChulaCOV-19, mid-next year.
Kiat Raxrungtham, head of the Covid-19 vaccine development project, said ChulaCov-19 is about to enter its third phase of human trials with jabs scheduled to be administered early next year to March.
Trial results are expected for analysis during April-May before an application is filed with the Thai Food and Drug Administration (FDA) mid-next year for emergency use approval, he said.
According to Dr Kiat, if the vaccine registration is approved, the research team is required to conduct the fourth phase trial to gather information about the vaccine's safety and effectiveness from some 30,000 recipients.
However, by the time the trial is launched next year most people will have been fully vaccinated, he said, noting that research will also be conducted on the vaccine's effectiveness as a booster dose.
He said the research team has begun developing second- and third-generation vaccines with trials beginning on mice.
Based on data from the second-phase human trial, ChulaCov-19 is effective against several variants of Covid-19 including Delta, he said. Low fever was reported after the second jab while serious side effects such as clotting were not detected.
Dr Kiat said the research team's goal in developing the vaccine is to produce a high-standard vaccine that is accepted by other countries and recognised by the World Health Organisation.
The government has recently approved a budget of 2.3 billion baht to support the development of the vaccine with 1.3 billion baht being earmarked for human trials with the balance to be set aside to cover materials and production costs.
Meanwhile, Suthira Taychakhoonavudh, co-founder and CEO of Baiya Phytopharm Co, said researchers are collecting data about the safety of its plant-based "Baiya Vaccine" following the first phase of a clinical trial.
Asst Prof Suthira said no serious side effects were reported so far among the participants of the trial that began in September. Her team is also recruiting people aged 61-75 for a trial next month. She also said the second generation of the vaccine has been produced for the first-phase human trial beginning January next year.