Chula mRNA vaccine in line for April rollout after Delta success
Chulalongkorn University researchers have launched the second human trial of Chula-Cov19 mRNA vaccine, after the Phase 1 trial greatly boosted volunteers’ antibodies against the Covid virus.
The vaccine proved effective against all four variants of the virus in Phase 1 and is expected to be registered by the Thai Food and Drug Administration (FDA) in April next year, said Chula.
The vaccine “can induce a very strong antibody response, [which is] as good as Pfizer”, said Dr Kiat Ruxrungtham, director of the Chula-Cov19 mRNA development programme and founder of the Chula Vaccine Research Centre behind ChulaCov-19.
On Saturday, researchers declared “satisfactory” results from the first trial on 72 volunteers – 36 aged 18-55 and 36 aged 65-75.
After being injected with the mRNA vaccine, Phase 1 volunteers developed 94-per-cent protection against Covid-19 symptoms, with high antibody activation. The vaccine also stimulated T-cell immunity, which helps to kill the virus in the cells of infected people.
The vaccine was effective against the original strain as well as its four main variants, namely Alpha, Beta, Gamma and Delta. Delta currently accounts for more than 90 per cent of new infections in Thailand.
Volunteers experienced mild to moderate side effects in the seven days after vaccination. Most of the symptoms – pain at the injection spot, fatigue, low fever and chills – occurred after the second shot and lasted 1-3 days. The vaccine is now on track to become Southeast Asia’s first mRNA jab.
Chula-Cov19 has a longer storage life than other mRNA vaccines, said Dr Kiat.
The vaccine can also be produced quickly as it does not require large production facilities.
Results of previous tests in mice indicated that the vaccine is non-toxic, can prevent symptoms, reduces the viral load in the nose and lungs, and halts its spread into the bloodstream.
The second phase involves a 2a trial on 150-300 volunteers followed by a 2b trial on 5,000 volunteers in October. If all goes well, a third and final-phase trial will be conducted on 15,000-30,000 volunteers.
“The vaccine should be registered by April 2022 if possible,” said Kiat.