Chinese developed SARS-CoV-2 mRNA vaccine granted emergency use authorization in Indonesia
2022-09-30
The Indonesian Food and Drug Authority authorized Walvax-Abogen SARS-CoV-2 mRNA vaccine developed in China for emergency use in individuals 18 years of age or above, as either primary or booster dose. [Photo/Xinhua]
Kunming -- The Indonesian Food and Drug Authority authorized Walvax-Abogen SARS-CoV-2 mRNA vaccine developed in China for emergency use in individuals 18 years of age or above, as either primary or booster dose, announced the vaccine developer Friday.
"Obtaining the Indonesian Emergency Use Authorization (EAU) is a remarkable achievement in the commercialization stage of the vaccine. As a proprietary mRNA vaccine independently developed in China, it is indeed a proof for the effectiveness of our mRNA technology platform," said Li Yunchun, Chairman of Walvax Biotechnology Co., Ltd.
The company based in Kunming, Yunnan province and Suzhou Abogen Biosciences Co., Ltd. Jointly developed the mRNA vaccine against SARS-CoV-2.
"Indonesia is the country with the fourth largest population and most Muslim in the world, so we believe the certified halal vaccine will be a safe, effective option for Indonesian people, which is also in alignment with their culture. This is the first step, and we are hoping to see more families across the country and the rest of the globe are protected, which is a shared goal for us all," he said.
The EUA for primary 2-dose series is primarily based on safety and efficacy data from the pivotal phase 3 clinical study, which is currently ongoing in 31 sites from 3 countries of Indonesia, Mexico and Philippines, with preliminary data focusing on the safety profile and the efficacy as a 2-dose regimen against COVID-19 of different outcomes obtained.
The protective efficacy for the Indonesian cohort was demonstrated to high against either COVID-19 of any severity or against moderate diseases caused by the circulating Omicron variant, in line with the effectiveness against SARS-CoV-2 Omicron variant of similar listed mRNA vaccines as mostly addressed by real-world effectiveness studies.
Indonesian Government has declared an emergency situation as a result of pandemic outbreak of COVID-19 that justifies the emergency need of using AWcorna as an option in this situation.
In response, the drug authority has issued EUA for the use of AWcorna, which is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and above.
