Novavax Receives First Emergency Use Approval for COVID-19 Vaccine in Indonesia... "A Monumental Moment"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The Indonesian health authorities have granted the first emergency use authorization for the COVID-19 vaccine developed by the U.S. pharmaceutical company Novavax. The Novavax vaccine had been embroiled in quality concerns and had not received emergency approval applications from any country, sparking controversy. However, following this approval, there is growing optimism that emergency use authorizations submitted to the World Health Organization (WHO) and various countries will be approved.

According to the Associated Press on the 1st (local time), Stanley Erck, CEO of Novavax, stated in a press release, "The emergency approval of the Novavax vaccine by Indonesian authorities is a monumental moment, and in the coming weeks or months, approvals for the Novavax vaccine will continue worldwide." He emphasized, "We are committed to equitable access to the vaccine and will meet the demand of Indonesia, the world's fourth most populous country."

The Novavax vaccine supplied to Indonesia will be manufactured and supplied under contract by the Serum Institute of India (SII) under the name 'Covovax.' The Novavax vaccine is administered twice at three-week intervals and can be stored at refrigerated temperatures, making it easier to transport compared to mRNA (messenger ribonucleic acid)-based vaccines like Pfizer and Moderna.

Previously, Novavax announced that it had applied for emergency use authorization not only in Indonesia but also with Canadian health authorities, the European Medicines Agency (EMA), the World Health Organization (WHO), India, and the United Kingdom. However, due to quality concerns raised during the development and manufacturing process, emergency use approvals had not been granted by these countries.

Novavax is also planning to apply for emergency use authorization with U.S. health authorities within the year. CEO Erck added, "We have resolved all manufacturing difficulties, and regulatory authorities will no longer have concerns about the production process." He further stated, "We are in consultation with the U.S. Food and Drug Administration (FDA) and will fully submit the documents within a few weeks."

This content was produced with the assistance of AI translation services.