(Reuters) – Novavax Inc and companion Serum Institute of India mentioned on Monday they acquired emergency use authorization for his or her COVID-19 vaccine in Indonesia, making it the primary approval anyplace on this planet for Novavax.
Shares of Novavax rose about 11% earlier than the opening bell after the corporate additionally mentioned it had filed an software for emergency use for the vaccine to Canada and the European Medicines Company.
For Indonesia, the shot will likely be manufactured by the world’s largest vaccine producer, Serum Institute, and offered underneath the Indian firm’s model identify, Covovax.
Novavax mentioned preliminary shipments into Indonesia are anticipated to start imminently.
The nation is slated to obtain 20 million doses of the protein-based vaccine this 12 months, in accordance with the federal government.
Penny Lukito, chief of the Nationwide Company for Drug and Meals Management of Indonesia, didn’t instantly reply to a Reuters request for remark.
Novavax has to this point utilized for EUA in varied international locations, together with the UK, Australia, India and the Philippines.
The corporate, together with Japanese companion Takeda Pharmaceutical Co, mentioned on Friday it was making ready to hunt regulatory approval for a rollout in Japan early subsequent 12 months.
Novavax and Serum Institute have dedicated to collectively present greater than 1.1 billion doses to the COVAX facility, co-led by the World Well being Group. The provision of the vaccine will begin this 12 months after securing an emergency use itemizing from the WHO and proceed into 2022.
Novavax has delayed submitting for U.S. approval to the tip of this 12 months, and Politico reported final month that the corporate has confronted manufacturing and high quality issues.
The Novavax shot was proven to be greater than 90% efficient, together with in opposition to a wide range of regarding variants of the coronavirus in a big, late-stage U.S.-based medical trial.
(Reporting by Dania Nadeem, Leroy Leo in Bengaluru and Stanley Widianto in Jakarta; Modifying by Maju Samuel)
