Novavax Inc has reportedly received its first EUA (emergency use authorization) from Indonesia for its COVID-19 vaccine. The company is also expecting to get approval from regulators of the Philippines and India within weeks.
Serum Institute in India (SII), the largest vaccine manufacturer in the world, will be manufacturing the shot for Indonesia and selling under the brand name Covovax. The company stated that the initial shipments of the vaccine are expected to commence soon.
According to the government of Indonesia, the country is expected to get around 20 million doses of the vaccine this year.
Stanley Erck, the Chief Executive Officer of Novavax stated that the regulatory filing of Novavax is been reviewed by the WHO (World Health Organization) and the drug manufacturer expects it to be resolved over the forthcoming weeks.
Once WHO approves the application, Novavax will commence the shipment of the vials to the COVAX program under which vaccines are supplied to low-income nations. SII and Novavax have jointly committed to offering over 1.1 billion doses to the program co-led by the World Health Organization.
Erck stated that the company will be able to get some doses to the COVAX program in 2021 but it expects to make large shipments to the program in the first quarter of 2022.
He added that the company has resolved all its manufacturing issues and the regulators would not have any concerns regarding its production processes. The company is in talks with the U.S. FDA and it expects a complete submission within the next weeks.
So far, Novavax has applied for EUA in the UK, the Philippines, India, and Australia. Erck has affirmed that the review of the company’s regulatory submissions will be done in weeks and possibly approve the shot for use.
The Novavax vaccine was found to be more than 90% effective against many different coronavirus variants in a late-stage, large-scale U.S.-based trial.
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