Novavax COVID-19 Vaccine Gets First Authorization

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November 1. Novavax Inc (NVAX.O) expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.

For Indonesia, the shot will be manufactured by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.

The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.

A green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.

The Novavax shot was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based trial.

Source: Reuters

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85330cookie-checkNovavax COVID-19 Vaccine Gets First Authorization