By Jack Denton
Novavax's long-awaited Covid-19 vaccine has been authorized for emergency use in Indonesia and is on the road to authorization in Canada and the European Union, the company said Monday.
The news helped the stock surge, with shares in Novavax (ticker: NVAX) jumping more than 6% in U.S. premarket trading Monday.
The emergency-use authorization in Indonesia came as Novavax submitted its Covid-19 vaccine candidate for authorizatio n in Canada and completed the submission of data for review in the EU.
"The first authorization of Novavax's Covid-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population," said Stanley C. Erck, Novavax's president and CEO, in a statement.
"This also marks the first regulatory authorization worldwide of a protein-based Covid-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favorable safety profile," Erck added. "This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally."
Novavax's Covid-19 vaccine is protein-based, unlike the vaccine based on messenger RNA drug technology from Pfizer (PFE) and BioNTech (BNTX) as well as the one from Moderna (MRNA), or the carrier vaccines developed by AstraZeneca (AZN) and Johnson & Johnson (JNJ).
The vaccine has shown strong potential in late-stage trials. In one Phase 3 trial in the U.K. with 15,000 participants, the biotech company's shot demonstrated efficacy of 96.4% against the original strain of the virus that causes Covid-19, and held up strongly against a variant.
Novavax filed for authorization of its Covid-19 vaccine in the U.K. and Australia last week, and has also filed for emergency-use listing with the World Health Organization.
The company is expected to file for authorization in the U.S. with the Food and Drug Administration by the end of the year, and said it expects to complete additional filings in multiple markets shortly.
As Barron's reported last week , Novavax would enter a crowded Covid-19 vaccine market in the developed world if its shot is given the go-ahead by regulators -- and just how it will fit into that landscape remains unclear.
Write to Jack Denton at jack.denton@dowjones.com