Topline
Indonesia has become the first country in the world to greenlight Novavax’s Covid-19 vaccine, the Maryland-based biotech announced Monday, a possible game changer in the fight against the pandemic and a major milestone for the company, which has been plagued with manufacturing difficulties and has not managed to bring a vaccine to market in its 34-year history.
Novavax's Covid shot was approved on an emergency basis in Indonesia.
Key Facts
Indonesia’s medicines regulator granted emergency use authorization to Novavax’s Covid-19 vaccine Monday, which will be produced by the Serum Institute of India, the world’s largest vaccine manufacturer by volume.
The green light marks the first time a regulator has approved a protein-based vaccine for Covid-19 based on late-stage clinical data, Novavax said, and the first time a regulator has approved any vaccine produced by Novavax.
Novavax said a phase 3 trial of the shot, which is given in two doses 21-days apart, found it was 100% effective against moderate and severe disease and was 90% effective at preventing Covid-19.
Key Background
While late to arrive, the Novavax shot has a number of advantages over existing vaccines and could help ramp up vaccination worldwide. It appears to have an efficacy on par with mRNA vaccines from the likes of Moderna and Pfizer and, unlike those widely used shots, uses a protein containing part of the coronavirus to stimulate an immune response, an older technology that many more hesitant individuals may be more comfortable with. The shot can also be stored and shipped at normal refrigeration temperatures and not the ultracold freezers needed by some of the most widely used vaccines. The pressure on Novavax has been increasing as it faces mounting delays and manufacturing issues, especially in light of its more than 1 billion doses promised to low- and middle-income countries and the widening chasm in vaccine access between wealthy nations and the rest of the world.
What To Watch For
Stanley Erck, Novavax’s chief executive, said the “landmark moment… is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine.” Alongside the Serum Institute of India, Novavax has already filed for emergency authorization in India, the Philippines and the World Health Organization. Individually, Novavax filed submissions with the European Medicines Agency, Canada, the U.K. and Australia, announcing the former two on Monday. The company says it anticipates filing with the U.S. Food and Drug Administration by the end of the year.
Surprising Fact
Despite having not brought a vaccine to market in its 34-year history, the U.S. government bet big on Novavax being able to rapidly develop a shot to tackle Covid-19. Operation Warp Speed—the Trump Administration’s project intended to ramp up vaccine development and production—invested $1.6 billion in the company, more than any other investment in a vaccine maker at the time.
Further Reading
How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine (NYT)
Novavax Nears Covid-19 Vaccine Game Changer—After Years of Failure (WSJ)
‘Bereft’: How Operation Warp Speed’s decisions left the world waiting for a vaccine (Politico)
The Long Shot (Science)
