Novavax Inc. (NASDAQ: NVAX) said Monday its Covid-19 vaccine has been granted emergency use authorization in Indonesia, the first such approval for the Gaithersburg biotech that has been taking its two-dose, protein-based vaccine through regulatory processes around the globe.
"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 President and CEO Stanley Erck said in a statement.
The Serum Institute of India is the company's manufacturing partner. The vaccine will be marketed by the SII in Indonesia, the world's fourth-most-populous country, under the brand name Covovax. It's the first protein-based Covid-19 vaccine to receive authorization anywhere "based on phase 3 clinical data demonstrating efficacy and a favorable safety profile," Erck said in his statement.
Novavax said it has now completed all regulatory submissions in India and the Philippines as well as Indonesia. Also on Monday, the biotech submitted for emergency use authorization in Canada. It all comes after Novavax filed for regulatory approval in the U.K. last week. It said it expects to make its full submission for approval to U.S. regulators by the end of the year.
The company has faced numerous manufacturing challenges over the last several months related to supply-chain issues that have prolonged its ability to get its vaccine across the finish line in multiple markets — but the path appears to be clearing.
Novavax, which is developing a new manufacturing hub in Gaithersburg, uses what’s called recombinant nanoparticle technology in its vaccine, making it different from messenger RNA and viral vector vaccines. It’s the same platform Novavax uses for its experimental seasonal flu and other vaccines, but it swaps in the genetic sequence for the coronavirus in place of the other antigens to fight Covid.
Novavax's vaccine is stored in warmer temperatures than those made by Moderna Inc. and Pfizer Inc., opening it up to more traditional supply channels. That could increase access to the vaccine in Indonesia, where its archipelagic geography presents challenges in getting vaccines to those that need them.
The hard-hit country of about 270 million people has handed out more than 100 million doses so far. Last week, President Joko Widodo urged wealthier countries to share their vaccines with poorer ones.
"In this time of crisis, advanced countries need to do more in helping poor countries get vaccines, so that we can overcome this pandemic together," he told the BBC ahead of this week's COP26 climate meetings in Glasgow, Scotland.
Novavax said vaccine shipments to Indonesia were expected to begin imminently.
Shares in Novavax closed trading Friday at $148.96, down 1.19%. Its price jumped 15% in premarket trading Monday based on the news from Indonesia and Canada.
In pictures
This rendering shows the new FIS Champions Club that will open next season at Nationals Park, part of a partnership with FIS Inc., a Jacksonville, Florida, payments technology provider. The renovated club will feature new decor, including a display area for the 2019 World Series trophy, and upgraded food and beverage, according to a press release. Through the agreement, FIS is becoming the Nationals' exclusive payments partner and will manage all merchant transactions at the ballpark.
Odds and ends
- Metro is adding seven more trains to its scaled-back fleet on Monday, which will add service to the Silver Line and increase frequency on the Green Line. Service is expected to remain limited until Nov. 15 as the transit agency continues to assess its trains following a Blue Line derailment last month. (WTOP)
- The Montgomery County Council is poised to reject the acting health officer's recommendation to reinstate an indoor mask mandate that was just lifted last week. (NBC Washington)
- DBi Services, the contractor providing maintenance to portions of Interstate 66 and Capital Beltway in Northern Virginia as well as the rest areas on those roadways and the Woodrow Wilson Bridge, abruptly closed in late October, citing material costs, labor shortages and a loss of funding from a primary lender. (InsideNoVa)
- A bill in the D.C. Council would look to crack down on the District's marijuana "gifting" economy. (DCist)
- Bagel Place in College Park said Friday it is closed permanently after 35 years in business. (Hyattsville Wire)
- Scissors & Scotch, the retail chain that combines a barbershop with a full bar, has three more locations planned in Greater Washington. (Washingtonian)
- Virginia has seen more than $2 billion in sports wagers since the practice became legal in the state in January. (Richmond Times-Dispatch)
