In rapidly developing a COVID-19 vaccine—and a highly effective one at that—Novavax got the hard part right.
But the logistics of manufacturing the vaccine has proven to be a more daunting task for the small Maryland biotech, which still has yet to file for approval of the shot in the United States, falling behind its expected timetable.
The delays will severely impact the vaccine’s uptake in the U.S., where demand has been met primarily by mRNA vaccine suppliers Pfizer and Moderna, as well as Johnson & Johnson's adenovirus-based shot, according to Nancy Jaser, a Pharma analyst at GlobalData.
“Vaccination rates are decreasing in the U.S. while mRNA vaccine supplies remain plentiful,” Jaser wrote. “It is likely that a large amount of (Novavax) doses will go to other countries that have a more urgent need.”
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Last year, the U.S. bet big on the 34-year old company which had never brought a vaccine to the market. Novavax won a $1.6 billion grant in exchange for 100 million doses of the shot. But now those vaccines are likely destined for overseas.
Previously, the company set out to gain an FDA nod by the end of the second quarter of 2021. But last month Novavax announced it would not seek approval until late September.
Meanwhile, the vaccine has been posting clinical trial wins. In a phase 3 trial called Prevent-19, the shot showed 90.4% efficacy overall and 100% success in preventing moderate or severe disease, to go along with a strong safety profile. Still, the trial didn't test the vaccine in areas with high levels of the Delta variant, which has been growing in prevalence in many countries worldwide.
One of the first signs of trouble for Novavax came in October of last year when it had to delay the Prevent-19 trial to December because of production problems.
Then in April, CEO Stanley Erck admitted that the company was having difficulty securing some raw materials—more specifically, the large, sterile bags used to grow vaccine cells.
A month later, Novavax announced the delay in seeking FDA approval for the vaccine, citing its inability to show regulators that its manufacturing process was consistent across different sites.
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Novavax has secured large manufacturing contracts with the Serum Institute of India and SK Biosciences of South Korea, to go along with deals with Fujifilm Diosynth and GlaxoSmithKline in the U.K. and with Jubilant HollisterSteir in Spokane, Washington.
The company hopes to be able to produce 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the year.
Novavax also wants to find a place in the U.S. for the shot as a booster, citing evidence from an encouraging study, which has yet to be published in a medical journal.
In April, despite the production delays, GlobalData predicted a total of $33.3 billion in vaccine sales for Novavax from 2021-27, including $1.8 billion this year, growing to a peak of $7.2 billion in 2027. That forecast might have to be adjusted but there's still plenty of potential and a large market to serve, GlobalData says.
“While the U.S. might not see much uptake, this vaccine is a much-needed weapon to end the pandemic battle on a global level,” Jaser wrote.