Novavax targeted May, then it said maybe July. Now, the company is saying it's yet again pushing back a request for emergency use authorization from the FDA for its COVID-19 vaccine.
It's been a rough ride for the jab, which hit 90.4% efficacy in a pivotal phase 3 trial that pitted it against similar numbers from Moderna and Pfizer.
The latest roadblock—which will advance the timeline by just a couple weeks—spurred a 17.25% drop in Novavax's shares to about $195 apiece as of 10:41 a.m. ET Friday morning. It seems investors are fed up with delay after delay.
In a regulatory filing, Novavax said the U.S. government wants the company to work with the FDA on issues regarding analytic methods before moving forward on further U.S. manufacturing. The federal government will not put money behind more U.S. manufacturing until the two parties come to an agreement.
President and CEO Stan Erck was confident Novavax can get the work finished up and submitted to the FDA quickly.
"We’re talking weeks here, we’re not talking months," Erck said during a Thursday earnings call, addressing the updated timeline.
The Trump administration signed on to buy 110 million doses of the company's vaccine. And in April, Novavax disclosed that it received another $147.34 million from Operation Warp Speed, which brought the federal government's total support for the jab to $1.74 billion.
The New York Times reported that the Department of Health and Human Services wants Novavax to "strengthen its testing and quality control operation." The company told the paper it doesn't expect an impact on the public-private deal.
Production failures came front and center in the vaccine roll-out earlier this year when Emergent BioSolutions ruined tens of millions of doses of Johnson & Johnson's and AstraZeneca's vaccines.
Despite the U.S. delay, Novavax said Thursday during second-quarter earnings that regulatory submissions for emergency use have been filed in India, Indonesia and the Philippines with its partner Serum Institute of India. Novavax will produce 100 million doses per month by the end of this quarter and ramp up to 150 million by the end of the quarter.
The European Medicines Agency has yet to approve Novavax's vaccine, but the European Commission on Wednesday purchased 100 million doses and secured the option to buy an additional 100 million through 2023. A rolling submission to the EMA is slated to be completed this quarter, the company said.
Other regulatory filings for the vaccine are on the docket, including the World Health Organization and the UK later this quarter. "Within weeks" of the UK filing, the company expects to request approval from the EMA, Australia, Canada and New Zealand.
The company also released preliminary data on a booster shot phase 2 trial underway in the U.S. and Australia.
The updates come as Novavax reported a net loss of $352 million for the second quarter or a nearly 20x increase over the same quarter last year. Revenue was $298 million compared to $36 million the year prior.