Samples from the Novavax Phase 3 Covid-19 clinical vaccine trials.
Karen Ducey/Getty Images
We’ve heard it before. But maybe it’s for real this time?
The world has been waiting for results from Novavax’s large, U.S.-based Covid-19 vaccine trial for months. They still haven’t come, and the company said on an earnings call in early May that it would now not submit the vaccine for regulatory authorization until the third quarter of this year.
But the wait may be almost over. On Tuesday, Novavax (ticker: NVAX) indicated that data from the Phase 3 trial was coming soon. Speaking at an investor conference hosted by Jefferies, company management said they would be unblinding data from the trial shortly.
The session wasn’t open to the press, and no transcript is available. But in a note out early Wednesday reporting on the conference session, Jefferies analyst Kelechi Chikere wrote that management has said twice in the past week that the data from the Phase 3 trial will be unblinded soon, allowing researchers to see for the first time which subjects received a placebo.
The company presented shockingly positive efficacy data on its U.K.-based Phase 3 trial in March, saying at the time that the vaccine had 96.4% efficacy against mild, moderate, and severe disease caused by the original strain of the virus that causes Covid-19, and 86.3% efficacy against the U.k. strain. Chikere wrote that the company expects efficacy in the U.S. trial will be between 80% and 85%.
Investors have since lost patience for Novavax, as the company has fallen farther behind the other Covid-19 vaccine makers. The stock closed at $257.67 on April 27, but has since fallen 43.6%, closing Tuesday at $145.40. The stock is still up 30% so far this year, and nearly 230% over the past 12 months.
Shares fell 1.5% on Tuesday, and were down another 1% in premarket trading on Wednesday.
Chikere said that Novavax management reiterated at the Tuesday conference session that the company will be making 100 million doses of the vaccine per month by the end of the third quarter, and 150 million doses per month by the end of the fourth quarter.
“It appears availability of raw materials (e.g. media, filters) is improving and with NVAX’s global sites now producing [Good Manufacturing Practice] product, the company should be in a position to ramp up production,” Chikere wrote.
The company’s filing plans for the FDA, however, couldn’t come at a busier time for the agency. As Chikere wrote in his note, the FDA will likely be examining applications from both Pfizer (PFE) and Moderna (MRNA) for full approval of their vaccines while also reviewing Novavax’s application for emergency use authorization of its vaccine.
Still, Chikere wrote, Novavax management said that government regulators remain interested in their Covid-19 vaccine.
Write to Josh Nathan-Kazis at [email protected]
