We’ve heard this before. But maybe this time everything is for real?
The world was waiting for results from
major trial of a Covid-19 vaccine in the United States over the course of several months. They haven’t arrived yet, and the company said on a phone call in early May that now the vaccine will not be submitted for regulatory approval until the third quarter of this year.
But the wait may almost end. Novavax (ticker: NVAX) announced on Tuesday that data on the third phase of the study is coming soon. Speaking at an investor conference hosted by Jefferies, the company said it would be disclosing these tests shortly.
The meeting was closed to the press and the transcript is not available. But in a note published Wednesday on the conference session, Jefferies analyst Kelechi Chikere wrote that management had said twice in the last week that data from the Phase 3 study would soon be revealed, allowing researchers to see for the first time what topics the placebo received.
In March, the company released shockingly positive data on the effectiveness of its Phase 3 study in the UK, claiming then that the vaccine had 96.4% effectiveness against mild, moderate and severe diseases caused by the original strain of the virus that causes Covid-19, and 86.3% efficacy against the UK strain. Chikere wrote that the company expects efficiencies in US trials to be between 80% and 85%.
Since then, investors have lost patience with Novavax as the company increasingly lagged behind other Covid-19 vaccine manufacturers. The stock closed at $ 257.67 on April 27 but has since plunged 43.6% to close at $ 145.40 on Tuesday. The stock is still up 30% this year and nearly 230% over the past 12 months.
Shares fell 1.5% on Tuesday and another 1% in premarket Wednesday.
Chikere said Novavax executives confirmed at a conference meeting on Tuesday that the company will produce 100 million doses of vaccine per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter.
“It seems that the availability of raw materials (eg media, filters) is improving and now the global NVAX sites are producing [Good Manufacturing Practice] product, the company should be able to increase production, ”wrote Chikere.
However, the company’s plans to file documents with the FDA could not have been more stressful for the agency. As Chikere wrote in his note, the FDA is likely to consider applications from both
(MRNA) for full approval of its vaccines, and is also reviewing Novavax’s application for an emergency vaccine authorization.
However, Chikere writes, Novavax officials said government regulators are still interested in their Covid-19 vaccine.
Email Josh Nathan-Kazis at email@example.com