Researchers working on samples from the Novavax phase 3 Covid-19 clinical vaccine trials in Seattle.
Karen Ducey/Getty Images
Hopes have been high for Novavax’s experimental Covid-19 vaccine, which demonstrated better-than-expected efficacy in a large trial in the U.K.
As the year progresses, however, investors have begun to worry that the company has missed the boat on the near-term Covid-19 vaccine market, and the stock fell 25.7% last week.
Those fears surfaced again on Monday after the Washington Post reported that the company would likely not ask the U.S. Food and Drug Administration for an emergency use authorization for its Covid-19 vaccine until June.
The Post said that results from the company’s large-scale U.S.-based trial of the vaccine would not be ready until the end of this month, and that delays had also been caused by a manufacturing issue related to a test used to check the quality of the vaccines as they are being made.
Shares of Novavax (ticker: NVAX) were down 9.1% early Monday. The stock is still up 44.2% so far this year, and more than 550% over the past 12 months. The company did not immediately respond to a request for comment on the Post report.
All eyes are now on the company’s quarterly earnings call, scheduled for after the market closes on Monday.
Analysts had been expecting data from the U.S.-based Phase 3 trial of the Covid-19 vaccine in the coming days. In a note on May 5, J.P. Morgan analyst Eric Joseph wrote that we “could see a data interim readout imminently.” The Post report now suggests it could take weeks.
“We empathize with the Street’s frustration with the lengthy regulatory submission/review process compared with competitor mRNA and adeno-vector programs, and would [look to] Monday’s earnings call for clarity,” Joseph wrote in the note.
The looming question is whether there is still time for the vaccine to find space in the Covid-19 market this year. Investors will focus on any comments management make on its call Monday evening.
“Clearly, investors are questioning whether NVAX can play a meaningful role in 2021 [worldwide] CV-19 vaccination campaign,” wrote Jefferies analyst Kelechi Chikere in a note out May 6. “While we fully acknowledge there are outstanding questions that have come to a head in the last week, we believe NVAX’s upcoming earnings call… will be a key event in removing the ongoing overhang on shares.”
Also on Monday, Novavax announced preclinical data on an experimental combination vaccine designed to protect against Covid-19 and the flu. The study, which measured immunogenicity and efficacy of the combo shot in ferrets and hamsters, found that the jabs induced flu and Covid antibodies.
“We believe that this novel combination vaccine candidate, which leverages Novavax’ technology platform and Matrix-M™ adjuvant, could be an important future tool in the long-term fight against both of these harmful respiratory viruses,” Novavax’s president of research and development, Dr. Gregory M. Glenn, said in a statement.
Write to Josh Nathan-Kazis at [email protected]
