Novavax Delays U.S. Submission for Covid Vaccine Clearance

(Bloomberg) -- Novavax Inc. said it expected to apply for U.S. emergency-use authorization of its Covid vaccine in the fourth quarter, another delay in its bid to gain approval of the closely watched shot.

Novavax filed for emergency clearance of its Covid vaccine in India, Indonesia and the Philippines, according to an emailed statement. A study showed a second dose of the shot resulted in four times more protective antibodies against the virus than the first, the statement said.

Some countries are eagerly awaiting the arrival of Novavax’s recombinant protein-based vaccine that was 90% effective in a nearly 30,000-person trial in the U.S. and Mexico, with relatively few side effects -- similar to the results from mRNA shots. The European Union has an advance purchase agreement for as many as 200 million doses of the vaccine.

The company said it expects to file with the U.K.’s Medicines and Healthcare Products Regulatory Agency in the third quarter, and with other agencies in Europe, Australia, Canada and New Zealand within weeks of that.

Novavax reported a net loss of $352 million in the quarter, or $4.75 a share. Analysts had been expecting a loss of $271 million, or $3.63 per share. Revenue was $298 million, below analysts’ expectations of $388 million.

Novavax fell as much as 12% in trading after U.S. markets closed. They had doubled in New York trading since the year began.

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