Novavax Asks WHO to Grant Emergency Clearance for Covid Shot

(Bloomberg) -- Novavax Inc. said it has filed with the World Health Organization for an emergency-use listing for its Covid-19 vaccine, a move that could help its inoculation reach more people at a time of vast global disparities in immunizations.

The company said in a statement on Thursday that the trial data submitted to the United Nations health agency shows that the shot provided 100% protection against moderate and severe disease and had 90.4% efficacy overall.

Shares of Novavax gained 4.1% in after-hours trading in New York. Through the close of trading in New York Thursday, the stock had gained 61% so far this year.

While Novavax has experienced production setbacks that prevented its shot from being a key player in the U.S. vaccination drive, it has been moving to gain access to more markets in other countries. Chief Executive Officer Stanley Erck has also said the company’s vaccine could eventually be an excellent booster candidate.

An emergency clearance from the WHO could mean that Novavax would quickly be able to offer its shot in many developing countries, where access to other vaccines has been hard to come by. Along with the WHO filing, Novavax has sought clearance in the U.K., Australia, Canada, New Zealand, the European Union, India, and the Philippines, the company said.

The company, which won clearance for its shot in Indonesia earlier this week, said it plans to submit data to the U.S. Food and Drug Administration by the year-end.

Separately, Novavax reported third-quarter revenue rose 14% from a year earlier, though that figure fell short of analysts’ estimates, on average, according to data compiled by Bloomberg. The company also posted a net loss of $4.31 a share.

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