When will Novavax’s vaccine be ready? CEO Stanley Erck says 10 countries may approve its COVID shot in next 90 days

January 11, 2022, 7:53 AM UTC

On Monday, Stanley Erck, the CEO of U.S. vaccine maker Novavax, said he expects 10 regulatory agencies including the U.S.’s to approve Novavax’s COVID-19 shot in the coming months.

“In the next 90 days we could have all 10 of them,” Erck told CNBC, without specifying which other regulatory agencies Novavax is applying to for approval. On its website, Novavax says it has pending applications in countries that include the U.S., Japan, Singapore, New Zealand, Canada, Australia, the U.K., South Korea, and the United Arab Emirates.

On Dec. 31, Novavax announced that it submitted its final data package to the U.S. Food and Drug Administration and said it expects to file its application for emergency use approval by the end of January.

Novavax is hoping that it has overcome past manufacturing issues that slowed its bid for regulatory approval. Erck said in March last year that he expected the vaccine to be approved by May 2021, but problems in some of Novavax’s factories reportedly delayed the company’s application for FDA approval, prolonging the process of bringing the vaccine to market.

Production issues aside, Novavax’s COVID-19 vaccine has long appeared safe and effective. The Novavax vaccine uses a protein subunit technology, which trains the immune system to make antibodies that fight off the virus. In clinical trials, the vaccine’s efficacy against infections has been as high as 96%. Novavax’s Phase III trials took place before the emergence of Delta and Omicron; the vaccine appeared at least 80% effective against the Alpha variant, but efficacy against infection dropped to 50% to 60% against Beta.

Novavax says that its vaccine’s protection against infection may wane versus the more vaccine-evasive Omicron variant, but the company believes the vaccine will still guard against severe cases and deaths when given as a stand-alone two-dose regimen or as a booster in patients who have received two doses of a different vaccine.

In a study Novavax announced in late December, it said that three doses of its vaccine provided as much protection against Omicron as two doses provided against variants prior to Delta. The initial results also suggested that three doses of Novavax’s vaccine may produce more antibodies against Omicron than three doses of Moderna or Pfizer’s mRNA vaccines.

Novavax’s COVID-19 vaccine “showed strong immune responses against Omicron and other circulating variants,” Gregory Glenn, president of research and development at Novavax, said in a press release. Glenn said that Novavax has also begun research into an Omicron-specific vaccine.

In December, the World Health Organization (WHO) granted two applications to approve Novavax’s vaccine for emergency use. The first approval pertained to Covavax, the version of Novavax’s vaccine that the Serum Institute of India is producing in partnership with Novavax that will be sent to low-income countries. Days later, on Dec. 20, both the European Commission and the WHO approved Novavax’s vaccine for the European market.

The World Health Organization approvals mean that Novavax’s vaccine is now available for use in 170 countries, according to Erck. But so far, only the Philippines and Indonesia have begun rolling out the jabs to their citizens. On Monday, Erck also announced that Novavax has shipped doses of its vaccine to Europe with plans to soon administer the vaccine across the continent.

“There is a lot of pent-up demand for our vaccine,” Erck told Bloomberg on Monday.

Erck has a point. Novavax has developed something of a cult following on social media.

On Reddit, the Novavax_vaccine_talk forum, which says it is dedicated to “us wanting the Novavax vaccine,” has nearly 2,000 followers. Some users believe that Novavax’s jab provides a safer and superior technology than existing mRNA vaccines, and say they will get vaccinated only when Novavax is available to them.

Separately, Novavax has become a popular meme stock among day traders after the Wall Street Bets forum on Reddit, which helped drive trading frenzies in stocks like GameStop and AMC theaters last year, touted Novavax shares.

Another Reddit forum, called NVAX, the name of Novavax’s stock ticker, has 4,000 followers, more than similar forums dedicated to Pfizer and Moderna.

Novavax’s stock price is up 6.5% since Erck’s comments on Monday, but shares are still down more than 50% from a high the company hit in February 2021 when it first released clinical trial data showing the efficacy of its vaccine.

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