Novavax delays FDA submissions on its Covid vaccine as it says U.S. is pausing funding for production

Novavax Inc. (NASDAQ: NVAX) has pushed back its projected timeline for seeking emergency use authorization for its Covid-19 vaccine as the manufacturing portion of the application continues to hamper the Gaithersburg company’s submission. 

The company now expects to seek emergency authorization with the Food and Drug Administration in the fourth quarter, it said Thursday in its quarterly earnings report. Previous goalposts for that submission were set at June and then September.

The delay is tied to the manufacturing of the vaccine, which the U.S. government recently weighed in on, Novavax said in its filing. The government will pause payments to Novavax for production of the vaccine candidate, called NVX-CoV2373, until the company resolves some items with the FDA on manufacturing. 

“The U.S. government has recently instructed us to prioritize alignment with the FDA on our analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made,” the company wrote in its report. 

The New York Times reported Thursday, citing an unnamed Health and Human Services department official, that the government is looking for Novavax to strengthen testing and quality control on its vaccine production.

Novavax was instructed by the U.S. government to continue its other work on its Covid vaccine, including clinical trials and discussions with regulators, being funded by the Operation Warp Speed effort, the company said in its quarterly report. It's not the first time manufacturing has slowed down the company's progress on the vaccine; production issues contributed to a later start than expected on pivotal trials in the U.S. and Mexico, the Washington Business Journal's Sara Gilgore reported in October.

Novavax CEO Stanley Erck told analysts on the company’s earnings call Thursday he hoped the company's finalized application for emergency use authorization would go to the FDA “early in the fourth quarter,” according to a Seeking Alpha transcript of the call. He told The Wall Street Journal that he was hoping for October, but that they have not yet set a date for the submission. 

The company said earlier in the week that it expected to submit its NVX-CoV2373 application to regulators in the United Kingdom and the European Union within the third quarter. It also said Thursday that it had submitted applications to regulators in India, Indonesia and the Philippines. 

Novavax hopes to be able to produce up to 150 million doses of NVX-CoV2373 per month by the end of 2021, using a variety of manufacturing partners around the world. The company in early August signed an agreement to sell up to 200 million doses to the European Union, and it has also committed 1.1 billion doses to the Gavi, the Vaccine Alliance, to provide vaccines to lower-income countries.

The Gaithersburg company reported a net loss of $352.3 million for the second quarter on $298 million in revenue — the vast majority of which, more than $240 million, came from government contracts. It had more than $2 billion in cash and cash equivalents on hand at the end of the second quarter.

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“Currently all Northern Virginia jurisdictions are experiencing substantial disease transmissions and are trending upward in their average number of daily cases. Based on this, the five Northern Virginia Health Departments recommend that individuals wear masks while indoors regardless of vaccination status, in government and other public settings.” — A letter from the health directors of Arlington, Fairfax, Loudoun and Prince William counties as well as the city of Alexandria to elected leaders and municipal administrators in Northern Virginia urging mask wearing indoors in all public settings in response to an uptick in case counts of the Delta variant of Covid-19.

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