Changes to Novavax manufacturing data were minor and process related: Source

Novavax's (NVAX) submission of new manufacturing data to the FDA on June 3, just days before a vaccine advisory committee recommended its COVID-19 doses for use in adults, was related to minor process changes, according to the company.

But the late addition has added to the volume of information the FDA has to sort through before authorization.

A report Thursday suggested there would be a delay in the process as a result, pressuring the stock during Thursday's session, but the timeline for Novavax has already detracted from other COVID-19 vaccine approval timelines.

A spokesperson at Novavax, speaking to Yahoo Finance on background, said that early-on manufacturing struggles and the expectation from prior authorizations, appear to be what is framing the perception of a delay.

"I do think there's this yardstick by which our process is being measured, that's one to two days, and the FDA is saying, 'we're going to do it when we do it,'" the person said, adding that the FDA has given no indication that there is any concern of an intentional delay in the process.

On one hand, there is no urgent demand in the way there was for the three other authorized and approved doses - a point repeatedly made at the FDA advisory meeting this week. Which is why Novavax CEO Stanley Erck noted the uncertain timeline in a recent interview with Yahoo Finance.

"I can't predict how long it's going to take the FDA to review the data that they have," he said. "We’ll be bringing product into the U.S. this month and it will go through the normal release process and the assays you have to do," Erck said Wednesday.

A wary FDA

In the past, the FDA acted quickly after emergency use authorization (EUA) filings to schedule an advisory committee, and then shortly after the advisory committee meeting an authorization was announced. But the situation for Novavax has been different from the start — including a months-long lag from its EUA filing in February to the scheduling of an advisory meeting in June.

In addition, the FDA has been extra wary about the company's manufacturing data, first because of early struggles with quality and analyses, and secondly due to the fact that the current contract manufacturer — the Serum Institute of India — is also a new player in the U.S.

While it boasts being the largest manufacturer of vaccines globally, the Serum Institute has not made vaccines for the U.S. before.

It's why the FDA advisory meeting date had been contingent upon the agency's inspection of SII in Pune, Maharashtra, the company source said.

Erck told Yahoo Finance five inspectors went through the plant and gave it the green light.

He noted that the company has been responsive to all the FDA's requests. Which is why when the FDA asked for updated information on June 2, Novavax complied on June 3, the spokesperson said. The company also continues to provide similar updated manufacturing data to the European Medicines Agency (EMA) as part of the post-approval process.

Novavax isn't the only company to face a longer timeline. Moderna (MRNA), another biotech, has yet to have its vaccine authorized for adolescents and older kids. Even though its shot for adults was authorized quickly, the others have lagged. The FDA's advisory committee will be meeting next week to discuss them for the first time. Pfizer (PFE)/BioNTech (BNTX)'s vaccine has been the only vaccine available for those ages to-date.

'Important manufacturing differences'

The FDA's Doran Fink expressed the complexity of wading through the new manufacturing data at Tuesday's meeting.

"I think it's important that the committee members and the public understand that ... Novavax has presented some additional data that FDA has not covered in our briefing documents," Fink said.

He noted that the reason for the discrepancies were many, including that there are "important manufacturing differences" between the doses used in the U.S. trial and other places around the world.

"We just cannot conclude comparability of their products ... That being said, we have laid out a case to support why we think that the available data from the U.S./Mexico trial could meet the statutory criteria of 'may be effective' that is required to support emergency use authorization," Fink said.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said the reason why the data reviewed at Tuesday's meeting was limited was because the FDA wanted to be sure to present consistency in data for the review.

"We needed to be comfortable that the process that was used to make the product that was studied was one that we were comfortable ... that what you're seeing is the product that you're getting," Marks said.

He added that the U.S. regulatory process has its own standard and does not benchmark against other countries. Novavax doses are already being administered in a handful of countries including in Europe, India and Australia.

The company's stock was down nearly 18% in Thursday's session.

Follow Anjalee on Twitter @AnjKhem

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