‌$Novavax(NVAX)$FDA 'slow-walking' Novavax authorization

The FDA declined to comment on the pending applications, and Novavax has no updates on a potential time for the FDA's advisory committee meeting.

Lawrence Gostin, director of the O'Neill Institute for National and Global Health Law at Georgetown University, says the FDA is "slow-walking" Novavax's authorization.

"They've got all the data that they need, but I'd say it's also kind of a general irritation with the company," Gostin told Yahoo Finance.

That "irritation" stems from earlier issues with manufacturing and other delays, which are now resolved. But in relying on a plant abroad — the Serum Institute of India, the world's largest vaccine maker — Novavax has opened the door for more scrutiny of manufacturing quality, Gostin said.

"I think another reason they're slow-walking it is there's a widespread perception that we have enough supply here, and that the mRNA vaccines are good, maybe better. But I think that's very short-sighted," he said.

Gostin noted that while mRNA vaccines have proven high efficacy, their durability is a problem. Pfizer has recently acknowledged the need to reformulate the vaccine for that reason.

https://finance.yahoo.com/news/fda-slow-walking-novavax-eua-expert-140156618.html‌