Three days after Food and Drug Administration advisors endorsed authorization for Novavax's Covid shot, the agency had yet to make a move, causing NVAX stock to topple Friday.
The hold-up is related to a recent manufacturing amendment Novavax submitted to the FDA. After the FDA scheduled the Vaccines and Related Biological Products Advisory Committee meeting for Tuesday, Novavax informed the agency of changes to its manufacturing process for the Covid shot, the FDA told Investor's Business Daily in an email. On June 3, Novavax submitted the amendment to its application.
"FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use," the FDA said.
Novavax also confirmed the change to its application in a separate email. The company said it first sent chemistry, manufacturing and controls data to the FDA on Dec. 31. A month later, Novavax officially asked the FDA to authorize its two-dose Covid shot. Since then, the company has continued to share relevant manufacturing data with the FDA, the company said.
"The data is part of the standard process improvements that have been made since submission and on June 3, Novavax submitted an amendment with this updated manufacturing information for the EUA to the FDA for review," Novavax said in its emailed statement.
NVAX Stock Hits Two-Day Dive
The delay sent NVAX stock down for a second day running. On today's stock market, NVAX stock fell 2.1% to 40.62. That followed a 17.2% dive on Thursday.
On Tuesday, the FDA's advisory committee voted 21-0, saying the benefits of the shot outweigh its risks. One panelist abstained. If the FDA authorizes the vaccine, the Centers for Disease Control and Prevention will have a chance to refine guidance around the vaccine.
But in the past, the FDA has authorized Covid vaccines for emergency use within a day — if not hours — of the committee's vote. Such was the case when Pfizer and Moderna secured their authorizations in December 2020. Those were the first Covid vaccines, however. Novavax's protein-based shot is a late contender.
Different Vaccine Technologies
The Novavax vaccine differs from Pfizer's and Moderna's shots. It uses established technology to create a protein subunit vaccine. Specifically, it employs moth cells to create a protein and tree bark to help boost the immune response.
In contrast, the Pfizer and Moderna vaccines use newer messenger RNA-based technology. Their Covid shots were the first to launch using mRNA platforms. Some people are reluctant to receive vaccines using the newer technology, giving Novavax a market even in the saturated U.S.
During the FDA's advisory committee meeting, Novavax Chief Medical Officer Filip Dubovsky referenced this population, saying "we haven't given up on them." About one-third of Americans are not fully vaccinated. That includes children under the age of 5 who are not eligible yet.
On Wednesday, CFRA Research analyst Stewart Glickman upgraded NVAX stock to a buy rating from hold. He also raised his price target to 71 from 14. He expects the vaccine to "fill a niche role for those who choose not to use an RNA-based vaccine."
"While we see several challenges ahead for management on commercial execution, shares are down 67% year to date and are so beaten down, in our view, that even skeptical assumptions on revenue cadence still yield upside potential on these high-risk shares," he said in a report.
As of Thursday's close, NVAX stock was down 71% for the year.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
