Two days after Food and Drug Administration advisors endorsed authorization for Novavax‘s (NVAX) Covid shot, the agency had yet to make a move, causing NVAX stock to topple Thursday.
The hold-up is likely related to a recent manufacturing amendment Novavax submitted to the FDA. The FDA may need additional time to review the new information. In a statement emailed to Investor’s Business Daily, Novavax said it first submitted chemistry, manufacturing and controls data to the FDA on Dec. 31. A month later, the company requested emergency use authorization for its shot.
“Since then, the company has continued to share relevant data with the FDA related to their review of the EUA application with updated manufacturing data as it has become available,” Novavas 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.”
The delay follows a 21-0 vote on Tuesday from the FDA’s Vaccines and Related Biological Products Advisory Committee, saying the benefits of the two-dose vaccine outweigh the 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 advisory committee’s vote. Such was the case when Pfizer (PFE) and Modern (MRNA) secured their authorizations in December 2020. Those were the first Covid vaccines, however. Novavax’s protein-based shot is a late contender.
On today’s stock market, NVAX stock skidded 17.2% to 41.48.
FDA representatives did not immediately return requests for comment from Investor’s Business Daily.
NVAX Stock: 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 US
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.
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