Novavax Stock Halted Ahead of FDA Advisory Panel Hearing on Covid Vaccine
Novavax labs in Gaithersburg, Maryland.
ANDREW CABALLERO-REYNOLDS/AFP via Getty Images
Trading in Novavax shares was halted Tuesday in anticipation of a Food and Drug Administration advisory panel meeting in which regulators will make a ruling on whether to approve the company’s Covid-19 vaccine.
Nasdaq halted trading of Novavax (ticker: NVAX
) stock at 6:55 a.m. Eastern time on Tuesday, citing news pending. The FDA vaccine advisory committee is meeting at 8:30 a.m. to review the data on the efficacy and safety of Novavax’s recombinant protein Covid-19 vaccine. The company applied for emergency use authorization in January.
Early in the meeting, one of the members of the FDA’s expert panel, Dr. Eric Rubin, asked a question that others, including Modern (MRNA) CEO Stephane Bancel, have asked in the past: Given that other Covid-19 vaccines are widely available, and two are fully approved, is the FDA allowed under the law to issue yet another emergency use authorization?
The director of the FDA’s Center for Biologics Evaluation and Leadership, Dr. Peter Marks, said that the agency could.
“The statute allows us some leeway,” Marks said. “It gives us the ability to have products that …would fulfill some unmet need.” Marks said that, because the Johnson & Johnson (JNJ) vaccine is no longer being used as a frontline option, it’s important to prove another choice for people who might not want an mRNA-based vaccine.
“Having a protein-based alternative may be more comfortable for some, terms of their acceptance of vaccine,” Marks said. “We do have a problem with vaccine uptake that is very serious in the United States, and anything that we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something we feel we are compelled to do.”
In materials released ahead of the meeting, regulators flagged that the vaccine could be linked to heart inflammation, a topic that will likely come up during Tuesday’s meeting.
Novavax shares were up 3.7% before the halt, and closed 6.2% higher on Monday.
Write to Sabrina Escobar at sabrina.escobar@barrons.com
