Novavax is part of the FDA’s COVID-19 booster debate, but its vaccine still hasn’t been authorized

Novavax’s recombinant protein COVID-19 vaccine candidate has been viewed as a possible alternative for people who are hesitant to be immunized with the newer mRNA technology used in the Moderna MRNA and BioNTech BNTX/Pfizer PFE shots. 

It’s been three weeks since the Food and Drug Administration’s advisory committee recommended authorization, which is the last step before the FDA makes its decision. Although JPMorgan analysts predict the FDA’s decision on Novavax’s vaccine will land in mid-July, the lag between the committee’s recommendation and the FDA’s final decision is a departure from how quickly the regulator previously granted authorizations to other COVID-19 vaccines.

“We have not given an emergency authorization yet,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Tuesday, “but I think it behooves us to understand when the [Novavax] vaccine might be available if the company is willing to discuss that ⁠— were an emergency use authorization to be granted.”

Marks is part of a group of federal health officials and independent vaccine experts who gathered Tuesday to discuss if and how to update the COVID-19 boosters for the fall to better combat omicron or other potential variants.

Executives at Moderna and Pfizer presented, in addition to Dr. Gregory Glenn, Novavax’s president of R&D, who told the committee that the company’s still-investigational primary shots appear to retain their durability of protection at the six-month mark and hold up against the troublesome and more transmissible subvariants of omicron.

“Boosting with the Novavax prototype vaccine may be an option, as it provides both high levels of antibodies recognizing variants and durable immune responses,” he said.

In response to Marks’ question, Glenn added that the company plans to have doses for its primary series of shots prepared to distribute in July, and Novavax could update its vaccine by the final three months of the year to focus on BA.4, which was behind 15% of new cases in the U.S. last week. (That’s in comparison to making up only 6% of cases the first week of June.)

With the Novavax authorization still up in the air, two temporary voting members of the Vaccines and Related Biological Products Advisory Committee raised questions about the status of Novavax’s application for the primary series of shots in a discussion intended to focus on a new generation of COVID-19 boosters.

“The most compelling thing that I’ve seen today is the data from Novavax, showing that their protein vaccine can elicit neutralizing antibodies to the prototype strain, to BA.1, BA.2, and BA.5,” said Dr. James Hildreth, president and CEO of Meharry Medical College. “Their data seems more impressive to me than the data presented by either Pfizer or Moderna. I just wonder whether or not it might be timely for the agency to quickly review the data and make a decision to approve the Novavax vaccine.”

Dr. Wayne Marasco, a professor of cancer immunology and virology at the Dana-Farber Cancer Institute, asked a similar question of regulators. 

“We did hear from Novavax about the potential of their vaccine getting coverage, but they haven’t been granted an EUA,” he said. “Is this going to be in the formula for the fall, as well? That this vaccine is going to be available? Or is that beyond what the committee should be discussing?”

Novavax’s stock has tumbled since its all-time high of $319.93 on Feb. 8. It’s dropped 63.7% so far this year, while the broader S&P 500
SPX,
-0.21%
is down 19.8%.