WASHINGTON — Novavax Inc.’s coronavirus vaccine won the support of a panel of U.S. government advisers, paving the way for authorization of another tool to fight the coronavirus.
Experts advising the Food and Drug Administration voted 21-0, with one abstention, that the benefits of the vaccine outweighed its risks in adults 18 and older. The FDA doesn’t have to follow the recommendations of its advisory panels, but it usually does.
Authorization would make Novavax’s shot the first vaccine authorized for U.S. adults that mimics the COVID-19 protein that the virus uses to enter cells. Use of the shot may be limited, as concerns about the pandemic wane, and health officials report falling demand for products from Pfizer Inc. and Moderna Inc. that have been on the market for months.
Optimism for the vaccine pushed Novavax to an all-time high of $319.93 in February 2021, but it has since fallen on investor concern that it might not be widely used. The vaccine maker has lost roughly $17 billion in market value since last year’s record. The shares were halted Tuesday in light of the panel discussion.
Novavax grappled with manufacturing delays during the early days of the pandemic, which prevented its shot from being a key player in the U.S. vaccination drive. After the company secured $1.6 billion in federal government funding in exchange for 100 million doses of the shot, the setbacks pushed Novavax’s U.S. clinical trial back to December 2020. By that time, COVID vaccines developed by Pfizer and Moderna had already been given the regulatory green light.
The vaccine has already been authorized for use in countries including the U.K. and Japan. In Europe, regulators are evaluating Novavax’s shot as a booster for adults, and the company is studying a combination shot to protect against the flu and COVID-19.
Data presented during the advisory meeting suggested Novavax’s two-dose vaccine was effective in preventing severe COVID-19 disease in clinical trials. However there is limited data on how effective it would be against omicron, as subjects enrolled in the trial before the highly transmissible variant emerged.
Hundreds of millions of Americans have already received mRNA shots that turn temporarily turn cells into vaccine-making factories. Novavax’s jab could be attractive to the vaccine-hesitant population who are wary of mRNA, or of clotting side effects linked to the J&J shot.
With waning immunity from the current U.S. authorized and approved vaccines, experts and health officials are concerned about a resurgence of variants of concern and the emergence of new strains of the virus that could cause an increased number of hospitalizations and deaths.
While booster doses are becoming an increasingly relied-upon tool to tackle this issue, experts have warned that it is not a sustainable solution. Researchers believe the vaccines will need to be periodically updated to counteract new strains, just like annual flu shots. This is where Novavax could potentially fit into the picture, but the FDA staff has said that more research is needed to establish whether booster shots of Novavax would be effective.
