Novavax won Food and Drug Administration approval for its Covid vaccine — ending a six-month wait — but NVAX stock tanked on Thursday.
In the U.S., the fact sheet accompanying the vaccine warns of a heightened risk of inflammation of the heart and tissues surrounding it following administration. That's in line with the same sheets for Pfizer's and Moderna's Covid vaccines. On Thursday, regulators in Europe added a warning against the risk of severe allergic reaction to the Novavax shot.
Still, experts hope adding a third vaccine technology to the U.S. coffers will help bolster the number of people vaccinated against Covid. Novavax's jab uses a protein-based technology and a tree bark chemical from Chile to boost the immune response. Pfizer and Moderna use newer messenger RNA platforms. Johnson & Johnson employs an empty virus to deliver its single-shot vaccine.
"Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help increase our country's vaccination rate," Karen Kotloff said in a written statement. Kotloff, assistant director of clinical studies at the Center for Vaccine Development and Global Health, helped run Novavax's study.
But on the stock market today, NVAX stock crashed 26.2% to 51.62.
NVAX Stock: Small Portion Of Unvaccinated People
Novavax is late to the market, however. Pfizer and Moderna won FDA authorization in December 2020 and J&J followed in February 2021. Further, the company tested its vaccine before the emergence of the delta and omicron variants.
Novavax has global authorizations, including in younger people, but in the U.S. it will only be allowed in adults who have yet to receive a Covid shot. The Centers for Disease Control and Prevention estimates that group accounts for just 10% of people in the country.
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The FDA didn't authorize Novavax's booster shot, which could have proved a boon for NVAX stock. Less than half of eligible people age 12 and older have gotten a Covid booster, the CDC says.
Still, the Novavax vaccine has impressed the FDA's advisors.
The company first asked for emergency use authorization in January. Last month, advisors to the FDA voted 21-0, saying the benefits of the vaccine outweigh its risks. In testing, the Covid vaccine proved about 90% effective against mild, moderate and severe infections. In people age 65 and older, it was roughly 79% effective, the FDA said.
Warning Against Myocarditis
Lee Brown, global sector lead for health care at research firm Third Bridge, said Novavax's vaccine offers an important option for people who carry a higher risk of serious Covid. But he noted the company tested its shot before the emergence of the delta and omicron variants. Recently, the FDA asked Novavax, Moderna and Pfizer to develop boosters that target the newest omicron sub-variants.
"With updated, bivalent Covid-19 vaccines poised to hit the markets soon, Novavax's (vaccines called) Nuvaxovid and Covovax remain a step behind the competition, but represent a new option that may play a critical role in getting the unvaccinated to seek vaccination our experts note," he said in a report.
Importantly, Novavax's Covid shot — like the mRNA vaccines — comes with a warning against an increased risk of myocarditis and pericarditis. These conditions are inflammation of the heart and tissues surrounding it. Boys and young men tend to be most susceptible.
As part of its authorization, Novavax and vaccine providers must report any serious side effects and cases of Covid that led to hospitalization or death to a monitoring system.
NVAX stock ended Thursday's session in line with its 50-day moving average, according to MarketSmith.com.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
