Novavax (NVAX) won Food and Drug Administration approval for its Covid vaccine – ending a six-month wait – but NVAX shares fell early Thursday.
In the United States, the fact sheet that accompanies the vaccine warns of an increased risk of inflammation of the heart and surrounding tissues after administration. It is in line with the same sheets too Pfizer‘s (PFE) and Moderntheir (MRNA) Covid vaccines. On Thursday, regulators in Europe issued a warning against the risk of a serious allergic reaction to the Novavax shot.
Nevertheless, experts hope to add a third vaccine technology to the US Treasury will help strengthen the number of people vaccinated against Covid. Novavax’s jab uses a protein-based technology and a wood bark chemical from Chile to boost the immune response. Pfizer and Moderna use newer messenger RNA platforms. Johnson & Johnson (JNJ) uses a blank virus to deliver its single-shot vaccine.
“Offering more vaccine technologies and options in our vaccination portfolio, including those built on technologies that have been used successfully for years, will hopefully help increase the 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, was involved in running Novavax’s study.
But during the midday trading in the stock market today, the NVAX stock fell 22.8% close to 54.
NVAX stock: Small proportion of unvaccinated people
However, Novavax is late in the market. Pfizer and Moderna won FDA authorization in December 2020 and J&J followed in February 2021.
Novavax has global authorizations, including in younger people, but in the US it will only be allowed in adults who have not yet received a Covid shot. The Centers for Disease Control and Prevention states that approximately 83% of people aged 5 years and older have received at least one Covid shot. About 71% are fully vaccinated.
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The FDA did not authorize Novavax’s booster shot, which could have been a boon for the NVAX stock. Less than half of qualified people aged 12 and older have received a Covid booster, says the CDC.
The Novavax vaccine has nevertheless impressed FDA advisors.
The company first applied for an emergency use permit in January. Last month, FDA advisers voted 21-0, saying the benefits of the vaccine outweigh the risks. In testing, the Covid vaccine proved to be approximately 90% effective against mild, moderate and severe infections. In people aged 65 and older, it was about 79% effective, the FDA said.
But Novavax conducted the study before the delta and omicron variants appeared. Recently, the FDA asked Novavax, Moderna and Pfizer to test Covid boosters that target the latest omicron variants. All three companies had already developed boosters aimed at a previous sub-variant.
Warning against myocarditis
More importantly, Novavax’s Covid shot – like the mRNA vaccines – comes with a warning against the increased risk of myocarditis and pericarditis. These conditions are inflammation of the heart and the tissues that surround it. Boys and young men tend to be most vulnerable.
As part of their authorization, Novavax and vaccine suppliers must report any serious adverse reactions and cases of Covid that led to hospitalization or death to a monitoring system.
The NVAX share ended Wednesday’s ordinary session just below a three-month high.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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