Novavax Wins FDA Authorization For Covid Vaccine In Adults

Novavax Wins FDA Authorization For Covid Vaccine In Adults

Novavax (NVAX) won Food and Drug Administration approval for its Covid vaccine — ending a six-month wait — but NVAX stock tanked early Thursday.




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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 (PFE) and Moderna‘s (MRNA) 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 (JNJ) 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 in midday trading on the stock market today, NVAX stock tumbled 22.8% near 54.

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.

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 say roughly 83% of people age 5 and older have received at least one Covid shot. About 71% are fully vaccinated.


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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.

But Novavax conducted the study before the delta and omicron variants emerged. Recently, the FDA asked Novavax, Moderna and Pfizer to test Covid boosters that target the newest omicron sub-variants. All three companies had already developed boosters targeting an earlier sub-variant.

Warning Against Myocarditis

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 Wednesday’s regular session just below a three-month high.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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