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Coronavirus Update: The FDA’s decision on the Novavax COVID-19 vaccine could come in weeks


Novavax Inc.

is still waiting for U.S. regulators to decide whether to authorize its COVID-19 vaccine, which some experts believe could serve as an alternative option for people who are hesitant to get a mRNA vaccine.

Novavax’s vaccine, called Nuvaxovid, is a recombinant protein-based shot that is similar in design to a flu shot that’s been available in the U.S. since 2013.

This type of vaccine has a different makeup than the mRNA vaccines developed by Moderna Inc.
BioNTech SE

and Pfizer Inc.

as well as the adenovirus shot from Johnson & Johnson

“I do think there is a minority group who would take a protein vaccine over an mRNA vaccine,” Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland, told Kaiser Health News. (Nuezil is a researcher for one of the Novavax vaccine trials.) 

The Food and Drug Administration is expected to make a decision after the regulator’s vaccines advisory committee is set to meet June 7 to discuss the risks and benefits of the investigational two-dose shot. 

Nuvaxovid has been authorized as a vaccine or booster in several countries, including Australia, Europe, Japan, the U.K., and Singapore, where a rollout of the shot is currently underway. The company said Wednesday it is participating in a new Phase 2 trial in the U.K. that gives a Novavax booster to teens who were vaccinated with the BioNTech SE

and Pfizer Inc.

vaccine. The company has also applied for authorization of a booster for teens in the U.K. earlier this month. 

That said, investor interest in Novavax has largely waned at the same time that the intensity of the pandemic has lessened. The stock hit an all-time high of $319.93 on Feb. 8, 2021, but has since tumbled 86% since through Wednesday’s closing price of $46.13.

“We see a difficult commercial setup for Nuvaxovid based on decreasing C-19 booster use, unclear benefit as a heterologous option, and waning immunity against new variants,” BofA Securities analyst Alec Stranahan said in a research note to clients last week.

The shot is expected to generate $4.2 billion in revenue this year, according to a FactSet consensus.

Other COVID-19 news to know: 

Some health care providers are prescribing a heart-failure drug to long COVID patients who have reported having heart palpitations, according to Bloomberg. The drug, Corlanor, is owned by Amgen Inc.
It was being tested as a treatment for postural orthostatic tachycardia syndrome (POTS) before the pandemic, and now it’s being used for patients with POTS who are considered COVID-19 long-haulers. 

Approximately 25,000 to 30,000 courses of Pfizer’s Paxlovid are being prescribed every day in the U.S. right now, reports the Associated Press. The White House also said Thursday it is working to open more federally backed test-to-treat sites, where someone can get tested for the virus and leave with the antiviral pills. 

Some universities and school systems are once again implementing mask mandates. This includes the University of Hawaii, which requires masks in most indoor spaces; the University of Delaware; and some public school systems in Rhode Island and Pennsylvania, according to the New York Times.

Here’s what the numbers say: 

The U.S. is averaging 110,614 cases a day, up 31% from two weeks ago, according to a New York Times tracker. The country is averaging 25,755 hospitalizations a day, up 29% from two weeks ago. The average daily death toll of 361 is up 10% from two weeks ago. — Ciara Linnane

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