Hate Elon? Read Immediately

Elon Musk is days away from launching the most radical economic transformation in American history. Please understand... you don't have long to act before Elon makes his move. Inside the next 100 days, I predict he's going to instigate an economic transformation that'll impact hundreds of millions of people.

FDA Delays Full Approval Decision On Novavax's COVID-19 Vaccine (UPDATED)

Vandana Singh
April 03, 2025

Editor’s Note: The story has been updated with comments from Novavax

In September 2024, the U.S. Food And Drug Administration (FDA) granted Emergency Use Authorization to Novavax Inc.'s (NASDAQ:NVAX) COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) for active immunization to prevent COVID-19 in individuals aged 12 and older.

Novavax's vaccine was included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.

Also Read: Wegovy Maker Novo Nordisk To Buy Novavax’s Czech Republic Manufacturing Facility For $200 Million

According to a media report on Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax's shot.

In an emailed statement to Benzinga, Novavax said, “Novavax can confirm that April 1, 2025, was the U.S. Food and Drug Administration (FDA)'s Prescription Drug User Fee Act date for our Biologics License Application (BLA) seeking the approval of our COVID-19 Vaccine. As of Tuesday, April 1, we had responded to all of the FDA's information requests and we believe that our BLA is ready for approval.

As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA. Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.”

Earlier this week, Peter Marks resigned from his role at the FDA's Center for Biologics Evaluation and Research.

Marks was a top regulator at the FDA and played a key role in pushing quick approvals of vaccines during the COVID-19 pandemic.

The Wall Street Journal writes that the agency is now delaying the decision and has reportedly asked for more data and that the application isn't likely to be approved soon, according to sources.

The FDA set an April 1 deadline for a decision.

Novavax reported fourth-quarter 2024 sales of $88.31 million, compared to $291 million a year, beating the consensus of $84.35 million. The decrease was due to lower product sales under APA agreements.

The COVID-19 vaccine maker reported an earning loss of 51 cents per share, down from $1.44 a year ago, in line with the Wall Street Estimate.

The news comes after vaccine stocks came under pressure last week following reports that the Trump administration plans to end financial support for vaccine alliance Gavi, which helps buy vaccines for children in developing countries. The Trump administration reportedly plans to cut billions in global health initiatives.

Price Action: NVAX stock is up 1.25% at $6.09 at the last check on Wednesday.

Read Next:

  • Edgewise Therapeutics Sees Meaningful HCM Treatment Gains With EDG-7500 In Phase 2 Study

Photo: Shutterstock

Continue Reading...

Popular

Faced with Trump's new tariff, French wine producers expect rough times ahead

CHABLIS, France (AP) — France’s wine producers are deeply concerned that the slapped by President Donald Trump will deal to the sector that relies on the U.S. as its top market.

Peter Thiel-Backed Nonprofit Sentient Aims To Be America's DeepSeek, Takes Aim At Closed AI Systems

Sentient, a Peter Thiel-backed nonprofit, has launched its open-source AI search framework, Open Deep Search (ODS), positioning it as America's response to China's DeepSeek and its challenge to the dominance of closed-source AI systems.

Elite Investors Are Buying This Dip Like Crazy - Ad

While everyday investors panic, billionaires are quietly accumulating crypto at these "artificially suppressed" prices. They know Trump's pro-crypto policies and institutional adoption are creating a coiled spring ready to explode upward once uncertainty clears. History shows these fear moments create the biggest fortunes.

Ryan Cohen Buys GameStop Stock On Thursday: What Investors Need To Know

GameStop Corp (NYSE:GME) shares are trading higher in Thursday’s after-hours session after a regulatory filing showed CEO Ryan Cohen increased his stake in the company.

Trump says things are 'going very well' after worst stock market drop in years over tariffs

WASHINGTON (AP) — offered a rosy assessment after the Thursday over his tariffs, saying, “I think it's going very well."

No.1 Opportunity for 2025 [Take Action Now!] - Ad

Starlink's potential IPO Could Be the Biggest in History--Silicon Valley insider James Altucher has uncovered a way to profit BEFORE the IPO--with as little as $50. Musk's $180B giant is set to launch--will you miss out? Claim your spot before it's too late.

Nvidia, AMD, Apple, Meta, Tesla: Why These 5 Stocks Are Trending On Trump's Liberation Day

NVDA, AMD, AAPL, META, TSLA were among the stocks trending as President Donald Trump unveiled new tariffs on Wednesday April 2, 2025.

Velora Rebrand Introduces Intents-Based Trading To Enhance DeFi Execution

Decentralized exchange aggregator ParaSwap rebranded to Velora, unveiling a major shift to intents-based trading and introducing new features for improved speed and efficiency in decentralized markets.

Maverick Trader Reveals 97% Accurate System - Ad

This man's simple strategy makes money in any market...With a 97% accuracy at hitting winners over the past 8 years!

Nvidia's Custom GPU Enhances Nintendo Switch 2 With AI Features, Real-Time Ray Tracing, 4K Support

Nintendo Switch 2, powered by Nvidia Corp processor, brings significant upgrades with up to 4K gaming, AI enhancements, and real-time ray tracing.

Bill Ackman: 'Just Pick Up The Phone'—Says Trump Will Reward Early Dealmakers, Punish Foreign Tariff Retaliation

As global markets shed $2 trillion in value following President Donald Trump's sweeping reciprocal tariffs, billionaire investor Bill Ackman offered pointed advice to foreign leaders.

DOGE's Next Target Set To Hand 401K Savers A Windfall? - Ad

Musk's Department of Government Efficiency has already uncovered $55B in waste--and Trump's backing his plan to return $2T in savings to taxpayers. But why wait? Unlock a legal Trump IRS loophole to protect & grow your wealth NOW!

Senate confirms Mehmet Oz to take lead of Medicare and Medicaid agency

WASHINGTON (AP) — Former heart surgeon and TV pitchman was confirmed Thursday to lead the Centers for Medicare and Medicaid Services.

Elon Musk's Memphis Secret... Revealed - Ad

What's happening inside this nondescript building in South Memphis is so incredible... That Elon's competitors have been flying drones over this place... Trying to get any kind of intel on his project. Tech legend Jeff Brown went there to investigate and what he found is truly a matter of national security.

Trump's latest auto tariffs explained: What car buyers should know this year

DETROIT (AP) — President Donald Trump’s are sending more tremors through an industry already being pummeled by and . The new tariffs, announced Wednesday, are likely to jack up new vehicle prices and will also impact the used car market.

The US Bank executive killed in a plane crash died of blunt-force injuries

MINNEAPOLIS (AP) — The U.S. Bank executive killed when his in suburban Minneapolis died of blunt-force injuries, a medical examiner ruled Tuesday.

Trump to Unlock 15-Figure Fortune for America (May 3rd)? - Ad

This map looks ordinary--but according to insider Jim Rickards, it reveals a hidden government asset so massive . Trump may soon unlock it--learn how to position yourself before it's too late!

Demand for viral 'torpedo' baseball bats has sent a Pennsylvania factory into overdrive

KING OF PRUSSIA, Pa. (AP) — A 70-year-old man who plays in an area senior hardball league popped into Victus Sports this week because he needed bats for the new season. Plus he just had to take some cuts with baseball's latest fad and see for himself if there really was some wizardry in the wallop off

Trump's Sweeping Tariffs Could Cost US $20 Trillion, Crash Markets Warn Economists: 'Monstrously Destructive'

Leading economists reacted with alarm after President Donald Trump announced sweeping new tariffs on U.S. trading partners, with some projecting potential economic losses of up to $20 trillion.

Here's Why Tesla Insiders Are Dumping Shares - Ad

Tesla is down 50%--insiders are cashing out big. Meanwhile, Elon is pouring billions into his secretive AI firm, xAI--growing 7x faster than OpenAI. We found a "backdoor" to invest before it goes mainstream.

Microsoft founder Bill Gates reflects upon a 50-year-old computer code that reshaped technology

Even as he grows older, Microsoft founder Bill Gates still fondly remembers the catalytic computer code he wrote 50 years ago that opened up a new frontier in technology.

Unemployment benefits for striking workers being considered in Oregon, Washington

SEATTLE (AP) — Lawmakers in Oregon and Washington are considering whether striking workers should receive unemployment benefits, following recent walkouts by , and in the Pacific Northwest that highlighted a .

U.S. Gov't Backs Small Firm Solving the AI Energy Crisis - Ad

The AI sector's explosive growth is setting us on a collision course where a single company's energy needs could rival those of entire nations. But ONE company holds the key to preventing this crisis...With a breakthrough tech designed to fulfill the surging power needs of our AI-driven future. Its shares are currently selling for just a few dollars.

Mexico bans junk food sales in schools in its latest salvo against child obesity

MEXICO CITY (AP) — A government-sponsored junk food ban in schools across Mexico took effect on Saturday, officials said, as the country tries to tackle one of the world’s worst obesity and diabetes epidemics.

Hong Kong's richest man, Li Ka-shing, is in hot water over his company's Panama Ports deal

HONG KONG (AP) — Hong Kong tycoon Li Ka-shing’s business empire is in the after CK Hutchison Holdings chose to sell its Panama Canal to a consortium that includes U.S. investment firm BlackRock Inc., apparently angering Beijing.

Microsoft, Amazon, and OpenAI Pour Billions Into Breakthrough Tech - Ad

We're heading into the biggest energy crisis we've ever faced. The computational power needed for AI models is DOUBLING every six months...That's why tech companies are investing BILLIONS into an AI "Master Key" technology that's crucial for the advancement of AI...And there's one pioneering company at the forefront of its development.

Dollar Tree, GameStop And 3 Stocks To Watch Heading Into Wednesday

With U.S. stock futures trading mixed this morning on Wednesday, some of the stocks that may grab investor focus today are as follows:

Forget DOGE -- Here's What Elon Is Really up To - Ad

While the media chases DOGE drama, Elon's building a secretive AI empire in Memphis--growing 7X faster than OpenAI. It could outshine Tesla, SpaceX, and PayPal. We found a $100 "backdoor" in. Click to see how you could invest before the masses.

Oil Execs Challenge Trump's Drilling Agenda, JD Vance Criticizes Denmark, And More: This Week In Politics

The past week was filled with significant developments, from oil and gas executives expressing their frustration with President Donald Trump's drilling policies to Vice President JD Vance raising security concerns over Greenland.

Jeff Bezos Quietly Backing World-Changing Tech (Not AI) - Ad

The Amazon founder is quietly advancing a radical technology that could change society forever and make early investors rich.

Trump's reciprocal tariffs will overturn decades of trade policy

WASHINGTON (AP) — President Donald Trump is taking a blowtorch to the rules that have governed world trade for decades. The that he is expected to announce Wednesday are likely to create chaos for global businesses and conflict with America’s allies and adversaries alike.

A river 'died' overnight in Zambia after an acidic waste spill at a Chinese-owned mine

KITWE, Zambia (AP) — Authorities and environmentalists fear the long-term impact of an acid spill at a mine that contaminated a major river and could potentially affect millions of people after signs of pollution were detected at least 100 kilometers (60 miles) downstream.

Trump to Trigger 3rd Financial Reset - Ad

Markets are falling, prices are rising, and trust is breaking. But a man who has known Trump for years and served as his advisor believes it's not failure--it's a plan. A secret financial reset, decades in the making, is already unfolding...The question is: will you be blindsided--or benefit?

Trump's 'Reciprocal Tariff' Plan Hits Market Confidence As Dow Futures Drops Over 830 Points

U.S. stock futures plunged on Wednesday after President Donald Trump unveiled broad new tariffs on key trading partners, sparking fears of a global trade war that could further weaken the U.S. economy.

Elon's Biggest Secret Could Save Your Retirement - Ad

From a near-fatal car crash to surviving deadly malaria, Musk's fearless drive built Tesla, SpaceX, and Starlink. Now, he's warning America--and smart investors are listening. Discover the Trump IRS Loophole to protect your IRA & 401(k).

Mark Cuban Calls Out Elon Musk Over DOGE Productivity Emails: 'Already Forgotten. Typical. Ready Fire Aim.'

Mark Cuban has raised questions about Elon Musk's silence regarding the productivity emails that the White House DOGE office required federal employees to submit last month.

Trending Now

Information, charts or examples are for illustration and educational purposes only and not for individualized investment management This message contains commercial elements, such as advertising. We only send these offers to those who have opted in to our newsletter. Past performance is not indicative of future results. For these reasons we strongly suggest trading in a DEMO/Simulated account. The information provided by us is for educational and informational purposes only. We make no representations or warranties concerning the products, practices or procedures of any company or entity mentioned or recommended and have not determined if the statements and opinions of the advertiser are accurate, correct or truthful. If you use, act upon or make decisions in reliance on information contained or any external source linked within it, you do so at your own peril and agree to hold us, our officers, directors, shareholders, affiliates and agents without fault.

Copyright technicaltrading.org
Privacy Policy | Terms of Service