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

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

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

Tennessee safety agency says workers killed in flooding were given time to evacuate

NASHVILLE, Tenn. (AP) — Workers at an East Tennessee plastics company who from last year's Hurricane Helene had time to evacuate, albeit by “makeshift routes,” according to an investigation from the Tennessee Occupational Safety and Health Administration released on Wednesday.

Retail Stocks Slammed As Trump's Tariff Plan Sends Shockwaves Through Sector

The retail sector is under heavy selling pressure on Thursday as Wall Street digests President Trump's tougher-than-anticipated tariff plan. 

One Coin to Rule Them All... - Ad

Hardly any investors are talking about this coin but I believe that's about to change with some potentially huge news! Get in on the ground floor while it's rock bottom with this new how-to guide, just $3.

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

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).

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.

Trump Threatens Russian Oil Tariffs, Says He's 'Very Angry' At Putin

President Donald Trump has expressed fury over recent remarks by Russian President Vladimir Putin suggesting Ukrainian President Volodymyr Zelenskyy should be replaced.

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!

Amazon Stock's Recent Pullback Offers 'Unique Opportunity': Analyst

Amazon shares are down 9% over the last month, but WestPark Capital analyst Curtis Shauger sees a buying opportunity in the stock's recent pullback. 

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.

Warren Buffett's Investing Partner's Shocking Final Move - Ad

Before he passed away, Charlie Munger, Warren Buffett's investing partner of 60 years, was rumored to have quietly made one final investment... Up until now, it has remained hidden from the public. It's potentially the smartest, most profitable, and most under-valued AI investment you can make today.

Elon Musk Attacks Netflix Hit Series, Shares 'Anti-White Propaganda' Allegation: Here's How The Show's Writer Claps Back

One of Netflix's biggest hits in 2025 has been attacked for its use of race. One of the show's co-writers spoke out about the allegations, which were amplified by Elon Musk.

Could This Be the Best Gold Play of 2025? - Ad

An exploration company is making waves with high-grade finds. They even convinced a major billion dollar competitor to fund their exploration.

Is US Taking Cues From Argentina's Bold Reforms That Sparked A Market Rally?

Argentina's fiscal reforms helped curb inflation and ignite a market rally, Could the U.S. be on a same path under D.O.G.E. and Trump?

Trump To Target 'Dirty 15' Countries With Tariffs: Which Countries Could Be Included?

President Donald Trump is preparing to announce his most expansive tariff plan to date, set to take effect on April 2. What countries could be targeted?

Trump's Tariffs Just Split the AI Market in Two - Ad

Make no mistake, AI as a whole is still a game changer for the global economy. But within the AI sector, Trump's tariffs have created a huge divergence. There are those AI companies that will rise to the top...And those that will sink to the bottom. Which one do you want to be positioned in?

Republicans moving ahead with Trump's 'big' bill of tax breaks and spending cuts amid tariff uproar

WASHINGTON (AP) — After a long wait, the Senate is launching action on "big, beautiful bill” of tax breaks and spending cuts at a risky moment for the .

'I bought their dream': How a US company's huge land deal in Senegal went bust

DAKAR, Senegal (AP) — Rusting pipes in a barren field and unpaid workers are what remain after a U.S. company promised to turn a huge piece of land in Senegal — about twice the size of Paris — into an agricultural project and create thousands of jobs.

Defi Coin Triggers All "Buy" Signals and Could Break Out Soon - Ad

Some are calling this the most promising DeFi project since Ethereum itself. Here's the #1 DeFi Coin Set to Soar. While Bitcoin grabs headlines, this lesser known DeFi coin is quietly gearing up for a monster rally. Experts say now is the time to buy before it reaches escape velocity.

MrBeast Reveals What He'd Fix at Meta If He Were CEO - And Zuckerberg Agreed

In a recent interaction with Meta CEO Mark Zuckerberg, YouTube star MrBeast proposed ways to enhance Meta's multilingual content reach.

CEO of fast-fashion brand Primark steps down after allegations of bad behavior in social situation

LONDON (AP) — The chief executive of Primark, one of Europe’s biggest fast fashion retailers, has resigned after an investigation into his behavior toward a woman in a social environment.

Elon Musk Drops Stunning Bombshell? - Ad

Behind closed doors, Musk revealed a game-changing breakthrough technology that could shake the tech world & crush major companies. Why is no one talking about it? Luckily, we had a man on the inside - watch now to see the details & how to profit!

Why Elon Musk May Regret Ignoring Warren Buffett's Political Strategy

The political activities of Elon Musk, the CEO of Tesla Inc. (NASDAQ: TSLA) and SpaceX, have led to a significant backlash, causing a decline in Tesla's sales and triggering protests against the company.

Trump is set to announce 'reciprocal' tariffs in a risky move that could reshape the economy

WASHINGTON (AP) — After weeks of White House hype and public anxiety, President Donald Trump is set Wednesday to announce a barrage of self-described on friend and foe alike.

Hate Elon? Read Immediately - Ad

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.

IRS crime fighting arm announces modernization program as financial crimes use more tech

WASHINGTON (AP) — As the nature of changes, with technology and AI increasingly used to perpetrate illegal acts, the IRS' crime fighting arm —IRS Criminal Investigation— is announcing a new program intended to improve how it interacts with financial institutions.

Mozilla's Thunderbird Evolves With Thundermail And Pro Features To Compete With Gmail, Microsoft 365 In The Email Wars

Mozilla is revamping its Thunderbird email client with the launch of Thundermail and Thunderbird Pro, introducing new privacy-focused features to compete with Gmail and Microsoft 365.

Tiny AI Firm Could Outperform NVIDIA - Ad

This could be the single-biggest investment opportunity of the AI era. As AI's rapid expansion pushes energy needs to levels comparable with entire nations... A small company's innovative technology stands ready to tackle this challenge and satisfy the escalating power requirements of AI. Remarkably, its stock is currently available for just a few dollars.

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?

Apple Reportedly Fights UK Government's 'Unacceptable' Encryption Order Behind Closed Doors - No Press Or Public Allowed

Apple reportedly challenged a secretive UK government order to weaken iCloud encryption in a closed-door hearing, sparking global privacy concerns and criticism from civil liberties groups.

Buffett's $29B Oil Bet--Here's How to Earn 22% Yields Monthly - Ad

Buffett is loading up on oil stocks--10% of his portfolio is now in energy. But while he earns modest dividends, we've found an ETF yielding 22% annually with monthly payouts! Get the full details now--before the next oil surge!

As war draws men to fight, Ukraine's women take tough new jobs in machinery and mines

DNIPROPETROVSK REGION, Ukraine (AP) — Kateryna Koliadiuk was curious. The 19-year-old Ukrainian agronomy student spotted an ad seeking women to enroll in a tractor driving course and decided to try. But the industrial vehicle was huge and complex, and she wasn’t sure she could operate it.

The Most Important "AI Stock" You've Never Heard Of - Ad

The AI revolution is moving faster than anyone expected. But what no one is talking about is the one company AI simply can't exist without. It may be the single most important AI investment, yet most people don't even know its name. For now. The moment Wall Street catches on, this $20 stock could explode.

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.

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 systemtrading.ca
Privacy Policy | Terms of Service