Novavax Inc (NVAX) Quote

Form 8-K filed for Annual Shareholders Meeting results.

Form 8-K

RJ, I disagree with the author's assessment and would not be surprised to see Novavax as the sole provider of Approved Covid and CIC vaccines in the US market. I don't think the Pfizer and Moderna vaccines will meet the FDA's preferred primary endpoint in the upcoming required trials.

re: https://seekingalpha.com/article/4794696-novavax-new-vaccine-same-old-story-still-a-sell

Did y'all notice that MAHA's new Chief Medical Officer, "...Dr. Malhotra outlined his top three priorities — revising national dietary guidelines, cracking down on ultraprocessed foods and pushing for a moratorium on mRNA COVID-19 vaccines?.

https://publichealthpolicyjournal.com/new-head-of-maha-revealed-as-he-lays-bare-radical-plan-to-transform-us-health-and-ban-covid-shots-more/

RFK Jr. taps eight new members for CDC's vaccine advisory panel
The new members include well-known vaccine skeptics and others who have been critical of Covid vaccines or pandemic interventions like lockdowns.

https://www.nbcnews.com/health/health-news/rfk-jr-cdc-acip-vaccine-panel-eight-new-members-rcna212477

I might have thought the NR from yesterday would boost the SP. It seems MMs are intent to keep the SP at $7. Sigh.

The new ACIP appears on the surface to be skeptical on vaccines in general and some members have a history of a hate-on for mRNA shots in particular. I'm wondering if there is a path forward for Novavax being recently approved by the "new" FDA and a non mRNA platform that might see it go from ugly duckling under the "old" FDA to darling under the "new" FDA. Staying patient to see what unfolds on this and other fronts we know about for Novavax regarding new partnerships and their pipeline.

Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial

https://ca.finance.yahoo.com/news/novavaxs-covid-19-influenza-combination-110000526.html

imo... Bottom_man... i think this forum needs a blast of suppressant....~~~~~~~~~~~~NVAX





NVAX


IHuser

Sanofi to buy US biopharma group Blueprint for up to $9.5 billion

https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-buys-us-biopharma-group-blueprint-91-bln-deal-2025-06-02/

"Sanofi has ramped up research and development spending in recent years, prompting the company to abandon its long-term profit margin targets two years ago, as it seeks to build on the success of its blockbuster drug Dupixent for eczema and other conditions. ...The Blueprint acquisition "represents a strategic step forward in our rare and immunology portfolios. It enhances our pipeline and accelerates our transformation into the world's leading immunology company," said Sanofi CEO Paul Hudson.

It is the latest in a series of deals by Sanofi. Last month, it announced the $470 million purchase of Vigil Neuroscience (VIGL.O) and in January 2024 it struck a $2.2 billion deal for U.S biotech firm Inhibrx. Hudson said the deal complemented Sanofi's recent acquisitions of other early-stage medicines and added that it still retained a sizable capacity for further deals."

Let's hope this trend continues and the pieces continue to line up for Novavax as a prime takeover target for Sanofi. I can see this happening if enough Matrix-M advantages are found in Sanofi's existing (and now expanded) pipeline and if the CIC combo's also work out.

Novavax to Participate in Upcoming Investor Conferences

GAITHERSBURG, Md., May 29, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it will participate in the following upcoming investor conferences:

Jefferies Global Healthcare Conference
Fireside Chat
Wednesday, June 4, 2025
2:00 – 2:30 p.m. Eastern Time (ET)
New York, NY

Goldman Sachs 46th Annual Global Healthcare Conference
Presentation
Wednesday, June 11, 2025
2:00 – 2:35 p.m. ET
Miami Beach, FL

A webcast of the fireside chat and presentation will be available on the Events & Presentations page of the Company's website at ir.novavax.com. A replay of the webcasts will be available for 30 days.

https://ir.novavax.com/press-releases/2025-05-29-Novavax-to-Participate-in-Upcoming-Investor-Conferences

New Form 8-K filing

On May 27, 2025, the Board of Directors of Novavax, Inc. (the “Company”) determined to eliminate the position of Chief Operating Officer, and terminate the employment of John Trizzino with the Company effective as of June 20, 2025. Mr. Trizzino will continue to provide consulting services to the Company following the termination of his employment, as further described below.

In connection with the termination of his employment, the Company and Mr. Trizzino entered into a general release of claims and separation agreement (the “Separation Agreement”). The Separation Agreement provides that, in consideration of Mr. Trizzino’s execution and non-revocation of a general release of claims and his compliance with the applicable restrictive covenants, the Company will pay Mr. Trizzino separation pay of a gross amount of $601,778, less applicable withholdings and deductions, to be paid in a lump sum within 15 days calendar days of entering into the Separation Agreement. Subject to Mr. Trizzino timely electing COBRA coverage, the Company will also pay Mr. Trizzino’s full COBRA premiums for up to 12 months (or, if earlier, Mr. Trizzino becomes eligible for health insurance coverage through a new employer, or ceases to be eligible for COBRA during the 12 month period.)

The Company and Mr. Trizzino also entered into a consulting agreement (the “Consulting Agreement”) pursuant to which Mr. Trizzino will provide consulting services to the Company commencing on June 20, 2025 until December 31, 2025 (subject to earlier termination, the “consulting period”). The Consulting Agreement provides that the Company will pay Mr. Trizzino a consulting fee of $15,000 per month and provides that the equity awards previously granted to Mr. Trizzino will continue to vest, subject to his continued service during the consulting period, in accordance with their existing terms, and any stock options that remain outstanding and unexercised as of the last day of the consulting period will remain exercisable for a period of 90 days following the end of the consulting period. Upon termination of the Consulting Agreement, any unvested portion of the non-statutory stock options granted pursuant to the March 7, 2023 option award shall immediately vest as of the termination date. All other provisions of the Non-Statutory Stock Option Agreement shall remain unchanged. The Company may terminate the Consulting Agreement immediately for Cause (as defined in the Consulting Agreement), at which time the Company will have no further obligation to pay consulting fees thereunder and the continued vesting of Mr. Trizzino’s equity awards will cease.

The post-termination period applicable to Mr. Trizzino’s current non-competition and non-solicitation covenants will commence upon the termination of his employment with the Company.

The foregoing descriptions of the material terms of the Separation Agreement and the Consulting Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Separation Agreement and Consulting Agreement, respectively, copies of which will be filed with the SEC as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.

Form 8-K filing

This is the Grok AI evaluation of the Cleveland Clinic study, which is posted in the responses to this video, and tends to put this claim in the proper perspective.

The claim about the 2024-2025 flu vaccine having -26.9% efficacy comes from a Cleveland Clinic study of 53,402 employees, suggesting vaccinated individuals had a 27% higher flu risk. This study is a preprint, not peer-reviewed, and only included healthy healthcare workers, limiting its scope. It didn’t assess severe outcomes like hospitalization. CDC data, however, shows the vaccine was 32%-60% effective in outpatient settings and 41%-78% against hospitalization, indicating protection, especially for severe cases. The $6.3 billion revenue claim for flu vaccines is plausible, within market estimates of $4-$17.77 billion. The study raises questions, but broader evidence supports vaccine benefits.

Personally, I've had the flu once, in 1989, and never want to go through that experience again. I have taken the flu vaccine every year for 35 years since and have never had the flu again. My only reaction to the vaccine has been soreness at the injection site, and not with every vaccination. YMMV

New study: The Cleveland Clinic found that the influenza vaccine was not effective last winter

“It had a negative efficacy of 26.9%. In other words, if you took this flu vaccine, you were 26.9% more likely to get influenza”

Big Pharma makes $6.3 billion annually on this vaccine pic.twitter.com/V6NCzkp22E— Wall Street Apes (@WallStreetApes) May 26, 2025 $NVAX

Agreed 1000%!

The great earnings report was largely due to the one-time recognition of revenue from the cancellation of the APA with Canada. Investors discussed this in depth on the investment forums months before the earnings release, but apparently analysts were caught off guard by the large jump in reported revenue, as none of the analysts had adjusted their earnings targets accordingly. Some analysts were quick to cover their asses with subsequent downgrades on the stock, using the one-off as their reasoning, failing to mention they were apparently unaware of the pending revenue recognition that investors understood completely.

Absolutely the MMs and analysts are manipulating the stock. Most institutions investors have followed are continuing to increase their share positions. I noticed the huge block buys as well. 84M shares traded on the day of the BLA announcement, far exceeding the normal trading volume, but the share price certainly didn't move as high as one would reasonably expect.

In my opinion, most analysts are only working to drive public sentiment on an investment to be advantageous to whatever their firm is doing with the stock. Investors who base their decisions solely on analysts recommendations are both naive and lazy.

After great quarter report NVAX jumped up $2 and sank back down to $6 with 48 hrs. I was stunned! But also noticed hug block buys going through. That was 2 weeks ago. This week, monster news hits with approval.

Think MM let his buddies in cheap?

NVAX should be $10+ by EOW.

With the BLA approved, Novavax can now market their Nuvaxovid Covid vaccine to both doctors, pharmacies, and patients. This should greatly increase awareness of a non-mRNA vaccine option, and differentiate Novavax's protein-based vaccine safety profile from that of the mRNA options. Also, with transfer of sales and marketing of the vaccine to Sanofi, I expect a strong marketing campaign to begin immediately.

Greater awareness should lead to greater sales, more revenue, and higher share price. Still, the BLA is only one piece of the overall puzzle. The Covid-Influenza Combined vaccine trial data readout this summer is expected to bring in a new partner if all goes well, and I expect one or two additional partners to be signed over the summer for Matrix-M licensing.

No one knows how fast or how high share price may rise, but looking at historical charts shows dramatic rises multiple times based on certain key events. There is a large short position that hinders any substantial upward movement, making such gains temporary at best. Perhaps with enough catalysts coming within a few months span, the price movement can overcome the shorting pressure. One would expect with all that's expected over the next few months, shorts would close out their positions and find a more lucrative target, but we haven't seen much evidence of that yet.

Personally, I feel Novavax may be the target of a buyout within a year or two, probably by one of the pharma companies who have established a licensing agreement. I'm hoping there will be a bidding war to drive the buyout price even higher, if that occurs.

What does it mean to the stock price

Agreed. We will find out Thursday. WHO already recommended JN.1 and KP.2. Let's see... While the BLA was expected it's nevertheless nice to have and it's foundational to partnerships and pipeline development.

FDA Director Makary has stated they are releasing the new requirements soon, which I expect will be announced this week given the Virus and Related Biological Products Advisory Committee (VRBPAC) meeting on May 22. I listened to last year's VRBPAC meeting where Peter Marks tried his best to change the committee's unanimous recommendation of the "trunk of the tree" JN.1 target already starting production by Novavax, while pushing the "freshest milk" argument for KP.3 which supported Pfizer and Moderna's faster development mRNA platform. In retrospect, JN.1 was the correct choice, and I suspect will likely be recommended again this year. I plan to listen to the meeting again this year.

I expect the restrictions on mRNA vaccines will likely be stricter than protein-based vaccines based on their track record so far. There are a lot of voices, both citizens and those in the medical community, who are calling for a complete ban of mRNA vaccines. Some states have already done this, or at least are not recommending mRNA Covid vaccines. Certainly there should be heavy restrictions on mRNA Covid vaccine use in teenagers and young adults under 30, as this seems to be the groups hit hardest with serious issues from the vaccine.

I wonder if the same restrictions will apply to mRNA now going forward.

NEWS: U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine

https://ir.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavaxs-COVID-19-Vaccine

5/16/25 – FDA approves BLA for NUVAXOVID Covid vaccine

https://www.fda.gov/media/186545/download?attachment

Since CEO Jacobs has repeatedly stated that they are working towards enhancements to the existing Sanofi deal, I am inclined to think Novavax is definitely a part of these plans.

https://www.contractpharma.com/breaking-news/sanofi-to-invest-20b-in-the-u-s-through-2030/

I wonder if Novavax is a factor in these plans announced by Sanofi today.

"Alongside levelling up existing sites, Sanofi stated it would expand its US presence via partnerships with other domestic manufacturers."

RFK Jr and those around him are unqualified and dangerous.

It’s happening !!

Dr Marty Makary says there is no good data for keeping the Covid shot on the Childhood schedule and expects an announcement to be made shortly. 🔥🔥

This will also remove liability protections for Big Pharma. pic.twitter.com/THEuBuYrSX— Kat A 🌸 (@SaiKate108) May 13, 2025 $NVAX

Novavax Reports First Quarter 2025 Financial Results and Operational Highlights

https://ir.novavax.com/press-releases/2025-05-08-Novavax-Reports-First-Quarter-2025-Financial-Results-and-Operational-Highlights

Novavax to Participate in BofA Securities 2025 Health Care Conference

GAITHERSBURG, Md., May 7, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it will participate in the BofA Securities 2025 Health Care Conference.

Conference Details:  Fireside Chat
Date:  Wednesday, May 14, 2025
Time:  3:00 – 3:30 p.m. Pacific Time (PT)
Location:  Las Vegas, NV

Conference Event:  Investor Meetings
Date:  Wednesday, May 14, 2025

A webcast of the fireside chat will be available on the Events & Presentations page of the Company's website at ir.novavax.com. A replay of the webcast will be available for 30 days.

https://ir.novavax.com/press-releases/2025-05-07-Novavax-to-Participate-in-BofA-Securities-2025-Health-Care-Conference

Novavax Announces Significantly Improved Terms for Collaboration and License Agreement with Takeda for Nuvaxovid® in Japan

•  Improved financial terms for Novavax and streamlined operations will help both companies better meet the needs of the Japanese market

•  Nuvaxovid®, a protein-based, non-mRNA COVID-19 vaccine, will continue to be available in Japan, the world's third largest pharmaceutical market

GAITHERSBURG, Md., May 5, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) has updated the terms of the previously announced collaboration and licensing agreement (CLA) with Takeda. The improved financial terms of the amended agreement for the development, manufacturing and commercialization of Nuvaxovid® in Japan include an upfront payment, payment related to the 2024/2025 season, annual milestones associated with regulatory approvals and royalties on net sales earned every season moving forward.

"Our ongoing partnership with Takeda is important for Novavax and our strengthened agreement enhances our ability to operate effectively in the Japanese market," said John C. Jacobs, President and Chief Executive Officer, Novavax. "This partnership further validates our cutting-edge technology platform and proprietary Matrix-M® adjuvant and our efforts to become a partner of choice."

https://ir.novavax.com/press-releases/2025-05-05-Novavax-Announces-Significantly-Improved-Terms-for-Collaboration-and-License-Agreement-with-Takeda-for-Nuvaxovid-R-in-Japan

Form 8-K filing

Novavax to Report First Quarter 2025 Financial Results on May 8, 2025

https://ir.novavax.com/press-releases/2025-05-01-Novavax-to-Report-First-Quarter-2025-Financial-Results-on-May-8,-2025

2025 Proxy Statement for Annual Shareholders Meeting

https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=319114454&type=HTML&symbol=NVAX&cdn=785062be160650df80deb287a01c9b5c&companyName=Novavax+Inc.&formType=DEF+14A&dateFiled=2025-04-29

Novavax 2024 Annual Report

https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=319114461&type=PDF&symbol=NVAX&cdn=1f6f2fc88140bdbfb9148579f99a4bb1&companyName=Novavax+Inc.&formType=ARS&dateFiled=2025-04-29

Novavax Appoints Charles Newton to Board of Directors

GAITHERSBURG, Md., April 29, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced the appointment of Charles Newton to its board as an independent director. Mr. Newton brings extensive experience in public markets and healthcare investment banking to his role on the Novavax Board of Directors.

"Charles brings a wealth of expertise across corporate finance and capital markets to Novavax," said John C. Jacobs, President and Chief Executive Officer, Novavax. "The knowledge he brings to our already experienced board will be invaluable as we continue to execute our corporate growth strategy focused on forging strategic partnerships for our R&D assets and our Matrix-M® adjuvant."

Mr. Newton currently serves as Chief Financial Officer of Lyell Immunopharma, with past leadership experience in healthcare investment banking at Bank of America Merrill Lynch, Credit Suisse and Morgan Stanley.

"This is a very exciting time to be joining the Novavax Board," said Mr. Newton. "I am looking forward to supporting the innovative partnership work the Company is prioritizing to ensure broad access to its cutting-edge technology platform, including its proprietary Matrix-M® adjuvant, while bringing maximum value to shareholders."

Mr. Newton brings vast board experience to Novavax as well. He currently serves as a member of the board of directors of Coherus BioSciences and 2seventy bio, Inc. Mr. Newton holds a Bachelor of Science degree in Finance from Miami University and a Master of Business Administration from The Tuck School at Dartmouth College.

https://ir.novavax.com/press-releases/2025-04-29-Novavax-Appoints-Charles-Newton-to-Board-of-Directors

NEWS: Novavax Board of Directors Appreciates the Formal Support and Strategic Guidance of Shah Capital

April 28, 2025

Through constructive engagement with Shah Capital, a holder of approximately 7% of Novavax shares and who has pledged support for our Board of Directors, we have received valuable feedback and are in alignment on a range of transformative initiatives. These include significant cost reductions and company reshaping, support for more partnerships and additional expertise in research and development and artificial intelligence.

At Novavax, we continue to successfully advance our corporate growth strategy and remain confident that our actions will drive sustainable profitable growth. As we are preparing for our Annual Shareholder Meeting planned to occur on June 20, 2025, we would like to both acknowledge and extend our appreciation for the formal support of our Board and collaborative input we have received from Shah Capital and other long-term investors.

We have always welcomed the beneficial perspectives of all our shareholders and appreciate the shared belief in the tremendous promise of Novavax’s technology and the value it can bring to the healthcare landscape globally. We are proud of the progress that has been made with the support of all our shareholders. It is because of their trust and support that we are able to continue progressing in our mission to leverage our science, technology and people to innovate and collaborate to tackle the world’s most significant health challenges.

https://ir.novavax.com/press-releases/Novavax-Board-of-Directors-Appreciates-the-Formal-Support-and-Strategic-Guidance-of-Shah-Capital

NEWS: Latest update on U.S. FDA BLA for Novavax's COVID-19 Vaccine

April 28, 2025

Last week, Novavax responded to the formal communication received from the U.S. Food and Drug Administration (FDA) for our Biologics License Application (BLA) and our response addresses the request for a postmarketing commitment (PMC) for a clinical trial. PMCs by their nature are completed after BLA approval. PMCs are not unusual with many approved drugs and/or biologics having at least one PMC or requirement. We believe our application is approvable upon alignment on the details of the PMC. We look forward to continued engagement with the FDA.

https://ir.novavax.com/press-releases/Latest-update-on-U-S-FDA-BLA-for-Novavaxs-COVID-19-Vaccine-1

A Novavax investor on Stocktwits asked the Grok 3 AI to analyze the WSJ article with what we already know from both company and FDA regarding the pending BLA approval. Here are image captures of the Grok 3 response.

The Wall Street Journal released a story today that sent Novavax stock into a massive selloff just 40 minutes before market close. The story appears to be a rehash of a Novavax press release issued earlier this week that stated the FDA had issued a request via a postmarking commitment (PMC) to generate additional clinical data. A PMC is not a condition for approval, but something that is fulfilled after a product has been approved, indicating approval was near.

The timing of the WSJ article is suspect and makes no mention of the PMC nor the fact the additional data would be generated following vaccine approval. Also, the article incorrectly gives the impression Novavax is cash strapped and may be unable to fulfill the FDA request, a fact that is blatantly false and misinformed, as Novavax reported over $1 Billion in cash and receivables in the most recent filings.

The article appears to be worded to generate panic among shareholders, inciting a massive sell-off, possibly to allow a group of short-sellers to cover their short positions before the BLA is approved next week. They could have easily waited until market close to release the story, yet released it near the end of the trading day, allowing no time for the company to respond to dispute the article. I expect we'll hear from the company on Monday prior to market open.

Here's the hit piece issued by the WSJ. Their standards for accurate and responsible journalism have certainly hit a new low, IMO. I hope the SEC investigates as this appears to be intentional market manipulation.
_________________________________________________________________________

FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say

April 25, 2025 3:20 pm ET

Federal regulators are asking Novavax NVAX to complete an additional randomized clinical trial on its Covid-19 vaccine after previously delaying approval, people familiar with the matter said, a request that could be so prohibitively expensive the company might not be able to fulfill it.

The Maryland-based company was asked by the Food and Drug Administration to show its vaccine is effective with another randomized study after appointees under Health Secretary Robert F. Kennedy Jr. intervened in the approval process, the people said. The additional step goes beyond what other Covid-19 vaccine makers had to do to win approval, and could be an early sign of new challenges for drug makers hoping to get approval.

The company's shot already showed 90% efficacy in a 30,000-person, placebo-controlled trial, and it is already available in the U.S. under an Emergency Use Authorization and has won full approval in Australia, Europe and Japan.

A new randomized trial with enough participants to judge the vaccine's ability to prevent disease could cost tens of millions of dollars, vaccine experts said.

The FDA's request for new data gives Novavax room to negotiate for a smaller, less expensive study, perhaps costing only a few million dollars, a person familiar with the matter said.

The company responded to the agency earlier this week, the person said.

Negotiations will need to move quickly for the company to have time to adjust its vaccine to the strain of the virus most likely to dominate in the fall and request approval for an updated shot tweaked to match.

https://www.wsj.com/health/healthcare/novavax-covid-19-vaccine-clinical-trial-fda-de5d3bb3

As FDA delays Novavax' COVID vaccine approval, patients fight back

     •  Patients with long COVID advocate for Novavax approval
     •  FDA delays Novavax approval, requests more clinical data
     •  Kennedy criticizes Novavax, claims single-antigen vaccines ineffective



CHICAGO, April 24 (Reuters) - Thousands of Americans campaigning for the Novavax (NVAX.O), opens new tab COVID-19 booster got some good news this week: the FDA signaled it might still win approval after Health Secretary Robert F. Kennedy Jr cast doubt on its efficacy.

The Novavax vaccine is the only COVID-19 booster in the United States that does not use messenger RNA technology - which some states have begun to ban - and the only option for many people who cannot or will not take an mRNA vaccine.

While more traditional vaccines, including the Novavax shot, inject a portion of the virus into the body, mRNA vaccines carry instructions for human cells to make the viral protein that triggers an immune response.

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which rival mRNA shots from Moderna and Pfizer already have - was due from the Food and Drug Administration by April 1, but had been delayed by the FDA without explanation.

On Wednesday, the company got word that the FDA would consider approving the vaccine, provided Novavax agrees to produce additional clinical data on the vaccine's efficacy following its approval.

Based on its communication, the company said it now believes its application is "approvable."

Asked the reason for delay and the request for more data, an HHS spokesperson said the agency remains committed to "ensuring products are safe for the American people and grounded in gold-standard science."

Without FDA approval, patients and vaccine experts say a group of people, including many patients with long COVID, will be left without a means of protecting themselves.

"It's reassuring to see an update, but we're not celebrating just yet," said Paul Hennessy, 35, an entertainment project manager from Los Angeles and volunteer with Organizing for a Better Tomorrow, a long COVID advocacy group.

Hennessy helped organize more than 3,200 people to submit written comments to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices on April 16. The group has also been calling and emailing officials at the FDA.

VACCINE PROMISES

Kennedy, a longtime vaccine critic and environmental lawyer who in 2021 petitioned the FDA to revoke the emergency use authorization, opens new tab for all COVID vaccines, attributed the delay to the shot's design in an April 10 CBS interview.

He said the Novavax shot targets only one antigen or part of the virus to produce an immune response and "single-antigen vaccines have never worked for respiratory illnesses."

The comments baffled vaccine experts, who noted many examples of effective single-antigen vaccines against respiratory illnesses.

All of the first-generation COVID-19 vaccines were single-antigen vaccines, "so they clearly worked," said one vaccine researcher who requested anonymity for fear of retribution against his university.

Kennedy has repeatedly said he would not take away anyone's vaccine, including during his Senate confirmation hearing and most recently in his CBS interview. But patients are wary.

"It feels like the complete opposite of that - that he intends to take this option away from many people who need it," said Kaiti Murphy of Brooklyn, New York.

Murphy, 32, has long COVID and mast cell activation syndrome, a condition in which the immune system becomes hyperactive, which her doctor believes was triggered by her COVID infection in 2020.

"He has advised me not to take any mRNA vaccines," she said.

She, like many people with long COVID, relies on COVID boosters to avoid reinfections with the virus, which can cause their symptoms to flare.

"Pulling it off the market would really be a threat to my health," said Salvatore Mattera, a finance manager for a technology company who has long COVID, a collection of debilitating symptoms that persist among some people long after a COVID-19 infection.

Mattera, 36, of Foster City, California, has had adverse reactions after taking an mRNA vaccine, including numbness in his face severe enough to send him to the hospital ER.

After he switched to Novavax - which he has had three times - he has had no negative side effects beyond a sore arm.

As with much about long COVID, evidence on the impact of COVID boosters is scant.

In a small, soon-to-be published study by Yale immunobiologist Dr. Akiko Iwasaki and colleagues, the team found that while most people with long COVID fared well with an mRNA booster, 3 out of 16 volunteers had worsening symptoms, including one patient who was hospitalized.

The Novavax vaccine was not available during the study period, but Iwasaki said because it has lower reactogenicity, opens new tab, or short-term side effects such as arm pain or fatigue, "I suspect that patients with long COVID may have an easier time with it."

In written comments to CDC's advisory panel last week, many people gave fewer side effects as their reason for urging approval.

Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said that while he thinks the Novavax booster may eventually win approval, "it appears that they are trying to increase the regulatory burden," something he said is to be expected from a department headed by an anti-vaccine advocate such as RFK Jr.

Meanwhile, as the current batch of Novavax boosters expires on April 30, many on the social media platform Reddit are swapping information on where to find the scarce last doses ahead of what has become a routine summer wave of COVID.

"It's a step in the right direction," Hennessy said of the FDA action, "but we still need access."

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-delays-novavax-covid-vaccine-approval-patients-fight-back-2025-04-24/

I see this in the $20 to $30 range in 2025 based on BLA approval and positive Phase 3 CIC trial data, and the add-ons to these 2 events and other things we know about could drive it higher than $50, perhaps significantly higher.

•  BLA brings a $175M Sanofi milestone payment
•  BLA could bring an enhancement to the existing Sanofi partnership
•  Positive CIC trial data likely brings a new partner into the mix
•  Additional Matrix-M licensing deals with top-10 pharmas currently bench testing Matrix-M
•  Advancements in other pipeline assets reported (they are not standing still on those)
•  Enhanced Matrix-M development news
•  Short squeeze of NVAX shares due to highly shorted status
•  Current administration enacts restrictions or bans of mRNA Covid vaccines

Where do you see this in 2025 and give me a rationale reason and not a greeny picture beco you own it

I'm currently up $68,900 on my Novavax investment, and this gain will go MUCH HIGHER very soon, and will eventually exceed $1M.

2025 is going to be a great year for NVAX. I'll be sure to keep you updated on my investment success with NVAX.

Unlike the scam MONI which has 10-year-plus bag holders such as yourself still pumping it, and the really bad investment choice IBIO which is headed for delisting and another reverse split, in addition to the 3 reverse splits they've done over the last 7 years.

NEWS: Latest update on U.S. FDA BLA for Novavax's COVID-19 Vaccine

April 23, 2025

We believe that our Biologics License Application (BLA) is approvable based on conversations with the U.S. Food and Drug Administration (FDA), as of our Prescription Drug User Fee Act (PDUFA) date of April 1 and through today.

We have recently received formal communication from the FDA in the form of an information request for a postmarketing commitment (PMC) to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.

https://ir.novavax.com/press-releases/Latest-update-on-U-S-FDA-BLA-for-Novavaxs-COVID-19-Vaccine

From ChatGPT:

A Postmarketing Commitment (PMC) is not a condition for approval, but something that is fulfilled after a product has been approved. In essence, the agency is saying: "We approve the product, but you still need to provide us with additional data afterward."

If it's a mandatory requirement, it’s usually referred to as a Postmarketing Requirement (PMR). A PMC is typically considered a bit more flexible but is still officially documented.

In Novavax’s case, this means the FDA sees no major obstacles to approval, but wants Novavax to conduct additional studies post-approval.

Health secretary RFK Jr. declares certain vaccines have ‘never worked,’ flummoxing scientists

‘He’s wrong,’ one expert said, as stock prices of some vaccine makers tumble

https://www.statnews.com/2025/04/10/rfk-jr-single-antigen-vaccines-novavax-fda-decision/

April 10, 2025

Health secretary Robert F. Kennedy Jr. has expressed another unorthodox view on vaccines, with the long-time vaccine critic declaring that vaccines for respiratory bugs that target a sole part of the pathogen they are meant to protect against do not work.

The claim was dismissed as erroneous by vaccine experts, who were befuddled by the secretary’s theory, espoused during an interview with CBS News.

Kennedy made the claim in explaining a controversial recent decision by political appointees at the Food and Drug Administration to delay granting a full license to Novavax’s Covid-19 vaccine, which is still given under an emergency use authorization or EUA.

“It is a single antigen vaccine. And for respiratory illnesses, the single antigen vaccines have never worked,” Kennedy said when asked by CBS’s chief medical correspondent, Jonathan LaPook, why the decision was delayed.

Scientists who have developed and studied vaccines were blunt in their assessment of Kennedy’s claim.

He’s wrong,” said Paul Offit, an infectious diseases expert at Children’s Hospital of Philadelphia who was one of the developers of a successful rotavirus vaccine. “He believes falsely that a single protein vaccine can’t effectively prevent a serious mucosal infection and of course it can. We have several examples.”

Peter Marks, the former head of the FDA’s biologics center, which regulates vaccines, said Kennedy’s idea about single antigen vaccines isn’t based in science.

“A tenet of virology is that you go after one of the proteins on the surface that generates a good immune response, and that’s what you target. This principle has withstood the test of time because we’ve made multiple good vaccines in that manner,” said Marks, who was pushed out of the FDA late last month at the behest of Kennedy.

“This is another example of Kennedy being an ignoramus about vaccination, if not other things as well. And you can quote me on that,” said Stanley Plotkin, a co-developer of the rotavirus vaccine and of the vaccine that protects against rubella. Plotkin is a professor emeritus at the University of Pennsylvania.

An antigen is a substance that activates the immune system to protect against a specific disease threat. Some vaccines, such as the one that protects against measles, target multiple parts of the pathogen they are designed to stave off.

But others focus on a sole protein. All Covid vaccines target a single antigen, a part of the SARS-CoV-2 virus known as the spike protein. Most flu vaccines effectively target a single antigen, the hemagglutinin protein on the exterior of flu viruses. And vaccines against respiratory syncytial viruses are also single antigen vaccines, targeting RSV’s F protein.

In addition to puzzling experts, Kennedy’s statement could bode poorly for multiple Covid vaccines currently under review. They are made by Novavax, Moderna, and Pfizer, along with its partner BioNTech.

Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season.

The agency is also studying applications from Moderna and Pfizer to have their pediatric Covid vaccines given full licenses — known in the industry as BLAs. Though Pfizer’s and Moderna’s adult Covid vaccines were long ago issued BLAs, the pediatric formulations are still being used under EUAs.

And the agency must decide by May 31 whether to approve a next-generation Covid shot that has been developed by Moderna.

Financial markets appeared to take notice of Kennedy’s single antigen claim, with Novavax’s stock price dropping 20% and Moderna’s falling 8% at a point on Thursday.

Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, said Kennedy’s comment makes him worried, both about the continued availability of the Novavax vaccine in this country, but also for Covid vaccines in general.

“I think any single antigen vaccine based on his rhetoric right now has to be considered at risk,” Osterholm said.

Marks shared that concern.

“Our children, our older people in this country, for that matter, all of us deserve the best available vaccines that come through the gold standard evaluation process for quality, safety and effectiveness from the Food and Drug Administration without any political interference,” he told STAT in an interview. Marks said political interference in vaccine approvals could be “disastrous” as it could prevent products that would protect people from being used. Plotkin too is worried about Kennedy’s reach into the FDA’s decision-making process.

“Obviously, if Kennedy is making decisions, that is going to hurt vaccine development. And more specifically, if decisions have to be made and those decisions are delayed or changed, then the public will suffer because [they] will not be made based on scientific decisions,” he said.

Update on Status of Novavax's COVID-19 Vaccine BLA

April 10, 2025

As we have previously stated, we believe that our Biologics License Application (BLA) for our COVID-19 vaccine included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We have not yet received an official response from the U.S. Food and Drug Administration regarding the status of our BLA.

https://ir.novavax.com/press-releases/Update-on-Status-of-Novavaxs-COVID-19-Vaccine-BLA

Sorry for the duplicate link. Here's the other..
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175821245

Seems a good plan. Maybe I'll do the same when ELTP (loaded big from portion of my NVAX holding in 2021) is acquired - basically sitting in the catbird seat. GL to both NVAX and ELTP!

Thanks, but I prefer to focus solely on Novavax. When this is acquired, or as I start to sell off part of my holdings after multiple partnerships announced, I will focus exclusively on investing in leveraged ETFs using Lichello's AIM algorithm. I have backtested 32 leveraged ETFs across multiple sectors and indexes and results are extraordinary. AIM significantly reduces risk associated with leveraged ETFs and significantly outperforms buy-and-hold in almost every case, and this is with only part of your funds invested in shares.

https://investorshub.advfn.com/A-I-M-Users-Bulletin-Board-AIMUSERS-949

Hey Joe! I'm Long on NVAX mostly posted on ymb. At this time of macroeconomic uncertainties. Its best to seek defensive stocks in the market. One of which, I have included links for your reference.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176042856
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176042856

MAJOR overreaction by the market to RFK Jr's comments about the Novavax vaccine approval by FDA. While he has openly supported the Novavax Covid vaccine numerous times in the past, his comments yesterday in a CBS interview clearly spooked Novavax investors into believing their vaccine won't get BLA approval by FDA that was pending just as FDA leadership changed. I picked up more shares on the dip, although wish I would have waited as it went much lower than my buy price. Still happy to have lowered my overall cost basis yet again.

I still believe Novavax will gain BLA approval. The mainstream attack is on safety and effectiveness of mRNA Covid vaccines, not the protein-based Novavax vaccine. Kennedy's remarks about single-antigen respiratory vaccines having never worked are in error. Novavax has the best Covid vaccine on the market, and their combination Covid/Flu vaccine currently in phase 3 clinical trials, with results due during the summer, will be exactly the kind of respiratory vaccine Kennedy favors. But people still need a choice, and may opt for single Covid vaccine in lieu of the combination vaccine. And, Kennedy doesn't dictate FDA approvals has HHS Director. I believe approval is still on, possibly coming as early as tomorrow, or sometime next week. I bet Sanofi isn't just sitting back waiting to see what happens, but is actively in discussions with FDA. We might even see another press release from Novavax today regarding their BLA application.

I feel today is a massive buying opportunity for Novavax investors that doesn't come along very often. Buy when others are in panic mode.

Looks like we may have experienced the bottom this week, and with the volume over last 2 days, a lot of the shorts may be covering before BLA approval is announced, followed by CIC trial results and high likelihood of additional partnerships announced over the summer.

The departure of FDA's Peter Marks is very welcomed news for Novavax shareholders. He was given the choice of resigning or being fired by the Trump administration. RFK Jr. is tasked with cleaning up the FDA and HHS, and Marks was well-known to be a Pfizer puppet.

Marks was instrumental in the numerous delays experienced by Novavax in every aspect of the FDA approval process. He gave preferential treatment to Pfizer and Moderna in the Covid vaccine space, such as delaying EUA approval status of the Novavax vaccine for weeks or months to give the mRNA vaccines a chance to capture market share every year since the Covid outbreak.

I watched the 2024 advisory panel meeting where the 16 members overwhelmingly voted for Novavax's decision to target the JN.1 lineage ("trunk of the tree" reasoning). Marks was visibly agitated and became confrontational since they didn't choose the KP.3 strain that Pfizer was targeting. He earned the title "Milkman" with his reasoning that folks buying milk at the grocery store always choose the freshest milk, not the milk that has closer expiration dates. A week after the committed unaminously voted for JN.1, Marks overrode the committee and the FDA officially targeted the KP.3 Covid strain, stating the Novavax vaccine could be used as an alternative to mRNA if people wanted a choice, but at the risk of lesser protection against the currently circulating KP.3 strain. But as the committee had already discussed, KP.3 was not expected to be the dominant strain by the time the vaccine was ready for use in the fall 2024 to spring 2025 season, and JN.1 would provide more than adequate protection against whatever strain was dominant since it was the "trunk of the tree" for the lineage of the viral strains. Again, Marks used his position to promote his favorited mRNA vaccines and delay Novavax EUA approval by more than a week.

While the impact of Marks' resignation may have negatively impacted all virus makers stock prices, including Novavax, it actually benefits Novavax by removal of a major and recurring roadblock in their dealings with the FDA. Shareholders on other message boards I read are overwhelmingly positive about Marks getting canned, and want the Trump administration to investigate his bias and actions at FDA for violating the integrity of the institution and failure to serve the best interests of the American people vs. serving the best interests of Pfizer. They expect his Pfizer masters to offer him a cushy position in an advisory role, a practice the Trump administration has stated they will want to eliminate as part of returning credibility to the FDA.

Most shareholders are not overly concerned about the existing debt as CEO Jacobs has been successful at eliminating debt and transferring short-term debt to long-term debt to provide additional time for the partnership and licensing strategy to generate sufficient revenue. Novavax is in a pretty strong financial situation currently, and Jacobs has announced two top-10 pharma companies are currently testing Matrix-M in their labs and licensing deals could come at any time. Plus, the Sanofi deal is going well and the upcoming BLA approval will generate another $175M in milestone payment. CIC trial data due over summer, and expanded Sanofi deal is expected as well.

Regardless of current share price, which is largely due to continued shorting, I feel the future of Novavax is very promising and shareholders who don't panic will be greatly rewarded.