JoeForkeyBolo
14 시간 전
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.
JoeForkeyBolo
2 주 전
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.
JoeForkeyBolo
2 주 전
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.
JoeForkeyBolo
3 주 전
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.
vinmantoo
1 월 전
I had the measles as a kid, and so did everyone else I grew up with, and none of us were harmed from the event. So it's difficult for me to find fault with his comments, as they are correct. However, if there is a proven vaccine against measles, that is an option for people to choose.
I am glad you and people you knew weren't harmed when you contracted the measles. However, your personal experiences are irrelevant. Many people died each year or were hospitalized each year after contracting measles. Kennedy is unqualified to make judgements and he is a liar and a conman.
https://www.cdc.gov/measles/about/history.html
Measles might be a bigger problem than most realize.
https://time.com/7266454/measles-outbreak-essay-ashish-jha/
The problem is, America has lost faith in the FDA and other government health agencies we thought were working to protect us. But we are finding more evidence each day they have been primarily focused on promoting drugs and vaccines to increase profits of big pharma. The scrutiny the FDA has given the Novavax Covid vaccine compared to how little testing, if any, was required for the mRNA vaccines, is a prime example. And now more evidence of significant harm to humans from these mRNA vaccines is surfacing, yet FDA continues to promote them and stand by their prior decisions.
Yeah, conmen like Kennedy and other anti-vaxxers have done a lot of damage. mRNA vaccines aren't dangerous and are effective. NVAX's vaccine is quite good too.
If you're a Novavax shareholder and feel you are correct in your assessment of Kennedy and the impact on Novavax, perhaps it's time to reevaluate your position as a shareholder. I try to encourage people to follow their convictions, especially regarding investments.
Why are you making this about NVAX? It isn't. I hope you make a lot of money on NVAX. Kennedy is a lying conman and is dangerous. That is the point.
JoeForkeyBolo
1 월 전
I had the measles as a kid, and so did everyone else I grew up with, and none of us were harmed from the event. So it's difficult for me to find fault with his comments, as they are correct. However, if there is a proven vaccine against measles, that is an option for people to choose.
The problem is, America has lost faith in the FDA and other government health agencies we thought were working to protect us. But we are finding more evidence each day they have been primarily focused on promoting drugs and vaccines to increase profits of big pharma. The scrutiny the FDA has given the Novavax Covid vaccine compared to how little testing, if any, was required for the mRNA vaccines, is a prime example. And now more evidence of significant harm to humans from these mRNA vaccines is surfacing, yet FDA continues to promote them and stand by their prior decisions. Want to explain why it takes so long for Novavax to obtain the BLA? They made the request and data submission last June. I believe FDA intentionally scheduled review for 10 months later once again to give preferential treatment to mRNA vaccines over Novavax, which continues to operate under EUA. Since Kennedy is a fan of Novavax, I expect he will dig deeper into this.
It doesn't help when we see FDA officials who were key decision makers leaving FDA for lucrative careers in the same BP's they supposedly regulated. This is a major conflict of interest, which I hope Trump and Kennedy will end.
If you're a Novavax shareholder and feel you are correct in your assessment of Kennedy and the impact on Novavax, perhaps it's time to reevaluate your position as a shareholder. I try to encourage people to follow their convictions, especially regarding investments.
JoeForkeyBolo
2 월 전
During the TD Cowen 45th Annual Health Care Conference on 3/4/25, CEO John Jacobs announced another top-10 pharmaceutical company that signed an MTA to experiment with Matrix-M across their pipeline, and this makes 3 top-10 pharmaceutical companies working with Matrix-M across assets in their pipeline and in their labs. This is stated by Jacobs at 1:40 in the audio, which can be accessed at the link below.
This is a clear indication that others besides Sanofi are interested in Matrix-M and we should expect new partnerships, which according to Jacobs in the recent earnings presentation, "could be announced at any time."
The current share price is a gift, in my opinion. I expect the share price to be multiples higher in 2025.
https://wsw.com/webcast/cowen177/nvax/2045967
MarauderVoyager38
2 월 전
"Shortly after President-elect Donald J. Trump nominated Robert F. Kennedy Jr. to lead the Department of Health and Human Services (HHS), the biotech market — specifically those involving vaccines — responded negatively. It wasn’t really surprising. Without getting into the political weeds, Kennedy has long espoused unconventional views of science and medicine that threaten to disrupt business as usual.
To be sure, Kennedy proponents may argue that such disruption is exactly the point: the idea is that for too long, big pharma and big food companies have, for lack of a better word, “poisoned” the American people in the name of the almighty dollar. Specifically, RFK pinned the prevalence of chronic disease and childhood illness on food and drug industries.
Following Trump’s nomination of Kennedy, several top enterprises such as Pfizer (PFE) saw their shares erode. However, one of the few notable exceptions was Novavax (NVAX). One of the rags-to-riches tales during the onslaught of COVID-19, Novavax was on the verge of collapse prior to the public health crisis. Cynically, though, the SARS-CoV-2 virus brought NVAX stock back into the game.
Of course, the recovery story was relatively short-lived. With other companies delivering their solutions to the clinical finish line first, NVAX stock flirted once again with irrelevancy. Ironically, though, Novavax’s key disadvantage at the time — the deployment of a protein subunit vaccine as opposed to the innovative but controversial messenger RNA — could be its saving grace moving forward.
Essentially, what it comes down to is that Novavax delivers science that Trump’s conservative base trusts. Should another health crisis erupt, Novavax would presumably be in a much better position compared to big pharma giants that are on RFK’s naughty list."
https://www.theglobeandmail.com/investing/markets/stocks/NVAX/pressreleases/30336420/options-alert-why-novavax-nvax-could-be-the-biotech-hero-of-trump-20/
JoeForkeyBolo
2 월 전
Kennedy has stated his entire family is vaccinated, and he has specifically mentioned Novavax in a positive light on numerous occasions. Kennedy is not a fan of mRNA vaccines nor the FDA's willingness to approve them with very limited data, while holding others like Novavax to a much higher standard. Not sure where you are getting your info, but hey, one should follow their beliefs regarding their investments, even if it is misinformed, so good luck with that move.
I bought 20K NVAX shares on Friday at $8.00. Looking forward to earnings release this week and update on Novavax pipeline of new products. Also, I'm expecting another partnership announcement at any time. The Sanofi deal was announced in conjunction with earnings release, so it's possible the next deal might be announced in the same manner. And then there's the BLA approval in April, and Phase 2/3 clinical trial data on the CIC vaccine this summer. I believe it's a great time to be invested in Novavax.I'M SELLING ALL MY SHARES MONDAY AT OPEN. Kennedy will kill vaccines
JoeForkeyBolo
4 월 전
Item 2.01 Completion of Acquisition or Disposition of Assets.
On December 30, 2024, Novavax CZ a.s. (the “Seller”), an indirect, a wholly owned subsidiary of Novavax Inc. (the “Company”), completed the previously-announced sale of the Company’s biologics manufacturing campus located at Bohumil, Jevany, Czech Republic (the “Facility”) to Novo Nordisk Production Czech s.r.o. (the “Purchaser”), pursuant to an asset purchase agreement, dated as of December 3, 2024 (the “Asset Purchase Agreement”), by and among the Seller, the Company, the Purchaser and Novo Nordisk A/S. Pursuant to the Asset Purchase Agreement, the Seller sold, transferred and assigned to the Purchaser: (i) properties owned by the Seller registered on folio No. 894 maintained by the Cadastral Office for Central Bohemian Region, Detached Cadastral Office Prague-East, for the cadastral area Jevany, comprising land in the settlement known as Bohumil, as well as certain moveable assets and equipment located at the manufacturing facility (the “Transferred Assets”); (ii) contracts related to the operation and management of the Transferred Assets (the “Transferred Contracts”); and (iii) certain employees currently providing services related to the Transferred Assets (the “Transferred Employees”). The total purchase price for the Facility was $200 million and the assumption by the Purchaser of liabilities (on a look-forward basis) pertaining to the Transferred Assets, Transferred Contracts and Transferred Employees. On the closing date, the Purchaser received a cash payment of $180 million, net of the initial payment of $10 million made in September 2024 and $10 million placed in an escrow account to be released to the Seller on the date which is 12 months following the closing date (subject to adjustment for any claims the Purchaser may have against the Seller under the Asset Purchase Agreement). Pursuant to the terms of the Asset Purchase Agreement, the Company was also reimbursed approximately $2. 6 million, subject to adjustments, for costs in continuing to operate and maintain the Transferred Assets, Transferred Contracts and Transferred Employees between December 3,2024 and the completion of the sale.
The foregoing description of the Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Asset Purchase Agreement, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2024.
https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=318815916&type=HTML&symbol=NVAX&cdn=742ca96f5c4d25df192d823f151d9c8a&companyName=Novavax+Inc.&formType=8-K&dateFiled=2024-12-30
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