JoeForkeyBolo
4 weeks ago
Novavax’s outgoing R&D lead says future will be different for Maryland biotech
June 26, 2024
https://www.bizjournals.com/washington/news/2024/06/26/novavax-filip-dubovsky-covid-vaccine-pandemic.html
Novavax outgoing R&D head Filip Dubovsky reflects on 4 years with vaccine maker.
Dr. Filip Dubovsky was the first person to see the clinical results from Novavax’s initial Covid-19 vaccine study in 2020.
The company’s chief medical officer looked at the data on his screen — just raw numbers. He didn’t need any graphs or charts to illustrate what he already knew. He charged down the hall to tell then-CEO Stan Erck and Dr. Greg Glenn, the company’s research and development lead at the time: “Guys, we have a vaccine.”
“I’ve been at this my entire career, all I’ve done is develop vaccines — and I’ve certainly had many, many more failures than successes,” Dubovsky told me. “You can generally tell when you look at those immune responses if you have a winner or not, and there was no doubt in my mind that we had a winner the very first time I saw that data.”
Dubovsky, 59, joined Novavax (NASDAQ: NVAX) that year, as the local biotech, still licking its wounds from a near collapse, entered the race in earnest to develop a coronavirus vaccine. Until then, the Gaithersburg company had been direct competition with Dubovsky, who was at AstraZeneca, in the RSV space. But Novavax’s technology was too attractive to pass up, he said.
Dubovsky was Novavax’s chief medical officer, then became president of R&D after Glenn retired — and through that time was instrumental in the company’s voyage to get its shot to the public.
He’s stepping away now because his wife took early retirement “and there was no way in the world I was going to let her start that journey without me,” he said with a laugh. They moved to Miami Beach last month and are preparing to become nomadic, as he describes it: first traveling to Europe, then setting out on a 5,000-mile driving tour through northern Canada in their SUV.
He’ll remain an adviser to Novavax’s team — remotely — as well as a shareholder with equity input.
But his departure also makes sense, he said, because Novavax’s recent deal with Sanofi to commercialize its Covid vaccine “actually de-risked the entire game of getting this technology pushed out there,” he said, noting that up to this point, “there was uncertainty whether the company would have the wherewithal to do it.”
Dr. Filip Dubovsky is stepping away from Novavax, after a critical four years with the company.
Novavax can now shift its focus back to its R&D roots and away from commercialization.
“The company going forward is going to be very different from the one that we have right now,” Dubovsky said, reinforcing a sentiment CEO John Jacobs has conveyed since striking the Sanofi deal. “We don’t need to be spending our resources on the commercial side; we do need to be spending our resources on expanding our pipeline and developing our technology.”
Novavax is still deciding what its new structure will look like, and whether it’ll tap someone to succeed Dubovsky in the same position, or “rejig it a bit,” as he put it.
But one thing that’s clear, he said, is that Novavax’s Matrix-M adjuvant — the immune-boosting secret sauce in its Covid vaccine — can be used for much more than that.
It’s already baked into a seasonal influenza vaccine and Covid-flu combination vaccine that Novavax is testing, as well as a malaria vaccine now shipping to countries in Africa. That’s a product that only drives small revenue for the company, but uses its technology to help save kids’ lives — ironic, after Dubovsky started his career in malaria vaccines, he said. And “that’s just the tip of the iceberg,” he added.
Going forward, Novavax could dive back into the RSV arena, or develop a vaccine for bird flu — which Novavax is now exploring with the U.S. government “because it would be the obvious purchaser for such a vaccine,” Dubovsky said.
Here’s more from my conversation with Dubovsky about his four years with Novavax — about the early days, the highs and lows, and the future.
What were your first months like at Novavax, at the height of the health crisis?
Remember, those were the dark days — people weren’t allowed to come in to work. In our buildings, there were maybe four of us that would come in regularly to work. And those were very long hours, seven days a week for two years. It was also extremely engaging, because we were the underdogs. We were playing in the Super Bowl, the Stanley Cup and the Kentucky Derby all at once.
Why was that work exciting for you?
I knew the technology had promise, that it would work. We just had to get it through the hoop. And eventually we did. In a sense, the licenses we’ve gotten globally, and the use we’ve had with millions of doses, has really validated the technology. And now there’s a wide-open field that this tech can be used in.
What does the Sanofi deal mean for Novavax?
There’s no reason this technology can’t be applied to the entire portfolio of vaccines going forward. And that’s what the company hopes to do. The money we’re getting from Sanofi — we’ll be able to do that, because now we’re finally in the financial position to stabilize the company, which is stabilized, but actually start growing the portfolio.
Novavax has had some high highs and low lows. What have been the biggest challenges?
There’s no denying we were late to the party. And as far as getting our vaccine licensed — we did something that no one’s ever done before: We got licensed in a couple of years. Unfortunately, Pfizer and Moderna did it in a year and a half. And that means that they got the financial rewards from it. There were a lot of concerns about pushing forward. This company had never manufactured a commercial vaccine before, and that turned out to be a real issue.
What has the impact been?
Our vaccine is a complex biological product. That has a different regulatory path and different regulatory requirements than the mRNA vaccines. That’s why we paid the time penalty. In the end — it’s validated, it’s fully licensed in many places, it’s authorized in the U.S. And certainly, the Sanofi partnership shows the technology is developable.
What’s one standout moment as you look back?
In the early days, all the governments and people were very anxious to get a product. We would get calls from world leaders and governments on a routine basis, seeing when our vaccine would be ready, when they could access it. And that was very new for me. That was, personally, slightly intimidating for me, but also, kind of fun — because it showed the value of science, it showed society and governments and leaders really valuing science, which is something I’m a huge believer in. So it kind of validated my existence. The world was paying attention to vaccines.
JoeForkeyBolo
2 months ago
BREAKING: 9th Circuit Court of Appeals Rules mRNA COVID-19 Jab is NOT a Vaccine Under Traditional Medical Definitions
by Jim Hoft
June 8, 2024
https://www.thegatewaypundit.com/2024/06/breaking-9th-circuit-court-appeals-rules-mrna-covid/
The United States Court of Appeals for the Ninth Circuit has delivered a seismic decision that could reshape public health policy across the nation.
In a contentious case involving the Health Freedom Defense Fund and other plaintiffs versus the Los Angeles Unified School District (LAUSD), the court has declared that mRNA COVID-19 injections do not qualify as vaccines under traditional medical definitions.
The case revolved around the LAUSD’s COVID-19 vaccination policy, which required all employees to be fully vaccinated against COVID-19 by a specified deadline.
The plaintiffs argued that the district’s vaccine mandate infringed upon their fundamental right to refuse medical treatment, as the mRNA injections do not prevent the transmission of COVID-19 but merely mitigate symptoms for the recipient.
The court’s opinion, penned by Circuit Judge R. Nelson and supported by Judge Collins, asserts that the mRNA shots, marketed as vaccines, do not effectively prevent the transmission of COVID-19 but merely reduce symptoms in those who contract the virus. This crucial distinction undermines the foundational premise of the vaccine mandates enforced by various governmental and educational institutions.
Judge Nelson pointed out that the mandate was inconsistent with the Supreme Court’s century-old ruling in Jacobson v. Massachusetts, a case that upheld the state’s right to enforce smallpox vaccinations due to their proven effectiveness in preventing disease spread. In contrast, the mRNA COVID-19 shots do not offer such public health benefits, thus failing the criteria established by Jacobson.
The ruling points out that traditional vaccines are designed to provide immunity and prevent transmission, which is not conclusively proven in the case of mRNA COVID-19 shots.
The Gateway Pundit previously reported that the Centers for Disease Control and Prevention (CDC) had modified the definition of “vaccine” to include the mRNA shots.
So, look at what the CDC did. Here’s the definition the CDC used on 26 August 2021:
• Vaccine– “a product that stimulates a person’s immune system to produce immunity to a specific disease.”
• Vaccination– “the act of introducing a vaccine into the body to produce immunity to a specific disease.”
Rather than admit the COVID-19 vaccine is not working as advertised, the CDC took a page out of Orwell’s 1984 and opted for new spin language.
Here is the new definition:
• Vaccine– “a preparation that is used to stimulate the body’s immune response against diseases.”
It can be recalled that Pfizer’s President of International Developed Markets, Janine Small, admitted in an EU hearing that the vaccine had never been tested on its ability to prevent transmission, contrary to what was previously advertised.
Judge Collins, in a concurring opinion, highlighted that compulsory medical treatments for individual health benefits infringe upon the fundamental right to refuse such treatments. This perspective aligns with the constitutional principles protecting personal liberty against unwarranted governmental intrusions.
You can read the full ruling at the link below:
Ruling No. 22-55908
JoeForkeyBolo
2 months ago
NEWS: Novavax gets grant for vaccine for treating or preventing c. difficile bacterial infection
https://www.pharmaceutical-technology.com/data-insights/novavax-gets-grant-for-vaccine-for-treating-or-preventing-c-difficile-bacterial-infection/?cf-view
June 7, 2024
Novavax has developed a vaccine composition to treat or prevent C. difficile infection. The multivalent immunogenic polypeptide contains portions of multiple toxins from bacteria, inducing effective immune responses. The patent aims to provide innovative methods for combating bacterial infections.
According to GlobalData’s company profile on Novavax, Anti-RSV vaccines was a key innovation area identified from patents. Novavax's grant share as of April 2024 was 41%. Grant share is based on the ratio of number of grants to total number of patents.
A recently granted patent (Publication Number: US11938179B2) discloses a multivalent immunogenic polypeptide designed to target Clostridium difficile infections. The polypeptide consists of a binary toxin (CDT) portion, a Toxin A portion, and two Toxin B portions, each derived from a C. difficile toxin protein. The patent specifies the amino acid sequences for each portion, emphasizing a high degree of homology to specific sequences (at least 90%, 95%, 97%, 98%, or 99% homology). The arrangement of the portions, with the Toxin A portion positioned between the two Toxin B portions, and the presence of specific amino acid linkers between them, are also detailed in the claims.
Moreover, the patent covers a nucleic acid molecule encoding the polypeptide, along with a method for its preparation involving expression in an insect host cell and isolation using a non-ionic detergent. An immunogenic composition comprising the polypeptide and a suitable carrier, excipient, or diluent is also described, with the inclusion of an adjuvant, particularly a saponin-based adjuvant containing specific fractions in defined proportions. This patent highlights a novel approach to developing an immunogenic polypeptide targeting C. difficile infections, with a focus on specific amino acid sequences, arrangement, and production methods, offering potential advancements in combating this challenging medical condition.
JoeForkeyBolo
2 months ago
NEWS: Novavax Prepared to Deliver JN.1 Protein-based Non-mRNA COVID-19 Vaccine This Fall Consistent with U.S. FDA VRBPAC Recommendation
https://ir.novavax.com/press-releases/Novavax-Prepared-to-Deliver-JN-1-Protein-based-Non-mRNA-COVID-19-Vaccine-This-Fall-Consistent-with-U-S-FDA-VRBPAC-Recommendation
June 5, 2024
Today the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend that COVID-19 vaccines be updated to a monovalent JN.1-lineage composition for 2024-2025 and expressed a preference for the JN.1 strain. The Committee acknowledged the importance of having a protein-based option available at the start of the vaccination season, alongside other alternatives. Novavax expects to be ready for the commercial delivery of a protein-based JN.1 COVID-19 vaccine in the U.S. in September this fall, pending authorization.
The Committee acknowledged the advantages of a JN.1 vaccine in providing broad protection against circulating and future strains, based upon data presented by all manufacturers, and the need to minimize confusion in making public health recommendations. Novavax’s JN.1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for a range of JN.1 descendant viruses, including KP.2 and KP.3. We believe updating to the JN.1 lineage or JN.1, as recommended by the World Health Organization and the European Medicines Agency and as unanimously recommended by VRBPAC today, will provide the protection needed this fall against COVID-19.1,2
Our most recent nonclinical data have demonstrated that our JN.1 vaccine candidate induces broad neutralization responses to JN.1 lineage viruses including those with the F456L mutation (e.g., JN.1.16), the R346T mutation (e.g., JN.1.13.1), to “FLiRT” variants that contain both mutations such as KP.2, currently the most common circulating variant in the U.S., and to “FLuQE” variants that are increasing in circulation (e.g., KP.3).1,3,4 Our JN.1 vaccine candidate also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants including those containing the F456L, R346T and FLiRT mutations (e.g., KP.2).1 These responses indicate that our vaccine technology induces broadly neutralizing responses against multiple variant strains, including to circulating forward drift variants.
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