The Novavax Vaccine Data, and Spike Proteins in General: Should You be Concerned?
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Science ^
| Dr. Derek Lowe
1. Novavax Clinical DataWord came yesterday that Novavax had very good safety and efficacy in the trial of their recombinant protein vaccine. This
is good news. By this point, the vaccine is much less needed here in the US, but it could be a very important part of getting many other countries vaccinated, due to its less demanding storage requirements and (relatively) straightforward production process. The company does intend to file for FDA approval, and is in the last stages of getting all of its manufacturing and quality control procedures ready for that. I hope that this opens up to...
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Australia Approves Novavax COVID-19 Vaccine and New COVID Oral Drug Treatments - Pfizer's Paxlovid, Merck's Lagevrio
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Epoch Times ^
| 01/19/2022 | Nina Nguyen
The national drug regulator has given the green light to the Novavax vaccine, along with two oral treatments for patients currently suffering from COVID-19.The Therapeutic Goods Administration (TGA) on Thursday approved the Novavax vaccine, also called Nuvaxovid, for adults aged 18 years and over, making it the first protein-based COVID-19 vaccine in
the country’s arsenal.It is advised to be used as a primary vaccine only as studies into using Novavax as a booster shot are still in progress.Health Minister Greg Hunt on Thursday said he hoped the new jab would increase the nation’s vaccination rates.“We know that some people have...
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Novavax Covid Vaccine: Safe and Effective? An Analysis of Trial Results
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Sebastian Rushworth, MD Blog ^
| 01/15/2022 | Dr. Sebastian Rushworth, MD
I’ve been getting frequent requests for at least the last six months to write about the Novavax covid vaccine. I’ve
been resisting, mainly because it’s seemed uncertain whether it would ever actually be approved in the western world. Now that it’s been approved for use in the EU, however, that has changed, and I figure that I can put it off no longer.I guess the reason so many people are excited about the Novavax vaccine is that it uses a traditional technology that’s been used many times previously, rather than the new-fangled technologies used in the mRNA and adenovector vaccines...
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South Korea approves Novavax coronavirus vaccine, making it the fifth coronavirus vaccine available in the country.
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MSN ^
| 01/13/2022 | Andrew Jeong
SEOUL — South Korea’s drug regulator on Wednesday granted final authorization to Novavax’s coronavirus vaccine for use in adults, health officials said in a news release, making it the fifth coronavirus vaccine available in the country. Although
the authorization is conditioned on the Maryland-based company’s submission of the final results of clinical studies regarding its vaccine, the Ministry of Food and Drug Safety said Novavax’s coronavirus vaccine has received “final” approval in South Korea. The vaccine, which will be produced locally, is effective and safe, the regulator said. The AstraZeneca-Oxford, Pfizer-BioNTech, Moderna and Johnson & Johnson coronavirus vaccines have been...
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U.S. Could Authorize Novavax Covid Vaccine—An MRNA Alternative—In February 2022, CEO Says
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Forbes ^
| 01/10/2022 | Zachary Snowdon Smith
Novavax’s Covid-19 vaccine, already available for use in 170 countries and most well-known for being a non-mRNA vaccine alternative, could be approved for use in the U.S. in February and in up to 10 other countries within 90 days, CEO Stanley Erck told CNBC Monday. The Maryland-based biotechnology company submitted its final
data packages to the U.S. Food and Drug Administration on New Year’s Eve, but won’t be able to request emergency use authorization until January 31, after which the company expects a decision within one month, Erck said. Erck said the company expects its vaccine to be approved for...
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What Happened to the Novavax Vaccine? As mRNA vaccines saturate the U.S. market, is there room for another?
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Medpage Today ^
| 01/02/2022 | Jennifer Henderson
In June 2021, MedPage Today wrote about whether Novavax and its "tried-and-true" subunit protein approach to a COVID-19 vaccine could potentially ease vaccine hesitancy. In
this story, we explore what's known about the vaccine and why it still isn't on the market. Pfizer, Moderna, and Johnson & Johnson: Ask any American, and they'll likely be able to rattle off the trio of COVID-19 vaccines available in the U.S. But what about Novavax's "tried and true" protein subunit vaccine? Early this year, public health experts told MedPage Today that Novavax -- whose vaccine strategy is used in other vaccines on the...
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Novavax files COVID-19 vaccine data with FDA Clearing the Way for Emergency Authorization in 2022
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The Hill ^
| 12/31/2021 | Brad Dress
Novavax on Friday filed final data with the Food and Drug Administration (FDA) for its COVID-19 vaccine, clearing the way for a potential emergency approval next year. The
move was the last step for the Maryland-based biotechnology company to fulfill prerequisites for its protein-based vaccine, which is different than the other three vaccines approved in the U.S. from Pfizer, Moderna and Johnson & Johnson. If all goes well, Novavax could seek emergency approval next month as the U.S. continues to prioritize booster shots amid a spike in confirmed coronavirus cases driven by the highly transmissible omicron variant. "Novavax is committed...
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Good News for Novavax as Vaccine Works on Omicron Variant
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Tip ranks via NASDAQ ^
| 12/30/2021 | Steve Anderson
Drug maker Novavax (NVAX) recently revealed a bit of good news that gave the stock an extra 3.4% boost in premarket trading last Thursday. The positive momentum did not last long, as the stock was seen drops approaching 6% in trading Thursday morning. The
unexpected fluctuations in trading aside, I'm bullish on Novavax. There are some significant potential expansions ahead, and investors have an excellent opportunity to take advantage of these. The latest news should be more helpful than the market seems willing to accept. Novavax revealed that its COVID-19 vaccine is effective against the Omicron variant. However, as seems...
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Novavax’s Covid-19 Vaccine Approved by EU: Move paves way in Europe for first shot using an established vaccine technology
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ABC News ^
| 12/21/2021 | Mike Corder, Associated Press
THE HAGUE, Netherlands -- The European Union’s drugs regulator gave the green light Monday to a fifth COVID-19 vaccine for use in the 27-nation bloc, granting conditional marketing authorization to the two-dose vaccine made by U.S. biotech company Novavax. The European Medicines Agency decision to recommend granting conditional marketing authorization for the
vaccine for people aged 18 and over, which must be confirmed by the EU’s executive commission, comes as many European nations are battling surges in infections and amid concerns about the spread of the new omicron variant. Novavax says it currently is testing how its shots will hold...
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New Novavax COVID-19 Vaccine Found To Be Safe and Effective in Trial – “Highly Efficacious and Very Safe” After Clinical Trials
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SciTech Daily ^
| 12/18/2021 | UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE
An investigational COVID-19 vaccine made by Novavax was found to be 90 percent effective at preventing COVID-19 illness, according to results from a Phase 3 clinical trial published on December 15, 2021, in the New England Journal of Medicine. The University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and
Global Health served as one of the trial sites, and Karen Kotloff, MD, Professor of Pediatrics at UMSOM, served as Co-Chair for the trial protocol. In the study, researchers recruited nearly 30,000 adult volunteers at 113 clinical sites in the United States and six sites in Mexico. Approximately...
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WHO approves Novavax COVID vaccine
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Fox News via AP ^
| 12/17/2021
The World Health Organization has given emergency approval to a coronavirus vaccine made by U.S.-based Novavax and the Serum Institute of India, paving the way for its inclusion in the U.N.-backed program to get vaccines to poorer countries around the world. The
vaccine, known as CovavaxTM, is the ninth to be granted an emergency use authorization from the U.N. health agency, marking a vote of confidence for Novavax that could also mean the shots will be accepted by some countries that only admit travelers vaccinated with WHO-backed jabs. The U.N.-backed COVAX program, which is shipping coronavirus vaccines to many poor...
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Novavax working on vaccine to combat Omicron variant
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The hill ^
| 11/27/2021 | Lexi Lonas
Biotechnology company Novavax is working on a vaccine to combat the new Omicron coronavirus variant that was first detected in South Africa. Public health officials in the U.S. and abroad are worried the Omicron variant could be more transmissible and resistant to the current vaccines due to the 30 mutations at the
spike protein. This protein is the region that interacts with human cells prior to entry.
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Novavax developing vaccine that targets new COVID-19 "Omicron" variant detected in Africa: Ready for testing and manufacturing in the next few weeks.
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Reuters ^
| 11/26/2021
Nov 26 (Reuters) - Novavax Inc (NVAX.O) said on Friday it had started working on a version of its COVID-19 vaccine to target the variant detected in South Africa and would have the shot ready for testing and manufacturing in the next few weeks. The
company's COVID-19 shot contains an actual version of the virus' spike protein that cannot cause disease but can trigger the immune system. The vaccine developer said it had started developing a spike protein specifically based on the known genetic sequence of the variant, B.1.1.529. "The initial work will take a few weeks," a company spokesperson...
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Novavax Developing Vaccine Against the Omicron Variant That Appeared 72 Hours Ago – Will Be Ready in Two Weeks, Already in Emergency Use Trials in Indonesia and the Philippines
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The Conservative Treehouse: The Last Refuge ^
| 11/26/2021 | Sundance
Wow, 72 hours ago no one even heard the name Omicron variant. Now,
in less than three days, a variant has been identified, global travel has been halted, states of emergency have been declared, and now we see a pharmaceutical company announcing the variant specific vaccine trial that will begin in the U.S. in a few weeks. This government relationship with Big Pharma is certainly generating some fast action, eh?If a person was cynically inclined; while knowing governments’ need to control inflation yet cannot raise interest rates or stop purchasing debt because current legislative spending continues – a remarkable control...
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Novavax: Covid-19 Vaccine Gathering Momentum in Asia and Europe
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NASDAQ ^
| 11/22/2021 | Marty Shtrubel
Novavax (NVAX) investors have had to be patient, as delays have seen its Covid-19 vaccine lag competitors’ offerings. However,
recently the vaccine has been showing evidence it could still play a prominent role in the ongoing global fight against the coronavirus. On Wednesday, the company announced two positive developments. First off, the biotech announced that NVX-CoV2373 has been granted emergency use authorization (EUA) in the Philippines, where it will go to market under the brand name COVOVAX. The Philippines is one of the world’s most populace countries, with over 110 million people, however, only 22% are considered fully vaccinated, although...
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The Novavax Vaccine Data, And Spike Proteins In General (Don't be deceived. Novavax is pure spike proteins!)
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seekingalpha.co ^
| Jun. 16, 2021 | Derek Lowe
ransomnote: This article promotes the Covid "vaccines". It
makes statements since disproven (e.g., falsely states spike proteins are not harmful). I'll put related links in post #1)4. Back to the Novavax ResultsThere is another line of argument to make. Remember, the Novavax vaccine does not cause cells to produce the Spike protein. It is the Spike protein, injected directly into a person’s body, along with an adjuvant to make the immune reaction that much more vigorous.It does not get cleaved to make S1 protein, because that cleavage site has been mutated to keep that from happening, but it does bind...
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Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines
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Business Insider ^
| 11/17/2021
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Novavax' recombinant
nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX™. "With less than a third of the Philippine population fully immunized, we expect the option for a protein vaccine, built on a well-understood technology...
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European Regulator Starts Assessing Novavax’s Covid Vaccine—Stock Jumps 8%; Green Light Could Come "Within Weeks"
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Forbes ^
| 11/17/2021 | Robert Hart
Europe’s medicines regulator said Wednesday it could greenlight Novavax’s Covid-19 vaccine “within weeks” if data provided is able to demonstrate the shot’s efficacy and safety, a major boon for the Maryland-based biotech, which has been plagued with manufacturing difficulties and until November had not managed to bring a vaccine to market in
its 34-year history. KEY BACKGROUND While Novavax may be late to arrive, the shot has a number of advantages over existing vaccines and has the potential to dramatically boost vaccination rates worldwide. It appears to have an impressive efficacy on par with mRNA vaccines from the likes of...
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Novavax asks for FDA meeting after first global authorization for its COVID-19 vaccine: CEO
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AOL ^
| 11/11/2021 | ANJALEE KHEMLANI
Novavax (NVAX) is getting some momentum for its two-dose COVID-19 vaccine, starting with a series of emergency use fillings globally and the first authorization in Indonesia this month. The
company is on track to file with the U.S. Food and Drug Administration (FDA) by the end of the year, and has already called for a meeting with the agency to move forward, according to CEO Stanley Erck. Erck told Yahoo Finance Live on Wednesday that the company expects to hear back from the FDA "very soon" and believes Novavax could receive up to five authorizations in the coming 6-8 weeks...
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COVID News: Novavax says its vaccine could win over skeptics; Plans to submit complete data to the US FDA soon for emergency use authorization
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MSN ^
| 11/07/2021
The biotechnology company Novavax plans to submit complete data to the US Food and Drug Administration soon for possible emergency use authorization of its coronavirus vaccine, CEO Stanley Erck told CNN in a phone interview Friday. Novavax's vaccine, called NVX-CoV2373, is made using somewhat more conventional methods than the vaccines already authorized
for use in the US. It uses small, laboratory-made pieces of the coronavirus to stimulate immunity -- an approach some people may be more familiar or comfortable with. Viral vector and mRNA Covid-19 vaccines have thus far been the work horses in Western countries. But, these are not...
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