Posted on 11/17/2021 10:19:57 AM PST by SeekAndFind
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 platform, to contribute substantially to increased vaccination rates," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Novavax looks forward to SII's delivery of the vaccine to the Philippines, and with additional authorizations expected elsewhere soon, to helping control the COVID-19 pandemic around the globe."
Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas.
"The approval of COVOVAX in the Philippines is another step forward in the global fight against the coronavirus," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to deliver the first protein-based COVID-19 vaccine to the Philippines."
The Novavax/SII vaccine has recently received EUA in Indonesia and the companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency.
(Excerpt) Read more at markets.businessinsider.com ...
Not many places to run and hide on an island.
SOME Q&A about the Novavax Covid vaccine:
SOURCE:
Q: When can I get a Novavax coronavirus vaccine?
A: The vaccine, called NVX-CoV2373, is not currently available in the United States. The company expects to submit data to the Food and Drug Administration by the end of the year. Once authorization is requested, a rigorous review process will take place before the shot is cleared for use in the general public.
Q: What makes this coronavirus vaccine different from the ones we already have?
A: The Novavax vaccine is protein-based and uses the same platform as shots for shingles and hepatitis. The proteins deliver immune stimulation directly into a person’s cells as opposed to a fragment of genetic code. It is not an mRNA as is the case with Moderna and Pfizer, or an adenovirus vector, such as the Johnson & Johnson vax.
Q: How does it work?
A: The Novavax coronavirus vaccine is engineered from the genetic sequence of coronavirus with nanoparticle technology. The technology binds with human receptors targeted by virus which is critical for effective protection. When the vaccine is injected, it stimulates the immune system to produce antibodies.
Q: Is it safe and effective?
A: Clinical trials for the Novavax shot have shown an overall 90% efficacy against coronavirus and 100% protection against moderate and severe disease. Most common side effects include injection site pain and tenderness, fatigue, headache and muscle pain. No single adverse reaction was reported by more than 1% of trial participants.
Q: Can foreign travelers show proof of the Novavax vaccine to enter the United States?
A: Yes. Novavax clinical trial participants from sites outside the U.S. are considered fully vaccinated if they received the same product that was administered in the U.S. clinical trials. It is one of the vaccines already approved by the Centers for Disease Control and Prevention for air travel in the U.S., giving the 30,000 in the trial for the jab a passport to move around, whereas other shots haven’t made the cut.
Q: Could children get this vaccine?
A: The vaccine is not yet authorized for use in the United States, but Novavax initiated a pediatric expansion of a phase 3 clinical trial in May 2021 for children ages 12-17. The company intends to pursue authorization in that age group and younger age groups.
Q: How is it administered?
A: Two doses are given three weeks apart.
If I were unvaccinated, I would get whatever vaccine is available. The supply chain implications of the Novavax vaccine are interesting, but they have had difficulty manufacturing their vaccine. Hopefully they will figure out the manufacturing and be able to supply COVID-19 vaccines to countries with tropical climates that aren’t able to handle the logistics of cryogenic storage of mRNA vaccines.
What was wrong with Ivermectin?
This is the one and only vaccination that many here locally says they will take, myself included. It just has to get approved for usage here in the US.
It works and there is no $ to be made by the scientist at big pharma...
perhaps a long vacay in the Philippines
“This is the one and only vaccination that many here locally says they will take, myself included.”
Ditto. It is the ONLY vaccine I will so much as consider...
I am a little confused.
Is the Novavax vaccine a true vaccine in that it is a neutered virus or is it just another variation of the same mRNA delivery system that is used in the other covid vaccines?
If it is the old technology it has the potential for being safer since it is a tried and true method of immunization. But if it is mRNA like the others, then I’d be concerned.
I don’t believe this is what we would consider a traditional vaccine, however it is supposedly NOT mRNA.
I read a little about it’s development in that they use some sort of moth to develop the spike protein which is injected.
This spike protein is what causes the antibody response.
I’m sure I muddle that up...anyone add to this?
This website describes the technology behind the Novavax Covid Vaccine on detail:
Please see Post #12 of this thread.
Okay, now I am even more concerned. Protein?
What about the old tried and true neutered virus? Nothing fancy like moth cells and tree bark. Just the good old process that produced the Polio vaccine that everyone like to give as the example of a successful vaccine.
Thanx a bunch.
RE: What about the old tried and true neutered virus? Nothing fancy like moth cells and tree bark.
The Chinese have that with their Sinovac vaccine. Results were just as “effective” ( note the quotes ) if not even worse than the western vaccines.
India has one that just completed development and mass testing using the traditional inactivated virus. It’s called COVAXIN.
RE: Okay, now I am even more concerned. Protein?
The Protein stack technology is ALREADY IN EXISTENCE. The Hepatitis, Tetanus and Diphtheria vaccines are all based on this technology. I’ve had the Hepatitis vaccine 5 years ago ( never felt any side effects).
So does it follow the dead virus process? Apparently not.
So it is new... as of 5 years ago.
And no one is asking — okay we can do it but should we?
I guarantee that the people creating these concoctions don't know what they are doing 100%. And they don't know the risks.
This could be the end of humanity as we know it. But so be it. We dodged the nuclear annihilation bullet. Maybe we will get lucky here too. Or maybe we wont.
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