Posted on 08/11/2021 12:17:27 PM PDT by SeekAndFind
Biotech company Novavax has announced it will be initially prioritizing regulatory submissions for its promising COVID-19 vaccine in countries with urgent needs such as India, Indonesia and the Philippines. The long-anticipated vaccine is also being trialed as a third booster in people initially administered other vaccines.
Novavax’s COVID-19 vaccine is what's known as a protein subunit vaccine. Currently available COVID-19 vaccines are designed to coax cells into producing a part of the SARS-CoV-2 virus which then trigger the immune system to recognize it. Novavax’s candidate is a little different. It directly delivers lab-grown coronavirus spike proteins into the body in the form of nanoparticles created to mimic the structure of the virus.
So far, Phase 3 trials have demonstrated incredibly promising efficacy, but the company has been facing some challenging manufacturing hurdles.
Most recently the company revealed its manufacturing facilities in the United States were struggling to pass the US Food and Drug Administration’s regulatory requirements, delaying its local approval until the end of 2021.
A recent announcement from Novavax reveals it is moving forward with manufacturing in India as part of a massive production deal with the Serum Institute of India. Regulatory submissions have now reportedly been filed with India, Indonesia and the Philippines.
The plan is to soon sort regulatory approval with the World Health Organization in order to allow low-income countries to access the vaccine. Over one billion doses are promised to these regions through a WHO scheme named COVAX.
"Today's submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax's transformation into a commercial global vaccine company," says Novavax CEO Stanley Erck. "This important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic was made possible through our strategic partnership with Serum Institute of India, and it demonstrates the power of global collaboration."
With current vaccine supplies not a problem in countries such as the US, it is unsurprising Novavax is shifting its current focus toward those parts of the world in great immediate need. Looking forward to 2022, Novavax is positioning its vaccine to be the booster of choice for countries with populations initially immunized with other vaccines.
Early data from an ongoing booster study indicate very effective antibody responses are generated by a third dose against new virus variants such as Delta. While that data is from trials investigating individuals vaccinated solely with Novavax’s candidate, a large mix-and-match booster trial in the United Kingdom is set to deliver valuable insights into the efficacy of different vaccines given as a third dose.
The study is called COV-Boost, and it's studying immune responses in people given a third dose of a COVID-19 vaccine at least three months after initial vaccination with either Pfizer or AstraZeneca vaccines.
Almost 3,000 subjects have been recruited for the booster study, with each participant randomly administered a booster of one of seven different COVID-19 vaccines. Initial data will evaluate immune biomarkers such as antibody responses, but subjects will be followed for a year, with subsequent infection data collected over the longer follow-up.
No data has been officially released from the COV-Boost trial so far, but Erck has suggested Novavax’s vaccine is being positioned as the, “universal booster of choice and the preferred vaccine for annual re-vaccination.”
What the f*ck is wrong with just having a straight up traditional vaccine as an option - enough of the scientific gymnastics
Handouts, payoffs, bribes and kickbacks is why we can’t.
I agree.
If somebody wants a booster, or first vax, this is the one.
This IS a traditional vaccine.
Same tech as Rubella, which every kid in America gets.
Well, the problem there is…..NO LAB HAS the ACTUAL FRIGGIN’ VIRUS.
You can’t make a vaccine from a dead virus if no one has the virus in a lab.
Ponder that.
At least, outside of the Wuhan Biowarfare lab.
This mass injection experiment is based on modeling the virus structure from what info the CCP provided last year. And injecting your body with billions of spike proteins that travel through your blood vessels to every organ, which then is where the antibodies go to war.
What could possibly go wrong,
after 35 million Americans have had Covid, how can they not have the actual virus ?
“Novavax positions its COVID-19 vaccine as “universal booster of choice””
yep, that’s just perfect for anyone wanting to be injected with their secret ingredient, Matrix-M ...
What do you mean “traditional”? You mean an attenuated or inactivated whole pathogen? Hasn’t been the standard since the 1980s. Conjugate, subunit, toxoid, and other types of vaccines have dominated since then. You’re missing about 35 years of vaccine development where safer, more effective vaccines have emerged.
Attenuation is particularly tricky. Get it wrong and it reverts to wild type and starts distributed infection clusters. Very few vaccines have been developed in the last 25 years that rely on that outdated way of doing things because it’s too dangerous.
I’m hoping that when my now 16 year old is mandated to take the vaccine, that she’ll be eligible for either the Norovax or the J&J (if they can fix their clotting problem for young women).
Every testing center in the world has samples of the virus. And selected specimens get whole genome sequencing to determine the precise variant.
The entire genome for SARS-CoV-2 is available for anyone in the world to browse any time: https://genome.ucsc.edu/covid19.html
And it’s been imaged many times as well. Both transmission and scanning electron microscopy images of SARS-CoV-2 are readily available from labs all over the US.
If J&J makes any significant changes to how their vaccine functions, they’ll need to restart clinical trials on it. I wouldn’t count on that. Further, J&J used fetal stem cells for R&D and testing, so if you’re pro-life, also a non-starter.
Novavax used ethical cell lines for their R&D and testing. The mRNA vaccines did as well. If AstraZeneca/Oxford ever get approved in the US (and I don’t think they will), they also used fetal stem cells for R&D and testing.
...a large mix-and-match booster trial in the United Kingdom is set to deliver valuable insights into the efficacy of different vaccines given as a third dose.
—
The Whitman’s Vaccine Sampler Pack. There’s Pfizer Nougat, Moderna Crunch, J&J Creme, and Novavax Cluster.
The novavax shot is a traditional one
An injection of pure spike proteins. What could possibly go wrong?
Please define the word traditional in the context of Novavax’s approach.
The list is long.
for later
Better to get just the spike proteins than the whole virus.
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