AunBear89 said:
sycasey said:
oski003 said:
sycasey said:
oski003 said:
sycasey said:
oski003 said:
sycasey said:
oski003 said:
sycasey said:
oski003 said:
sycasey said:
oski003 said:
AunBear89 said:
chazzed said:
Snowflakes are not able to adapt. What happened to the rugged Anerican?
Science evolves and changes as new data is gathered.
Republicans are incapable of this.
I knew a year ago that the vaccines didn't clear the virus in the nose and airways. This was well documented in the data from the primate challenges. Unfortunately, the data did not support the CDC's public policy driven goals.
The original "alpha" variant did show far reduced transmission after people had been vaccinated. Delta is more transmissible. The CDC was correct about the version of COVID that was in circulation at the time. Now there is a new version.
Is this the first ever coronavirus to mutate? Or does it mutate like EVERY single coronavirus? It would be one thing if the trials showed the vaccine was actually effective against getting the virus. The monkey challenge data was clear as the vaccinated monkeys did not clear the ALPHA virus in the nose. As for humans, only AZN tested their trial participants regularly, which is why they showed such low efficacy and had a lot to do with their rejection. Moderna and Pfizer participants had to show symptoms and then call and get a recommendation to get tested. They still all do very well against severe disease though.
Sorry that the CDC (or anyone else) was not able to accurately predict exactly which way this coronavirus would mutate.
We have a worldwide pandemic that has been mutating for more than a year and the CDC convinced you that a less infectious version may likely spread more than a more infectious version? Do they also sell ice to Eskimos?
This question doesn't make any sense.
Fact 1: highly infectious worldwide pandemic
Fact 2: this virus is a coronavirus and they mutate
Fact 3: this virus has been mutating for more than a year
Fact 4: Sycasey and the CDC are somehow stunned that a more infectious variant is in the U.S.
1. I never said mutation was a surprise.
2. I said no one can predict exactly HOW or WHEN or WHERE the virus will mutate, including the CDC.
3. That means you can't just assume a more contagious variant will emerge. The CDC can only make recommendations based on current conditions.
Got it?
Take the red pill and wake the **** up.
Got it?
Edited to add that this is my favorite excuse:
The CDC can only make recommendations based on current conditions.
You get bonus points.
"Excuse." Only a person deep in the conspiracy rabbit hole would use that language here.
A lot of people would have been alive today if the CDC acted on the information provided by China and didn't bow down to politics. Oh no, the Coronavirus won't come here (while Congress sells their stocks)! It is not airborne, no need to wear masks! The vaccinated don't need to wear masks indoors (meanwhile the grocery store check out clerk is powerless to ask if some is actually vaccinated)!
I won't get drawn in to defending every decision the CDC has made. I am only saying that their recent change to their recommendations is reasonable.
In RWNJ land, the perfect is the enemy of the good.
Zydus Cadila Group could make history after applying for approval for the first ever human DNA vaccine in India. But that could be just the start for a technology that could treat a vast array of diseases, including cancer, infectious diseases and chronic diseases.
But it may come as a surprise that it's more than 15 years since the first DNA vaccine was approved to counter the West Nile virus in horses.
Since then, pharma and biotech firms have been working on the technology for human use, hoping that it could confer a huge advantage over conventional vaccines that until recently were grown in hen's eggs and took years to develop.
DNA vaccines could be faster to design and produce, now that technology is available to create non-replicating plasmids containing pretty much any gene. That allows vaccines to be custom-made to produce an immune response against emerging pathogens, or antigens found on cell surfaces, including those on tumors.
DNA vaccines could also have a significant advantage over the RNA vaccines that have already been developed and approved for COVID-19, as they are more stable and can be stored at room temperature.
DNA vaccines are capable of creating a humoral (antibody-based) response as well as calling in an attack from T cells against the target, whether it's a virus or an unwanted cell.
Zydus Cadila, of Ahmedabad, India, hopes that its ZyCoV-D could be the first DNA vaccine approved in humans, following a filing with the country's national regulator at the beginning of July.
Results from a phase III study produced efficacy numbers that were slightly lower than those seen with mRNA but the company noted that the study was conducted India, at the epicenter of the outbreak of the more infectious Delta variant.
Cell machinery
DNA vaccines work along the same lines as RNA vaccines they are injected into a host and instruct the cell's machinery to produce antigens, which are recognized by the immune system.
They are based around plasmids circles of free-floating DNA which include a code for a gene or gene fragment, that is read by the host's cells to produce a protein.
That protein then produces an immune reaction against the desired target.
DNA vaccines had already been suggested for a next-generation approach to flu vaccines, but the COVID-19 pandemic has focused efforts to develop them. The technology was just becoming viable in humans as the pandemic emerged, after years of tweaking the delivery system and adjuvants that ensure vaccine particles are delivered to the right place in the body and have a strong enough clinical effect.
There are now around 18 DNA vaccines in the clinic for COVID-19 alone, including the shot from Zydus Cadila.
But that's a tiny fraction of the 504 DNA vaccines now in clinical development for all indications, according to figures from Clarivate Cortellis.
DNA vaccines are being developed to tackle diseases, including numerous forms of cancer, peanut hypersensitivity, HIV, Ebola, diabetes and Alzheimer's disease.
One of the closest DNA vaccines to market for COVID-19 is from Inovio Pharmaceuticals Inc., in partnership with the International Vaccine Institute and Advaccine (Suzhou) Biopharmaceutical Co., Ltd.
In April Inovio announced that the vaccine candidate INO-4800 appears active against variants, producing both neutralizing antibodies and T-cell responses against all spike protein variants tested in the phase I study, including those first detected in the U.K., South Africa and Brazil.
Finish line approaching
Phase III development is now underway in COVID-19 and Kate Broderick, Inovio's senior vice president of research and development, said the technology is closer than ever to the market.
Kate Broderick, senior vice president, R&D, Inovio
"We feel we are really close to the finishing line," she told BioWorld.
According to Broderick, DNA vaccines have taken a long time to develop because simply because they needed considerable work to get them ready for human use.
She said, "Veterinary products are highly regulated; for human beings its times 1,000. That quite rightly should be a complex process to ensure any new technology is tested as rigorously as possible."
Designing the DNA is the easy bit, thanks to modern technology, Broderick pointed out.
"Anyone could download a sequence from the internet, but would that work in the clinic? No. We have spent 10 years using AI to come up with algorithms that help to optimize the DNA sequences and make them work as well as possible in human beings."
Sequences must be as immunogenic as possible but not inflammatory and DNA can't be injected like a standard vaccine.
Inovio has gone down the route of using a delivery system that uses gentle pulses of electricity to send the vaccine to the target cells, which are in the skin for COVID-19 and in muscles for oncology vaccines.
One of the worries with DNA vaccines in the early days was that the plasmid could become integrated into the host itself, a potentially dangerous outcome.
Broderick added, "We have had 15 years to test that hypothesis and there has been no evidence of any integration events."
Sally Adams, chief development officer at U.K.-based Scancell Holdings plc, a rival of Inovio that is developing DNA vaccines against cancer, puts it in more technical terms.
"Theoretically calculated estimates indicate that the probability of injected DNA having a harmful effect is less than 10-16 to 10-19 per DNA molecule," she said.
"This includes the cumulative probabilities of degradation of the injected DNA by nucleases, absorption and uptake into cells, integration and the probability of integration into an oncogene or tumor suppressor gene.
"These calculations are supported by experimental data that also show a very low risk of insertional mutation associated with direct DNA injection."
Safety benefits
As a result, the FDA only requires studies to check for integration events in certain limited circumstances if large quantities of plasmids seem to be hanging around after treatment in animal studies.
Adams noted that off-target effects on the immune system can occur with mRNA vaccines but are much less of a problem with DNA. "mRNA is highly unstable and requires complex formulations to protect the nucleic acid from degradation," she said. "These formulation components themselves have the potential to induce side effects and significantly increase the complexity of manufacture and storage.
"The manufacturing process for mRNA also has the potential to generate double-stranded RNA as a product-related contaminant, which is a potent signaling molecule."
That double-stranded RNA induces a response from type 1 interferons, which can cause a strong immune reaction in the recipient.
Both Adams and Broderick added that DNA vaccines could be used repeatedly with much lower risk of a neutralizing response from the recipient's immune system, a problem that occurs with mRNA and vaccines that use a viral vector to deliver genetic material.
Storage and logistics
The inherent stability of DNA also translates into a product that is easy to store compared with mRNA.
Inovio's formulation is stable at room temperature and does not require the ultra-cool temperatures needed to ensure mRNA vaccines retain their integrity.
Even though there are now several vaccines already on the market for COVID-19, Broderick said she expects that the ease of storage, safety profile and possibility of multiple doses means DNA vaccines will play an important role in the later stages of the pandemic.
"COVID-19 is not going anywhere. The chances are we are going to need booster shots. DNA vaccines have been shown to be re-administered multiple times."
But Inovio and Scancell have their sights on using the technology to fight cancer and the technology is now well established in the clinic.
Inovio has a vaccine targeting precancerous cervical dysplasia in phase III development and several other oncology targets in phase II. That includes a potential vaccine for glioblastoma multiforme, one of the toughest to treat cancers with very poor outcomes.
As was the case with RNA vaccines, COVID-19 has proved to be a catalyst for development of DNA vaccines, which could be used in a wide range of settings outside of infectious diseases.
"Before last year nobody knew what an RNA vaccine was," Broderick said. "Now we talk about it all the time. That's amazing. We have brought on a new technology and embraced it. and we are on the brink of doing the same thing with DNA."