Coronavirus 2019-2020 thread (no unsubstantiated rumours!)

[vincent]

Yes, I know. Many fellow members have been criticizing the genetic based technologies most likely because the perception has been that China has been exclusively focusing on the traditional methods. I have disagreed with this view from the beginning. The purpose of my past several posts has been to show that China is also pursuing genetic based vaccine technologies, just like everyone else. The progress of these Chinese genetic based vaccines is not my concern. In fact, the lack of (or slower) progress of these genetic based vaccines in China has partially contributed to the fact that their most advanced vaccines have been based on traditional techs.

My beef with mRNA vaccines is that they have never been approved for the market plus the fact that normal vaccine developments have taken years (MMR was the shortest at 3 years), yet mRNA vaccines from Pfizer and Moderna (who had never had made a vaccine before) were approved for mass market in less than a year. We have no idea what potential long term effects they may have

 

[Shaolian]

Have Pfizer, or any other vaccines for that matter, released its Phase 3 trial results yet? Because here in Malaysia, we could always hear news of various new vaccine purchases by the government, but then our Health Director General would make a statement that final approval for any particular vaccine would be based on their Phase 3 results, and as far as he's concerned, none has so far produced a Phase 3 report.

 

[KYli]

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[KYli]

Have Pfizer, or any other vaccines for that matter, released its Phase 3 trial results yet? Because here in Malaysia, we could always hear news of various new vaccine purchases by the government, but then our Health Director General would make a statement that final approval for any particular vaccine would be based on their Phase 3 results, and as far as he's concerned, none has so far produced a Phase 3 report.

Pfizer and Moderna did release their Phase 3 results but the duration of the trial is too short so many feel the results can not be entirely trusted until further data is released.

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Key limitations of the data are the short duration of safety and efficacy follow-up. The trial is ongoing, and a follow-up duration of 2 years is planned, with possible changes to the trial design to allow participant retention and ongoing data collection. Another limitation is the lack of an identified correlate of protection, a critical tool for future bridging studies. As of the data cutoff, 11 cases of Covid-19 had occurred in the mRNA-1273 group, a finding that limits our ability to detect a correlate of protection. As cases accrue and immunity wanes, it may become possible to determine such a correlate. In addition, although our trial showed that mRNA-1273 reduces the incidence of symptomatic SARS-CoV-2 infection, the data were not sufficient to assess asymptomatic infection, although our results from a preliminary exploratory analysis suggest that some degree of prevention may be afforded after the first dose. Evaluation of the incidence of asymptomatic or subclinical infection and viral shedding after infection are under way, to assess whether vaccination affects infectiousness. The relatively smaller numbers of cases that occurred in older adults and in participants from ethnic or racial minorities and the small number of previously infected persons who received the vaccine limit efficacy evaluations in these groups. Longer-term data from the ongoing trial may allow a more careful evaluation of the vaccine efficacy in these groups. Pregnant women and children were excluded from this trial, and additional evaluation of the vaccine in these groups is planned.

 

[vesicles]

My beef with mRNA vaccines is that they have never been approved for the market plus the fact that normal vaccine developments have taken years (MMR was the shortest at 3 years), yet mRNA vaccines from Pfizer and Moderna (who had never had made a vaccine before) were approved for mass market in less than a year. We have no idea what potential long term effects they may have

Genetic based vaccines have been used for other diseases for over two decades. It's the first time it's been used against a coronavirus, yes. But patients with many other infectious and malignant diseases have been getting these vaccines for many years. Animal testing and clinical trials, as well as real-world data, have shown this tech is safe and effective. It's time to move on...

I've intentionally picked some old publications published over 10-15 years about these genetic based vaccines. This technology is NOT fresh-out-of-the lab.

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And a newer study:

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[vincent]

Genetic based vaccines have been used for other diseases for over two decades. It's the first time it's been used against a coronavirus, yes. But patients with many other infectious and malignant diseases have been getting these vaccines for many years. Animal testing and clinical trials, as well as real-world data, have shown this tech is safe and effective. It's time to move on...

I've intentionally picked some old publications published over 10-15 years about these genetic based vaccines. This technology is NOT fresh-out-of-the lab.

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And a newer study:

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How many mRNA/gene-based vaccines have tried on humans and how big are those trials? Any follow-up on potential long-term effects?

Pretty sure you can't guarantee there are no long-term side effects since the the trials are so short. Like i said, the shortest vaccine development in history was

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(my mistake earlier)

 

[vesicles]

How many mRNA/gene-based vaccines have tried on humans and how big are those trials? Any follow-up on potential long-term effects?

Pretty sure you can't guarantee there are no long-term side effects since the the trials are so short. Like i said, the shortest vaccine development in history was

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(my mistake earlier)

I have to apologize that I have no time digging too deep into this as of now. The publications that I showed above are all old publications that came out about a decade after the technology came out. It's natural that most of the trials conducted back then had been short. I'm sure longer trials have been conducted since then. Some of the genetic based vaccines are now in clinical use too.

Anyways, most of us actually have no choice. Those of us living in western nations either get a genetic based vaccine or no vaccine at all. People in China will most likely get traditional vaccines, or nothing at all. So most of us are left with no choice at all. I myself have no problem with genetic based vaccines. I will get my second shot (Moderna) tomorrow and hope to get immunity 15 days from now. I can't wait.

Also, after working with genetic materials for 20 years, the most we've struggled with has been to keep the exogenous genes in the host mammalian/human cells. These external genes tend to disappear as time goes. Our cells want to eliminate external stuff even if we design tricks to go around these mechanisms. It's a struggle we all have to face. So the most that I worry about these new genetic based COVID-19 vaccines is how long they can stay effective, even if the virus stops mutating.

Also, keep in mind that about 8% of our current genome is comprised of various viral genes. Throughout evolution, we have been infected with so many kinds of viruses. Many of these viruses have incorporated their genes into our own genome. And we have been passing on these viral genes to our offsprings for millions of years. Even IF the genetic vaccine somehow manages to incorporate into our genome (the likelyhood of that happening is slim to none), it's only a minute percentage of the viral genes that we already have in our genome.

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[vincent]

I have to apologize that I have no time digging too deep into this as of now. The publications that I showed above are all old publications that came out about a decade after the technology came out. It's natural that most of the trials conducted back then had been short. I'm sure longer trials have been conducted since then. Some of the genetic based vaccines are now in clinical use too.

Anyways, most of us actually have no choice. Those of us living in western nations either get a genetic based vaccine or no vaccine at all. People in China will most likely get traditional vaccines, or nothing at all. So most of us are left with no choice at all. I myself have no problem with genetic based vaccines. I will get my second shot (Moderna) tomorrow and hope to get immunity 15 days from now. I can't wait.

Also, after working with genetic materials for 20 years, the most we've struggled with has been to keep the exogenous genes in the host mammalian/human cells. These external genes tend to disappear as time goes. Our cells want to eliminate external stuff even if we design tricks to go around these mechanisms. It's a struggle we all have to face. So the most that I worry about these new genetic based COVID-19 vaccines is how long they can stay effective, even if the virus stops mutating.

Also, keep in mind that about 8% of our current genome is comprised of various viral genes. Throughout evolution, we have been infected with so many kinds of viruses. Many of these viruses have incorporated their genes into our own genome. And we have been passing on these viral genes to our offsprings for millions of years. Even IF the genetic vaccine somehow manages to incorporate into our genome (the likelyhood of that happening is slim to none), it's only a minute percentage of the viral genes that we already have in our genome.

Again, there have never been a mass marketed mRNA vaccine in history and now we have two that have Phase 3 trials measured in months instead of years like in the past. No one knows what, if any potential long-term effects they may have. I don't care how long the technology have been around. Hydrogen fuel cell were invented in 1839 and no one have been successfully commercialized it.
FYI, I'm in Canada and I don't like my choices (Pfizer or Moderna). I prefer not to have foreign RNA messing around in my cells, thank you very much. I much prefer tried and true inactivated ones

 

[vesicles]

How many mRNA/gene-based vaccines have tried on humans and how big are those trials? Any follow-up on potential long-term effects?

Pretty sure you can't guarantee there are no long-term side effects since the the trials are so short. Like i said, the shortest vaccine development in history was

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(my mistake earlier)

Again, there have never been a mass marketed mRNA vaccine in history and now we have two that have Phase 3 trials measured in months instead of years like in the past. No one knows what, if any potential long-term effects they may have. I don't care how long the technology have been around. Hydrogen fuel cell were invented in 1839 and no one have been successfully commercialized it.
FYI, I'm in Canada and I don't like my choices (Pfizer or Moderna). I prefer not to have foreign RNA messing around in my cells, thank you very much. I much prefer tried and true inactivated ones

There are long-term side effects associated with taking any medicine. Even something as common as aspirin can give you some very nasty side effects after you take it for over a decade at low doses. Giving it to a baby can literally kill the baby. For adults, GI issues have been the most common ones. A stomach ulcer is no joke when you have an internal bleeding. It's always a trade-off with medicines.

I respect your decision for not taking it and I fully understand your concerns. This will be my last post on this issue as I am not trying to push/convince anyone to take it. And I have no problem and am glad to be your guinea pig for the foreseeable future. I will let you know when/if I grow a third ear. I may have a chance to become the "COVID-Man"...

 

[taxiya]

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An interview of Gao Fu, the head of China's CDC. Some key points of China's choice of vaccine and considerations.

1. Why west did not (so far or as early as China) make traditional vaccine?
   • Inactivated vaccine need P3 protection standard, China made P3 labs for vaccine production. West did not.
   • As far as I know there are not many P3 lab in the world and most of them belongs to governments or universities, not companies.
2. Concern of mRNA tech
   • It is only used for medicine for cancer so far. Never used as vaccine for healthy people. There are unknowns. Traditional vaccine is a known. To be precaution, China takes traditional vaccine as the preferred choice.
   • IMO: this is saying use for cancer patient is worth the long term risk because otherwise the person dies, any possible long term side-effect is not acceptable for a healthy person.
3. China takes multiple approach
   • It is not competition between companies or countries. COVID-19 is a unknown, if any one of the approaches works, it is good for humanity.
   • Focusing on only one approach is bad, what if it does not work?

Here is a link to directive regarding mRNA vaccine development by NMPA (National Medical Products Administration) published in August 2020

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It is in Chinese and very technical, I won't translate, but it listed some concerns about the efficiency and reliability of mRNA all because of uncertainties. Having such document shows that China is taking a much more conservative approach.