4 ms·

Further we're long past beta testing with a large percentage of people being vaccinated How is a large percentage of people getting the beta an indication that

Further we're long past beta testing with a large percentage of people being vaccinated How is a large percentage of people getting the beta an indication that we're past beta testing? None of the vaccines have FDA approval.

bb88 5y ago
Yes. Yes they have FDA approval.
- AnimalMuppet 5y ago
  So, for those of us who think the last state of play was that they did not have approval, can you point us to something official?
  - jaybrendansmith 5y ago
    They have emergency approval. All major studies are completed, Clinical Study Reports are submitted with all evidence, Case Report Forms, datasets. It is important but largely a bureaucratic and scientific exercise at this point. These vaccines are safer and more effective, with less side effects, than the bulk of all medicines submitted last year. People have been working around the clock for the last 18 months on these treatments in an attempt to save more lives. If the propagandists cared a whit about humanity they would encourage everybody to vaccinate immediately. It is quite possible that a variant will be created by the unvaccinated that is resistant to the vaccines, one that is perhaps even more deadly, instantly turning the world back to lockdown for another year.
    - HdiJWQCycmpbGd 5y ago
      The COVID-19 vaccines are all "leaky" in that they don't really prevent infection and transmission but simply attenuate and reduce the severity of symptoms. Therefore, Sars-Cov-2 will continue to evolve in both unvaccinated and vaccinated populations, but the vaccine will put evolutionary pressure on Sars-Cov-2 in the vaccinated population that will select for fitter variants (this has happened before in other "leaky" vaccines, see: https://en.wikipedia.org/wiki/Marek%27s_disease#Prevention https://en.wikipedia.org/wiki/Marek%27s_disease#Prevention and https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1002198 https://journals.plos.org/plosbiology/article?id=10.1371/jou...). I'd argue that fitter, more dangerous variants will probably evolve in the vaccinated population as opposed to the unvaccinated for this reason. Having said that, these new variants will mostly be a threat to the unvaccinated and, if so, I can see a future where we'll be vaccinating kids very early on to prevent serious disease.
      - jaybrendansmith 5y ago
        While I hear what you're saying, were we all vaccinated, we would quickly reach herd immunity and the virus would stop bouncing around completely, thus rendered a historical footnote like Polio and Smallpox.
  - bb88 5y ago
    I had no problem running a Google search to find this. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coro... And if you care to read it, the decision memo is here. https://www.fda.gov/media/144416/download https://www.fda.gov/media/144416/download Granted that's the Pfizer vaccine. Google is your friend here for other vaccines approved by the FDA.
tablespoon 5y ago
> How is a large percentage of people getting the beta an indication that we're past beta testing? Because testing is giving it to people and seeing what happens. The more people you give it to, the more rare and unusual reactions you can find. IIRC, drug testing involves giving the drug to progressively larger groups of people, to mitigate the damage if there are serious adverse side effects. > None of the vaccines have FDA approval. While technically they don't have "full approval," they do have "emergency use approval." At this point, full approval is just a bureaucratic exercise, because the widespread emergency use rollout has tested these vaccines far, far better than any typical pharmaceutical testing program. Per Wikipedia (https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_III https://en.wikipedia.org/wiki/Phases_of_clinical_research#Ph...), a Phase III trial involves 300–3,000 test patients. About 50% of the US population has been vaccinated, so you can think of that as a test on 150 million people. That's 50,000 times more than in your typical drug trial. At this point, refusing the vaccine because it hasn't been tested enough is like refusing a common drug like ibuprofen for the same reason.

bb88 5y ago

Yes. Yes they have FDA approval.

AnimalMuppet 5y ago
So, for those of us who think the last state of play was that they did not have approval, can you point us to something official?
- jaybrendansmith 5y ago
  They have emergency approval. All major studies are completed, Clinical Study Reports are submitted with all evidence, Case Report Forms, datasets. It is important but largely a bureaucratic and scientific exercise at this point. These vaccines are safer and more effective, with less side effects, than the bulk of all medicines submitted last year. People have been working around the clock for the last 18 months on these treatments in an attempt to save more lives. If the propagandists cared a whit about humanity they would encourage everybody to vaccinate immediately. It is quite possible that a variant will be created by the unvaccinated that is resistant to the vaccines, one that is perhaps even more deadly, instantly turning the world back to lockdown for another year.
  - HdiJWQCycmpbGd 5y ago
    The COVID-19 vaccines are all "leaky" in that they don't really prevent infection and transmission but simply attenuate and reduce the severity of symptoms. Therefore, Sars-Cov-2 will continue to evolve in both unvaccinated and vaccinated populations, but the vaccine will put evolutionary pressure on Sars-Cov-2 in the vaccinated population that will select for fitter variants (this has happened before in other "leaky" vaccines, see: https://en.wikipedia.org/wiki/Marek%27s_disease#Prevention https://en.wikipedia.org/wiki/Marek%27s_disease#Prevention and https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1002198 https://journals.plos.org/plosbiology/article?id=10.1371/jou...). I'd argue that fitter, more dangerous variants will probably evolve in the vaccinated population as opposed to the unvaccinated for this reason. Having said that, these new variants will mostly be a threat to the unvaccinated and, if so, I can see a future where we'll be vaccinating kids very early on to prevent serious disease.
    - jaybrendansmith 5y ago
      While I hear what you're saying, were we all vaccinated, we would quickly reach herd immunity and the virus would stop bouncing around completely, thus rendered a historical footnote like Polio and Smallpox.
- bb88 5y ago
  I had no problem running a Google search to find this. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coro... And if you care to read it, the decision memo is here. https://www.fda.gov/media/144416/download https://www.fda.gov/media/144416/download Granted that's the Pfizer vaccine. Google is your friend here for other vaccines approved by the FDA.

tablespoon 5y ago

> How is a large percentage of people getting the beta an indication that we're past beta testing? Because testing is giving it to people and seeing what happens. The more people you give it to, the more rare and unusual reactions you can find. IIRC, drug testing involves giving the drug to progressively larger groups of people, to mitigate the damage if there are serious adverse side effects. > None of the vaccines have FDA approval. While technically they don't have "full approval," they do have "emergency use approval." At this point, full approval is just a bureaucratic exercise, because the widespread emergency use rollout has tested these vaccines far, far better than any typical pharmaceutical testing program. Per Wikipedia (https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_III https://en.wikipedia.org/wiki/Phases_of_clinical_research#Ph...), a Phase III trial involves 300–3,000 test patients. About 50% of the US population has been vaccinated, so you can think of that as a test on 150 million people. That's 50,000 times more than in your typical drug trial. At this point, refusing the vaccine because it hasn't been tested enough is like refusing a common drug like ibuprofen for the same reason.