3 ms·

General question to the community here. I have zero background in medicine or biology after high school. I barely understand the difference between virus and ba

General question to the community here. I have zero background in medicine or biology after high school. I barely understand the difference between virus and bacteria. I read a lot of articles which dismiss anti-vaxxers as morons and anti-science, I have first hand seen the immense benefits a vaccine like polio vaccine has brought to India so I am all for more vaccines. But what is the standard of evidence that X vaccine won't cause some harm to me ? Is is more formal proof but looking at the molecular structure of he virus, vaccines human biology and proving that only possible effect is on new anti-bodies and it won't bring any harm ? Or this is more about just ensuring vaccine meets FDA's guidance ? I have lot more faith in science but next to no faith in FDA, CDC and other government bodies.

fabian2k 6y ago
The standard is a phase III trial, in this case the trials were with around ~40,000 people each for the current vaccine candidates. Then you look at the observed efficacy and the observed side effects and decide whether the benefits are worth the side effects. There is nothing even close to a formal proof here, that is simply far outside of what science can do today. In the end we always have to run trials and observe.
- generalizations 6y ago
  The other trouble is that these excellent trials will only be able to observe relatively immediate side effects. If there's other long-term side effects, they won't be detected for years or more.
  - entropicdrifter 6y ago
    While this is true, the Pfizer vaccine was created by essentially reverse engineering the SARS-COV-2 virus and copying a small section of mRNA from it in order to stimulate the body into creating antibodies. Unlike older methods of creating vaccines this has a much lower risk of side effects because only a harmless portion of the virus's genetic code that allows it to infect people is being injected, rather than deactivated virus cells. Pretty interesting stuff: https://www.forbes.com/sites/alexknapp/2020/11/10/what-you-need-to-know-about-pfizers-covid-19-vaccine/?sh=4160d1f04c46 https://www.forbes.com/sites/alexknapp/2020/11/10/what-you-n... Apparently the Moderna vaccine is also based on the mRNA tech: https://www.nytimes.com/live/2020/moderna-covid-19-vaccine https://www.nytimes.com/live/2020/moderna-covid-19-vaccine There are a number of vaccines based on the older methods of creating a vaccine, including the J&J vaccine, but most are not as far along in the trial process.
    - generalizations 6y ago
      > Unlike older methods of creating vaccines this has a much lower risk of side effects because only a harmless portion of the virus's genetic code that allows it to infect people is being injected, rather than deactivated virus cells. > Apparently the Moderna vaccine is also based on the mRNA tech: https://www.nytimes.com/live/2020/moderna-covid-19-vaccine https://www.nytimes.com/live/2020/moderna-covid-19-vaccine That's exactly what I have a problem with: mRNA vaccines have never been approved for use in humans, and they're only getting an emergency approval this time. https://en.wikipedia.org/wiki/RNA_vaccines https://en.wikipedia.org/wiki/RNA_vaccines Don't tell me it's 'pretty interesting stuff': tell me that we're not using an experimental drug that's not using a novel type of vaccine that's never been used in humans prior to this year, for which long-term side effects are pretty much unknown.
  - Exmoor 6y ago
    The mechanism for how these vaccines work is pretty straightforward, well understood, and quick acting. They trigger your immune system to be aware of a threat and train it to defeat that threat. This is something your body does fairly constantly with natural pathogens without any known delayed long-term effects. This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent. The two modern (last 50 years) incidences where a vaccine may have caused a serious side effect in a statistically significant way [0][1] may have taken a little bit of time to be noticed, but it was because they were so statistically rare, not because the actual problem was delayed in occurring. Interestingly, both those incidents involved auto-immune illnesses which would have likely been much more likely to occur if the vaccinated folks caught the virus itself. [0] https://en.wikipedia.org/wiki/Pandemrix https://en.wikipedia.org/wiki/Pandemrix [1] https://en.wikipedia.org/wiki/1976_swine_flu_outbreak https://en.wikipedia.org/wiki/1976_swine_flu_outbreak
    - generalizations 6y ago
      > The mechanism for how these vaccines work is pretty straightforward, well understood, and quick acting. Before 2020, mRNA was only considered a theoretical or experimental candidate for use in humans. Sure, we have a theory behind the mechanism, but that's it. Your implication that we know all about what these novel, unfamiliar mRNA vaccines will do is flat out wrong. > This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent. That's because there's almost no precedent at all. https://link.springer.com/protocol/10.1007%2F978-1-4939-6481-9_1 https://link.springer.com/protocol/10.1007%2F978-1-4939-6481... https://en.wikipedia.org/wiki/RNA_vaccines https://en.wikipedia.org/wiki/RNA_vaccines
    - oicu812 6y ago
      > This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent. RotaShield [0] was a vaccine for the rotavirus that was released in 1998 and taken off the market in 1999 because of intussusception (bowel folding on itself). 5 cases of this issue occurred during during trials of 10,054 participants, which was deemed "not statistically significant". After the vaccine was licensed and widely distributed, the CDC determined the risk of this complication from the vaccine was 20 to 30 times over the expected risk and the vaccine was pulled off the market. [0] https://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-rotashield-historical.htm https://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-rotashiel...

fabian2k 6y ago

The standard is a phase III trial, in this case the trials were with around ~40,000 people each for the current vaccine candidates. Then you look at the observed efficacy and the observed side effects and decide whether the benefits are worth the side effects. There is nothing even close to a formal proof here, that is simply far outside of what science can do today. In the end we always have to run trials and observe.

generalizations 6y ago
The other trouble is that these excellent trials will only be able to observe relatively immediate side effects. If there's other long-term side effects, they won't be detected for years or more.
- entropicdrifter 6y ago
  While this is true, the Pfizer vaccine was created by essentially reverse engineering the SARS-COV-2 virus and copying a small section of mRNA from it in order to stimulate the body into creating antibodies. Unlike older methods of creating vaccines this has a much lower risk of side effects because only a harmless portion of the virus's genetic code that allows it to infect people is being injected, rather than deactivated virus cells. Pretty interesting stuff: https://www.forbes.com/sites/alexknapp/2020/11/10/what-you-need-to-know-about-pfizers-covid-19-vaccine/?sh=4160d1f04c46 https://www.forbes.com/sites/alexknapp/2020/11/10/what-you-n... Apparently the Moderna vaccine is also based on the mRNA tech: https://www.nytimes.com/live/2020/moderna-covid-19-vaccine https://www.nytimes.com/live/2020/moderna-covid-19-vaccine There are a number of vaccines based on the older methods of creating a vaccine, including the J&J vaccine, but most are not as far along in the trial process.
  - generalizations 6y ago
    > Unlike older methods of creating vaccines this has a much lower risk of side effects because only a harmless portion of the virus's genetic code that allows it to infect people is being injected, rather than deactivated virus cells. > Apparently the Moderna vaccine is also based on the mRNA tech: https://www.nytimes.com/live/2020/moderna-covid-19-vaccine https://www.nytimes.com/live/2020/moderna-covid-19-vaccine That's exactly what I have a problem with: mRNA vaccines have never been approved for use in humans, and they're only getting an emergency approval this time. https://en.wikipedia.org/wiki/RNA_vaccines https://en.wikipedia.org/wiki/RNA_vaccines Don't tell me it's 'pretty interesting stuff': tell me that we're not using an experimental drug that's not using a novel type of vaccine that's never been used in humans prior to this year, for which long-term side effects are pretty much unknown.
- Exmoor 6y ago
  The mechanism for how these vaccines work is pretty straightforward, well understood, and quick acting. They trigger your immune system to be aware of a threat and train it to defeat that threat. This is something your body does fairly constantly with natural pathogens without any known delayed long-term effects. This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent. The two modern (last 50 years) incidences where a vaccine may have caused a serious side effect in a statistically significant way [0][1] may have taken a little bit of time to be noticed, but it was because they were so statistically rare, not because the actual problem was delayed in occurring. Interestingly, both those incidents involved auto-immune illnesses which would have likely been much more likely to occur if the vaccinated folks caught the virus itself. [0] https://en.wikipedia.org/wiki/Pandemrix https://en.wikipedia.org/wiki/Pandemrix [1] https://en.wikipedia.org/wiki/1976_swine_flu_outbreak https://en.wikipedia.org/wiki/1976_swine_flu_outbreak
  - generalizations 6y ago
    > The mechanism for how these vaccines work is pretty straightforward, well understood, and quick acting. Before 2020, mRNA was only considered a theoretical or experimental candidate for use in humans. Sure, we have a theory behind the mechanism, but that's it. Your implication that we know all about what these novel, unfamiliar mRNA vaccines will do is flat out wrong. > This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent. That's because there's almost no precedent at all. https://link.springer.com/protocol/10.1007%2F978-1-4939-6481-9_1 https://link.springer.com/protocol/10.1007%2F978-1-4939-6481... https://en.wikipedia.org/wiki/RNA_vaccines https://en.wikipedia.org/wiki/RNA_vaccines
  - oicu812 6y ago
    > This idea that there is some sort of known risk of a significant issue popping up out of nowhere months or years down the road has no historical precedent. RotaShield [0] was a vaccine for the rotavirus that was released in 1998 and taken off the market in 1999 because of intussusception (bowel folding on itself). 5 cases of this issue occurred during during trials of 10,054 participants, which was deemed "not statistically significant". After the vaccine was licensed and widely distributed, the CDC determined the risk of this complication from the vaccine was 20 to 30 times over the expected risk and the vaccine was pulled off the market. [0] https://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-rotashield-historical.htm https://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-rotashiel...