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>They tried corona virus vaccines already after the first SARS outbreak. When patients were re-exposed to the virus they had severe auto-immune lung pathologies

by ksk 6y ago

>They tried corona virus vaccines already after the first SARS outbreak. When patients were re-exposed to the virus they had severe auto-immune lung pathologies. Sounds super problematic. You're talking about a candidate vaccine, there are thousands of those at any given moment. My company is currently working on 9 vaccines, and there are dozens of different formulations of each that we're testing for. Vaccines that fail safety do not get manufactured. Vaccines with documented adverse affects do not get manufactured. No regulatory body is going to give license to manufacture such a product when there is substantial evidence that it harms people. I think you need to understand more about the process before leveling such accusations.

1996 6y ago
> Vaccines that fail safety do not get manufactured. Vaccines with documented adverse affects do not get manufactured All good in theory, except you only find rare side effects like autoimmune disorders during postmarket studies. So again, "no plan survives contact with the enemy" This is the reason why old drugs are generally safer than new drugs: they have been "tested" on millions of patients.
- ksk 6y ago
  Well if anything serious is found post-sale then like any medication, a recall should be issued. But like you said, all good in theory :) If any vaccine manufacturer engages in fraud and massages the data, then that is a human greed issue, not really unique to our industry. I do make a distinction between pharmaceutical and biologics though. But on the whole I would say that due to the strong regulatory framework in place, and the active role that the FDA plays, we have less of that compared to other industries like finance/markets for e.g.
  - Madmallard 6y ago
    There are so many awful drugs still in use that have taken decades for people to rile up enough of a backlash for the FDA to do something about it. And even then they're bought out to do things like "blackbox warnings" instead of take drugs off the market. These warnings basically are 'we should take the drug off the market because it causes serious problems' but it never happens. Take fluoroquinolones for example. In use since the 70s. Studies since the 90s knew about serious toxic adverse effects. Took until just this last decade for their use to become limited, with an unknown number of people whose lives have been likely ruined or terminated by the drugs.
- Madmallard 6y ago
  You literally cannot know what is causing the auto-immune responses through current research methods. There are way too many factors and variables to weed through yet it's becoming more and more prevalent.
programmarchy 6y ago
> Vaccines with documented adverse affects do not get manufactured. Wait, what? I can't think of a single vaccine that does not have an "adverse effect". I'm not an anti-vaxxer, but this type of cavalier attitude about the safety of vaccines makes it seem like the industry does not take the risks seriously. We have a child with an autoimmune disorder, and were very lucky to have a pediatrician who understood these risks and helped us weigh which vaccines to administer, and which to avoid. Many vaccines list seizures, comas, severe allergic reactions, or death. [1] These side effects may be rare for most people, but we know people with autoimmune disorders are particularly at risk, and about 5% of the US population have an autoimmune disorder. [2] There are some guidelines for contraindications from the CDC but autoimmune disease is still very poorly understood. For the majority of people, taking a vaccine is a no-brainer, but other people may seriously need to weigh the risks. Vaccines are not a silver bullet for everyone. [1] https://www.cdc.gov/vaccines/vac-gen/side-effects.htm https://www.cdc.gov/vaccines/vac-gen/side-effects.htm [2] http://www.autoimmuneregistry.org/autoimmune-statistics http://www.autoimmuneregistry.org/autoimmune-statistics
- ksk 6y ago
  >Wait, what? I can't think of a single vaccine that does not have an "adverse effect". I'm not an anti-vaxxer, but this type of cavalier attitude about the safety of vaccines makes it seem like the industry does not take the risks seriously. We have a child with an autoimmune disorder, and were very lucky to have a pediatrician who understood these risks and helped us weigh which vaccines to administer, and which to avoid. You have simply imagined this so called "cavalier attitude". There is no such attitude at my company. We have pumped in tens of millions of dollars in products only to retract them because of safety concerns after testing in mice/rabits/etc. >Many vaccines list seizures, comas, severe allergic reactions, or death. [1] These side effects may be rare for most people, but we know people with autoimmune disorders are particularly at risk, and about 5% of the US population have an autoimmune disorder. [2] There are some guidelines for contraindications from the CDC but autoimmune disease is still very poorly understood. For the majority of people, taking a vaccine is a no-brainer, but other people may seriously need to weigh the risks. Vaccines are not a silver bullet for everyone. Vaccines are made for healthy people, in-order to to keep them healthy. If you have an underlying condition, or suffer from other pathologies then all bets are off. You have to evaluate them separately on a case by case basis. I don't think I ever said vaccines are a silver-bullet so not sure why you are refuting something I didn't say or agree with.
Madmallard 6y ago
There hasn't been substantial evidence for many drugs having serious problems before market in the last few decades. Then post-marketing people die left and right and the FDA steps in to put in "black-box" warnings and then the drugs use eventually gets more limited. Even then, maybe not.

by ksk 6y ago

1996 6y ago

> Vaccines that fail safety do not get manufactured. Vaccines with documented adverse affects do not get manufactured All good in theory, except you only find rare side effects like autoimmune disorders during postmarket studies. So again, "no plan survives contact with the enemy" This is the reason why old drugs are generally safer than new drugs: they have been "tested" on millions of patients.

ksk 6y ago
Well if anything serious is found post-sale then like any medication, a recall should be issued. But like you said, all good in theory :) If any vaccine manufacturer engages in fraud and massages the data, then that is a human greed issue, not really unique to our industry. I do make a distinction between pharmaceutical and biologics though. But on the whole I would say that due to the strong regulatory framework in place, and the active role that the FDA plays, we have less of that compared to other industries like finance/markets for e.g.
- Madmallard 6y ago
  There are so many awful drugs still in use that have taken decades for people to rile up enough of a backlash for the FDA to do something about it. And even then they're bought out to do things like "blackbox warnings" instead of take drugs off the market. These warnings basically are 'we should take the drug off the market because it causes serious problems' but it never happens. Take fluoroquinolones for example. In use since the 70s. Studies since the 90s knew about serious toxic adverse effects. Took until just this last decade for their use to become limited, with an unknown number of people whose lives have been likely ruined or terminated by the drugs.
Madmallard 6y ago
You literally cannot know what is causing the auto-immune responses through current research methods. There are way too many factors and variables to weed through yet it's becoming more and more prevalent.

programmarchy 6y ago

> Vaccines with documented adverse affects do not get manufactured. Wait, what? I can't think of a single vaccine that does not have an "adverse effect". I'm not an anti-vaxxer, but this type of cavalier attitude about the safety of vaccines makes it seem like the industry does not take the risks seriously. We have a child with an autoimmune disorder, and were very lucky to have a pediatrician who understood these risks and helped us weigh which vaccines to administer, and which to avoid. Many vaccines list seizures, comas, severe allergic reactions, or death. [1] These side effects may be rare for most people, but we know people with autoimmune disorders are particularly at risk, and about 5% of the US population have an autoimmune disorder. [2] There are some guidelines for contraindications from the CDC but autoimmune disease is still very poorly understood. For the majority of people, taking a vaccine is a no-brainer, but other people may seriously need to weigh the risks. Vaccines are not a silver bullet for everyone. [1] https://www.cdc.gov/vaccines/vac-gen/side-effects.htm https://www.cdc.gov/vaccines/vac-gen/side-effects.htm [2] http://www.autoimmuneregistry.org/autoimmune-statistics http://www.autoimmuneregistry.org/autoimmune-statistics

ksk 6y ago
>Wait, what? I can't think of a single vaccine that does not have an "adverse effect". I'm not an anti-vaxxer, but this type of cavalier attitude about the safety of vaccines makes it seem like the industry does not take the risks seriously. We have a child with an autoimmune disorder, and were very lucky to have a pediatrician who understood these risks and helped us weigh which vaccines to administer, and which to avoid. You have simply imagined this so called "cavalier attitude". There is no such attitude at my company. We have pumped in tens of millions of dollars in products only to retract them because of safety concerns after testing in mice/rabits/etc. >Many vaccines list seizures, comas, severe allergic reactions, or death. [1] These side effects may be rare for most people, but we know people with autoimmune disorders are particularly at risk, and about 5% of the US population have an autoimmune disorder. [2] There are some guidelines for contraindications from the CDC but autoimmune disease is still very poorly understood. For the majority of people, taking a vaccine is a no-brainer, but other people may seriously need to weigh the risks. Vaccines are not a silver bullet for everyone. Vaccines are made for healthy people, in-order to to keep them healthy. If you have an underlying condition, or suffer from other pathologies then all bets are off. You have to evaluate them separately on a case by case basis. I don't think I ever said vaccines are a silver-bullet so not sure why you are refuting something I didn't say or agree with.

Madmallard 6y ago

There hasn't been substantial evidence for many drugs having serious problems before market in the last few decades. Then post-marketing people die left and right and the FDA steps in to put in "black-box" warnings and then the drugs use eventually gets more limited. Even then, maybe not.