8 ms·

How do they classify something like this as safe for the long term if long term experiments are not conducted? Is there any substitute for time trials for drugs

by mybrid 6y ago

How do they classify something like this as safe for the long term if long term experiments are not conducted? Is there any substitute for time trials for drugs other than these new vaccines? These are the questions my relatives are asking me and my answers are I don't know, I don't. The scientific community needs to do a better job of communication. Why are we confident that a trial of only three months is sufficient when the only efficacy test for long term effects is long term trials?

valarauko 6y ago
They are not classified as safe for long term use - they're still not approved. They're been cleared by an EUA for emergency use. We don't know how safe they are for long term use yet, since those trails are still ongoing - Pfizer's 3rd Phase trials run till the summer of 2021, and Moderna's trial runs till mid 2022. We'll have more concrete answers then. That's why an Emergency Use Authorization is just that - there's an emergency. The FDA is well aware that long term safety is still unclear, but given the circumstances, the risks posed by vaccination for the general public are outweighed by the benefits.
- mybrid 6y ago
  The only problem is from a communication with the public is that as many people has physically possible will be vaccinated. How is this "emergency" approval any different then a general approval if the end result of the same? " but given the circumstances, the risks posed by vaccination for the general public are outweighed by the benefits. " That's the problem, we don't. We don't know what the risk is long term, it is unknown. It is illogical to say that an completely unknown risk has any logical comparison.
  - valarauko 6y ago
    While we don't have an exact handle on the risks posed by the vaccine long term, we do have reasonable bounds on what they may be. For example, it's entirely possible 0.05 - 0.6% of people who receive the vaccines develop long term severe negative outcomes. Perhaps that number is 3% - we don't know, but more unlikely. We can be fairly certain that number isn't as high as 40%. We don't have all the numbers, but we have reasonable assumptions - these are non integrative mRNAs that have a very short lifespan inside the body, so long term effects other than immunity are not expected. Of course, there is uncertainty in everything. This is more uncertainty than the FDA would accept in the usual course of events - but this is an unusual time. The FDA has no adequate, approved, and available alternatives to the emergency authorization when faced with the pandemic. The investigational vaccine appears to be safe and effective against COVID-19 for the general population. Yes, the vaccine poses some unknown risks, but they are very likely vanishingly smaller than the very present health risks posed by the pandemic. For any given individual, they're much more likely to suffer negative health outcomes within the next 5 years from COVID than from the vaccine. Nobody is stating that risk to be zero. But that also doesn't mean "the risk is completely unknown so why even bother?" How is the emergency authorization any different from an approval? If tomorrow an effective treatment for COVID-19 were to be approved or the pandemic ends, the EUA for the vaccine would be rescinded. Pfizer/Moderna must also track any adverse reactions more closely, and report them to the FDA on an ongoing basis. They also cannot sell them to private players - they're being provided to the FDA & their authorized parties. The vaccines are not licensed for COVID or any other use.
    - mybrid 6y ago
      Thanks, you gave more information than is being publicly disseminated. I'd like to see CDC publications on the long term bounds cited. Random people on the Internet is not compelling. Also, mRNA vaccines have been ongoing for years. We need better communication on why now other than we're really smart, now, and the gov. spent billions. If that is all it took we'd have cured cancer long ago.

by mybrid 6y ago

valarauko 6y ago

They are not classified as safe for long term use - they're still not approved. They're been cleared by an EUA for emergency use. We don't know how safe they are for long term use yet, since those trails are still ongoing - Pfizer's 3rd Phase trials run till the summer of 2021, and Moderna's trial runs till mid 2022. We'll have more concrete answers then. That's why an Emergency Use Authorization is just that - there's an emergency. The FDA is well aware that long term safety is still unclear, but given the circumstances, the risks posed by vaccination for the general public are outweighed by the benefits.

mybrid 6y ago
The only problem is from a communication with the public is that as many people has physically possible will be vaccinated. How is this "emergency" approval any different then a general approval if the end result of the same? " but given the circumstances, the risks posed by vaccination for the general public are outweighed by the benefits. " That's the problem, we don't. We don't know what the risk is long term, it is unknown. It is illogical to say that an completely unknown risk has any logical comparison.
- valarauko 6y ago
  While we don't have an exact handle on the risks posed by the vaccine long term, we do have reasonable bounds on what they may be. For example, it's entirely possible 0.05 - 0.6% of people who receive the vaccines develop long term severe negative outcomes. Perhaps that number is 3% - we don't know, but more unlikely. We can be fairly certain that number isn't as high as 40%. We don't have all the numbers, but we have reasonable assumptions - these are non integrative mRNAs that have a very short lifespan inside the body, so long term effects other than immunity are not expected. Of course, there is uncertainty in everything. This is more uncertainty than the FDA would accept in the usual course of events - but this is an unusual time. The FDA has no adequate, approved, and available alternatives to the emergency authorization when faced with the pandemic. The investigational vaccine appears to be safe and effective against COVID-19 for the general population. Yes, the vaccine poses some unknown risks, but they are very likely vanishingly smaller than the very present health risks posed by the pandemic. For any given individual, they're much more likely to suffer negative health outcomes within the next 5 years from COVID than from the vaccine. Nobody is stating that risk to be zero. But that also doesn't mean "the risk is completely unknown so why even bother?" How is the emergency authorization any different from an approval? If tomorrow an effective treatment for COVID-19 were to be approved or the pandemic ends, the EUA for the vaccine would be rescinded. Pfizer/Moderna must also track any adverse reactions more closely, and report them to the FDA on an ongoing basis. They also cannot sell them to private players - they're being provided to the FDA & their authorized parties. The vaccines are not licensed for COVID or any other use.
  - mybrid 6y ago
    Thanks, you gave more information than is being publicly disseminated. I'd like to see CDC publications on the long term bounds cited. Random people on the Internet is not compelling. Also, mRNA vaccines have been ongoing for years. We need better communication on why now other than we're really smart, now, and the gov. spent billions. If that is all it took we'd have cured cancer long ago.