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IMO there is only one argument for not dropping all restrictions and a complete return to normalcy, it's "what about the children?" Here is their BS response:

IMO there is only one argument for not dropping all restrictions and a complete return to normalcy, it's "what about the children?" Here is their BS response: "The FDA is undergoing a process now to evaluate a vaccine for children under the age of 12, and under the President’s plan, the Administration will do whatever it takes to support those efforts, while continuing to respect and defer to the scientific decision-making of the agency." I feel like our entire society has been held hostage by the FDA. I think a bold plan to completely get rid of the FDA would have been more appropriate. Just dismantle the whole organization. It's too broken to fix. Figuring out if the vaccine is safe for children under 12 takes a maximum of 8 weeks (1 week to administer, 6 weeks to watch, 1 week to organize results). It's been 4 weeks since the association of pediatric doctors reviewed the data and begged the FDA to lift the ban. It has been well over a year now since phase II safety results were in from adults. It's been many months. I don't understand why there isn't a wide, bipartisan push to remove the FDA from our lives. Multiple presidents, multiple heads, all a complete and total catastrophe.

ctrlp 5y ago
I guess you don't subscribe to the possibility of mid-term and long-term effects of gene therapies. A pregnancy takes 9 months (which is longer than 8 weeks if my math is correct) and involves a child under 12 (again, check my math). But you're right! All this hand-wringing about 'the children' is just safetyism.
- chinathrow 5y ago
  mRNA vaccines are not altering your genes and are not generally viewed as "gene therapy".
  - ctrlp 5y ago
    Nature.com doesn't agree with you. At least in 2019 it wasn't controversial to say so: "Because mRNA falls into the broad vaccine category of genetic immunogens, many of the guiding principles that have been defined for DNA vaccines (162) and gene therapy vectors (163,164) can likely be applied to mRNA with some adaptations to reflect the unique features of mRNA." [0] And still in 2021, Nature.com felt they were gene therapies: "However, these mRNA vaccines, which have been developed and approved within a few months, signify a breakthrough in the field of gene therapy, which has battled to achieve ordinary acknowledgement due to a large number of sceptical and conservative scientists and other claimed safety and translational concerns."[1] [0] https://www.nature.com/articles/nrd.2017.243 https://www.nature.com/articles/nrd.2017.243 [1] https://www.nature.com/articles/s41435-021-00136-6 https://www.nature.com/articles/s41435-021-00136-6
    - freemint 5y ago
      And the FDA disagrees with that definition of gene therapy: "Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms: Replacing a disease-causing gene with a healthy copy of the gene Inactivating a disease-causing gene that is not functioning properly Introducing a new or modified gene into the body to help treat a disease" [1] Yes there are competing definitions. However the important part of the grandparent remains unchanged. mRNA are extremely unlikely to modify genetic information of your body. [1] https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy https://www.fda.gov/vaccines-blood-biologics/cellular-gene-t...
awillen 5y ago
There's also the reason that dropping all restrictions means hospitals become overwhelmed (which we are currently seeing in some parts of the country). This means that quality of emergency medical care is potentially severely compromised for both Covid and non-Covid patients, and it means that non-emergency medical care must be postponed (and just because it's non-emergency doesn't mean there aren't negative consequences of postponing it).
notacoward 5y ago
> I don't understand why there isn't a wide, bipartisan push to remove the FDA from our lives. Don't understand, or feel contempt based on ideology without understanding? Even if you disagree with how the FDA has handled COVID vaccines - largely in the face of pressure and infiltration by an administration sharply opposed to any regulatory mission - there are many other things that it does. Would you forego all FDA oversight of food, drugs (not just vaccines), medical devices, and radiation-emitting products? Throw that all into the courts, which can never address a harm until after the fact and even in those cases is even less equipped to handle the issues under FDA's mandate? People who've done at least minimal diligence can certainly disagree with some of the things FDA does. There's plenty of room for that, but "fail to understand" why others don't share your spitting hatred of the agency as a whole? Sorry, but that's not even a position that deserves to be taken seriously.
mint2 5y ago
Googling Thalidomide may help you understand. The fda is the reason tens of thousands of US children weren’t born with preventable deformities.

ctrlp 5y ago

I guess you don't subscribe to the possibility of mid-term and long-term effects of gene therapies. A pregnancy takes 9 months (which is longer than 8 weeks if my math is correct) and involves a child under 12 (again, check my math). But you're right! All this hand-wringing about 'the children' is just safetyism.

chinathrow 5y ago
mRNA vaccines are not altering your genes and are not generally viewed as "gene therapy".
- ctrlp 5y ago
  Nature.com doesn't agree with you. At least in 2019 it wasn't controversial to say so: "Because mRNA falls into the broad vaccine category of genetic immunogens, many of the guiding principles that have been defined for DNA vaccines (162) and gene therapy vectors (163,164) can likely be applied to mRNA with some adaptations to reflect the unique features of mRNA." [0] And still in 2021, Nature.com felt they were gene therapies: "However, these mRNA vaccines, which have been developed and approved within a few months, signify a breakthrough in the field of gene therapy, which has battled to achieve ordinary acknowledgement due to a large number of sceptical and conservative scientists and other claimed safety and translational concerns."[1] [0] https://www.nature.com/articles/nrd.2017.243 https://www.nature.com/articles/nrd.2017.243 [1] https://www.nature.com/articles/s41435-021-00136-6 https://www.nature.com/articles/s41435-021-00136-6
  - freemint 5y ago
    And the FDA disagrees with that definition of gene therapy: "Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms: Replacing a disease-causing gene with a healthy copy of the gene Inactivating a disease-causing gene that is not functioning properly Introducing a new or modified gene into the body to help treat a disease" [1] Yes there are competing definitions. However the important part of the grandparent remains unchanged. mRNA are extremely unlikely to modify genetic information of your body. [1] https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy https://www.fda.gov/vaccines-blood-biologics/cellular-gene-t...

awillen 5y ago

There's also the reason that dropping all restrictions means hospitals become overwhelmed (which we are currently seeing in some parts of the country). This means that quality of emergency medical care is potentially severely compromised for both Covid and non-Covid patients, and it means that non-emergency medical care must be postponed (and just because it's non-emergency doesn't mean there aren't negative consequences of postponing it).

notacoward 5y ago

> I don't understand why there isn't a wide, bipartisan push to remove the FDA from our lives. Don't understand, or feel contempt based on ideology without understanding? Even if you disagree with how the FDA has handled COVID vaccines - largely in the face of pressure and infiltration by an administration sharply opposed to any regulatory mission - there are many other things that it does. Would you forego all FDA oversight of food, drugs (not just vaccines), medical devices, and radiation-emitting products? Throw that all into the courts, which can never address a harm until after the fact and even in those cases is even less equipped to handle the issues under FDA's mandate? People who've done at least minimal diligence can certainly disagree with some of the things FDA does. There's plenty of room for that, but "fail to understand" why others don't share your spitting hatred of the agency as a whole? Sorry, but that's not even a position that deserves to be taken seriously.

mint2 5y ago

Googling Thalidomide may help you understand. The fda is the reason tens of thousands of US children weren’t born with preventable deformities.