What are we to infer from the fact that after 50 years not one mRNA drug had been approved by the FDA? Human clinical trials on mRNA drugs started in 2001. Human trials on mRNA vaccines started in 2013. By 2021 no mRNA drug had FDA approval after years of development and testing.
But the COVID vaccines were all set after 7 months? No longer term data might have been beneficial in decision making?
For comparison AdderalXR was in clinical trials for 2 years, and this was after Adderal was already approved by the FDA and it was part of a well known class of drugs.
The COVID vaccines were among humanity’s greatest accomplishments. I’m not suggesting the FDA cut any corners. I personally believe taking them was the right thing to do.
BUT they absolutely were a calculated risk, with no long term data, and there was a concerted effort to mislead the public about that.
TBF most of the red tape around mRNA development is due to people being afraid of immortal cell lines, stem cells, and anything involving human DNA, not because of the actual difficulty of the accomplishment.
But I think that hesitancy was responsible and justified. It’s not like we grappled with our moral quandries, and were able to move forward because we had cleared those intellectual hurdles.
We just decided that those risks, which weren’t worth it a year prior, were now worth it when compared to the risk of extending the pandemic. Everything that gave them pause for twenty years was still in play. It was an informed risk, and it worked out incredibly well.
But it’s not like they were rolling out this season’s update to the flu shot, and we shouldn’t pretend it is.
That isn’t the smoking gun you think.
What are we to infer from the fact that after 50 years not one mRNA drug had been approved by the FDA? Human clinical trials on mRNA drugs started in 2001. Human trials on mRNA vaccines started in 2013. By 2021 no mRNA drug had FDA approval after years of development and testing.
But the COVID vaccines were all set after 7 months? No longer term data might have been beneficial in decision making?
For comparison AdderalXR was in clinical trials for 2 years, and this was after Adderal was already approved by the FDA and it was part of a well known class of drugs.
The COVID vaccines were among humanity’s greatest accomplishments. I’m not suggesting the FDA cut any corners. I personally believe taking them was the right thing to do.
BUT they absolutely were a calculated risk, with no long term data, and there was a concerted effort to mislead the public about that.
TBF most of the red tape around mRNA development is due to people being afraid of immortal cell lines, stem cells, and anything involving human DNA, not because of the actual difficulty of the accomplishment.
That’s entirely fair.
But I think that hesitancy was responsible and justified. It’s not like we grappled with our moral quandries, and were able to move forward because we had cleared those intellectual hurdles.
We just decided that those risks, which weren’t worth it a year prior, were now worth it when compared to the risk of extending the pandemic. Everything that gave them pause for twenty years was still in play. It was an informed risk, and it worked out incredibly well.
But it’s not like they were rolling out this season’s update to the flu shot, and we shouldn’t pretend it is.