3 ms·

It's one thing to inject an antigen that your body makes antibodies for. It's one thing to use a viral vector to reprogram some number of cells. Due to the Eme

It's one thing to inject an antigen that your body makes antibodies for. It's one thing to use a viral vector to reprogram some number of cells. Due to the Emergency Use Authorization, much of the safety testing has been skipped.

pas 6y ago
What was skipped? phase 1, 2, 3 happened, right?
- weaksauce 6y ago
  nothing was skipped maybe aside from testing on animals first. it was however on a compressed observational and manufacturing timeline. normally a company doesn't want to run the next trial while the previous trial is ongoing. they compressed stages one and two(safety studies where they do tens of people and then hundreds of people to strictly look for adverse outcomes). Then they did a efficacy trial in stage three of thousands (which also looks out for large adverse outcomes). the regulatory review stage was also shortened because the drug manufacturers were supplying more real time data to the regulators to expedite the approval. the normal way they do it is to run every stage back to back and then after stage 3 is finished they would submit the data to the fda and get an approval back within a year or two. Then the manufacturing would start to ramp up... this was a moonshot type of project that hoped the trial would be successful and started to manufacture the drug before full approval occurred. you can see timelines here: https://www.bbc.com/news/health-55056016 https://www.bbc.com/news/health-55056016 tldr: nothing skipped; however it was compressed.
ahartmetz 6y ago
AFAIU time-compressed is more accurate than skipped. Obviously, observation of long term effects has been skipped. Other mRNA vaccines have been tested though (but not introduced) so the class of vaccines does have long-term data available and there are no known risks worse than other vaccines. Seems safe enough. Hopefully not famous last words...
rolph 6y ago
mRNA is not a viral vector. the mRNA vaccine does not contain the entire viral code, and is not carried by the SARS virion but by a constructed liposome used as an mRNA delivery vector
learc83 6y ago
MRNA vaccines don’t use a viral vector. Your thinking of several other vaccines that haven’t been approved yet. And much of the safety testing hasn’t been skipped. The vaccine went through full phase 2/3 trials. The post trial surveillance phase was shortened, but it’s still ongoing.

pas 6y ago

What was skipped? phase 1, 2, 3 happened, right?

weaksauce 6y ago
nothing was skipped maybe aside from testing on animals first. it was however on a compressed observational and manufacturing timeline. normally a company doesn't want to run the next trial while the previous trial is ongoing. they compressed stages one and two(safety studies where they do tens of people and then hundreds of people to strictly look for adverse outcomes). Then they did a efficacy trial in stage three of thousands (which also looks out for large adverse outcomes). the regulatory review stage was also shortened because the drug manufacturers were supplying more real time data to the regulators to expedite the approval. the normal way they do it is to run every stage back to back and then after stage 3 is finished they would submit the data to the fda and get an approval back within a year or two. Then the manufacturing would start to ramp up... this was a moonshot type of project that hoped the trial would be successful and started to manufacture the drug before full approval occurred. you can see timelines here: https://www.bbc.com/news/health-55056016 https://www.bbc.com/news/health-55056016 tldr: nothing skipped; however it was compressed.

ahartmetz 6y ago

AFAIU time-compressed is more accurate than skipped. Obviously, observation of long term effects has been skipped. Other mRNA vaccines have been tested though (but not introduced) so the class of vaccines does have long-term data available and there are no known risks worse than other vaccines. Seems safe enough. Hopefully not famous last words...

rolph 6y ago

mRNA is not a viral vector. the mRNA vaccine does not contain the entire viral code, and is not carried by the SARS virion but by a constructed liposome used as an mRNA delivery vector

learc83 6y ago

MRNA vaccines don’t use a viral vector. Your thinking of several other vaccines that haven’t been approved yet. And much of the safety testing hasn’t been skipped. The vaccine went through full phase 2/3 trials. The post trial surveillance phase was shortened, but it’s still ongoing.