Quote:
Originally Posted by NoSoup4U
Some in the epidemiology community have been complaining about people getting unblinded when their jobs get them tested. I know there was at least one study participant who found out he was in the vaccine arm when he took a test for work (he's a cop and was assigned to security for a Trump campaign stop) and they initially told him it looked like he was just getting over a severe case. There is sort of a conundrum about what to do with people from the trials. Traditionally, once the vaccine is approved, placebo arm participants get the first doses. But in normal times, they would already have got lots of long-term side effect information. The medical ideal is to leave the arms separate for like 18-24 months, but that is obviously not cool right now. The last thing I read said that participants would likely be notified and vaccines offered to the placebo arm.
Yes I found an interesting article about this subject. Basically it seems as though those in the placebo arm will eventually be unblinded and allowed to get the vaccine, however the question is when. It seems several regulatory bodies may have some say in when that can happen. Also they may not want trial participants to skip the line ahead of healthcare workers etc.
https://www.statnews.com/2020/11/12/...s-complicated/
When I asked this question at the clinic, I was told that they "hoped" Pfizer would let everyone in the trial know which arm they were in once EUA was obtained, but they didn't know for sure. I was also told I could still get a vaccine if one (either from Pfizer or another manufacturer) became available.
Although, I would think that would mess up the trial integrity just as much as unblinding everyone... how can you measure the long-term effects of the Pfizer vaccine, if many of the trial participants are also getting a vaccine from Moderna or Astrazeneca, etc.? Or even if members of the placebo group go out and get the Pfizer vaccine through regular channels? Or what about those who got the real vaccine getting it again, would that possibly impact the safety data?
Seems to me it makes sense in this compressed timeframe to just unblind the participants and give the placebo group the vaccine. Not ideal in a perfect world but this is definitely not a perfect world.