3 ms·

We’re about to get 10 million data points. To me it doesn’t look like they have a lot of data yet. Don’t these studies typically need to go for much longer?

We’re about to get 10 million data points. To me it doesn’t look like they have a lot of data yet. Don’t these studies typically need to go for much longer? The Pfizer study: 43,448 patients ages 16 and up. 19,000 vaccinated patients 170 people caught the Coronavirus Of the sick people: - 162 received a placebo - 8 received the vaccine

Kliment 6y ago
They typically need to go for much longer for two reasons: 1. You normally don't expose so many people to an untested medicine, so trials tend to be smaller than this. In this case there was no shortage of volunteers, and the larger the trial the faster it can reach a certain level of confidence in a result. 2. Normally, with vaccines, you need to wait a very long time for enough people to contract the disease and measure how effective it actually is. In this case, there are so many people infected in the general population, that reaching the required number of participants infected happened much faster than usual. In fact, when the trial was planned in the spring, it was expected that it wouldn't reach its required 164 infected participants until sometime in late summer 2021. The reason this happened so quick is that the number of infections in the general population exploded, and so the required data was available much earlier.
- melling 6y ago
  They want the long-term study to continue, without giving those with a placebo the vaccine. What are the next steps and goals?
  - Kliment 6y ago
    There is actually a plan to gradually offer all placebo group patients the vaccine. This will be done in small groups at a time, in order to not inform all remaining participants which group they are in. The plan is to have all placebo group participants be offered a vaccine before the end of the trial. This doesn't break the trial, because there is already a good confidence level for the efficacy results, and the side effects investigation can always use additional participants. This also enables in-patient control, where you can compare the placebo condition and the treatment condition within the same patient.

Kliment 6y ago

They typically need to go for much longer for two reasons: 1. You normally don't expose so many people to an untested medicine, so trials tend to be smaller than this. In this case there was no shortage of volunteers, and the larger the trial the faster it can reach a certain level of confidence in a result. 2. Normally, with vaccines, you need to wait a very long time for enough people to contract the disease and measure how effective it actually is. In this case, there are so many people infected in the general population, that reaching the required number of participants infected happened much faster than usual. In fact, when the trial was planned in the spring, it was expected that it wouldn't reach its required 164 infected participants until sometime in late summer 2021. The reason this happened so quick is that the number of infections in the general population exploded, and so the required data was available much earlier.

melling 6y ago
They want the long-term study to continue, without giving those with a placebo the vaccine. What are the next steps and goals?
- Kliment 6y ago
  There is actually a plan to gradually offer all placebo group patients the vaccine. This will be done in small groups at a time, in order to not inform all remaining participants which group they are in. The plan is to have all placebo group participants be offered a vaccine before the end of the trial. This doesn't break the trial, because there is already a good confidence level for the efficacy results, and the side effects investigation can always use additional participants. This also enables in-patient control, where you can compare the placebo condition and the treatment condition within the same patient.