[dabigv13]

https://www.nytimes.com/2020/09/12/healt...sumes.html

Oxford AstraZeneca vaccine resumes trials, but only in UK,  not US and other trial sites. No reason given for that, or any information given about why they felt it was safe to resume at all.

Also I think more notably, the Pzifer BioNTech vaccine is expanding their trial from 30k to 44k. They are still saying they could have early data by end of October. 

Considering their protocol is two injections a month apart, I think that is really optimistic to have data by then as they have not even finished enrolling their original 30k. In the press release they mention their goal is to include more patients with other comorbidities. 

Only way to have any data by end of October in my mind is if a substantial effect is seen, and that after only one injection.

Another reason you might expand a trial is because the effect of the intervention is not as strong as initially hoped, or that the prevalence of the disease is not high enough to see an effect, quickly enough.

I think the expansion is an ominous sign  But more data is always welcome. 

I suspect we will see trials ended early without as clear data on efficacy and safety as we would like.

[dabigv13]

https://www.nytimes.com/2020/09/12/healt...sumes.html

Oxford AstraZeneca vaccine resumes trials, but only in UK,  not US and other trial sites. No reason given for that, or any information given about why they felt it was safe to resume at all.

Also I think more notably, the Pzifer BioNTech vaccine is expanding their trial from 30k to 44k. They are still saying they could have early data by end of October. 

Considering their protocol is two injections a month apart, I think that is really optimistic to have data by then as they have not even finished enrolling their original 30k. In the press release they mention their goal is to include more patients with other comorbidities. 

Only way to have any data by end of October in my mind is if a substantial effect is seen, and that after only one injection.

Another reason you might expand a trial is because the effect of the intervention is not as strong as initially hoped, or that the prevalence of the disease is not high enough to see an effect, quickly enough.

I think the expansion is an ominous sign  But more data is always welcome. 

I suspect we will see trials ended early without as clear data on efficacy and safety as we would like.