SAEs seem like a key issue. The Pfizer 6-month study appears to withhold SAE counts while pretending to disclose them. I have been drafting a post and would appreciate any feedback.
Good observations...also they offered the vaccine to the placebo group after a couple of months which diminished any chance of collecting robust safety data.
Thanks! It's true that unblinding reduced the possibility of safety monitoring. But unblinding doesn't explain the missing the numbers.
An average of 3.6 months post-dose-two per patient was available during blinded follow up. Yet, the "6 Month" Pfizer paper reports only on one month of SAE data after dose two.
Thank you for this important work Maryanne.
Thanks Kim
SAEs seem like a key issue. The Pfizer 6-month study appears to withhold SAE counts while pretending to disclose them. I have been drafting a post and would appreciate any feedback.
https://norstadt.substack.com/p/6e46ec5e-5e41-4e23-8878-ebd1e75a987f
Good observations...also they offered the vaccine to the placebo group after a couple of months which diminished any chance of collecting robust safety data.
Thanks! It's true that unblinding reduced the possibility of safety monitoring. But unblinding doesn't explain the missing the numbers.
An average of 3.6 months post-dose-two per patient was available during blinded follow up. Yet, the "6 Month" Pfizer paper reports only on one month of SAE data after dose two.