I have questions:
1. The follow-up is 2 years after the 2cd dose in the Moderna trial. You cannot enroll if you plan to get another vaccine.
If I get randomized to placebo, & the drug gets approved, will the blind be broken at that time & will I be told I got placebo?
1. The follow-up is 2 years after the 2cd dose in the Moderna trial. You cannot enroll if you plan to get another vaccine.
If I get randomized to placebo, & the drug gets approved, will the blind be broken at that time & will I be told I got placebo?
2. Is it ethical to have 15,000 people who were enrolled but received placebo, and don't know that they were randomized to inactive placebo in the context of this and other vaccines being approved?
If they knew, they could elect to get an active vaccine.
If they knew, they could elect to get an active vaccine.
3. You could argue that the blind should be maintained to collect 2 year safety & effectiveness data. This is a valid argument to look at long term effects.
But the placebo patients are not being vaccinated, and there is an approved, effective vaccine available.
Is this fair?
But the placebo patients are not being vaccinated, and there is an approved, effective vaccine available.
Is this fair?
4. You could argue that once the drug is approved at the end of the year, all placebo patients are notified, and they are provided access to the drug.
If you argue this, then we will have vanishing little long term safety and effectiveness data.
If you argue this, then we will have vanishing little long term safety and effectiveness data.
5. So people are saying the follow up can't be 2 years. Here is a screenshot from the clinicaltrials.gov site. The trial will be completed in October of 2022. 
6. You could argue we assess efficacy through the end of the year, unblind, and in an unblinded fashion look at safety through 2 years. If you have ever seen reports of adverse events, you know that about half of placebo patients complain on non-specific things like headache etc
7. If all patients are unblinded after a year, all the "adverse events" will be assigned to the vaccine, when many placebo patients may have also reported a similar proportion of side effects. This may cause us to overestimate the side effects of vaccines and lead to hesitancy.
8. If the Moderna vaccine reduces #COVID19 mortality, should all placebo patients be dosed?
9. If the Moderna vaccine trial reduces #COVID19 mortality or severe illness, should the Moderna vaccine be THE standard of care vaccine against which upcoming vaccines are compared to?
10. If the Moderna trial reduces #COVID19 mortality or severe illness, is it ethical to continue to randomize patients to inactive placebo vaccine or should all patients be randomly compared to active Moderna vaccine as the Standard of Care control arm?
12. Would you check your antibody status to unblind your self to find out if you received an active vaccine or placebo so that you could be sure you were treated? Why or why not?
13. In deciding to check or not check your antibody status, who do you feel you have a greater ethical duty to:
A) I would check antibodies to assure I received active drug for the safety of me and my family
B) I would remain blinded as an eithical obligation to society
A) I would check antibodies to assure I received active drug for the safety of me and my family
B) I would remain blinded as an eithical obligation to society
14. If you checked, and you had no antibodies after being randomized, (meaning you may have received placebo) would you sign up for another trial in the hopes of getting active vaccine despite this being a violation of the inital trials rules?
15. If one of the early trials is successful and the vaccine is approved as safe and effective, would you sign up for the trial of an even newer vaccine? Why or why not?
16. What percent of new #COVID19 cases does a vaccine need to prevent for YOU to consider it effective? Why?
17. Are you going to sign up sooner for a #COVID19 vaccine trial to get protected immediately OR wait to see if an early winner emerges and be treated with an approved vaccine?
18. Should the US government be spending billions of dollars on MULTIPLE vaccines if people are voting to be vaccinated with the first one that is approved?
19. Would you be willing to be randomized to the 140th #COVID19 vaccine?
20. If under 20% of people are willing to get randomized after the first approved vaccine, should the US government fund newer #COVID19 vaccine trials?
