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Death is known as a “hard” outcome because it is totally objective. It is also clearly an important outcome.
So what happened to the participants in the Moderna trial. How many died? It depends when and where you look. Here are the results chronologically.
Up to 25th November 2020
1. Included in an EMA submission. There was no mention of covid deaths.
- 6 placebo
- 4 vaccine
2. In an FDA submission on 17th December 2020, Moderna claimed to be including all deaths up to 25th November 2020
“On December 7, 2020, the Sponsor submitted additional follow-up data from these participants with a cutoff of November 25, 2020, which represents a median of 9 weeks (>2 months) of follow-up post-dose 2. Key safety data from this later submission, including death, other serious adverse events, and unsolicited adverse events of interest were independently verified and confirmed not to change the safety conclusions from the interim safety analysis.”
The submission also stated there were no covid deaths, “There were no deaths due to COVID-19 at the time of the interim analysis to enable an assessment of vaccine efficacy against death due to COVID-19.”
- 4 placebo
- 3 vaccine
Two placebo and one vaccine death have vanished.
3. Moderna published a paper in the New England Journal of Medicine in February 2021 still with a safety cutoff of 25th November 2020.
- 3 placebo
- 2 vaccine
Half the deaths from each group have disappeared by now. Plus one of the deaths has become a covid death “Thirty participants in the trial had severe Covid-19; all 30 were in the placebo group… and one death among these participants was attributed to Covid-19.”
3rd December 2020 – EMA submission
A separate EMA submission as above comments on deaths up to 3rd December 2020 (only an extra 8 days).It says, “However, based on the pharmacovigilance database which includes data from study start through 03 Dec 2020, there have been 13 deaths during the study. Six participants who died received mRNA-1273 and 7 received placebo.”
- 7 placebo
- 6 vaccine
26th March 2021 – final study report sent to EMA
- 16 placebo
- 16 vaccine
There are now 32 deaths altogether during the period prior to unblinding or the 26th March 2021, whichever was earliest.
However, in this same document there are conflicting tables.
In the safety table there was an additional vaccinated death.
4th May 2021 EMA submission
The same document also includes data up to 4th May 2021 – an extra 39 days. This includes the period after unblinding and cross over. That means each group was told what they had had and the placebo group were offered a vaccine.
Now the deaths have really mounted up.
- 19 placebo
- 24 vaccine
The last 39 days apparently saw an extra 3 deaths in the placebo group and an extra 8 deaths in the vaccine group.
Of course by then the unblinding meant that any formal safety follow up had been trashed because there was no control group to compare to.
There remained only one claimed covid death in the placebo group.
Overall therefore, injecting 14,000 people could be claimed to have prevented a death from covid but also could have taken the lives of 5 people within an average of 8 months. The numbers are small so any conclusions are hard to draw conclusively.
The last FDA submission for the Pfizer/BioNTech trial had 21 deaths in the vaccine arm and 17 in the placebo arm.
Altogether the risk of dying was 24% higher for Pfizer/BioNTech and 26% higher for Moderna than for the unvaccinated.
Why are there so many contradictions in the Moderna data?