13 people died during Moderna’s COVID vaccine trial
WASHINGTON, D.C, December 21, 2020 (LifeSiteNews) — Official documents from the U.S Food and Drug Administration (FDA) record that 13 people died during trials of the Moderna vaccine, while the FDA has also issued a new warning regarding Bell’s Palsy as a potential effect of the vaccine.
A sponsor briefing document prepared for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) recorded the various outcomes on participants in the Moderna vaccine trial, listing the effects of those who had received the vaccine and those who had taken the placebo.
The evidence presented listed 13 deaths in the trials, with 6 deaths being people who had taken the vaccine, and 7 those who had received the placebo. Results were correct up until December 3.
An FDA briefing presentation provided a breakdown of those who died. Of those in the vaccine group who had died, one was a 78-year-old who suffered “cardiac arrest 21 days after dose 1”; a 77-year-old died of “[m]yocardial infarction 45 days after dose 2.” Two participants were found dead at home, and their deaths are declared to be of “uncertain” cause: a 70-year-old was found dead at home “57 days after dose 2,” and a 56-year-old was found likewise “37 days after dose 1.” However, the FDA document continues by saying that for the 56-year-old person, head trauma was given as the official cause of death.
Two more participants died from the vaccine recipient group, a 72-year-old having “multiorgan failure” 59 days after the second dose, while the last committed suicide “21 days” after the first dose. The person who had multi-organ failure was “hospitalized for thrombocytopenia and acute kidney failure due to obstructive nephrolithiasis” prior to developing “complications” that resulted in organ failure.
Out of the 7 participants who took the placebo, three died from “myocardial infarction,” one from “intra-abdominal perforation,” and another from “systemic inflammatory response syndrome in the setting of known malignancy.” Another died from “COVID-19,” and the cause of death for the last person was not known.
Moderna does not connect any of the 13 deaths to either the vaccine or the placebo, saying instead that “[t]hese deaths represent events and rates that occur in the general population of individuals in these age groups.”
The document comes in addition to the news of a Ukranian Greek Catholic priest who died suddenly in his home after previously being a volunteer in the testing of Moderna’s vaccine. Fr. John Fields apparently suffered a heart attack just under two months after his second jab, although it is still unclear if the 70-year-old’s death is related to the vaccine.
ActivistPost.com showed an image of a version of the FDA briefing document, which contained interesting information not found in current versions. The old version of the document stated that during “data cleaning,” one participant who received the vaccine was updated from “death” to “SAE” or severe adverse event. In contrast, a participant who received the placebo was updated from “SAE” to “death” on his record. ActivistPost also referenced an as yet unpublished document by Dr. James Lyons-Weiler, president and CEO of The Institute for Pure and Applied Knowledge (IPAK), who has analyzed the FDA Moderna document, finding worrying and false evidence in the text.
Despite the 13 deaths in the trial, the FDA gave emergency use authorization (EUA) to the Moderna vaccine on December 19, after the VRBPAC voted 18-0 in recommending the vaccine.
An FDA press statement on the issuing of the EUA read: “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.”
However, the FDA previously released its own warning for any potential COVID-19 vaccine, including strokes, encephalitis, auto-immune disease, birth defects, and Kawasaki disease among the potential side-effects to be monitored. First on the list of 22 possible conditions is “Guillain-Barré syndrome,” described as “a rare disorder in which your body's immune system attacks your nerves.” The syndrome has “no known cure,” and its mortality rate is “4% to 7%.”
“There may be limited information available at licensure on level and duration of effectiveness,” the text reads. This might prompt manufacturers to “conduct certain COVID-19 vaccine effectiveness post-licensure studies.”
Since then, the FDA has also issued a staff report, warning of “facial paralysis,” or Bell’s Palsy, as a possible condition to be looked for in those who take the Moderna vaccine. Four out of the 30,000 original participants in the trial developed the condition, with 3 in the vaccine group and 1 in the placebo group.
The report notes a “small imbalance” in participants reporting Bell’s Palsy, adding that one lady in the vaccine group had to be hospitalized “for stroke due to new facial paralysis 32 days after vaccination.” Two other cases of the condition in the vaccine group reported the effects 28 days and 22 days after vaccination.
“[C]onsidering the temporal association and biological plausibility, a potential contribution of the vaccine to the manifestations of these events of facial palsy cannot be ruled out,” the FDA writes.
It is worth noting that in trials for the Pfizer vaccination, 4 out of the 43,000 participants developed Bell’s Palsy, all of whom had received the vaccine.
Dr. Paul Offi, a member of the VRBPAC, spoke to CNBC about the importance of monitoring the condition, saying, “I’m not dismissing that yet.” CNBC mentioned how five cases of Kawasaki disease found in the vaccine recipients of Merck’s rotavirus vaccine were “statistically significant,” resulting in the company having to alter its label to mention the disease.