Fact: 2 died. They took the vaccine.
Fact: 4 died. They did not take the vaccine but a placebo.
Six people died in Pfizer’s late-stage trial of the COVID-19 vaccine, the US Food and Drug Administration has revealed just hours after Britain became the first country in the world to roll out the vaccine.
But the deaths are said to raise no new safety issues or questions about the vaccine’s effectiveness because all represented events that occurred in the general population at a similar rate, the FDA concluded.
Its 53-page briefing report, released on Wednesday morning (Australian time) is the first detailed analysis of the vaccine trial by Pfizer and BioNTech, which found in November that its vaccine was 95 per cent effective in preventing coronavirus infections.
The documents revealed that two people who received the experimental vaccine had died during the trial. Four others who died were on a placebo.
“All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate,” the report said.
Ahead of the FDA’s Thursday meeting on the Pfizer vaccine, the administration announced Tuesday that two trial participants had died after receiving it. One of the deceased individuals was immunocompromised, meaning the person’s immune defenses were low.
The information was obtained from documents released by the FDA on Tuesday.The documents were released ahead of a meeting on Thursday of external experts who will debate whether emergency authorization for the vaccine should be granted.
Israel’s Midaat Association responded to the report on the deaths, explaining that when vaccines are administered to at-risk populations “there may be unfortunate cases. One should not infer from this about the safety of the vaccine, but welcome the transparency required from the pharma companies in the drug approval process.”
The association noted that in large trials of tens of thousands of people, death can occur without any connection to the trial, but that companies such as Pfizer are required to report those deaths.
“According to the published data, six of the participants in the experiment died, two of whom received the vaccine and four of the control group,” said Dr. Uri Lerner, the scientific director for Midaat. “After an in-depth examination, no connection was found between the experiment and the cause of death.”
Posted on: Tuesday, December 8th 2020 at 6:45 am
Written By: GMI ReporterThis article is copyrighted by GreenMedInfo LLC,
Our report on 2 deaths within the Pfizer Covid vaccine trial reported in the FDA guidance document released on Dec. 8th, 2020, has been temporarily withdrawn for editorial review by Greemedinfo.com staff. This decision was made in response to the sudden removal by the Jerusalem Post of their article from Dec. 8th titled, “FDA announces deaths of two Pfizer vaccine trial participants,” which can be found in web archived format here: https://web.archive.org/web/20201208142015/www.jpost.com/breaking-news/two-individuals-die-from-pfizer-vaccine-651488
The other critical issue: Safety. Pfizer has reported no serious side effects. Some recipients experienced flu-like reactions – including fever, fatigue or muscle aches – especially after the second dose. It is likely a sign the immune system is revving up, able to recognise and fight back if the real virus comes along.
There were a total of six deaths in Pfizer’s late-stage trial of the vaccine, with two deaths among patients receiving the vaccine and the rest in those on a placebo, the documents showed. All deaths represent events that occur in the general population at a similar rate, FDA staff said.
BREAKING: FDA announces 2 deaths of Pfizer vaccine trial participants from “serious adverse events”
Following only a day after our report that the FDA knows about and is preparing for COVID-19 vaccine adverse outcomes which include deaths, a newly released document on the FDA website shows that 2 participants died as a result of “serious adverse events” from the experimental Covid vaccine.
In an FDA Briefing Document released on December 8th titled, “Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020,” clinical trial results from the Pfizer/BioNTech COVID-19 vaccine reveal two study participants died from what were classified as “Serious Adverse Events.” On page 41 of the document two vaccine recipients classified as “>55 years of age” died: “[O]ne experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1.”
As reported in the Jerusalem post:
“The FDA announced on Tuesday that two trial participants have died after receiving the Pfizer coronavirus vaccine, according to Reuters. According to Walla, one of the deceased individuals was immunocompromised.
The documents were released ahead of a upcoming meeting on Thursday of outside experts who will debate whether emergency authorization for the vaccine should be granted.
The FDA also said on Tuesday that the data they’re presented with is in line with emergency use authorization, raising hopes for Thursday.
According to Maariv, the sister publication of The Jerusalem Post, the FDA announced on Tuesday that there currently is not enough research to guarantee the vaccine’s safety for immunocompromised groups, pregnant women and children.”
This report follows closely on the heels of the discovery that the FDA’s own public discussion and documents about the COVID-19 vaccines acknowledge that deaths and 21 other conditions, many of which are life-threatening, may result as adverse outcomes from these vaccines. Read more about this developing story here: