Vaccine flash news: 6 deaths - no concerns?

Following the news platform News.Ru we report:


“Six people have died in trials of a vaccine developed jointly by the US company Pfizer and Germany’s BioNTech, according to the website of the US Food and Drug Administration (FDA).


During the reporting period, there were six deaths (two deaths in the vaccinated group, four in the placebo group), TASS reports.


In the group of those who received the vaccine, one participant with atherosclerosis and obesity died three days after the first dose of the drug. Another participant died of cardiac arrest 60 days after the second dose.


However, in the placebo group, two people died from a stroke and heart attack, the cause of death of two more participants has not been established. Half of those died in all groups were over 55.


The FDA has scheduled a meeting for December 10 to approve the vaccine developed by Pfizer and BioNTech.


The UK has already certified the COVID-19 vaccine on December 2. The product has been approved for use by Pfizer and BioNTech. The vaccine will become available in the country within the next week.


Mass vaccinations are expected to begin in the spring of 2021. The development’s effectiveness was estimated at 95 percent, said the head of the working group of the UK Commission on Human Medicines Munir Pirmohamed.


NEWS.ru reported earlier that BioNTech and Pfizer applied for registration of coronavirus vaccine in the European Union.”





From the Hello Ireland team:


There are few additional points I would like to make in relation to the Pfizer vaccine.


Firstly, the group of people the 95% effectiveness was showed accounts for only 170 people out of 41,135 participants who reached the second dose. Mind you, 43,661 people has been excepted to the phase 3 trial for that vaccine so it would be interesting to know what happened that 2,526 (5,7%) participants did not show up for the second dose.


Secondly, as per Pfizer press release from 18 Nov 2020 “The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2.” The question is: what Grade 3 adverse events less than 2% in frequency did the phase 3 clinical trial notice in the participants? How serious they were? How many different side effects occur with less than 2% in frequency? Were they those aches and fever or hangover like feeling reported early November by the trial participants? We do not know, do we?


And the final point is that if the reported deaths in both groups – vaccine and placebo - occurred in people over 55 years old should we be worried that the vaccine that is to protect the vulnerable and elderly may give such questionable effects in people more exposed to risky course of COVID19?


And if we were to dismiss those death as coincidental – as it is very often done in clinical trials – why Pfizer need indemnity from governments buying that vaccine?



Source:


https://news.ru/en/health/6-participants-die-in-pfizer-vaccine-trials/


https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine


https://www.lifesitenews.com/news/pfizer-covid-19-vaccine-trials-showed-severe-side-effects-fever-and-aches


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