Spread rumors with a mouth, refute rumors and run off legs
Written by | Yan Xiaoliu
Source | "Medical Community" public account
"Unfortunately, people with a heart, especially those who are anti-COVID-19 vaccines, have taken advantage of VAERS's misconception-prone weaknesses to spread disinformation that the COVID-19 vaccine is a tool used by the government to kill people."
Lin Qingshun, a retired professor at the University of California, San Francisco School of Medicine, recently publicly published this view, what is the situation?
It all started in the past 1 week, when the Pfizer mRNA vaccine was exposed to a "massive list of adverse reactions".
On March 1, local time, the US Food and Drug Administration (FDA) released some review documents for the Pfizer mRNA vaccine. These include a Cumulative Analysis of Post-authorization Adverse Event Reports (hereinafter referred to as the "Cumulative Analysis").
The document is 38 pages long. There are 9 pages of appendices entitled "List of Adverse Events Of Special Interest"
This appendix has been excerpted, translated, and extracted details such as "9 pages of side effects", "more than 1,000 kinds of side effects", "42,000 deaths and 1223 cases", which have been widely circulated on the Internet.
Six days later, Lancet Infectious Diseases released the latest study from the U.S. Centers for Disease Control and Prevention (CDC), saying that data on mass vaccination for 6 months supported the safety of the mRNA vaccine, and most adverse event reports were mild and short-lived. The accompanying editorial said the report was "reassuring."
Why does the same vaccine lead to two very different results?
Misread "adverse event reports"
According to FDA press officer Alison Hunt told Reuters in January, the Cumulative Analysis is part of Pfizer's biologics licensing application (BLA) with the U.S. FDA.
The Cumulative Analysis included a total of 42,086 reports of adverse events after vaccination between 1 December 2020 and 28 February 2021. Of these, 25,379 were medically validated.
A total of 158,893 adverse events were reported. The highest reported adverse event was headache (24.1%). It was followed by fever (18.2%), fatigue (17.4%), chills (13.1%), and pain and nausea at the site of vaccination (all reported at 12.3%).
There are two details in Cumulative Analysis that attract attention. The first is that the appendix to the document, the List of Adverse Events of Particular Concern, lists 1291 types of adverse events. Some have never been reported before, including fasciitis, eye swelling, alopecia areata, anaphylactic shock, pregnancy allergic reaction syndrome, acute cardiomyopathy, acute respiratory failure, etc.
Second, 1,223 deaths were recorded in 42,086 reports.
Some media divided 1223 by 42086 to get 2.9%, saying that "the mortality rate caused by vaccination, up to 2.9%, is higher than the mortality rate of infection with new crown".
"Unfortunately, people with a heart, especially those who are anti-COVID-19 vaccines, have taken advantage of VAERS's misconception-prone weaknesses to spread disinformation that the COVID-19 vaccine is a tool used by the government to kill people." On March 6, local time, Lin Qingshun, a retired professor at the University of California, San Francisco School of Medicine, verified the source and posted on his personal website.
What he calls "VAERS", whose full name is "Vaccine Adverse Event Reporting System" (VAERS), has been established and operated for more than 30 years.
Lin Qingshun clarified that the data cited in the Cumulative Analysis came from VAERS. As a notification system, VAERS records adverse event data that anyone actively uploads, but does not "confirm".
The VAERS website also has a corresponding reminder not to draw conclusions based on website data, as these records have not been verified.
Reuters asked Viki Male, an expert in reproductive immunology at Imperial College London, for advice. The latter said the adverse event reports described in the document do not necessarily mean that doctors or patients believe that the event originated from vaccination, "they only occur after vaccination." ”
Dr. Li Bingying, a member of the Expert Advisory Group of the Taiwan Epidemic Command Center, explained in an interview with the media that the "Adverse Event" described in the Cumulative Analysis refers to "adverse events that do not necessarily have a causal relationship". A causal relationship is called an Averse Reaction, or "adverse reaction." In addition, Side Effect, translated as "side effect," means relevant, but not necessarily harmful. "The difference from adverse events to adverse reactions is that the latter must be judged by scientific evidence or experts."
The Cumulative Analysis states: "In interpreting these data, the limitations of post-marketing adverse drug event reporting should be taken into account... One limitation is that the accumulation of adverse event reports does not necessarily indicate that a particular adverse event was caused by a drug; rather, the event may be caused by an underlying disease or some other factor, such as a history or concomitant medication. ”
According to past studies, the reasons for reporting adverse events after vaccination are complex and the effects of the "placebo effect" are not excluded.
In January, JAMA Network Open published a study saying that subjects receiving placebo reported very high rates of adverse events. After the first dose, 35.2% of the placebo group participants reported at least 1 adverse event. The highest reported rates were headache (19.3%) and fatigue (16.7%).
In response to the 1223 deaths and the 2.9% "mortality rate caused by vaccination" calculated from it, Lin Qingshun described it as "people with hearts who add fuel and vinegar, bulls take the horse's mouth, and evolve into garbage that is not surprisingly dead".
Such calculations are completely out of touch with reality.
In December 2020, the Pfizer mRNA vaccine was approved for marketing in the United Kingdom and the United States. Taking the United States as an example, mass vaccination began on December 14, 2020 local time. Pfizer has stated that it will deliver 25 million doses of vaccines per month from December 2020 to March 2021. Therefore, to count related adverse events, the denominator should not be more than 40,000 reported cases, but tens of millions of vaccinations.
Is the FDA's information "strong"?
Confacts, a suspicious information verification platform that insists on fact checking, is also concerned about the above information.
Under the relevant terms, some netizens provided arguments, saying that THE PHMPT organization participated in related events, and its official website has uploaded 150 relevant documents. These documents are from the FDA.
Lin Qingshun wrote that PHMPT is a non-profit organization with the full name of Public Health and Medical Professionals for Transparency. Chinese can be translated as "public health and medical professionals demanding transparency".
According to the phMPT website, to join the organization, simply fill in the name, title, postal code, email address, and identity on the website. The website offers 4 identity options, including medical practitioners, public health practitioners, scientists or journalists. At present, PHMPT shows that about 500 people have signed and joined.
Lin Qingshun also traced the source and pointed out that the FDA's disclosure of relevant documents did stem from PHMPT's filing of lawsuits and requests for disclosure in court. But there are no details such as "FDA refuses to disclose".
According to public media reports, the FDA has a huge amount of data in its possession, mixed with many legal trade secrets. Due to limited manpower, fda asked the court to give them 55 years to collate and publish all the information. In the end, it was Pfizer that it was willing to pay a million dollars to let the FDA hire 15 contractors to collate the data for early release.
What does the latest research data say?
The authoritative journal Lancet Infectious Diseases published a peer-reviewed article that considered the mRNA vaccine to be "safe."
The study, completed by the U.S. CDC, used all data from VAERS and the post-immunization health self-test procedure V-safe for the period from December 14, 2020 to June 14, 2021. V-safe is a self-developed program of the CDC in the United States for people to record and upload their symptoms after vaccination.
During these time periods, nearly 300 million doses of mRNA were administered nationwide. Among them, more than 160 million doses are Pfizer mRNA new crown vaccine.
VAERS received a total of 340,522 adverse event reports. 164,669 doses were derived from the Pfizer mRNA covid-19 vaccination. The analysis showed that 91.4% reported that it was "not serious". The top three adverse event reporting rates were headache (20.5%), fatigue (16.5%), and no appetite (14.7%).
The study also looked at post-vaccination deaths. Pfizer mRNA vaccination populations reported 1,753 deaths, more than 80 percent of whom were over the age of 60. "In the case of emergency authorization, especially among the elderly population, the rate of VACCINATION of COVID-19 vaccines is unprecedented." One of the authors of the article, David Shay, noted in a statement that "due to age, the baseline mortality rate in this population is already higher than that of the general population." We did not find abnormal patterns in the cause-of-death report. The findings are similar to mortality rates in this age group after receiving other vaccines. ”
In the accompanying editorial, Matthew Krantz and Elizabeth Phillips of Vanderbilt University School of Medicine in the United States found the study "reassuring." "COVID-19 vaccine safety surveillance uses the most robust surveillance system in U.S. history. The two surveillance systems used in this study complement each other and increase confidence in the safety of the mRNA vaccine. ”
They also argue that the predictability, non-severity and transience of adverse events, which provide an objective basis for companies to develop paid leave rules, help increase individual confidence and acceptance of vaccines.
Source:
1.Fact Check-Pfizer FDA document does not show COVID shot caused miscarriages or neonatal deaths in ‘all injected mothers’. Reuters
2.Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. The Lancet Infectious Diseases. doi.org/10.1016/S1473-3099(22)00054-8
3. Was Pfizer forced to disclose vaccine data? Side effects are a full 9 pages?. professorlin.com/
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