Is 99% unclear causality?
September 22, 21:48
99.3%.
Of the 1093 people who were confirmed dead after vaccination with the new coronavirus vaccine, the percentage of those who were judged by the expert group of the Ministry of Health, Labor and Welfare that "the causal relationship cannot be evaluated due to lack of information" (as of August 22).
Under these circumstances, some bereaved families want to know why their son died shortly after vaccination.
Why is there not enough information to assess causality?
How is the national census conducted?
(Hiroshima Broadcasting Station reporter Ayaka Morota, Social Affairs Department reporter Sachiyo Sugita)
Sudden death 3 days after inoculation
This is Hiroyuki Okamoto (30) from Hiroshima Prefecture.
Three days after receiving the second vaccination, he was found dead at home.
Hiroyuki said that he worked for an automobile-related company and found it rewarding to interact with customers.
He loved soccer and was in good health.
His father, Yuji, says he still can't accept the death of his beloved son.
Father Yuji
"It
's
not really bright, but it's a shy person. He was a kind, energetic and active son. He had no underlying illness and no ongoing illness."
Inoculation received "for the surroundings"
Hiroyuki received his first vaccination on July 18th.
Hiroyuki, who often comes into contact with customers, said he decided to inoculate so that he would not get infected and inconvenience people around him.
After the first inoculation, I had a slight fever, but there were no particular abnormalities.
The second inoculation is on August 22nd.
It is said that the fever of about 40 degrees came out that night.
The next day, I had a fever, so I took an antipyretic analgesic and took a break from work.
On the 24th, two days after the inoculation, he went to work because his fever had dropped.
After returning home, I ate dinner as usual and went to my room around 9:30 pm.
It is said that it did not seem to change normally.
That was the last appearance of Hiroyuki-san as seen by his family.
Father Yuji
"I didn't get up in the morning, so when my wife went to my son's room when I couldn't make it to the office, I was dead. My body was so stiff and cold."
What is the relationship between son's death and vaccination?
Sudden death at the young age of 30.
The next day, the Ministry of Health, Labor and Welfare announced that it would suspend the use of some Moderna vaccines.
It also included the lot number of the vaccine given to Mr. Hiroyuki.
Although no abnormalities were directly confirmed, metal fragments were found in a vaccine manufactured in the same process at the same time, so they were to be recovered.
Why did my son die and is it related to the vaccine?
Yuji waited for the result of the dissection by the government.
However, only the word "unknown" was recorded in the cause of death column of the dissection results shown 6 days after death.
Father Yuji
"Wait with this one sheet of paper. I don't know what this is. This one sheet is absolutely strange. I'm not convinced."
The next thing Yuji expected was an expert group called the "Vaccine Reaction Study Group / Pharmaceutical Safety Measures Subcommittee" of the Ministry of Health, Labor and Welfare, which investigates the causal relationship between death and vaccination.
At the meeting on September 10, Hiroyuki's death was also considered.
However, the result is "γ (cannot be evaluated)".
Even if the vaccine contained metal pieces, the association with death could not be evaluated.
Hiroyuki wasn't the only person who was given "γ" in the session on that day.
α (alpha) = causal relationship cannot be denied ... 0 cases
β (beta) = causal relationship not found ... 8 cases
γ (gamma) = causal relationship cannot be evaluated due to lack of information ... 1085 cases
(as of August 22) )
99.3% said that the causal relationship could not be evaluated.
Why lack of information?
What does lack of information mean?
How is the national census conducted?
The Ministry of Health, Labor and Welfare has established a "Vaccine Reaction Suspicion Reporting System" to investigate side reactions.
The law requires vaccinated doctors and medical institutions to report symptoms of suspected adverse reactions.
Similarly, pharmaceutical companies are required to collect and report information from medical institutions.
The subjects of the report are anaphylaxis (= severe allergic symptoms) and thrombosis (symptoms of blood clots that clog blood vessels).
In addition, it is a symptom that the doctor judged to be "highly related to inoculation" and led to hospitalization, death, disability, etc.
In addition to the type of vaccine inoculated, the content to be reported includes allergies and the presence or absence of underlying diseases.
The report also has a column called "Summary of Symptoms", which describes the results of diagnosis and tests, and the course of symptoms.
The report destination is the independent administrative agency "PMDA" = Pharmaceuticals and Medical Devices Agency.
After confirming that there are no omissions in the received report, experts such as PMDA doctors and pharmacists will evaluate the causal relationship with vaccination.
The report is the only source of judgment, and you do not go to a medical institution to check the medical record directly or interview the person or family.
The evaluation results issued by PMDA are all reported to the expert group of the Ministry of Health, Labor and Welfare, which is made up of 15 members including doctors, pharmacists, and infectious disease experts, and the evaluation is verified.
Yuji's father said that the result of "γ (cannot be evaluated)" was given in this way.
Father Yuji
"I don't think the safety of the vaccine has been deliberated, just because the expert group announced that the association (inoculation and death) could not be evaluated."
The limit of the system?
Why are there so many "γ"?
A person in charge of the Ministry of Health, Labor and Welfare explains:
A person in charge of the Ministry of Health, Labor and Welfare
"This expert group will also examine the causal relationship of individual cases, but the main purpose is to monitor the overall tendency of side reactions and to determine the direction of" whether to continue inoculation ". Think about it. Even if you don't understand each causal relationship, when the number of people gathers, the relationship may come out or the correlation may become visible. "
This may not convince Hiroyuki's family.
I asked the person in charge if I would like to take any further action.
A person in charge of the Ministry of Health, Labor and Welfare
will continue the investigation with the attitude that "something may be found" and "a problematic side reaction may occur" even with γ. As a result, it became γ once. In some cases, similar cases were subsequently reported and later causal. "
An expert group that examined more than 1000 people and said that 99% could not be evaluated.
The committee members also questioned how the information should be disclosed.
Committee member A
"There will be a lot of γ. Even if you look carefully at the death cases, it may be difficult to evaluate the causal relationship, but you need to keep in mind to provide information that does not cause misunderstanding."
Committee member B
"Specialty The judgment of the evaluation by the house is a collegial system or a black box. It should be explained so that the public can understand how the experts decide, what kind of process and why there are many γ. "
In response to this opinion, a person in charge of the Ministry of Health, Labor and Welfare said, "I would like to think about how to present information in a more understandable way," and the session on September 10 ended.
Another mechanism to investigate causality
Another national system is to investigate the causal relationship between death and vaccination.
That is the "Vaccination Health Damage Relief System".
If a side reaction is suspected after vaccination, the person or family member applies to the municipality, and if a certain causal relationship is found, the medical expenses will be borne by the individual and the monthly medical allowance will be up to 37,000 yen. Will be paid.
If you die, you will be paid a lump-sum death allowance of 44.2 million yen.
The certification is carried out by an expert examination committee of the Ministry of Health, Labor and Welfare called the "Disease / Disability Certification Examination Committee".
Here, doctors, lawyers, infectious disease specialists, etc. also check medical records and investigate the causal relationship in more detail.
The examination of the new coronavirus vaccine has started on August 19.
Two examinations have been conducted so far.
A total of 66 people were certified as "the possibility of anaphylaxis or acute allergic reaction caused by vaccination cannot be denied", and medical expenses and medical allowances will be paid.
However, the examination of those who died after vaccination has not yet begun.
The Ministry of Health, Labor and Welfare has not disclosed the number of applications, but explained that "as with other vaccine death cases, it takes time to collect the necessary materials and proceed with the examination procedure."
A system that allows inoculation with peace of mind
"If you don't appeal properly, no one will be interested in
it,
"
said Yuji Okamoto, who revealed the reason why he responded to the interview with his real name.
I applied for a relief system to further examine Hiroyuki's death and investigate the cause.
It contains the hope that as the inoculation of the younger generation progresses, we would like everyone to take a step toward receiving the inoculation with peace of mind.
Yuji Okamoto
"There is only a vaccine that can beat Corona now. I want people in their 20s and teens to inoculate it by creating a system that can establish safety properly."
The government has stated that it will continue vaccination, saying, "There have been no cases of death that have been concluded to have a causal relationship with vaccination, and there are no serious concerns."
However, is the current system sufficient to explain the most important "safety" to the public?
And is it really close to the feelings of the bereaved family of those who suffer from symptoms for which the causal relationship is unknown after inoculation and those who have died?
We will continue to cover the matter.
Hiroshima Broadcasting Station Reporter
Ayaka
Moroda Joined in 2020
Coverage on the theme of new corona and sexual damage issues
Social section reporter
Sugita Sachidai
2010 joined
mainly incident or disaster in charge in Wakayama stations and Osaka stations
Ministry of Land, Infrastructure and Transport in society part from 2016, is now through the Ministry of the Environment in charge of the Ministry of Health, Labor and Welfare