Why can’t Japan evaluate 99% of the 1,325 deaths following COVID vaccinations?

A Ministry of Health, Labor and Welfare’s expert committee document showing the gamma sign, indicating the causal relationship between the vaccine and a death “cannot be evaluated,” is seen in Tokyo’s Chiyoda Ward. (Mainichi/Hidenori Yazawa)

About 70% of Japan’s population is fully vaccinated against the coronavirus, but of the 1,325 people who had died as of Oct. 24 after receiving their shots, the Ministry of Health, Labor and Welfare says a causal relationship between vaccination and death cannot be confirmed for 99%, or 1,317 cases. Why is this?

“Instead of just saying it ‘can’t be evaluated,’ I want them to draw a proper conclusion,” said Yuji Okamoto, 63. His son Hiroyuki, a resident of the city of Higashihiroshima in Hiroshima Prefecture, died aged 30 after getting his second Moderna Inc. vaccine shot. Though Yuji asked the health ministry about the causal relationship between the vaccine and his son’s death, he still hasn’t received a convincing answer.

Hiroyuki got his second shot on Aug. 22. The next day he developed a fever, so he took an antipyretic, and recovered on Aug. 24. But despite him then going to work, he was found dead in his futon the next morning. Hiroyuki had no underlying health issues or allergies. The vaccine administered to him was manufactured on the same line and at the same time as batches found to be contaminated with foreign objects, but his death certificate after a judicial autopsy says his cause of death is “unknown.”

Of the 1,325 people who died after getting COVID shots as of Oct. 24, 1,279 had Pfizer Inc. shots and 46 received Moderna vaccines. Deaths tend to be higher among those receiving Pfizer vaccines, which are widely available to elderly people.

Experts have concluded that an overwhelming number of the deaths following COVID shots cannot be evaluated. Of the 1,325 cases, it was ruled that a causal relationship between vaccines and deaths could not be confirmed in 1,317 — including 1,272 in which people received Pfizer shots — due to a lack of information and other reasons. Experts have drawn conclusions for just eight people. In all of these eight cases, they say a causal relationship between vaccination and their deaths cannot be confirmed.

Among the 1,325, the most common causes of death included ischemic heart disease, heart failure and strokes. Eighty-four percent of the deceased were aged 65 or older. Because elderly people are more likely to die from chronic illnesses, investigation can be difficult. Eight individuals whose deaths were said to have no causal relationship were considered to have suffered from the progression of chronic diseases such as cancer.

But Hiroyuki was young and had no chronic conditions. His father said angrily, “Even if the national government tells me I should be convinced (by what they’ve presented), that will never happen.”

How, exactly, are deaths after receiving coronavirus shots investigated?

Japan has a national adverse reaction reporting system for vaccines. When an inoculated person dies, doctors on site and medical institutions must, based on autopsy results and other information, conclude whether the death is “related,” “not related” or “cannot be evaluated” due to a causal relationship with the vaccine, and report it to the national government.

The reports are first checked by the Pharmaceuticals and Medical Devices Agency, an independent incorporated administrative body, then by the health ministry’s expert committee, for the national government to verify whether the evaluations are appropriate.

Many experts are involved in the decision, but in reality, as many as 99% of cases are classed as “cannot be evaluated.” One reason for such a high figure is that various causes of deaths, other than from vaccines, can occur coincidentally. Furthermore, it is necessary to draw a comparison with the uninoculated to determine if a symptom is an adverse reaction, but no such database exists in Japan.

“It’s difficult to assess in a short period of time whether a death was due to the vaccine or not,” a senior health ministry official explained. The World Health Organization has not requested cause of death determinations for individual cases, and it seems there are many instances where the conclusion simply remains that they can’t be evaluated.

But the United States’ Vaccine Safety Datalink (VSD) system can statistically verify the causal relationship between vaccines and symptoms occurring after inoculation. More than 12 million members of the public participated, with data such as their history of vaccination and consultation at medical institutions anonymously accumulated. If adverse reaction symptoms are reported after inoculation, they can be checked against the database to confirm if they are actual side effects.

Based on analysis by VSD and other methods, the U.S. Centers for Disease Control and Prevention has stated there is currently no clear causal relationship between the cases of deaths and Pfizer and Moderna’s messenger RNA vaccines.

But it has also been found that myocarditis, which causes inflammation including of the heart muscle, can develop on very rare occasions among vaccinated younger people. This has led to an effective response, including issuing warnings of the symptom as a side effect.

While the database is considered useful for drawing certain conclusions, it uses personal information, which needs management and protection. “It’s not possible to build (such a database system) overnight,” a senior health ministry official said.

Japan’s current system for determining a causal relationship between vaccines and deaths seems to be at its limit. At this rate, with vaccination rates rising in Japan, the number of cases that cannot be evaluated will only increase, and the public’s anxiety and distrust over the vaccine will likely spread.

Source:  mainichi.jp/english/articles/20211119/p2a/00m/0na/042000c

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