No Plans to Develop Database for Post-COVID-19 Vaccination Deaths: FDA

Zachary Stieber
By Zachary Stieber
January 30, 2021US News
No Plans to Develop Database for Post-COVID-19 Vaccination Deaths: FDA
A firefighter paramedic prepares COVID-19 vaccination doses at a Los Angeles Fire Department (LAFD) fire station in Los Angeles, Calif., on Jan. 29, 2021. (Mario Tama/Getty Images)

Federal health officials have no plans to develop a database for adverse events to people who receive a COVID-19 vaccine, the Food and Drug Administration (FDA) told The Epoch Times.

“At this time there are no specific plans to develop a public database of deaths and adverse events associated with vaccination,” a spokesperson said via email.

If a link between an adverse event or death to a vaccination were verified, the health officials would communicate the findings and consider if additional regulatory actions were warranted, such as product labeling.

The number of deaths post-vaccination submitted to the Vaccine Adverse Event Reporting System (VAERS) is up to 288 as of Jan. 29. The system is passive and anyone can submit reports. Health professionals are encouraged by public health officials to use the system.

Over 3,000 patients have suffered adverse effects after getting a COVID-19 vaccine, including 106 who have suffered a permanent disability, according to VAERS reports.

Physicians at the Centers for Disease Control and Prevention (CDC) and the FDA review all reports of death submitted to the reporting system, Dr. Tom Shimabukuro of the CDC’s COVID-19 Vaccine Task Force told members of a panel that advises the CDC this week.

The physicians make an assessment if any immediate action is necessary and attempt to obtain death certificates and autopsy reports to ascertain the cause of death.

About 65 percent of the deaths occurred among longterm care facility residents (LTCF), according to data through Jan. 18 that was studied for the presentation. Based on the data so far, physicians expect 11,440 deaths among such residents, Shimabukuro told the Advisory Committee on Immunization Practices.

Virus Outbreak Arizona Vaccine
A nurse (L) answers questions after an elderly woman received a CCP virus vaccination inside Yuma Civic Center in Yuma, Ariz., on Jan. 28, 2021. (Randy Hoeft/The Yuma Sun via AP)

“Mortality in LTCF residents is high and substantial numbers of deaths in this population will occur following vaccination as temporally associated coincidental events,” his presentation stated.

Officials have cautioned that a person dying after being vaccinated doesn’t mean the vaccine caused the death. As of now, there appear to be no deaths conclusively linked to a vaccine. The CDC didn’t respond to a request for comment. Officials last month said an ingredient in the vaccine could be causing adverse reactions and later warned against individuals who reacted to polyethylene glycol and polysorbate getting vaccinated.

Officials are relying on VAERS and other passive systems in the early phase of the U.S. vaccination program, according to Dr. Grace Lee, co-chair of the Advisory Committee on Immunization Practices’ COVID-19 Vaccine Safety Technical Subgroup. Down the road, they plan to use data from population-based surveillance systems such as the National Institutes of Health’s Genesis system to examine the risk of adverse events following vaccination.

The rate of severe life-threatening adverse reactions was initially occurring at higher rates among those vaccinated against COVID-19 than those who get injected against influenza. That rate has climbed even higher, to 45 per million doses administered, according to data submitted to VAERS and presented to the advisory panel this week.

CDC officials have said no post-vaccination deaths related to the life-threatening reactions have been reported. The most commonly reported adverse events are headache, fatigue, and dizziness.

From The Epoch Times

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