Federal health officials have no plans to develop a database for adverse events that happen 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 spokesperson said.
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.
More than 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 deaths submitted to the reporting system, Dr. Tom Shimabukuro of the CDC’s COVID-19 Vaccine Task Force this week told members of a panel that advises the CDC.
The physicians then make an assessment about whether 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 long-term care facility (LTCF) residents, 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.
“Mortality in LTCF residents is high, and substantial numbers of deaths in this population will occur following vaccination as temporally associated coincidental events,” he states in the presentation.
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 to examine the risk of adverse events following vaccination.
The rate of severe life-threatening adverse reactions to Pfizer’s vaccine was initially occurring at higher rates among those vaccinated against COVID-19, 11.1 per million, than those who get injected against influenza. That number has decreased to 5 per million. The number for Moderna’s vaccine is 2.8 per million, a slight increase over the figure reported several weeks prior.
The number of serious adverse events is 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.
Correction: A previous version of this report misstated the number of anaphylaxis events. The Epoch Times regrets the error.