Detection
A CDC spokeswoman, according to one of the emails obtained by The Epoch Times, told a reporter on Sept. 21, 2022, that the CDC was aware of reports of tinnitus after COVID-19 vaccination lodged with the Vaccine Adverse Event Reporting System (VAERS). That CDC-run system accepts reports from anybody, although most are filed by health care workers.
The CDC opted to explore potential links in VSD.
“Unlike VAERS, which relies primarily on voluntary reports … the VSD uses data from electronic health records,” Ms. Sharan said. “Consequently, the VSD data are less likely to be affected by the reporting biases and other biases that impact spontaneous reporting patterns to VAERS and data quality.”
The analysis of VSD data showed that “to date, no clustering of tinnitus diagnoses have been observed post-vaccination,” she added.
Katherine Yih, PhD, leads analyses of VSD data to monitor vaccine safety. She’s an assistant professor at the Harvard Pilgrim Health Care Institute’s Department of Population Medicine and receives funding from the CDC.
Ms. Yih informed CDC officials on Sept. 29, 2022, that analyses of VSD data turned up “statistically significant temporal clusters” for tinnitus following receipt of the Pfizer and Moderna vaccines, another email obtained by The Epoch Times shows. Both vaccines utilize messenger RNA (mRNA) technology.
“Both strongest clusters for the mRNA vaccines start around 12-13 days after when dose 2 would likely have been received,” she said. “The relative risks are quite low and certainly it’s hard to see anything on visual inspection of the graphs, especially for Moderna, so this seems to be a subtle effect if it is truly a VAE, unless you’re one of the unlucky ones who got tinnitus.”
VAE stands for vaccine adverse event.
Ms. Yih told the officials they could discuss the matter during an upcoming call.
No Disclosure
Ms. Sharan informed Ms. Haelle that the VSD analysis did not show any clustering of tinnitus after COVID-19 vaccination. In a follow-up email on Sept. 29, 2022, attributed to Dr. Shimabukuro, he repeated the statement.
Hours later, Ms. Yih alerted Dr. Shimabukuro and others to the clustering that was found.
The CDC appears to have never alerted Ms. Haelle, or the general public, to the discovery.
Dr. Shimabukuro wanted to delay the interview, Ms. Sharan added soon after, because the CDC was going to conduct additional analyses of VSD data. The analyses would be done “relatively soon,” according to Dr. Shimabukuro.
On Dec. 19, 2022, Ms. Yih sent an “outline of tinnitus exploration” to Dr. Shimabukuro and other officials. The “outline for a possible report on COVID vaccination and tinnitus” was created at the request of one of the other officials, she said. Large portions of that and other emails were redacted.
On Jan. 8, 2023, Ms. Sharan told Ms. Haelle that the CDC “doesn’t have enough evidence to justify an epidemiologic study on tinnitus in VSD.”
Despite Ms. Haelle’s efforts, the CDC refused to provide the results of its analyses.
Other Countries Find Link
Other researchers and countries have identified a link between tinnitus and COVID-19 vaccines.
Due to increasing evidence of a link, the European Medicines Agency added tinnitus to the labels for the AstraZeneca and Johnson & Johnson COVID-19 vaccines. Tinnitus may affect up to one in 1,000 people after the shots, according to the agency.
Australian regulators have also placed tinnitus on the labels for the AstraZeneca and Novavax COVID-19 vaccines. The AstraZeneca shot has never been authorized in the United States.
The method by which the vaccines may cause the condition remains unconfirmed.