Officials are investigating the death of a University of Cincinnati student one day after he received Johnson & Johnson’s one-dose COVID-19 vaccine.
John Foley, 21, a pre-med junior, passed away on Sunday. His body was discovered shortly afterwards by his college roommates, reported FOX 19.
The Ohio Department of Health and the Hamilton County Coroner’s Office are awaiting medical records and test results before determining the cause of death.
It comes as the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) announced on Tuesday they were recommending a pause of the shot after six women developed rare, but serious, blood clots out of 7.2 million vaccinations.
A 2011 report by Harvard Pilgrim Health Care, Inc. for the U.S. Department of Health and Human Services (HHS) stated that fewer than one percent of all vaccine adverse events are reported to the government:4
Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.
There have been 8,087 vaccine-related deaths reported to VAERS, but that number likely represents only one percent of the total number of deaths that have actually occurred and the real number may be 808,700 vaccine–related deaths. Similarly, 17,394 reports of permanent disabilities have been reported to VAERS, but that number likely is closer to 1,739,400 vaccine-related disabilities.
Although the 1986 Act legally requires doctors and other medical workers who administer vaccines in the U.S. to report vaccine reactions, Congress did not include legal penalties in the law for those who refuse to comply with the reporting requirement.5 Therefore, VAERS is really a “passive” reporting system because there is no mechanism to compel compliance and hold vaccine administrators accountable for failing to report serious health problems, hospitalizations, injuries and deaths that occur after vaccination to the government.
The FDA and Centers for Disease Control and Prevention announced Tuesday that they are calling for an immediate pause on the use of the single-dose Johnson & Johnson vaccine after discovering six cases in the United States of a rare and severe type of blood clot that developed about two weeks after the vaccine was administered in these patients.
“Safety is a top priority for the federal government,” acting FDA Commissioner Dr. Janet Woodcock told reporters in a virtual news briefing, adding that while the blood clots were “extremely rare” the government was acting “out of an abundance of caution.”
“We are committed to patient safety,” Woodcock said, but she encouraged Americans to continue to get vaccinated with the Pfizer and Moderna vaccines.
As many as 246 Michigan residents considered fully vaccinated against COVID-19 were later diagnosed with the virus, and three have died, state officials confirmed Monday.
The cases were reported between Jan. 1 and March 31, and the 246 had a positive test 14 or more days after the last dose in the vaccine series, said Lynn Sutfin, a spokeswoman for the Michigan Department of Health and Human Services, in an email.
“Some of these individuals may ultimately be excluded from this list due to continuing to test positive from a recent infection prior to being fully vaccinated,” she said.
“These cases are undergoing further review to determine if they meet other CDC criteria for determination of potential breakthrough, including the absence of a positive antigen or PCR test less than 45 days prior to the post-vaccination positive test. In general, these persons have been more likely to be asymptomatic or mildly symptomatic compared with vaccinated persons.”
The University of Oxford has paused administering doses of the COVID-19 vaccine it developed with AstraZeneca PLC AZN, -0.63%AZN, +0.15% in a small U.K. study aimed at evaluating its safety and effectiveness in children and teenagers, to wait for further information on rare blood-clotting issues that have been found in a small group of adults that received it, the Wall Street Journal reported Tuesday. The trial was started in mid-February and involves more than 200 young people aged 6 to 17 years old, the paper said. It cited an Oxford spokesman as saying that the trial had not found any safety issues, but that broader concerns and a review of the vaccine by regulators in the U.K. and European Unions were behind the move. The European Medicines Agency said earlier it expects to update the public on its investigation of the blood-clotting issue later this week.