Federal authorities have received over 800 reports of heart inflammation in people who received a COVID-19 vaccine, a health official said Thursday.
The reports of myocarditis or pericarditis were submitted to the Vaccine Adverse Event Reporting System, a passive reporting system run jointly by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration, through May 31.
The bulk of the reports described heart inflammation appearing after the second of two doses of either the Pfizer of Moderna vaccines.
Authorities stress that anybody can submit reports through the reporting system but authorities have already verified that 226 of the reports meet the CDC’s working case definition, Dr. Tom Shimabukuro, a deputy director at the agency, said during a presentation of the data. Followup and review are in progress for the rest.
Of the 285 case reports for which the disposition was known at the time of the review, 270 patients had been discharged and 15 were still hospitalized, officials said. Myocarditis typically requires hospital care. No deaths were reported.
The CDC announced last month that it was investigating reports of heart inflammation in teenagers and young adults who received a COVID-19 vaccine, though it took no definitive action besides saying it would continue reviewing case data.
An advisory committee to the agency, the Advisory Committee on Immunization Practices, said in a little-noticed update published dated May 24 and published on June 1 that data from VAERS showed that in the 30 days following the second dose of mRNA vaccinations, “there was a higher number of observed than expected myocarditis/pericarditis cases in 16–24-year-olds.”
Data from the Vaccine Safety Datalink, an active reporting system that relies on nine healthcare organizations in seven states, did not show higher than expected cases, it added.
“However, analyses suggest that these data need to be carefully followed as more persons in younger age groups are vaccinated,” the advisory committee’s vaccine safety workgroup said in its report.
Israel’s Health Ministry said that same day that it found 275 cases of heart inflammation among the more than 5 million people in the country who received a vaccine between December 2020 and May. An Israeli study found “a probable link” between receiving the second dose of the Pfizer jab “and the appearance of myocarditis among men aged 16 to 30,” the ministry said.
Shimabukuro said the U.S. passive surveillance data “are consistent with the surveillance data that emerged from Israel.”
The figures are also consistent with other case reports and data from the Department of Defense.
The vast majority of the U.S. reports deal with male patients. Approximately 300 preliminary reports indicated the patients suffered chest pain, with nearly as many having elevated cardiac enzymes.
A case report examining myocarditis in seven adolescents following vaccination with Pfizer’s jab, published in Pediatrics, the journal of the American Academy of Pediatrics, this month, said all seven developed the inflammation within 4 days of receiving the second dose, did not have evidence of COVID-19 infection, and did not meet the criteria for MIS-C, a rare disease.
The seven males, between the ages of 14 and 19, all required hospital care but each was eventually discharged.
Authors, who did not respond to requests for comment, said no link has been established between the vaccines and myocarditis and that the benefits of the vaccines outweigh the risks. But they also urged healthcare workers “to consider myocarditis in the evaluation of adolescents and young adults who develop chest pain after COVID-19 vaccination.”
A commentary on the study published in the same journal, said “there are some concerns regarding this case series that might suggest a causal relationship and therefore warrant further analysis through established surveillance systems.”
“First, the consistent timing of symptoms in these seven cases after the second vaccination suggests a uniform biological process. Second, the similarities in clinical findings and laboratory characteristics in this series suggest a common etiology. Finally, these cases occurred in the context of a dearth of circulation of common respiratory viruses known to be associated with myocarditis, and thorough diagnostic evaluations did not identify infectious etiologies,” they added.
The expected number of myocarditis/pericarditis cases in those aged 16 or 17, based on background incidence rates and the number of doses administered to that population through May 31, is between two and 19. But based on the VAERS reports, the number is 79.
Likewise, the expected number for cases among young adults between the ages of 18 and 24 is eight to 83. The number based on the reports is 196.
“In the 16- to 17 year-olds and the 18- to 24-year-olds, the observed reports are exceeding the expected based on the known background rates that are published in literature,” Shimabukuro told members of a Food and Drug Administration vaccine advisory committee in the meeting on Thursday, though he cautioned that not all the reports will “turn out to be true myocarditis/pericarditis reports.”
“Of note, of these 528 reports after second dose with symptom onset within 30 days, over half of them were in these younger age groups, 12–24 years old, whereas roughly 9 percent of total doses administered were in those age groups, so we “clearly have an imbalance there,” he added later.
Data from the Vaccine Safety Datalink, which comes from nine healthcare groups that have collectively administered over 8.8 million doses—only some 284,000 of those have been given to 12- to 17-year-olds—did not indicate safety concerns, with just 60 myocarditis or pericarditis events reported through May 29, the doctor continued.
A Food and Drug Administration surveillance system, the Biologics Effectiveness and Safety Initiative, which utilizes claims data from CVS and two other partners, has detected 99 cases of myocarditis/pericarditis in the 42 days following vaccination among some 3.1 million shots given to people between the ages of 12 and 64, the panel was told earlier by an official from the drug regulating agency.
Another 1,260 were reported in people 65 or older through claims data from Medicare claims data.
Neither number raised safety signals, Steve Anderson, director of the FDA’s Office of Biostatistics and Epidemiology said.
This is an excerpt from The Epoch Times.
Scroll down to leave a comment and share your thoughts.