CDC report: Pfizer and Moderna vaccines cause heart problems in young men
Federal authorities have received over 800 reports of heart problems in people who have received the COVID-19 vaccine. The edition told in more detail The Epoch Times.
Myocarditis or pericarditis was reported through May 31 to the Vaccine Side Effects Reporting System, a passive reporting system operated jointly by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
Most reports, 475, describe myocarditis or pericarditis occurring in people aged 30 and under.
The problems mostly arose after the second dose of Pfizer or Moderna vaccine, both of which use messenger RNA technology.
Authorities emphasize that anyone can file reports through the reporting system, but authorities have already confirmed that 226 of the 475 reports involving individuals 30 and under fall within the CDC's definition of a work case. The rest are under investigation.
Of the 285 case reports, officials said 270 patients were discharged and 15 were still hospitalized. Myocarditis usually requires hospital treatment. No deaths were reported.
The CDC announced last month that it is looking into reports of heart problems in teens and young adults who have received the COVID-19 vaccine, but has taken no definitive action beyond stating that it will continue to analyze case data.
The agency's advisory committee, the Immunization Practices Advisory Committee, said VAERS data showed that within 30 days after the second dose of mRNA vaccine "there were more cases of myocarditis / pericarditis observed than expected 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.
"However, the analysis shows that these data need to be closely monitored as more people in younger age groups are vaccinated," the Advisory Committee's vaccine safety working group said in a report.
The Israeli Ministry of Health said on the same day that it had detected 275 cases of heart problems among more than 5 million people in the country who received the vaccine between December 2020 and May 2021. An Israeli study found a "likely link" between receiving a second dose of Pfizer vaccine "and the onset of myocarditis in men between the ages of 16 and 30," the ministry said in a statement.
Tom Shimabukuro, deputy director of the CDC's Immunization Safety Directorate, said the US passive surveillance data "is consistent with surveillance data from Israel." The numbers are also consistent with other reports.
The vast majority of US reports concern male patients. Approximately 300 preliminary reports indicated that patients suffered from chest pain, and almost as many had increased heart enzymes.
A case report of myocarditis in seven adolescents following the Pfizer vaccination, published in the American Academy of Pediatrics journal Pediatrics, states that all seven developed inflammation within 4 days of the second dose.
Seven men, between the ages of 14 and 19, required hospitalization, but all were eventually discharged.
The authors of the report stated that no link has been established between vaccines and myocarditis and that the benefits of vaccines outweigh the risks. But they also called on medical professionals to "take myocarditis into account when examining adolescents and young people who develop chest pain after being vaccinated against COVID-19."
The study commentary states that "there are some concerns about this series of cases that may indicate a causal relationship and therefore warrant further analysis with established surveillance systems."
“First, the consistent timing of symptom onset in these seven cases after the second vaccination suggests a single biological process. Second, the similarity of clinical data and laboratory characteristics in this series suggests a common etiology. Thorough diagnostic studies have not revealed an infectious etiology, ”- noted in the document.
The expected number of cases of myocarditis / pericarditis in people aged 16 or 17, based on background incidence and the number of doses given to this population before May 31, is between two and 19. But the number is reported to be 79.
Likewise, the expected number of cases among young people between the ages of 18 and 24 is between eight and 83. The number based on reports is 196.
“In adolescents between 16 and 17 years old and between 18 and 24 years old, the number of observed diseases is higher than expected,” said Shimabukuro.
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“It should be noted that of these 528 reports with symptoms onset within 30 days, over half were in the younger age groups, 12 to 24 years old,” he added.
Vaccine safety data from nine medical groups that co-administered more than 8,8 million doses - only about 284 of these were given to children 000 to 12 years old - did not indicate safety concerns. There were only 17 cases of myocarditis or pericarditis reported prior to May 60.
The FDA surveillance system identified 99 cases of myocarditis / pericarditis 42 days after vaccination among an estimated 3,1 million vaccinations, aged 12 to 64. Another 1260 cases were reported among people 65 years of age and older.
According to Steve Anderson, FDA Director of Biostatistics and Epidemiology, none of these numbers are a signal of danger.
Dr. Cody Meissner, head of the pediatric infectious diseases department at Tufts Children's Hospital and a panelist who heard from Shimabukuro and others, said after the presentations that he was "amazed at the fact" that myocarditis is "more common usually after the second dose."
He asked Shimabukuro about the incidence of blood clots in women between the ages of 30 and 49 after vaccinations - the majority in this population after the Johnson & Johnson vaccination, although officials eventually lifted the vaccination pause, saying the benefits outweighed the risks.
Shimabukuro said that unlike the clotting situation, where the data showed "strong evidence of a causal relationship early enough," further research on heart problems is needed.
“At the moment we are still studying the frequency of myocarditis and pericarditis. We continue to collect more information and I think that as more information is gathered, we will begin to get a better understanding of post-vaccination rates. Hopefully, over time, we will be able to get more detailed information on age groups, ”he explained.
And then he assured: "In the end, we will have enough information to answer all the questions."
Another team member, Dr. Jay Portnoy, director of Allergy, Asthma and Immunology at Children's Mercy Hospitals and Clinics, asked to compare the side effects in vaccinated and unvaccinated people.
Shimabukuro said the risk-benefit assessment will be provided by the CDC's advisory group, known as ACIP, on vaccines at the next meeting.
The CDC spokesman also recalled the meeting to be held on June 18. And he said that cases of myocarditis are still rare, given that more than 300 million doses have been administered in the United States.
“Given the number of doses of COVID-19 vaccine administered, these reports are rare. More than 18 million people aged 12 to 24 have received at least one dose of COVID-19 vaccine in the United States, he said. - The CDC continues to recommend COVID-19 vaccination for everyone 12 and older. Vaccination is the best way to protect yourself and your family from getting sick. ”
A Pfizer spokesman said the company is aware of federal data indicating "rare reports of myocarditis and pericarditis following vaccination, predominantly in adolescents and young males."
“With a huge number of people vaccinated to date, the benefit and risk profile of our vaccine remains positive,” the spokesperson said.
Dr. Monica Gandhi, professor of medicine and deputy director of the University of California, San Francisco, said that in light of the increased risk of myocarditis among young people, especially after the second dose, parents should closely monitor the publication of federal guidelines.
“Opportunities include vaccinating only children without prior infection, as there is a link between prior COVID-19 and this side effect; administration of 1 dose instead of 2 to 20 years; determination of the dosage of the vaccine (currently it is 30 mcg up to 12 years, which corresponds to the dose for adults); and an increase in the duration between doses, she commented. "I look forward to receiving guidance on this over the next few weeks."
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