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The U.S. Food and Drug Administration (FDA) on June 25 adds a warning to patient and provider fact sheets with Pfizer and Modern COVID vaccines indicate an increased risk of myocarditis and pericarditis after vaccination.
the warning notes Reports of adverse events suggest an increased risk of myocarditis and pericarditis, especially following the second dose and onset of symptoms a few days after vaccination.
Myocarditis is inflammation of the heart muscle that can lead to cardiac arrhythmia and death. According to researchers according to the National Organization for Rare Disorders, myocarditis can be the result of infections, but “myocarditis is usually the result of the body’s immune reaction to initial heart damage.”
The FDA update follows a review of the information and discussion with the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on June 23 where the committee identified 1,200 cases of heart inflammation in 16- to 24-year-olds and said that COVID mRNA vaccines should carry a warning statement.
“The data presented at this meeting reinforces the FDA’s decision to revise the fact sheets and further informs specific changes,” the FDA said. said in a statement.
Health officials said the benefits of receiving a COVID vaccine outweigh any risks. Doctors and other public commentators blamed the CDC during the meeting exaggerated the risk of young people to COVID, and reduced the risk of vaccines.
Meryl Nass, a doctor of internal medicine, pointed out several errors in the data used in the ACIP presentation:
“As of now, there are two main ways to reduce the rate of myocarditis [during the presentation] is lump lump people from the age of 39 and below – even if the highest price [of myocarditis] are in the youngest children. This water reduces the rate. The other method is to include only a very narrow window of time after vaccination is started in the 12-15 age group, thus eliminating most of the second doses, which is when the 75% or more of myocarditis cases Also, the genders are sometimes mixed. And rates for girls are lower than for boys. ”
CDC’s time presentations, Drs. Megan Wallance is the overall effectiveness of Pfizer’s COVID vaccine in the 12 to 15 age group 100% and Moderna’s are comparable. Wallace then performed a risk / benefit analysis comparing myocarditis cases versus hospitalization rates for COVID in people aged 12 and 29.
“The problem with his analysis is that now the used myocarditis rate is very low. But the danger comes COVID raised, ”Nass said.
Elizabeth Mumper, MD, FAAP, IFMCP and president and CEO of The RIMLAND Center, said:
The chance that a child less than 17 years of age will die from COVID-19 is 0.0005% according to the CDC’s own figures. Most pediatric patients have strong innate immune systems, meaning they have strong defenses against various viruses. Beta coronavirus infections, most likely in children, induce strong and long-lasting resistance to the nucleocapsid protein that is likely to protect children from serious problems from COVID 19. “
“Healthy teenage athletes changed the course of their lives by having serious reactions to these vaccines – myocarditis, brain clots, posture hypension and severe fatigue to name a few. I have seen alarming vaccine reactions in my practice in the short time that a small fraction of my patient population has received a novel vaccine. “
Another scary story! The OSU student, elite athlete + ROTC member developed serious heart complications following his second dose of Pfizer’s COVID vaccine.
– Robert F. Kennedy Jr. (@RobertKennedyJr) June 21, 2021
Both the FDA and CDC monitoring reports to heart inflammation and will be followed up to assess long -term consequences.
Agreed to most recent data from the CDC’s Bad Vacation Vaccine Reporting System (VAERS), there is already 1,342 cases of myocarditis and pericarditis in all age groups reported in the U.S. following COVID vaccination between Dec.14, 2020 and June 18, 2021. Of the 1,342 cases reported, 835 cases dedicated to Pfizer, 458 cases in Moderna and 45 cases of the COVID vaccine at Johnson & Johnson.
There were 237 reports of myocarditis and pericarditis in 12 to 17-year-olds with 234 cases dedicated to Pfizer’s COVID vaccine.
Calls are mounting for the FDA to fully approve COVID vaccines
Agreed to The Hill, the calls rise from some experts to fully FDA approve COVID vaccines, as some unsuspecting people see today Emergency Use Authorizations for vaccines as an indication that they are experimental and not fully tested.
Pfizer submitted the data for full approval May 7, but it’s unclear when the FDA will act, leading to calls to take the step. Moderna applied for full vaccine approval on June 1st.
Gigi Gronvall, senior scholar at the Johns Hopkins Center for Health Security, says that while there is no necessary “political pressure” from the FDA, he is interested in knowing what prevention is.
“It can have a huge impact on getting people [vaccinated] if it is approved by the FDA, ” Gronvall said. “I think it’s worth asking why it hasn’t happened yet.”
Ashish Jha |, dean of the Brown University School of Public Health, said Pfizer began applying on May 7. 6 weeks later. The data is there. Vaccines are safe and effective. It’s time for full approval. ”
Some experts say the FDA can damage public confidence if they cut the corner.
“If they speed it up and don’t completely complete their review, that’s actually going to have the opposite effect,” he said. Jesse Goodman, former FDA chief scientist. “I think that would damage trust.”
Nancy Allen LaPointe, with a faculty member at the Duke-Margolis Center for Health Policy, said it was important for trusting vaccines without “any mental or real cut” to be reviewed by the FDA for full approval.
Full approval of COVID vaccines is likely to lead to many more employee mandate. Boston Herald, a Boston -based hospital, announced June 24 that it requires more than 80,000 Mass General Brigham employees to be vaccinated against COVID once one of the three vaccines gets approval from the FDA.
Agreed to Los Angeles Times, the city of San Francisco announced last week that it would require 35,000 employees to get vaccinated against COVID or risk losing their jobs. Workers who refuse or fail to grant a religious or medical exemption may be terminated. The mandatory vaccination requirement will take effect once COVID vaccines are formally approved by the FDA, and will be extended to all city government employees, including police, firefighters, security guards and city hall clerks.