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Pfizer and Moderna will begin clinical trials to determine adverse heart risks from COVID-19 vaccines, such as myocarditis


By: PAUL SACCA | November 13, 2022

Read more at https://www.conservativereview.com/pfizer-and-moderna-will-begin-clinical-trials-to-determine-adverse-heart-risks-from-covid-19-vaccines-such-as-myocarditis-2658641780.html/

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The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on Dec. 11, 2020. A week later, the FDA issued an EUA for Moderna’s COVID-19 vaccine. Now, nearly two years later, Pfizer and Moderna will launch clinical trials to track adverse health issues stemming from the COVID-19 vaccines, such as myocarditis – inflammation of the heart muscle.

Pfizer is in the infancy of beginning clinical trials to determine if there are any health risks associated with their own vaccine. In a partnership with the Pediatric Heart Network, the trial will focus on vaccine recipients who have suffered heart issues following being jabbed with the COVID-19 vaccine. The clinical trials will monitor patients for five years.

Enrollment for the study in the U.S. and Canada has not started yet. However, the research team has already identified more than 250 patients with myocarditis, according to Dr. Dongngan Truong – a pediatrician at the University of Utah Health and a co-lead on the Pfizer study.

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NBC News reported on Friday, “The team will also compare the patients to a subset of patients with multisystem inflammatory syndrome in children, also known as MIS-C, which is associated with a COVID infection.”

The first findings are not expected to be released until sometime next year.

Moderna will be conducting their own studies about possible side effects of the COVID vaccines in five countries with the assistance of the European Medicines Agency. The data from those studies are not expected to be released to the public until next summer. Dr. Paul Burton – Moderna’s chief medical officer – admitted that scientists are not certain as to what causes the possible heart issues from the COVID-19 vaccine.

“We don’t understand yet and there’s no good mechanism to explain it,” Burton conceded to NBC News.

Burton theorized that the spike protein in the vaccine may stimulate a negative reaction in the body that could cause inflammation in the heart.

NBC News highlighted the alarming struggles of one Michigan man who suffered major health issues after receiving a COVID vaccine.

In October 2021, Detroit native Da’Vion Miller was found unconscious in the bathroom of his home one week after receiving his first dose of Pfizer’s COVID-19 vaccine. Miller, who was only 22 years old at the time, experienced chest pain two days after getting vaccinated. He also suffered from fatigue, dizziness, and shortness of breath. Miller was rushed to the Henry Ford West Bloomfield Hospital, where he was diagnosed with myocarditis and pericarditis – inflammation of the outer lining of the heart. Miller’s doctor advised him not to receive his second dose of the COVID vaccine.

In the year since being diagnosed with myocarditis, Miller is still experiencing chest pain and has been in and out of the hospital.

In July 2021, the Centers for Disease Control and Prevention (CDC) released a report that stated: “An elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed, particularly in males aged 12–29 years.”

The report found, “Myocarditis reporting rates were 40.6 cases per million second doses of mRNA COVID-19 vaccines administered to males aged 12−29 years.”

The CDC added, “Myocarditis and pericarditis have rarely been reported. When reported, the cases have especially been in adolescents and young adult males within several days after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna).”

In April, an Israeli large-population study of 196,992 unvaccinated adults who were post-COVID-19 infection were “not associated with either myocarditis or pericarditis.”

“We did not observe an increased incidence of neither pericarditis nor myocarditis in adult patients recovering from COVID-19 infection,” the authors wrote.

20 million Americans could receive Covid-19 vaccine in December


Reported by SARAH OWERMOHLE | Politico | November 16, 2020

Roughly 20 million people could be vaccinated against the coronavirus in December, the head of the Trump administration’s vaccine and drug accelerator said Friday. Americans can expect that about 25 to 30 million people could be vaccinated each month afterward, said Moncef Slaoui, co-lead of Operation Warp Speed, during a Rose Garden event with President Donald Trump and other top health officials.

That timeline depends on the Food and Drug Administration authorizing the emergency use of one or more vaccines — which could happen in a matter of weeks, Slaoui noted.

Pfizer announced promising data this week suggesting its vaccine is more than 90 percent effective, and has said it will apply to FDA later this month. Moderna, which is working closely with the National Institutes of Health, is preparing to announce its own efficacy data in a matter of days. An emergency-use application could soon follow, Slaoui said.

Gen. Gustave Perna, Operation Warp Speed’s chief operating officer, said that the government would begin vaccination within 24 hours after a shot secures emergency authorization.

But while manufacturers have developed coronavirus vaccines in record speed, and dozens more are still in the pipeline, Slaoui’s projections mean it will likely take months just for first-priority groups such as health care workers and the elderly to get a shot.

Both the Pfizer and Moderna vaccines are given as two doses, effectively cutting in half the government’s initial order of 100 million doses from each of the those manufacturers.

But Slaoui added that there could be more authorized vaccines in the spring, boosting chances for more people to get vaccinated. Four vaccines, including the Pfizer and Moderna shots, are now in late-stage U.S. trials, and at least one other company plans to start such a study this month.

“We may be able to immunize a larger number of Americans on an ongoing basis, per month,” Slaoui said after name-checking other promising candidates from AstraZeneca and Johnson & Johnson.

The government has not yet released a comprehensive plan to distribute any coronavirus vaccines, including how it will handle logistics for shots that need to be shipped in below-freezing temperatures and outreach to skeptical communities.

Because of the real-world challenges of vaccine distribution and supply, federal health officials including CDC Director Robert Redfield project that broad access will not be a possibility until summer 2021.

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