Oct. 12, 2021 – Researchers Retract Flawed Myocarditis Study:

On September 16, 2021, researchers from the University of Ottawa Heart Institute submitted an article to MedRxiv, which is a preprint server for health sciences where articles can be shared before they are peer reviewed. This article, titled “mRNA Covid-19 Vaccination and Development of CMR-confirmed Myopericarditis,” claimed that individuals receiving an mRNA COVID-19 vaccine have a 1-in-1,000 chance to develop myocarditis, which is a condition characterized by inflammation of the heart. Despite being a preprint article that had not yet been peer reviewed, the article’s findings were shared broadly. Based on the findings of this preprint study, unvaccinated individuals could conclude that receiving an mRNA vaccine is not in their best interest. However, on September 24, 2021, the authors of the preprint study unanimously withdrew the study from publication because it relied on flawed methodology, detailed below.

The preprint study calculated the incidence rate of myocarditis in Ottawa by analyzing the occurrence of myocarditis compared to the number of vaccinations administered in the region. The figures used in the study were 32 cases of myocarditis compared to 32,379 vaccinations administered in Ottawa. However, data published by Ottawa Public Health showed that 845,930 vaccines had been administered instead of 32,379. Accounting for the correct data, the actual incidence rate of myocarditis following vaccination with an mRNA vaccine is actually 25 times smaller than the incidence rate that was included in the preprint study.

In a statement from the University of Ottawa Heart Institute, the authors issued an apology about the error in the preprint study: “We are sorry this error led to misinformation about the incidence of post-vaccine myocarditis. COVID-19 vaccines are safe and have been proven effective against the disease. We invite anyone who has not yet received the shot to please get vaccinated.”

Following the approval of Comirnaty for adults 16 years of age and older, the U.S. Food and Drug Administration (FDA) is requiring Pfizer to conduct postmarketing studies to assess the risk of individuals developing myocarditis and pericarditis following vaccination. These postmarketing studies will also include an assessment of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. Should the risk of developing myocarditis and myocarditis after vaccination become significant, these postmarket studies will ensure that the FDA is equipped with the clinical data necessary to update guidance for patients regarding the risks associated with mRNA vaccines. Additionally, existing data from the CDC has established that the majority of acute cases of myocarditis are generally mild and resolve quickly with conservative treatment. If you have not yet been vaccinated against COVID-19, Pandemic Patients encourages you to meet with your health care provider to discuss getting vaccinated as soon as possible.

FDA Authorizes First Vaccine Booster for Children 5-11

On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to authorize the use of a single booster dose for children between the ages of five and eleven. The FDA authorized the administration of this booster at least five months after the completion of the primary vaccination series with the same vaccine.

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R.T. Asked: When Can I Get the COVID-19 Booster After Receiving Monoclonal Antibodies?

“When should immunocompromised patients get their second COVID-19 vaccine booster after receiving monoclonal antibodies? We are getting conflicting information from doctors, the news, medical literature, and hospitals on whether it is safe to receive a COVID-19 vaccine or vaccine booster after receiving monoclonal antibodies and whether doing this will reduce the efficacy of the vaccine. We are in a quandary, not knowing what to do.”

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