Recently, many people have been seriously concerned as the U.S. Food and Drug Administration (FDA) extended a fundamental research study into post-vaccination heart inflammation, but the information regarding this extension was not made public.
Pfizer is conducting a study to investigate the possibility of subclinical myocarditis (heart inflammation) resulting from its COVID-19 vaccine. The study is expected to be completed by June 20, 2022, and Pfizer must submit its findings to the FDA by December 31st of the same year in order to get approval for the vaccine. This is only one part of a list of conditions stipulated by the Food and Drug Administration in order to give approval to the jab.
However, the FDA updated its timeline without announcing it after the deadline had already passed. The FDA announced that the investigation into Pfizer-BioNTech's post-marketing obligations would be completed by June 30, 2023.
Despite several requests, both the FDA and Pfizer have not given any updates on the current status of their study. Jessica Adams, a former FDA regulatory review officer, believes the information being spread is not true. She argues that original dates cannot be changed, and she tweeted the agency to correct the misinformation. Dr. Vinay Prasad expressed his displeasure with the FDA's slow decision-making process, calling it pointless. On Twitter, he criticized the FDA for its failure.
Study
Pfizer is conducting a total of nine studies, with one of them aimed at studying adverse events that occur after receiving the vaccine. In this study, Pfizer is specifically looking into the possibility of myocarditis as an adverse effect after receiving a booster dose among individuals aged 16-30 years old. The company aims to gain a better understanding of any risks associated with administering their vaccine by collecting data and analyzing cases.
Pfizer submitted a timeline to the FDA last year that outlines their plan to submit a final protocol by November 2021 and complete the study by June 2022. They also promised to provide the FDA with the full report of their findings before New Year's Day 2023.
U.S. officials and experts have conducted thorough research on myocarditis and pericarditis, which are related conditions that can be triggered by the Pfizer and Moderna vaccines. Unfortunately, some cases of vaccine-induced myocarditis have led to fatalities. When considering Pfizer's vaccine for approval, FDA officials expressed concern about the possibility of heart inflammation after vaccination.
After Receiving a Booster Shot, It Is Important to Be Aware of Signs of Myocarditis
During a meeting on January 26th, Richard Forshee, an official, informed the FDA's vaccine advisory committee that the bivalent Pfizer vaccine caused concerns when it was administered to adults aged 18-35. However, both the bivalent Pfizer vaccine and Moderna's vaccine were approved by regulators in autumn 2022 regardless of the lack of clinical data available for either vaccine.
The Pfizer bivalent vaccine has been associated with concerning levels of adverse events. According to data from the FDA's Biologics Effectiveness and Safety initiative, which gathers information from systems like CVS Health, there have been high rates of such events. One specific issue that has been identified so far is myocarditis/pericarditis in adults aged 18 to 35 who received the Pfizer bivalent vaccine.
Although warning signals may suggest that a vaccine is linked to certain events, they do not confirm causation. However, officials have noted that the authorization process for bivalent vaccines is similar to that of the original vaccines, despite the lack of clinical evidence. Additionally, these officials have confirmed a definite causal link between messenger RNA vaccines and heart inflammation.
During meetings discussing adverse events, the main subject was ischemic stroke. As a result, Pfizer's booster shot for elderly individuals and receiving both Pfizer and Moderna's original vaccines in all adults reached a safety threshold.
There are reports of some people suffering from strokes after they received both the flu and COVID-19 vaccines on the same day. However, researchers are currently investigating to see if there is a link between these two vaccinations and strokes. No evidence of a link between strokes and either vaccine when administered individually has been found so far.
According to Dr. Nicola Klein, a researcher from Kaiser Permanente who works with the CDC to evaluate vaccine safety, there is a potential link between vaccination and stroke, but it is not as significant as the link with myocarditis. Klein suggests that this association should still be monitored closely, but it is not as apparent as the myocarditis which does not require any analysis to identify.
Panel Informed of CDC Evaluations
During the panel's public comment session, they were informed that the CDC had analyzed data from another monitoring system and found that there were hundreds of adverse events which exceeded the acceptable safety standard. Around 500 of those adverse events even exceeded the threshold for myocarditis.
In January, the Epoch Times released information obtained through the Freedom of Information Act, revealing over a dozen signs of stroke discovered by the CDC.
Nicole G., a concerned citizen, asked the committee to investigate why U.S. leaders allegedly hid these safety warnings.
In the public portion of the meeting, there was no discussion of the results. However, the CDC referred to research that examined a limited number of signals and did not explain their reasoning for considering these signs as “expected when questioned about it.
The CDC reported that 90% of signals indicating a potential adverse event were found to be false alarms after further investigation, before the launch of COVID-19 vaccines.
