article by David Gortler former senior consultant to the Food and Drug Administration (FDA)
From day one, the U.S. Food and Drug Administration knew that the Covid-19 vaccine was linked to severe heart problems in recipients. FDA medical officer review of Pfizer’s original Covid-19 application finds “clinically important serious adverse reactions [incluse] anaphylaxis and myocarditis / pericarditis ”, ie severe allergic reactions and inflammation of the heart and / or the sac containing the heart, respectively. At the time of this writing, the FDA has not released its review of the application of Moderna’s ‘Spikevax’ mRNA vaccine despite granting emergency use clearance well over a year ago and full approval at the end. last month.
The Vaccine Adverse Event Reporting System (VAERS), jointly operated by the FDA and the Centers for Disease Control, lists a long and impersonal number of cardiovascular events in young, healthy people. Without reading the underlying narratives presented with the reports, it is difficult to establish the precise causal links related to these adverse events. However, there are thousands of reports of heart attacks, myocarditis and pericarditis in the United States alone they should have push manufacturers and the FDA into a full investigation mode.
Studies recognized by FDA officials show that the various FDA safety databases only collect an estimated 1 to 13 percent of all adverse events that occur. Several FDA drug safety epidemiologists said during the official FDA presentation that a single, well-documented adverse event is enough to justify an investigation of safety signals and, in turn, to warn the American public of the potential risk.
Historically, the FDA has looked for safety warnings on labels, to include a “black box warning” and a prescription restriction known as a Risk Assessment and Mitigation Strategy (REMS) for much less. For example, in 2008, after fewer than 200 spontaneous VAERS reports of tendon rupture following administration of the class of antibiotics known as fluoroquinolones, the FDA added a “black box warning” and REMS prescription restrictions.
but yet thousands VAERS safety reports that are serious, debilitating and fatal as a result of vaccines and Covid boosters are not being maintained to the same regulatory standards. If about 1 to 13 percent of adverse events are reported, extrapolating those numbers means that the actual number of adverse health events could easily be hundreds of thousands in the United States and many millions worldwide.
In addition to VAERS, the CDC’s Vaccine Safety Datalink indicates an excessive risk of myocarditis and pericarditis in recipients after Pfizer and Moderna vaccines. The cardiovascular risk after any mRNA vaccine is high, but with Moderna it is about four times that of Pfizer.
Other public health agencies with much tighter budgets and staff than our FDA have stepped in months does. In October, Denmark, Finland, Norway and Sweden suspended the use of the Moderna vaccine for young people, but it is still in full swing here in the United States.
More data has since been released stating the same: On January 25, 2022, a CDC and FDA study published in JAMA shows that the risk of myocarditis following any type of Covid mRNA vaccination is greater than the background risk in the population. with the largest proportion of cases of myocarditis occurring among white males.
A comprehensive study out of Britain in December 2021 looked at data from over 42 million people who took a Covid-19 vaccine found a noticeable increase in myocarditis with the mRNA vaccines that persisted and increased with each dose and booster. “An association between Covid-19 infection and myocarditis was observed at all ages for both genders,” states the study abstract. “These findings have important implications for public health and vaccination policy.” Indeed they do, especially in light of the questionable way the FDA has approved vaccines in children ages 5 to 13 and pending applications from the FDA to approve vaccination in children 6 months of age and older.
The FDA, CDC, and manufacturers have access to VAERS and other high-quality denominator-based vaccine safety systems, including the Biologics Effectiveness and Safety Initiative (BEST) and the Vaccine Safety Datalink (VSD), respectively. Have manufacturers and our health agencies used these tools and others to thoroughly investigate the cardiovascular health risks of the vaccine? There is reason to doubt, given the political pressure the Biden administration has put on agencies to support vaccine intake hardly ever mentioning safety.
Myocarditis and pericarditis have historically been rare. They are defined respectively as inflammation of the heart muscle or of the layers of the pericardial sac. Both conditions cause easily recognizable ECG changes and have ambiguous symptoms that include shortness of breath and chest pain. Myocarditis and pericarditis can be easily diagnosed clinically with echocardiography and can be treated with inexpensive pharmacology and bed rest, but for this to happen, people need to know to seek medical diagnosis and treatment.
Herein lies the problem: Practitioners and patients are not adequately advised to monitor cardiovascular symptoms despite the increased incidence. As there is a failure by manufacturers and the FDA to address this and other negative effects of mRNA’s usefulness and mandates, outside drug safety experts must immediately publicly address the safety of mRNA Covid vaccine.
On February 4, 2022, a CDC advisory committee proposed extending the gap between Covid-19 hits to mitigate the vaccine’s cardiovascular damage. This indicates that the federal government is aware of the serious risk. However, instead of addressing the risk head-on by communicating the facts to the public, they seem to take a “half step” to change the interval and hope to mitigate the risk with no evidence that it will have any effect on the outcome.
In the very recent past, anyone who had warned of the exact same cardiovascular risk of this advisory panel spoke to less than a week ago was shamed and banned on social media by the “big tech” “verifiers”.
Vaccines are one of the most important inventions in human history, having saved millions of lives. This does not mean that every person should receive all vaccines. In addition, like any drug available, it is critically important to detect and report safety concerns quickly. We now have a federally mandatory vaccine that is clearly no longer effective and potentially causing further illness and death.
Failure to properly monitor and warn adverse events from the Covid vaccine has not only served to reinforce hesitation about the Covid vaccine, but has destroyed the credibility of public health authorities. The inability to speak openly about known adverse reactions erodes confidence.
In the 1950s, doctors didn’t tell patients when they had terminal cancer because they thought it was for their own good. We are now a long way from the day when withholding information from the public is considered good for public health. It never is. It is not only immoral and offensive, it is dangerous.
Dr. David Gortler is a pharmacologist, pharmacist and FDA member and member of health policy at the Ethics and Public Policy Center. He was a professor of pharmacology and biotechnology at Yale University School of Medicine, where he also served at the Yale Bioethicist Center, and was an FDA medical officer who was subsequently Appointed by the White House as Senior Advisor to the FDA Commissioner for Safety of farmaci. FDA Science Policy and FDA Regulatory Affairs. He is a columnist for Forbes, where he writes about drug safety, health care and FDA policy.
The response of our “scientists”:
Giorgio Palùpresident of the board of directors of Aifa, the Italian pharmaceutical agency, interviewed by Corriere della Sera explained that “It is too early to say whether Covid-19 is nearing its end”. Then he also talked about a possible new dose and the upcoming Covid therapies.
On the new duration of the Super Green Pass for those who have received the third dose, the expert stated that: «Unlimited is, from a lexical point of view, a misnomer. It cannot be understood that the booster confers persistent protection over time. It is more correct to speak of validity extended at the moment sine die ».
Sileri: premature to eliminate the green pass.
Ricciardi: “probable a booster dose every year. Green pass until winter. We don’t make the same mistakes as in previous years. “
Undersecretary Andrea Costa on the obligation to vaccinate over 50s: “We must be strict, even going beyond the deadline of June 15”.