Getting Pfizer’s Covid bivalent booster and a flu shot on the same day may raise the risk of a stroke, a small official analysis suggests.
The Food and Drug Administration (FDA) found the preliminary link while scouring vaccine injury databases after a separate safety concern was raised about Pfizer’s jab.
Double-jabbed’ Malhotra originally supported the program, until a series of events sent him digging into the evidence. What he discovered alarmed him and resulted in the publication of two evidence-based, peer-reviewed papers along with a call for the immediate suspension of the Covid mRNA roll-out…
Over following months, emerging data led Malhotra to question whether the vaccine was linked to his father’s death. The first was an abstract published in Circulation (November 8, 2021) by US cardiothoracic surgeon, Dr Steven Gundry, who followed several hundred of his patients after the mRNA (Moderna/Pfizer) jabs. Gundry found that inflammatory markers correlated with heart disease risk went through the roof. On average, that change increased the risk of those people having a heart attack or stroke within the next five years, from 11 per cent up to 25 per cent. This increase in risk is massive.
Although rare, a statistically significant association between BNT162b2 vaccination and myo/pericarditis and AKI was observed. While the association between BNT162b2 and myo/pericarditis has been confirmed internationally, further research is required to understand the association of AKI. BNT162b2 was not found to be associated with most of the AESIs investigated, providing reassurances around the safety of the vaccine.
Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.
The Centers for Disease Control and Prevention (CDC) says that a preliminary COVID-19 vaccine “safety signal” has been identified and is investigating whether the Bivalent Pfizer-BioNTech vaccine creates an increased risk of ischemic stroke in people 65 and older.
In the Friday statement, the CDC said that the preliminary signal hasn’t been identified with the Bivalent Moderna COVID-19 vaccine.
Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines.
This early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.
The purpose of this study is to determine the ECG parameter change and the efficacy of ECG screening for cardiac adverse effect after the second dose of BNT162b2 vaccine in young population. In December 2021, in cooperation with the school vaccination system of Taipei City government, we performed a ECG screening study during the second dose of BNT162b2 vaccines. Serial comparisons of ECGs and questionnaire survey were performed before and after vaccine in four male-predominant senior high schools. Among 7934 eligible students, 4928 (62.1%) were included in the study. The male/female ratio was 4576/352. In total, 763 students (17.1%) had at least one cardiac symptom after the second vaccine dose, mostly chest pain and palpitations. The depolarization and repolarization parameters (QRS duration and QT interval) decreased significantly after the vaccine with increasing heart rate. Abnormal ECGs were obtained in 51 (1.0%) of the students, of which 1 was diagnosed with mild myocarditis and another 4 were judged to have significant arrhythmia. None of the patients needed to be admitted to hospital and all of these symptoms improved spontaneously. Using these five students as a positive outcome, the sensitivity and specificity of this screening method were 100% and 99.1%, respectively. Conclusion: Cardiac symptoms are common after the second dose of BNT162b2 vaccine, but the incidences of significant arrhythmias and myocarditis are only 0.1%. The serial ECG screening method has high sensitivity and specificity for significant cardiac adverse effect but cost effect needs further discussed. What is Known: • The incidence of cardiac adverse effects was reported to be as high as 1.5 per 10 000 persons after the second dose BNT162b2 COVID-19 vaccine in the young male population based on the reporting system. What is New: • Through this mass ECG screening study after the second dose of BNT162b2 vaccine we found: (1) The depolarization and repolarization parameters (QRS duration and QT interval) decreased significantly after the vaccine with increasing heart rate; (2) the incidence of post-vaccine myocarditis and significant arrhythmia are 0.02% and 0.08%; (3) The serial ECG screening method has high sensitivity and specificity for significant cardiac adverse effect.
Our early warning safety system is the first to identify-four new statistical signals for modestly elevated risks (RR less than 2) of four serious outcomes of AMI, PE, DIC, and ITP following BNT162b2 vaccination. This FDA and CMS COVID-19 vaccine safety study is one of the largest studies of elderly persons aged 65 years and above including approximately 34 million doses administered to more than 17 million Medicare insured persons. Our surveillance monitoring did not detect statistical signals for the mRNA-1273and Ad26 COV2.S vaccines for any of the 14 monitored outcomes.
Analysis from The Epoch Times can be found here: Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA
Pfizer’s CEO has been rapped by the UK’s pharmaceutical watchdog for making “misleading” statements about children’s vaccines, The Telegraph can disclose.
…A code of practice panel, convened by the PMCPA, found that Pfizer had breached the code in a number of different ways, including by misleading the public, making unsubstantiated claims, and by failing to present information in a factual and balanced way.
A 14-year-old boy died three weeks after receiving his Covid vaccine, an inquest heard.
Coroner Pat O’Connor, of County Mayo, Ireland, described the death as a “significant public concern”.
Joseph McGinty was vaccinated with the Pfizer Covid-19 jab on August 20, 2021.
The vast majority of cases occur in young men, ages 16 to 24, according to the CDC. The agency did not have data available on the total number of cases in young adults 24 and younger, but it estimates there have been 52.4 cases and 56.3 cases per million doses of Pfizer’s and Moderna’s vaccines, respectively.
Symptoms of myocarditis include:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering or pounding heart
A study by Canadian researchers published Monday in the Journal of the American College of Cardiology found that men younger than 40 who got the Moderna vaccine had the highest risk of heart issues, usually within 21 days after the second dose. The study was observational, meaning it doesn’t prove cause and effect but it is one of only a few studies to compare the risk of myocarditis between the Pfizer and the Moderna vaccines.
So is there graphene oxide in the Pfizer shots? What Nixon found, and filmed, is bizarre to say the least. Inside a droplet of vaccine are strange mechanical structures. They seem motionless at first but when Nixon used time-lapse photography to condense 48 hours of footage into two minutes, it showed what appear to be mechanical arms assembling and disassembling glowing rectangular structures that look like circuitry and micro chips. These are not ‘manufactured products’ in the CDC’s words because they construct and deconstruct themselves but the formation of the crystals seems to be stimulated by electromagnetic radiation and stops when the slide with the vaccine is shielded by a Faraday bag. Nixon’s findings are similar to those of teams in New Zealand, Germany, Spain and South Korea.
…Nixon has shared his findings with Wendy Hoy, professor of medicine at the University of Queensland who has called on the Australian government and its health authorities to explain the apparent spontaneous formation of chips and circuitry in mRNA vaccines when left at room temperature, and the abnormal objects that can be seen in the blood of vaccinated people. Hoy thinks that these are ‘undoubtedly contributing to poor oxygen delivery to tissues and clotting events, including heart attacks and strokes’ and asks why there is no systematic autopsy investigation of deaths to investigate the role of the vaccine in Australia’s dramatic rise in mortality.
James catches up with Sonia Elijah, who is an investigative journalist for Trial Site News and TCW (as well as her own substack). They discuss the incredibly poor state of journalism and medical coverage (propaganda).
A senior Pfizer executive has admitted that the drug company did not know whether its Covid vaccine prevented transmission of the virus when it began rolling out the shots globally.
Janine Small, Pfizer’s president of international developed markets, was testifying before the European Union Parliament on Monday when she was asked the question by Dutch MEP Rob Roos…
“Millions of people worldwide felt forced to get vaccinated because of the myth that ‘you do it for others’,” he said in the video, which has been viewed more than five million times.
“Now this turned out to be a cheap lie. This should be exposed.”
See commentary by Off-Guardian here.
From 14 December 2020 through 31 May 2022 (persons 18–39 years) and 20 August 2022 (persons 5–17 years), 320 potential cases of myocarditis/pericarditis were identified 1 to 98 days after 6 992 340 vaccine doses as part of primary series COVID-19 vaccination, with 224 (70%) verified. Of these, 137 (61%) occurred 0 to 7 days after vaccination; 18 were after the first dose (of 3 562 311 doses administered) and 119 were after the second dose (of 3 430 029 doses administered).
In all age groups, incidence per million doses 0 to 7 days after vaccination was numerically higher in male than in female persons and after dose 2, although confidence intervals were wide and overlapped across sex for some age groups. Incidence was highest for male adolescents ages 12 to 15 years and 16 to 17 years following dose 2.
From 24 September 2021 through 20 August 2022, 101 potential cases of myocarditis/pericarditis were identified 1 to 98 days after 1 848 723 first booster doses, with 77 (76%) verified with a median onset of 4.5 days after vaccination; 39 cases (51%) were verified in the first week versus 38 during the subsequent 13 weeks.
In all age groups, incidence 0 to 7 days after first booster was higher for male compared to female persons, with adolescent males having the highest incidence in 16- to 17-year-olds and in 12- to 15-year-olds. In adults for whom both vaccine products were available, post-booster incidence was higher in male than in female adults and higher in males aged 18 to 29 compared to males aged 30 to 39.
Thousands of American teenagers may have suffered heart inflammation after getting a Covid jab, a study suggests.
Researchers found up to one in 7,000 boys aged 12 to 15 years old developed myocarditis after receiving the Pfizer vaccine.
The condition — which is mild for most but can cause a recurrent heart palpitation in rare cases — was most common after the second dose.
Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).
The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.
The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need. In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals, but there are studies ongoing and these will be provided when available. In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated. These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern. Adequate advice with regard to women of childbearing potential, pregnant women and breastfeeding women has been provided in both the Information for UK Healthcare Professionals and the Information for UK recipients.
Naomi Wolf graduated from Yale in 1984 and was a Rhodes scholar at New College, Oxford University. She is the author of the bestselling feminist books, “The Beauty Myth”, “Fire with Fire”, “Promiscuities” and “Misconceptions”. The New York Times called “The Beauty Myth” one of the 70 most significant books of the century. More recently, Naomi has written books critiquing the establishment’s advances in censorship, Covid-19 vaccinations and many more issues which she addresses with James.
Note: Title editorialised.
FDA officials said in a statement that they decided to restrict Johnson & Johnson’s vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination.