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.
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.
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).
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.
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.
The risk of myocarditis in this large cohort study was highest in young males after the second SARS-CoV-2 vaccine dose, and this risk should be balanced against the benefits of protecting against severe COVID-19 disease.
“This is quite alarming…”
Public Health and Medical Professionals for Transparency, Pfizer / FDA FOI https://phmpt.org
Adverse event reports
01 December 2020 through 28 February 2021
Cumulatively, through 28 February 2021, a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1,913), France (1,506), Portugal (866) and Spain (756) the remaining 7,324 were distributed among 56 other countries. Fatal, 1,223 Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA https://www.fda.gov/news-events/press… (Approval, 21st August 2021) Acting FDA Commissioner Janet Woodcock, M.D. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S. System Organ Classes (SOCs) that contained the greatest number (≥2%) of events, in the overall dataset, were General disorders and administration site conditions (51,335 AEs), Nervous system disorders (25,957), Musculoskeletal and connective tissue disorders (17,283), Gastrointestinal disorders (14,096), Skin and subcutaneous tissue disorders (8,476), Respiratory, thoracic and mediastinal disorders (8,848), Infections and infestations (4,610), Injury, poisoning and procedural complications (5,590), and Investigations (3,693). Cardiovascular AESIs Number of cases: 1403 (3.3% of the total PM dataset), of which 241 are medically confirmed and 1162 are non-medically confirmed; 5. SUMMARY AND CONCLUSION Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2. Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” “….. the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.” https://childrenshealthdefense.org/de… Austria https://www.nytimes.com/live/2022/03/… Karoline Edtstadler the law, passed in January, in force since early February, not proportionate, relatively mild symptoms experienced by most people who contract Omicron
[Ms. Spit] is part of a very small, little-discussed community of pandemic victims: those who have suffered—or had family or loved ones suffer—from rare but serious vaccine side effects recognized by doctors, regulators and researchers. They say they feel lost in wider Covid-19 statistics, which have shown vaccines to be extremely safe and effective for most of the population.
Faced with the gravest health crisis in memory, governments deployed newly developed vaccines in record time. Many countries indemnified pharmaceutical companies that made the shots, with some governments promising to consider compensation for suspected Covid-19 vaccine-related injuries.
Now governments, including the U.S. and U.K., are trying to live up to that pledge. They are in the very early stages of applying existing vaccine-injury programs to hundreds of claims of injury alleged from Covid-19 shots.
…The U.K.’s National Health Service has received more than 720 claims requesting Covid-19 vaccine-related compensation. The country’s vaccine-injury compensation program entails a one-size-fits-all cash payment of £120,000, equivalent to around $163,000. The volume of Covid-related claims has grown by about 20 a week, toward a projected 1,500 to 1,800 new claims this year, according to U.K. government projections.
The European Medicines Agency’s safety committee said on Friday it was reviewing reports of heavy menstrual bleeding and absence of menstruation from women who had received COVID vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE)and Moderna (MRNA.O).
The assessment was in view of reports of menstrual disorders after receiving either of the two vaccines, both based on messenger RNA technology, and it was not yet clear whether there was a causal link, the agency said.
Question What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US?
Findings In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across multiple age and sex strata. The rates of myocarditis cases were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively).
Meaning Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men.
The Covid modellers at Imperial College have begun to back down. About time too. Over the past few weeks, they have made extreme claims about the omicron variant that cannot be fully justified by fundamental science, let alone by clinical observation.
Dr. Peter A. McCullough, MD, MPH, is a board-certified cardiologist who has testified before committees of the US and Texas Senate regarding the treatment of COVID-19 and management of the ongoing pandemic.
Dec 10 (Reuters) – Most of the 43 COVID-19 cases caused by the Omicron variant identified in the United States so far were in people who were fully vaccinated, and a third of them had received a booster dose, according to a U.S. report published on Friday.
The U.S. Centers for Disease Control and Prevention (CDC) said that of the 43 cases attributed to Omicron variant, 34 people had been fully vaccinated. Fourteen of them had also received a booster, although five of those cases occurred less than 14 days after the additional shot before full protection kicks in.
While the numbers are very small, they add to growing concerns that current COVID-19 vaccines may offer less protection against the highly transmissible new variant.
Ministers have agreed a secrecy clause in any dispute with the drugs manufacturer Pfizer over Britain’s Covid vaccine supply. Large portions of the government’s contracts with the company over the supply of 189m vaccine doses have been redacted and any arbitration proceedings will be kept secret.
The revelation comes as Pfizer is accused by a former senior US health official of “war profiteering’’ during the pandemic. In a Channel 4 Dispatches investigation to be broadcast this week, Tom Frieden, who was director of the US Centers for Disease Control and Prevention under Barack Obama, said: “If you’re just focusing on maximising your profits and you’re a vaccine manufacturer … you are war profiteering.”
Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance.
The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.
FDA report shows Pfizer’s clinical trials found 24% higher all-cause mortality rate among the vaccinated compared to placebo group.
The clinical trials of Pfizer’s coronavirus vaccine found that the all-cause mortality rate of the vaccinated group was higher than that of the control group, months after the trials were launched, according to a recently released FDA report.
According to the report, which was released by the US Food and Drug Administration to provide background information on its August 2021 decision to grant full approval for the Pfizer-BioNTech coronavirus vaccine after offering limited emergency authorization of use in last December, six months after the vaccine’s clinical trial began, the total number of deaths reported in the vaccinated group was nearly one-quarter higher than the number of deaths in the placebo group.
BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA. The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is administered intramuscularly (IM) as a series of two 30 μg doses (0.3 mL each) 3 weeks apart.
For commentary, see FDA report finds all-cause mortality higher among vaccinated – Israel Nation News.