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.
“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.
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.
As U.S. health authorities expand use of the leading Covid-19 vaccines, researchers investigating heart-related risks linked to the shots are exploring several emerging theories, including one centered on the spike protein made in response to vaccination.
Researchers aren’t certain why the messenger RNA vaccines, one from Pfizer Inc. and partner BioNTech SE and the other from Moderna Inc., are likely causing the inflammatory heart conditions myocarditis and pericarditis in a small number of cases.
Some theories center on the type of spike protein that a person makes in response to the mRNA vaccines. The mRNA itself or other components of the vaccines, researchers say, could also be setting off certain inflammatory responses in some people.
Researchers who scoured the records of nearly 800,000 U.S. veterans found that in early March, just as the Delta variant was gaining a toehold across American communities, the three vaccines were roughly equal in their ability to prevent infections.
But over the next six months, that changed dramatically.
By the end of September, Moderna’s two-dose COVID-19 vaccine, measured as 89% effective in March, was only 58% effective.
Iceland on Friday suspended the Moderna anti-COVID vaccine, citing the slight increased risks of cardiac inflammation, going further than its Nordic neighbours which simply limited use of the jabs.
…This decision owed to “the increased incidence of myocarditis and pericarditis after vaccination with the Moderna vaccine, as well as with vaccination using Pfizer/BioNTech,” the chief epidemiologist said in a statement.
Peter McCullough, MD, MPH speaks at the 78th Annual Meeting of AAPS on October 2, 2021.
- 1min: Something was going very wrong very early in 2019.
- 2m: The threshold for shutting down a new biologic product is just a few cases.
- 3m: Covid-19 was going to be the showcase of what we could do for biotech.
- 5m: The spike protein created by the new Covid-19 is a deadly protein.
- 11m: Our institutions are all culpable in medical malfeasance.
- 13m: We have the biggest biological catastrophe on our hands with a medicinal product in human history…and no-one knows how to stop it.
- List of risk
- 14m: 86% of deaths have no other explanation other than the vaccines.
- 20m: We are in freefall into a lawless state. The Vaccines are not safe for use on either side of the Atlantic. It’s clear that this first generation of [Covid-19] vaccines is not safe.
- 22m: The FDA did not approve Pfizer. The gave a continuation of the emergency use authorization and then conditionally approved Comirnaty with BioNTech which is legally and potentially medicinally distinct. The Pfizer approval is a false talking point.
- 23m: When Pfizer came up for boosters, McCullough and his team presented at the FDA showing that death with the vaccine is greater than death just taking your chances with the infection. The vaccines aren’t safe across the board and the panel agreed 16:2 against the booster.
- 26m: Data for the efficacy of the vaccines do not take into account the Delta variant. These vaccines have failed against Delta and other variants. Two-thirds who get sick with Delta are fully vaccinated. Data shows that the vaccines can’t stop transmission.
- 27m: Effectiveness for Pfizer is at 42%. A vaccine that falls below 50% protection and can’t last a year is not a viable product. Pfizer has failed as a commercial product.
- 29m: The CDC was telling us in May 2021 that the vaccines were failing. They started to do asymmetric reporting to craft a narrative that this was going to be a crisis of the unvaccinated but the CDC data showed the opposite. The ineptitude and willful misconduct of the people running our public health agencies is astounding.
- 32m: The ‘99% of hospitalized were unvaccinated’ message was a propagandized false talking point because the data is not there.
- 33m: The vaccines have had zero impact on the epidemic curve. Mortality is a function of treatment.
- 34m: Many experts have been warning that we shouldn’t vaccinate into a pandemic because it creates resistance. As soon as we started vaccinating, the number of strains starting falling. The virus was figuring out how to thrive in the vaccinated.
- 36m: The Delta variant has achieved antigenic escape. The data shows that the vaccinated is an equal threat to the unvaccinated.
- 38m: Early home treatment is the only thing that makes sense. That’s what it should have always been.
- 40m: Doctors at my institution cannot look me in the eye because they are so ashamed of what they’ve done during the course of this pandemic.
- 44m: If you look through the clinical records [of those who have died] and I will tell you they were all inadequately treated.
- 50m: Natural immunity is superior to vaccine immunity. If we vaccinate people who are covid-recovered, we harm them considerably. The only backstop is natural immunity.
This nosocomial outbreak exemplifies the high transmissibility of the SARS-CoV-2 Delta variant among twice vaccinated and masked individuals. This suggests some waning of immunity, albeit still providing protection for individuals without comorbidities. However, a third vaccine dose may be needed, particularly in individuals with risk factors for severe COVID-19. Appropriate use of masks, especially in high-risk settings is advised.
The mRNA technology, which has proved so crucial to the vaccine breakthroughs, was, at the time, also considered too experimental by Dr Phil Dormitzer, Pfizer’s vice-president and chief scientific officer for viral vaccines.
The coercion of people to take these new on the market vaccines is something we’ve never seen before in our lifetimes in Britain. People have been bombarded with text messages and phone calls asking us to book a vaccine appointment. Anyone with a following who expresses the mildest of concerns about the vaccines and their promotion has been labelled an ‘anti-vaxxer’ or a ‘crank’ or ‘conspiracy theorist’. There’s been unedifying media witch-hunts against so-called ’anti-vaxxers’– with one columnist even suggesting that ‘refuseniks’ should have to wear a bell round their necks and a sandwich board declaring themselves ‘Unclean’.
This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity. Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant.
I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”
FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.