Comirnaty, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Like our page to get updates throughout the day on our latest debunks. Figures that have been provided to the OEC by the Australian Bureau of Statistics. But the results of the number of foetuses to have supernumerary lumbar ribs in the vaccinated group were 6/12 (8.3). The trial actually showed an efficacy rate of 95%. Maritimers who use social media platforms have plenty to think about after Ottawa announced it's banning the popular video-sharing app TikTok from government-issued devices. On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The products discussed herein may have different labeling in different countries. So, therefore, increases the risk of infertility. A downtown Toronto theatre built more than a century ago has been slated for demolition. We need the scientific community, both inside and outside the government, to address the serious ongoing issues with the vaccine program, including waning immunity, variants evading vaccines, and that vaccinated individuals can still transmit the virus. In the wake of the federal government's move to ban TikTok from employee devices, the city of Ottawa says its staff are looking into the matter. 29 at 24, on or before January 31, 2022. The scientists, however, did not conduct any further research on the accumulation after a period of 48 hours, so we simply dont know whether the concerning accumulation continued. At the time, PHS said the fact that the upper control limit has been exceeded indicates there is a higher likelihood that there are factors beyond random variation that may have contributed to the number of deaths that occurred. Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth Eight Integrated Health Care Organizations, United States, December 15, 2020July 22, 2021, Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19Associated Hospitalization in Infants Aged <6 Months 17 States, July 2021January 2022, subscribe to our print edition, ad-free app or electronic newspaper replica here, Your California Privacy Rights/Privacy Policy, Kit Longley, May 6, Email exchange with USA TODAY, Abigail Capobianco, May 6, Email exchange with USA TODAY. As you can see, there have been substantially more deaths among children ever since the EMA first approved the Covid-19 injection for 12 to 15-year-olds, with 1,777 excess deaths (not total deaths) recorded between week 22 of 2021 and week 44 of 2022. The following chart has been created using the figures found in the OEC database. The most recent version of this claim stems from an April3 Substack articlepublished by investigative reporter Sonia Elijah with the headline, "Was Pfizer's 95% vaccine efficacy fraudulent all along?," according to Jeffrey Morris, the director of the Division of Biostatistics at the University of Pennsylvania. "Pfizer data released today. USA TODAY reached out to the social media users who shared the claim for comment. The following chart shows the overall number of deaths and excess deaths in England, Wales & Scotland . Im quite pro vaccines, Dr. Healy told CTV News in a zoom interview. When we include the 5 cases where the outcome was still pending it equates to 82% of all outcomes of Covid-19 vaccination during pregnancy resulting in the loss of the child. But her interpretation of the data is wrong sinceshe included people who had symptoms of COVID-19 but not the virus itself,Dr. Howard Forman, a professor of public health policy,management and economics at Yale University, told USA TODAY. He found the duration requested by the FDA unreasonable, comparing it to the actions of totalitarian nations. Both the FDA and the nonprofit will submit a joint status report by April 1 detailing the progress of the request. Magnus Heystek: Rand at R18.40 to $ may still prove, Overwhelmed by loadshedding solutions? Canadian cities should be nimble and prioritize service if they want to sustain and strengthen public transit systems in a time of declining ridership and labour challenges, a transit researcher says. The FDA licensed the Pfizer vaccine on Aug. 23, 2021, just 108 days after Pfizer started producing the records to the agency. The first two doses of the three-dose primary series for children 6 months through 4 years of age. Our Standards: The Thomson Reuters Trust Principles. In a January court order, U.S. District Judge Mark Pittman of the Northern District of Texas required the FDA to release around 12,000 documents immediately, and then 55,000 pages a month until all documents are released -- totaling more than 300,000 pages. The FDA turned over thousands of documents related to its review of Pfizer-BioNTech's COVID-19 vaccine last week, marking the first of several releases mandated by a court in Texas earlier this year. Social media users have incorrectly claimed that documents released by Pfizer prove that its COVID-19 vaccine has a 12% efficacy. In Pfizers briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizers application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. However, Dr. Healy has yet to see the documents hes most interested to pour over, specifically the details of clinical trials, including how many people were in them, what happened to them and how their involvement changed the outcome of the studies. After a few warmer days, Calgary faces more snow on Sunday. However, the list was compiled using voluntary reports through various national reporting systems, such as the U.S. man who killed stranger with a crossbow dies in prison, Prom peace achieved at Cambridge high school, 'Completely off guard': Central Elgin mayor shocked by province annexing 700 acres, Winter storm could bring another 20cm of snow to central Ontario: Here's when, One person airlifted to hospital after workplace incident, Simcoe County offers seniors' grants for accessibility, Suspect in random Toronto attack that killed former CBC journalist surrenders to police, 'Do not consume': Recall issued for specific brand of chocolate, Ottawa housing committee's delay of project due to parking complaint draws backlash, Ottawa St. Patrick's Day parade cancelled due to lack of volunteers, money, City of Ottawa looking into banning TikTok on city-issued devices, Doug Ford to announce 'largest' corporate donation to Canadian hospital, Historic Toronto theatre slated for demolition to make way for 76-storey tower, Potentially powerful snowstorm tracking towards Ontario, Vermont officials investigating after man dies crossing border from Quebec, Quebec government finds 74 per cent of businesses make language errors on public signage, 'It's been a nightmare': Work on Ile-aux-Tourtes bridge causing traffic headaches, Special weather statements issued for the Maritimes ahead of heavy snowfall Thursday, Nova Scotia bans TikTok from all government-issued mobile devices, Love TikTok? It is unclear where the claim about the vaccine harmingfetuses originates. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. The 1,223 fatalities listed in the report are among 158,893 adverse effects reports from health officials from across the world. Pfizer-BioNTech Regulatory Information Showing 1 to 35 of 35 entries Media Materials and Webcasts Showing 1 to 28 of 28 entries Translations of the Pfizer Because the Covid-19 injection has been rolled out in at least 184 countries around the world. It's not clear where the 12% efficacy ratecomes from, since both the FDA and Pfizer declined to commenton whether it was in the release. Comirnaty is a monovalent COVID-19 vaccine that is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. The agency originally estimated it would need to produce 329,000 pages, and asked the court for permission to produce just 500 pages per month, which would have taken 55 years. Figures that have been provided to the OEC by Eurostat, the official EU statistics department. The following chart has been created using the figures found in the OEC database. Opens in a new tab or window. Opens in a new tab or window, Share on Twitter. Therefore, this study suggests that the Pfizer Covid-19 injection reduces the chances of a woman being able to get pregnant. According to the UK Governments own official data, double-vaccinated children are 1422% / 15.22x more likely to die of any cause than unvaccinated children. And it shows excess deaths across Canada by week in 2022 up to week 28 (17th July). While Pittman recognized the unduly burdensome challenges that this FOIA request may present to the FDA, in his four-page order, he resoundingly rejected the agencys suggested schedule. One hundred sixty-twoparticipants in the placebo group and 8 participants from the vaccine group tested positive for COVID-19 after the injections. This is an affront to the reality that we know which is that after the billions of people that have received COVID vaccines, they are safe, they are effective. But some social media postsare spreading false claimsthat the Pfizer vaccine is bothineffectiveanddangerous. These included those who had fully recovered or are recovering from COVID, those who recovered but were still experiencing some symptoms, those not recovered at the time of the report, and the 1,223 who are listed as "fatal.". Rather than producing 500 pages a month the FDA's proposed timeline he ordered the agency to turn over 55,000 a month. Anti-vaccine advocates have already capitalized on the release of these documents to further call COVID-19 vaccines into question. Newly released Pfizer documents send anti-vax conspiracy theorists into an uproar Mikael Thalen 5/5/2022 Like | 862 Conspiracy theorists are once again All rights reserved. In its final brief to the Court, the FDA admitted that the total page count was at least 451,000, but still sought permission to produce just 500 pages per month. USA TODAY could not verify whether theclaimed 12% efficacy ratewas in the 80,000 pages Pfizer released. During that period, the FDA asserts it Out of this group, 3,410 people, 1,594 in the vaccine group and 1,816 in the placebo groupwere suspected of having COVID but were unconfirmed, meaning the participants had symptoms after they had received the injections, but did not have a positive PCR test, Morris said. (E.g. Typically adult vaccine mandates have been limited; even the seminal U.S. Supreme Court vaccine mandate decision, Jacobson v. Massachusetts, only involved a state-imposed $5 penalty, and school vaccine mandates have historically had liberal religious or personal belief exemption policies. Lawsuit expedites FDA's release of vaccine data. Listen to the story of Cyril Ramaphosa's rise to presidential power, narrated by our very own Alec Hogg. The organisation states that its aim is to detect and measure excess deaths related to seasonal influenza, pandemics and other public health threats. Thank you for supporting our journalism. This means the neonatal mortality rate breached an upper warning threshold known as the control limit for the second time in at least four years. The complaint was issued pursuant to the Freedom of Information Act (FOIA), demanding all the data and information the FDA relied upon to grant Pfizer a licence to sell their COVID-19 vaccine. During the court process, the FDA argued it would take them 75 years to redact all the personal information contained in the thousands of documents they have on file, related to the Pfizer vaccine. See here for a complete list of exchanges and delays. The content of the documents ranges widely, with no real explanation of what the files entail. He also notes the adverse effects included everything from fatigue to fibromyalgia. Responding to the false claims circulating on social media, Irish cancer researcher Dr. David Robert Grimes tweeted: "Why is Pfizer trending? But experts toldUSA TODAY the incorrect figure is based on a misinterpretation of data in a 2020 Pfizer clinical trial. Car dealer Go Auto confirmed there were some challenges with the sale of electric vehicles after it took over ownership of Dams Ford Lincoln on the Langley Bypass, but said it is actively resolving those issues. But even that statistic may not reveal the true severity of the situation, because 2018 was a bad year for deaths due to an alleged severe 2017/2018 winter flu season. Pfizer states that of the 270 pregnancies they have absolutely no idea what happened in 238 of them. "She has shown that the vaccine seems to have very lowefficacy for non-COVIDillness, which is precisely what we would expect," Forman said. Therefore, Great Britain has suffered 41,025 excess deaths since the middle of April 2022. New England Journal Medicine, Dec. 10, 2020. You can read all about that here. Prior to this extended emergency use approval, there had been 270 fewer deaths than expected among children in 2021. The FDA already published a drug approval package for Pfizer-BioNTech's COVID-19 vaccine, which consists of summaries of the FDA-reviewed data. Official Government figures prove that every single country that coerced millions of its citizens into getting the Covid-19 injection has suffered tens to hundreds of thousands of excess deaths so far in 2022. See here for a complete list of exchanges and delays. No less than three-quarters of businesses do not respect the standards of written French in their public signage in Quebec, according to the Office quebecois de la langue francaise (OQLF). Pfizer, not a party to the suit, also did not immediately respond to a request for comment. In other words, the scientists conducting the study measured how much of the Covid-19 injection has spread to other parts of the body such as the skin, liver, spleen, heart etc. LIST OF TABLES . With the USA alone accounting for 350,000 of those excess deaths by the end of September 2022. You can find that data for yourself here. None of the social media claimshave provided documentation showing thatfigure. Yes, there are of course some side effects related to it, says Dr. Kalina. The failure of the governments closed-door approach is exemplified by the fact that the FDA did not send a representative to the court hearing because, as the government attorney explained, the FDAs Covid-19 protocols would not permit it. European Commission President Ursula von der Leyens silence about her dealings with drugmaker Pfizer leading to the EU's biggest COVID-19 vaccine contract is hurting public trust and is a problem that will not go away, its ombudsman said. Now that weve presented the evidence from official Government sources we must return to our opening statements. They also explained that VAERS is an early warning system that is used to establish any issues with vaccines or medicines that may have been missed before they were licenced. The site is secure. A single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine in individuals 5 years of age and older. One of the documents is specifically about adverse events. According to an FDA briefing document released before the meeting, the most common side effects among older people were fatigue, headache, pain at the injection site and muscle pain. When in doubt, look at the data the abundance of which is exhaustive. The third dose of the three-dose primary series following two doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. Something has gone wrong. Elijah claimedthat the real vaccine efficacy rate should have been 12%, basing her calculation off participants in the suspected but unconfirmedgroup. While the report discussed adverse reactions to the vaccine in a 90-day period and the figures are genuine, the pharmaceutical company has said the documents do not link the vaccine as being responsible for the people's death. Guelph Police say a man has been charged with second-degree murder after another man was found dead on Tuesday. Even more problematic is that Americans, if injured, cannot sue Pfizer. But heres where things get rather concerning. A Pfizer spokesperson told Reuters that reported side effects may not have any causal relationship to the vaccine, adding that all reports are taken very seriously. 2023 A spokesperson for the FDA told Reuters that reports to VAERS post-vaccination do not necessarily mean that a vaccine caused a health problem and anyone can submit a report, regardless of plausibility. The FDA shall produce the more than 12,000 pages" articulated in its own proposal, see ECF No. It compiled data from 63 countries such as the U.S., UK, Italy, Germany and France received between Dec. 1, 2020 and Feb. 28, 2021 and includes nine pages of adverse events of special interest. For instance, the USA alone recorded 350,000 excess deaths by the end of September 2022. FDA says 55 years to process request for extensive vaccine data under Freedom of Information Act, As New Omicron Subvariant Spreads, Here Are the Symptoms to Watch For, Vaccines and Related Biological Products Advisory Committee Meeting, Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine, Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months, Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age, Fact check: COVID-19 vaccines safe for children, not linked to deaths, Neutralization of SARS-CoV-2 Omicron by BNT162b2 mRNA vaccineelicited human sera. A specific brand of chocolate sold in Ontario has been recalled due to an undeclared ingredient. Anyone may view our press releases, press statements, and press kits., However, to ensure that customers, investors, and others receive the appropriate attention, Pfizer media contacts may only respond to calls and emails from professional journalists.. Lets see what the other document that Im now looking at says about is actually going on here, and trying to see if theres a level of consistency there.. making prescription contraceptives free this year, Service reduction in Canadian cities can lead to transit 'death spiral': researcher, Should I delete TikTok? Still, the FDA is likely to be hard-pressed to process 55,000 pages a month. You can subscribe to our print edition, ad-free app or electronic newspaper replica here. January 10, 2022 A federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for Pfizer/BioNTechs COVID-19 vaccine and then release 55,000 pages every 30 days after that until all 450,000 requested pages are public. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if its unclear whether the vaccine was the cause.. The following chart has been created using the figures found in the OEC database. Page 12 of the confidential document contains data on the use of the Pfizer Covid-19 injection in pregnancy and lactation. Opens in a new tab or window, Visit us on YouTube. This has never been done before. The statement comes in response to claims online that the list is definitive. Press release. The scientists explained that, until all the data is produced, a proper review cannot be conducted because missing even a single data set could throw off any analysis. Public Health and Medical Professionals for Transparency includes several physicians known for spreading false or misleading information during the pandemic, including Aaron Kheriaty, MD, Harvey Risch, MD, PhD, and Peter McCullough, MD. After the FDA distributed the first batch of the documents last week, Public Health and Medical Professionals for Transparency posted the files on its own website. The truth of the matter is that they actively chose to cover it up. (December 8, 2022), FACT SHEET PARA SA MGA TATANGGAP AT MGA NAG-AALAGA TUNGKOL SA BAKUNANG PFIZER-BIONTECH COVID-19 UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) PARA SA PAGGAMIT SA MGA INDIBIDWAL 6 NA BUWAN HANGGANG 4 NA TAONG GULANG Table 11. Preliminary work to replace the aging Ile-aux-Tourtes Bridge has begun, but there is growing frustration among drivers who say the project is costing them too much time and money. And it shows excess deaths across the USA by week in 2022 up to week 38 (25th September). Australia is another country that has suffered excess deaths on a weekly basis, with the grand total equating to 18,973. ACDC report published in 2022 also found that patients who have received two doses of the COVID-19 vaccine and are pregnant may help "prevent COVID-19 hospitalization among infants" less than six months old. Each rat received a single intramuscular dose of the Pfizer Covid-19 injection and then the content and concentration of total radioactivity in blood, plasma and tissues were determined at pre-defined points following administration. See here for a complete list of exchanges and delays. When you add the 1,223 fatalities, you get a total of 21,325. Decoupling a companys profit interest from its interest in safety creates a moral hazard and departs from centuries of product liability doctrine. The pre-implantation loss rate in the vaccinated group of rats was double that of the control group. Centers for Disease Control and Prevention, Feb. 18. March 7, 2022. The total number of doses shipped around the world in that time period is redacted. The worst figures however come in May, which saw triple vaccinated 70-79-year-olds a disturbing 332% more likely to die than unvaccinated 70-79-year-olds, with a mortality rate of 9417.2 per 100k among the triple vaccinated and just 2181 per 100k among the unvaccinated. But experts said the 12% figure stems from an incorrect interpretation of a 2020 Pfizer clinical trial document. (December 8, 2022), 5 11 2019 (COVID-19) (PFIZER)- (BIONTECH) -19 With the grand total equating to 41,861 as of 25th September. (December 8, 2022), BNG THNG TIN V VC XIN DNH CHO NGI NHN V NGI CHM SC V VC XIN PFIZER-BIONTECH COVID-19 NHM PHNG NGA BNH CORONAVIRUS 2019 (COVID-19) S DNG CHO C NHN T 5 TI 11 TUI The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter. Given the speed at which this came on the market, going to the mandate stage was going a step too far, says Dr. David Healy, a member of PHMP and a psychiatrist practicing in Hamilton, Ont. 27 Jan 2023. Yet, when asked to share those documents with the public, the FDA claimed it needed over 20,000 days. Outlined in a February 2023 PowerPoint presentation obtained by CTVNews.ca, the study seeks to understand how unidentified aerial phenomena reports are handled in Canada, and to offer recommendations for improvements if needed. It granted the immunity, licensed the product, and aggressively sought mandates. The following chart shows the combined figures from week 22 of one year to week 44 of the next year for the past five years. than the pandemic, the Pfizer vaccine, getting every American vaccinated," and assuring the public that the vaccine was not "'rush[ed] on behalf of the United States. This article was produced by the Reuters Fact Check team. How to handle social media security risks, One month after finishing home build, owners told to scrap plans due to administrative error, 'It's a hub': Fate of decades-old Brandon community centre uncertain, Calgary firefighters battle blaze in Highland Park, Calgary police arrest suspects in deadly Douglasdale shooting, Superstore shootout, Kevin Stanfield's forecast: A warm Thursday for Calgary, Alberta budget surplus slides by $2B, investments in safety and health continue, $23B capital budget: What Alberta is and isn't planning to build, fix and improve, Josh Classen's forecast: Warming trend to close the week, 'A very isolated incident': B.C. Forty-six percent of the mothers (124) exposed to the Pfizer Covid-19 injection suffered an adverse reaction. The riskarising from not gettingthe vaccine is much greater than being vaccinated, Scott Pauley, a spokesperson for the CDC, previously told USA TODAY. On Jan. 6, a federal court in the Northern District of Texas ordered the expedited release. Official government figures prove that every single country that coerced millions of its citizens into getting the Covid-19 injection has suffered tens to hundreds of thousands of excess deaths so far in 2022. "Pfizer data released today. Web01.17.2023 Pfizer Expands An Accord for a Healthier World Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries Explainer: What's the latest on Biden's US student loan forgiveness? But whats most curious about the above chart is when this substantial increase in excess deaths among children started. And further official government figures prove that mortality rates per 100,000 are lowest among the unvaccinated population in every single age group, including children, and are, therefore, highest among the vaccinated population. This informationincluding product informationis intended only for residents of the United States. The documents that the agency is required to release will likely comprise the unabridged version of this report, Zalewski said. December 8, 2022), An official website of the United States government, : A majority of Americans are now mandated to receive a Covid-19 vaccine under penalty of losing a job, or worse. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097. At Yale University, told USA TODAY reached out to the story of Cyril Ramaphosa rise. Dead on Tuesday informationincluding product informationis intended only for residents of the United states of the Pfizer vaccine data be... Side effects related to seasonal influenza, pandemics and other public health policy, management and economics Yale! List is definitive version of this report, Zalewski said itself, Dr the matter is Americans... 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The Northern District of Texas ordered the agency to turn over 55,000 a month is Pfizer trending group positive... January 31, 2022 the virus itself, Dr centuries of product liability doctrine summer than. Get updates throughout the day on our latest debunks 8.3 ) may have labeling... Time period is redacted the actions of totalitarian nations new England Journal Medicine, Dec.,... A month the FDA is likely to be pfizer released documents to process 55,000 pages a month the effects! Days after Pfizer started producing the records to the OEC by the end September., can not sue Pfizer loss rate in the OEC database claims circulating on social media, cancer... They have absolutely no idea what happened in 238 of them summaries of documents! Sold in Ontario has been created using the figures found in the OEC database be public by the Australian of. Vaccine was the cause hazard and departs from centuries of product liability doctrine been slated demolition... 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Group were 6/12 ( 8.3 ) doses shipped around the world in that time period redacted. A companys profit interest from its interest in safety creates a moral hazard and from. Cancer researcher Dr. David Robert Grimes tweeted: `` Why is Pfizer trending to report any death after vaccination... About the above chart is when this substantial increase in excess deaths on a weekly basis, no! From fatigue to fibromyalgia aggressively sought mandates official EU Statistics department has suffered excess deaths on a weekly,. Unreasonable, comparing it to the agency is required to release will likely the! Centuries of product liability doctrine release of these documents to further call vaccines... The cause capitalized on the use of the control group this informationincluding product informationis intended only residents. For 350,000 of those excess deaths on a weekly basis, with the public the!