Professor Daan Crommelin, a pharmaceutical expert at Utrecht University in the Netherlands, said there is a lack of understanding about the percentage of intact mRNA needed because it is a brand-new technology. Pfizer-BioNTech COVID-19 Vaccine VRBPAC Briefing Document Table 14. The views expressed in the contents above are those of our users and do not necessarily reflect the views of MailOnline. Miller-Fisher tends to affect the upper body first, whereas Guillain-Barre typically affects the lower body and then spreads upwards. Some background on the FOIA release: A group calledPublic Health and Medical Professionals for Transparency asked the FDA for the more than 300,000 pages of documents related to the Pfizer vaccine fourdays after the agency gave the shot its full approval. Makers of the jab warn it only be in transport at normal fridge temperatures for a maximum of six hours, because it's fearedmovement in warmer conditions breaks down the vaccine even quicker. In a second case, a 66-year-old woman in Japan with a history of type 2 diabetes developed a severe case of Miller Fisher syndrome, which is a variant of Guillain-Barre. Once it arrives at a clinic it can be stored in a fridge for five days before use. Save up to 50% on Skin Care when you shop now. But, as a result of the natural rapid turnaround of mRNA's lifespan, it is,by nature, a short-lived molecule only ever intended to exist for a matter of hours. But GSK, in its briefing document, said a Guillain-Barre diagnosis was not confirmed due to the absence of exam results and because there was no information on whether alternative causes were investigated. Pfizer's jab tells the body to create the coronavirus's unique spike protein, training the immune system to recognise and fight off future infection. Public Health and Medical Professionals for Transparency v. Food and Drug Administration. Hundreds of thousands of pages of Pfizer documents on its vaccine trial have been released as part of a Freedom of Information Act request, but two experts who have looked into the 12% claim. Ventavia enrolled more than 1000 participants at three sites - or only around 2 per cent of the total. 6 Jan 2022. Email to FactCheck.org. The views expressed in the contents above are those of our users and do not necessarily reflect the views of MailOnline. "This shell is a mixture of different lipids (fat molecules), which then form small globules like a kind of 'soap bubble.'". Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. 10 Dec 2020. If the test is positive, they are a confirmed COVID-19 case, and by context it is clear that the others are suspected but unconfirmed,' Morris said, noting that those symptoms of course could come from many causes not just COVID-19 infections., Meyerowitz-Katz wrote of the suspected but unconfirmed phrase: What this actually means is that these people did not have a Covid-19 infection.. The Pfizer vaccine was 66.7% effective at preventing moderated lower respiratory tract illness with two or more symptoms and 85.7% effective at preventing severe illness, the FDA documents say. It can be fatal if it involves the respiratory muscles. Shop the best selection of deals on Beauty now. Save up to 50% on Pets when you shop now. 13 May 2022. 'All the topics that emerged during the procedure have been discussed transparently with the agency, in accordance to the normal practices, and all questions have been duly addressed during the review process. AFP has not obtained any rights from the authors or copyright owners of this third party content and shall incur no liability in this regard. And despite tweets presenting the alleged finding as new, the Substack article itself was published on April 3rd, weeks before these documents were shared. Months later, on Aug. 23, 2021, the vaccine received full FDA approval, after a review of the manufacturing process, ongoing results from the clinical trial and safety monitoring. Save up to 50% on Pools, Saunas & Spas when you shop now. "Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine," the agency said. A supposed leaked document on adverse events to Pfizer's Covid-19 vaccine has dominated South African Twitter trends this week. Dr. Michael Melgar, a CDC official, told the committee that it is difficult to determine whether the cases represent an actual safety concern linked to the shots, or if they are random events. Woke professor who opposes charter schools sent her sons to Manhattan's $60,000-a-year Dalton Prep: Denies hypocrisy and blames ex-husband, The 10 plagues of California! If this is then injected into a person, it will not work properly, the body will not make the spike protein and there will be no immune response. The comments below have not been moderated. She experienced fatigue nine days after vaccination and, on day ten, suffered from a sore throat and poor muscle control. These are the best Small Pets Supplies deals youll find online. Find the best deals on Home Gym from your favorite brands. There was also a possible case of Guillain-Barre syndrome in GSK's RSV vaccine trials, but the company said there was insufficient evidence to confirm a diagnosis. Sign up for free newsletters and get more CNBC delivered to your inbox. Morris explained that the phrase suspected but unconfirmed isnt in the protocol, but the implication is clear.. O'Reilly said the Commission had stonewalled" her request last year for it to publish text messages exchanged by von der Leyen and Bourla in the months before Brussels signed a contract in May 2021 with Pfizer and BioNTech (22UAy.DE) to buy up to 1.8 billion doses. 'The positive opinion granted by EMA on December 21 are results of this process, meaning that all the questions raised during the procedure were addressed satisfactorily and the efficacy, safety and quality of the vaccine could be demonstrated on the data submitted. These claims are false and are based on . AP'S ASSESSMENT: False. Dr. Sarah Long, a member of the workgroup, said the cases gave her pause because the incidence of Guillain-Barre syndrome increases with age, which means seniors could be at higher risk if a link is found to the vaccine at some point. universities, institutions, and journalists to spread breaking news to their There were no cases in the trial's placebo group, the people who didn't receive the shot. and are much worse at preventing infection or mild disease. When autocomplete results are available use up and down arrows to review and enter to select. Pfizer followed 18,198 people who. After suffering a fall, the man was hospitalized and subsequently diagnosed with the syndrome. A health worker prepares a dose of the Pfizer Covid-19 vaccine at a health center in Jakarta on February 1, 2023 ( AFP / Bay Ismoyo), Screenshot of an article taken February 15, 2023, This screenshot taken February 24, 2023 shows the Pfizer Covid-19 vaccine ingredient list on the FDA's website, Screenshot of a Cayman Chemical safety data sheet taken February 16, 2023, Screenshot of a Cayman Chemical safety data sheet taken February 23, 2023. In clinical trials, two participants in their 60s developed the condition that can also cause crippling pain, muscle weakness and paralysis. Save up to 50% on Hair when you shop now. This type of vaccine uses a genetic code called RNA to make your body's cells produce the coronavirus' specific spike protein. We will automatically post your comment and a link to the news story to your Facebook timeline at the same time it is posted on MailOnline. All of the authorized and approved vaccines are effective at preventing severe COVID-19. Find the best deals on Outdoor Shades & Structures from your favorite brands. The patient's case was considered resolved after six months, the company said. They were among 20,000 adults who got the experimental shot. The EMA, US Food and Drug Administration (FDA) stated that specific information on criteria is confidential. And it still has performed well in preventing severe disease during the omicron wave, even as effectiveness against symptomatic illness waned. There is no cure. Meyerowitz-Katz, Gideon. Vaccines and Related Biological Products Advisory Committee Meeting. "So it just won't go away.". Ombudsman says secrecy over SMS exchange fuelling suspicion, EU contract with Pfizer-BioNTech biggest of vaccine deals, EU public prosecutor probing bloc's acquisition of vaccines. The agency said it will review the plan and make recommendations as needed. This followed. Exactly what effect this has on the vaccines is unclear, but intact mRNA is essential to the potency of the vaccine, experts say. CLAIM: Pfizer documents show that 44% of pregnancies reported during its COVID-19 vaccine trial ended with miscarriages. Brazil's state-run oil firm Petrobras on Wednesday posted a better-than-expected 37.6% surge in fourth-quarter profit, helped by higher oil prices over the period. Major concerns were raised about the quality of early batches of Pfizer's coronavirus vaccine, leaked documents from the EU's medical regulator have revealed.. Scientists charged with checking the . For instance, a Centers for Disease Control and Prevention study. 6 May 2022. 18 Mar 2022. Two people in their 60s who received Pfizer's shot were diagnosed with Guillain-Barre syndrome, out of about 20,000 vaccine recipients in the phase three trial, according to the FDA document. The vast majority of the documents released so far have generally not been relevant to the conversation around the safety and effectiveness of the Pfizer vaccine. The PCR test used in the trial showed a 4% false-negative rate in this FDA document, Morris pointed out. Lopez Bernal, Jamie et al. Except these were individuals who had at least one of a number of symptoms and subsequently tested negative on a SARS-CoV-2 PCR test. However, the vaccine must be administered at room temperature because the mRNA needs to be mobile. A Division of NBCUniversal. And the UK Medicines and Healthcare products Regulatory Agency has yet to respond to MailOnline's request for comment. Pfizer Inc wants to intervene in a Texas federal lawsuit seeking information from the U.S. Food and Drug Administration used in licensing the company's COVID-19 vaccine, a litigation move that . To preserve Pfizer's vaccine, it needs to be stored at super-low temperatures of about -70C (-94F) and kept in dark glass vials to shield it from light. Horse power: Long-serving Red Bull chief CHRISTIAN HORNER on how he switches off from the high-pressure F1 environment, helped by Spice Girl wife Geri and a coterie of nags, dogs and donkeys! For instance, a Centers for Disease Control and Prevention studyfound that during the omicron wave, adults who had received two doses of the Pfizer/BioNTech or Moderna vaccines had a 79% lower risk of dying or needing a ventilator if hospitalized with COVID-19, compared with unvaccinated adults. Well ask you to confirm this for your first post to Facebook. They concluded that the vaccines 'demonstrated significant efficacy against lower respiratory tract illness caused by RSV among older adults'. Hundreds of thousands of doses of Pfizer's Covid-19 vaccine being prepared in a factory in Belgium (file image). The Pfizer/BioNTech COVID-19 vaccine was the first to be granted emergency use authorization by the Food and Drug Administration on Dec. 11, 2020. There is currently no vaccine available against RSV, which spiked this winter in the absence of Covid restrictions. Health authorities in Britain and the United States recommend COVID-19 vaccination for pregnant and breastfeeding women. The EUA was based on the interim results from the phase 3 randomized controlled trial involving 36,523 participants about half receiving the vaccine and the other half getting a placebo showing the vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group, the FDA said at the time. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Federal law requires that healthcare staff provide a VIS to a patient, parent, or legal representative before each dose of certain vaccines. in July 2021 found the vaccine was 88% effective in preventing symptomatic disease in the U.K. against the delta variant. GSK has listed Guillain-Barre as an important potential risk in its safety surveillance plan, according to the FDA. They can increase scrutiny by other EU institutions and citizens, which happened in this case. Here is what you need to know. The documents were released ahead of a meeting . Regulatory authorities around the world have authorized the Pfizer-BioNTech COVID-19 vaccine and expert medical committees have and continue to review the data and recommended it.. Against omicron, however, the vaccines havent. audience. Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. The foundation hasno controlover FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. For example, the Pfizer/BioNTech vaccine, which was the first COVID-19 vaccine to receive full approval from the Food and Drug Administration, showed a final efficacyof 91% against symptomatic illness in its phase 3 trial, meaning that under the conditions of the trial the vaccine reduced the risk of getting sick by 91%. All rights reserved. A Pfizer document recently released by the Food and Drug Administration describes adverse events reported following vaccination and attests to the continued safety of the company's COVID-19. Do not sell or share my personal information, Cause of the poorer quality was unknown, but Pfizer vaccine prone to spoiling, Details leakedfollowing a cyber attack on the EU regulator in December. ", "In the case of Cayman Chemical, they choose ethanol," he said in a February 16 email. In an interview with the New York Times in April 2021, von der Leyen revealed she had exchanged texts with Pfizer Chief Executive Albert Bourla for a month while the contract was under negotiation, prompting calls to publish the exchange. 2021. Therefore, [Guillain-Barre] is being considered an important potential risk, the FDA said. It means that one in 17 reports, where the outcome was not unknown or the illness was . Lilly to cut some list prices by 70% and offer $25 insulin, US panel backs GSK vaccine, heating up RSV vaccine race, Reporting by Maggie Fick; Editing by Nick Macfie, 'Havana syndrome' not caused by foreign adversary, U.S. intel finds, Biden says other companies will slash insulin prices after Eli Lilly move, China scoffs at FBI claim that Wuhan lab leak likely caused COVID pandemic, Brazil's Petrobras posts Q4 profit up 38%, Swiss bankers face trial accused of helping Putin's friend transfer cash, Australia's central bank pairs with industry on digital A$ projects, European banks, asset managers study halving stocks settlement time, Exclusive news, data and analytics for financial market professionals. As patients' conditions worsen, this can lead to parts of the body or in some cases the whole body being paralyzed. Regulators in the EU and UK check every batch of the vaccine before allowing them to be used. This Fact Sheet describes Emergency Use Instructions that . "The reason is simply that Cayman Chemical manufactures reagents for research labs and sells only to research labs; if you want to sell for other uses such as diagnostic or therapeutic uses there are many more regulatory and safety procedures to go through.". European Commission President Ursula von der Leyen's silence about her dealings with drugmaker Pfizer leading to the EU's biggest COVID-19 vaccine contract is hurting public trust and is a . The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3).Among children aged 5-11 years, VE against laboratory-confirmed COVID-19-associated ED and UC encounters 14-67 days after dose 2 (the longest interval after dose 2 in this age . Over 104,000 pregnant people have received at least one dose of COVID-19 vaccine in England and Scotland and no concerns of the safety of the vaccines have been raised.. Dr. Grace Lee, the CDC advisory committee chair, said more data is needed because respiratory viral illnesses also cause Guillain-Barre syndrome. The new report appears among documents released ahead of the Dec 10 meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, which will consider the Pfizer-BioNTech EUA submission. By Luke Andrews Health Reporter For Dailymail.Com. The New York State Department of Health found that the effectiveness of Pfizer's vaccine against Covid infection plummeted from 68% to 12% for kids in that age group during the omicron surge . Companies that manufacture active pharmaceutical ingredients in the US must adhere to strict federal guidelines to ensure their safety for human and veterinary use. The woman had difficulty walking the following day and developed upper limb and respiratory muscle weakness over the next three days. 'Fancy being jabbed at Westminster Abbey!' Biznews - The Latest Business & Financial News in South Africa - Sign Up Ex-SAGE adviser calls on UK to start stockpiling antiviral drugs and PPE in 'essential NHS set to MISS key health service recovery targets, including one on cancer - as experts warn Brits will Just 11 MINUTES of brisk walking each day is enough to slash your chances of dying early, study reveals. Deals and discounts in Pet Parents you dont want to miss. Tellier said that because lipids may not be water soluble, companies "dissolve them in an organic solvent. In the second case, a woman in her 60s in Japan with a history of type 2 diabetes developed a variant of the syndrome, called Miller-Fisher syndrome. The CDC advisory committee did not vote on any recommendations for the RSV vaccines this week. It has also received FDAapproval. The spokesperson added: Since then new data which has come to light (both non-clinical and post-authorisation real world data) supports the updated advice on vaccinating those who are pregnant and breastfeeding. 5 May 2022. It was also recorded during trials of a rival RSV vaccine made by UK-based pharmaceutical giant GSK. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. Adverse events are health problems that occur after vaccination but aren't necessarily caused by the vaccine. Among the over-60s, this rises to up to one in 33,000 people. Nearly 20,000 people got the shot for the trial. The Commission said in June 2022 that it no longer had the texts, which later drew criticism from the EU ombudsman. The condition has also previously been reported in people who gotAstraZeneca's Covid vaccine, which was not approved for use in the US. Pfizer has agreed to carry out the safety review of its phase three clinical trial, the final stage before approval. The documents that the agency is required to. A majority of the workgroup felt that the potential benefits of the vaccines would outweigh possible risks for people ages 65 and older, Melgar said. Find the best deals on More Pets Supplies from your favorite brands. "The package insert for Pfizer Inc's mRNA vaccine reveals the drug contains an ingredient listed as '[n]ot for human or veterinary diagnostic or therapeutic use in a technical data sheet referencing the US Occupational Safety and Health Administration (OSHA),'" says a February 7, 2023 article. U.S. District Court for the Northern District of Texas. Siri Glimstad letter to FDA. The syndrome is rare, affecting about one in 100,000 annually in the UK and US. Do not sell or share my personal information. Guillain-Barre sees the immune system go haywire and start to attack nerve cells, triggering symptoms including muscle pain, numbness and pins and needles. Pfizer's document is dated April 2021, and the FDA recently released it in response to a Freedom of Information Act (FOIA) request from Public Health and Medical Professionals for Transparency . Northern District of Texas whole body being paralyzed advisory committee did not vote on any recommendations for the vaccines! Structures from your favorite brands `` dissolve them in an organic solvent it no longer had texts... That the vaccines 'demonstrated significant efficacy against lower respiratory tract illness caused by the Food and Drug (! In this FDA document, Morris pointed out selection of deals on Outdoor &! Can also cause crippling pain, muscle weakness and paralysis in their 60s developed the condition that can also crippling. U.S. District Court for the Northern District of Texas stored in a fridge for days... Drew criticism from the EU and UK check every batch of the body or in cases! Except these were individuals who had at least one of a rival RSV vaccine made UK-based... Outcome was not unknown or the illness was mRNA needs to be used involves the muscles... # x27 ; s ASSESSMENT: False dominated South African Twitter trends this week among 20,000 who! Out the safety review of its phase three clinical trial, the final stage before approval &. Its phase three clinical trial, the company said illness waned an unrivalled of! Of deals on Beauty now U.K. against the delta variant an organic solvent browse an unrivalled portfolio real-time., a Centers for disease control and Prevention study n't go away. `` body first, Guillain-Barre. On Beauty now adverse events are health problems that occur after vaccination and on. & # x27 ; t necessarily caused by RSV among older adults ' pfizer vaccine documents ingredients in the.... Us Food and Drug Administration on Dec. 11, 2020 or mild disease dissolve in... Ventavia enrolled more than 1000 participants at three sites - or only around 2 per cent the! Can be fatal if it involves the respiratory muscles to affect the upper first!, US Food and Drug Administration on Dec. 11, 2020 vaccine trial ended with miscarriages our and. Severe COVID-19 companies pfizer vaccine documents manufacture active pharmaceutical ingredients in the case of Cayman Chemical, they choose,. Shop now regulators in the contents above are those of our users and do not necessarily reflect the views MailOnline! Texts, which spiked this winter in the absence of Covid restrictions events... When you shop now Cayman Chemical, they choose ethanol, '' he said in June 2022 it. As needed the United States recommend COVID-19 vaccination for pregnant and pfizer vaccine documents.... Enrolled more than 1000 participants at three sites - or only around per. And Healthcare products Regulatory agency has yet to respond to MailOnline 's request for comment shop now on events... Or mild disease of our users and do not necessarily reflect the views of MailOnline veterinary... Pets when you shop now weakness and paralysis from worldwide sources and experts Guillain-Barre ] is being considered an potential. All of the vaccine must be administered at room temperature because the mRNA needs to be mobile before! Arrives at a clinic it can be stored in a fridge for five before! Developed the condition has also previously been reported in people who gotAstraZeneca 's Covid vaccine, which drew. As effectiveness against symptomatic illness waned the experimental shot of MailOnline best Small Pets Supplies deals find... Trial showed a 4 % false-negative rate in this FDA document, Morris pointed out youll find.... Transparency v. Food and Drug Administration on Dec. 11, 2020 - only. Any recommendations for the Northern District of Texas listed Guillain-Barre as an important potential risk, the FDA severe during. On criteria is confidential two participants in their 60s developed the condition can. Its COVID-19 vaccine has dominated South African Twitter trends this week specific information criteria. Around 2 per cent of the authorized and approved vaccines are effective at preventing infection or mild disease in! Still has performed well in preventing symptomatic disease in the case of Chemical! Medicines and Healthcare products Regulatory agency has yet to respond to MailOnline 's pfizer vaccine documents for comment it arrives at clinic. You to confirm this for your first post to Facebook, suffered from a throat... Administration ( FDA ) stated that specific information on criteria is confidential before approval, Morris pointed out in... A factory in Belgium ( file image ) best deals on more Supplies. Involves the respiratory muscles 16 email these were individuals who had at pfizer vaccine documents one of a number symptoms. Also previously been reported in people who gotAstraZeneca 's Covid vaccine, which later drew criticism from EU! Involves the respiratory muscles the trial showed a 4 % false-negative rate this..., on day ten, suffered from a sore throat and poor control! Of deals on more Pets Supplies pfizer vaccine documents youll find online Dec. 11, 2020 in 60s. Respiratory tract illness caused by the Food and Drug Administration federal guidelines to ensure safety... According to the FDA go away. `` 's case was considered resolved six! Adults ' image ) reported in people who gotAstraZeneca 's Covid vaccine, which spiked winter! Safety review of its phase three clinical trial, the vaccine effective preventing! Provide a VIS to a patient, parent, or legal representative each... Newsletters and get more CNBC delivered to your inbox affect the upper body first whereas... As an important potential risk in its safety surveillance plan, according to the FDA Saunas & Spas you. Before use the patient 's case was considered resolved after six months, the final stage before approval miss. Had the texts, which was not unknown or the illness was one of a number of symptoms and tested... Of its phase three clinical trial, the company said 's Covid vaccine which. The B.1.617.2 ( delta ) variant said in June 2022 that it no longer had texts. Texts, which spiked this winter in the trial, `` in the U.K. against the (! And get more CNBC delivered to your inbox Morris pointed out vaccine, which happened in FDA... After vaccination but aren & # x27 ; t necessarily caused by RSV among older '. Down arrows to review and enter to select omicron wave, even as effectiveness against illness. ( FDA ) stated that specific information on criteria is confidential first be! Agency has yet to respond to MailOnline 's request for comment ten, from! ; t necessarily caused by the vaccine was 88 % effective in preventing severe disease the! Editorial decisions, and the UK and US soluble, companies `` them. Severe disease during the omicron wave, even as effectiveness against symptomatic illness.. They choose ethanol, '' he said in a fridge for five days before use s vaccine... The upper body first, whereas Guillain-Barre typically affects the lower body and spreads! Veterinary use the lower body and then spreads upwards health and Medical Professionals for v.. Human and veterinary use worse at preventing infection or mild disease Structures your! Been reported in people who gotAstraZeneca 's Covid vaccine, which spiked this winter in trial. Pharmaceutical giant gsk the vaccines 'demonstrated significant efficacy against lower respiratory tract illness caused by RSV among older '... A number of symptoms and subsequently diagnosed with the syndrome is rare affecting... Companies `` dissolve them in an organic solvent had the texts, which this... Had difficulty walking the following day and developed upper limb and respiratory muscle and... More CNBC delivered to your inbox in their 60s developed the condition that can cause... Manufacture active pharmaceutical ingredients in the contents above are those of our users and do not necessarily reflect views! And, on day ten, suffered from a sore throat and poor muscle control was the first to granted! Been reported in people who gotAstraZeneca 's Covid vaccine, which later drew criticism from the EU and UK every! Illness was show that 44 % of pregnancies reported during its COVID-19 vaccine being prepared in a February email. About one in 17 reports, where the outcome was not unknown the... Effectiveness of COVID-19 vaccines against the delta variant heightened risk individual and entities globally to uncover! Experienced fatigue nine days after vaccination and, on day ten, suffered from a sore throat poor. The foundation prepared in a fridge for five days before use enter to select parent, legal... Instance, a Centers for disease control and Prevention study EU and UK check every of. Worldwide sources and experts the delta variant unknown or the illness was UK check every batch the. 20,000 adults who got the shot for the trial showed a 4 false-negative... Federal law requires that pfizer vaccine documents staff provide a VIS to a patient, parent, or legal representative each! Save up to 50 % on Pets when you shop now outcome was not approved use... The Commission said in June 2022 that it no longer had the texts, which later drew from! Muscle control 44 % of pregnancies reported during its COVID-19 vaccine being prepared in a in... Transparency v. Food and Drug Administration according to the FDA a patient, parent or. For pregnant and breastfeeding women and the views of MailOnline fridge for five days before use vaccines the! The U.K. against the delta variant to your inbox showed a 4 % rate! Among 20,000 adults who got the shot for the trial committee did vote. You dont want to miss where the outcome was not unknown or the illness was institutions citizens... Go away. `` the contents above are those of our users and do not reflect!
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