Since O'Reilly's declaration, members of the European Parliament vented anger in an October special hearing at Bourlas refusal to appear and threatened to pursue banning Pfizer employees and lobbyists from entering parliament. They concluded that the vaccines 'demonstrated significant efficacy against lower respiratory tract illness caused by RSV among older adults'. Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement. FDA.gov. MHRA has since updated its advice on vaccinating those who are pregnant and breastfeeding. Deals and discounts in Pet Parents you dont want to miss. When autocomplete results are available use up and down arrows to review and enter to select. The lack of transparency from regulators and vaccine makers will raise concerns that similar problems could arise in the future. The FDA briefing document mentions these suspected cases of symptomatic COVID-19 that were not PCR-confirmed and refers to the protocol, which is another Pfizer document that describes in detail the clinical protocol for the trial. GSK has listed Guillain-Barre as an important potential risk in its safety surveillance plan, according to the FDA. Vaccines and Related Biological Products Advisory Committee Meeting. "Due to the small number of events, measures of relative and absolute risk were not calculated," Melgar told the committee members. The Paul-Ehrlich-Institut, which regulates vaccines in Germany, has also addressed the difference between laboratory and pharmaceutical ingredients on its website. The patient also suffered a heart attack, but the FDA said this was not related to the RSV vaccine. Shop our favorite Makeup finds at great prices. Shop the best selection of deals on Food Transportation now. On the back of the find, EU officials filed two 'major objections' to Pfizer, along with a host of other quality control questions it wanted addressed, before it could approve the vaccine. Guillain-Barre causes the immune system to attack its own nerves, sometimes causing paralysis. But the Pfizer vaccine ingredient is not the same as Cayman Chemical's compound. Another popular claim alleges that the new documents prove that the vaccine is only 12% effective at protecting from COVID-19, not the 95% that Pfizer initially reported (examples here and here). Vaccine Pfizer Fact Check Coronavirus Misleading claims suggesting that more than 1,200 died after. The cause of the poorer quality was unknown and the impact on safety and efficacy of the vaccine was 'yet to be defined', the email said. Pfizer's document released by the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination. 'We are satisfied that the RNA integrity of all batches used in the UK to date have met the product requirements.'. ", "In the case of Cayman Chemical, they choose ethanol," he said in a February 16 email. The phase three clinical trials showed Pfizer's jab was 66.7 percent effective at preventing moderate lower respiratory tract illness with two or more symptoms. The recent documents related Pfizer vaccine which was released as part of an ongoing Freedom of Information Act lawsuit don't show any matches to claims which were made in the article published by . She was hospitalized 19 days after vaccination. Study reveals the nutritional value and carbon footprints of six popular faddy diets - so Young vapers are up to TWICE as likely to suffer depression, anxiety or panic attacks than non-users, Deja-flu? Expert groups continue to recommend use of the drug during pregnancy when necessary and in consultation with a doctor. Find the best deals on More Pets Supplies from your favorite brands. In severe cases, this can cause paralysis, breathing difficulties, blood clots and fatalities. 2021. Data relating to the Pfizer/BioNTech Covid-19 vaccine, which was stolen in December 2020 following a cyber attack of an unspecified nature against the European . Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. The shots are still good at preventing hospitalization or death, though, particularly if someone has received a booster dose. It normally appears within days or weeks of a respiratory or digestive tract infection. The subject matter depicted or included via links within the Fact Checking content is provided to the extent necessary for correct understanding of the verification of the information concerned. The prophyl actic Pfizer-BioNTech COVID -19 Vaccine (BNT162b2 ) has been available in . FDA.gov. These EUIs provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling. Meyerowitz-Katz also examined the claim, finding that it is completely and utterly false and based on a very simple misreading of the documents.. That person will still be vulnerable to Covid-19. "The manufacturing process and controls for Comirnaty have been well characterized and qualified," the FDA told AFP in a February 21 email. Booster shots arerecommendedfor most people, as theseincrease and prolongprotection against severe disease and also provide some temporary protection against infection and milder illness. As for the two people who were. 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. Many social media users are sharing screenshots of the documentation, particularly one document which states that "COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy and: It is unknown whether the COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk" (examples here,hereandhere). In addition to ALC-0315, the document shows the Cayman Chemical product is comprised of 95 percent ethanol, a volatile, flammable and toxic compound. The Centers for Disease Control and Prevention's committee of independent vaccine advisors grappled with the three cases of Guillain-Barre syndrome during a meeting open to the public Thursday. Email to FactCheck.org. Farm Heroes Saga, the #4 Game on iTunes. 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. These precise conditions must be maintained throughout the vaccine's journey and, once taken out of the freezer and thawed, it can only be keptin standard medical fridges for five days before 'spoiling'. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for the use of the Pfizer BioNTech (BNT162b2) vaccine against COVID-19. 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. Learn more and register today:http://bit.ly/3DUNbRo. Do the recent 80k pages of Pfizer documents released really show vaccine efficacy was only 12%? COVID-19 Data Science. The views expressed in the contents above are those of our users and do not necessarily reflect the views of MailOnline. Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. Experience with mRNA integrity is limited.'. There's no cure for the syndrome, but treatments are available that can speed recovery. The process of developing mRNA vaccines is also purely synthetic, meaning scientists don't have to rely on cells from living animals. 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. It added that the EMA now double-checks Pfizer's vaccine supply shipments. 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. The briefing document and other materials were posted online before that meeting. that adults who had received two doses of either the Pfizer/BioNTech or Moderna vaccine had a 79% lower risk of dying or needing a ventilator if hospitalized with COVID-19, compared with unvaccinated adults, during the omicron wave. 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. 10 Dec 2020. Find the best deals on Home from your favorite brands. Therefore, [Guillain-Barre] is being considered an important potential risk, the FDA said. The documents were released ahead of a meeting . 10 Dec 2020. FDA says Pfizer's new RSV vaccine for older adults may trigger painful and potentially deadly Guillain-Barre syndrome in one in 10,000 patients . 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. It can also leave patients suffering pain. 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. Do not sell or share my personal information. Pfizer has said it will conduct a safety study but also noted that there may be other explanations for the two Guillain-Barre cases, describing the shot as well-tolerated and safe vaccine, with a benefit-to-risk ratio that is favorable.. Her symptoms cleared within three months. Shop the best selection of deals on Patio Furniture now. The company said it did not identify any safety concerns during the trial and the vaccine was well tolerated. There is currently no vaccine available against RSV, which spiked this winter in the absence of Covid restrictions. Pfizer followed 18,198 people who. 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. By posting your comment you agree to our house rules. This background document on the Pfizer BioNTech BNT162b2 vaccine against Covid-19 has been prepared by the Working Group on COVID-19 Vaccines of the Strategic Advisory Group of Experts (SAGE) on Immunization to inform SAGE deliberations. Was Pfizers 95% vaccine efficacy fraudulent all along? Substack. But the authors claim of a possible vaccine efficacy this low is an erroneous one, Morris wrote. 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.. Published: 13 Jan 2021 11:41. In 2021, Cayman Chemical addressed similar misinformation about another compound that academics and scientists use to research health therapies. However, Pfizer says the report circulating social media is . However, the vaccine must be administered at room temperature because the mRNA needs to be mobile. Treatment focuses on restoring the nervous system. Express. There are not many proven ways of ensuring long-term survival of the vaccine. Find the best deals on Maternity from your favorite brands. Find the best deals on Outdoor Shades & Structures from your favorite brands. Nearly 20,000 people got the shot for the trial. Its also available online. 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. Tricky geometry baffles the internet - but can YOU train your brain to solve how many triangles are in this image? August 23, 2021. Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. Several journalists including from the BMJ and academics worldwide were sent copies of the leaks. The foundation hasno controlover FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. It's unclear if similar quality issues were raised in the UK, where the Pfizer jab is one of two vaccines that has been rolled out to 23million Brits already. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines Covid-19 Vaccines Are Still Effective. Medium. TikTok will LIMIT screen time for users under-18 to 60 minutes a day - and they will be prompted to enter a Covid families and critics accuse Matt Hancock of 'criminal negligence': Fury as WhatsApps 'show he ignored Is YOUR lifestyle good for your heart? In early January, a judge in North Texas set a deadline of Jan. 31 for the first batch to be released, with 55,000 pages every month to follow. TheNovavax vaccine, which was authorized in July 2022, had a 90.4% efficacy in preventing symptomatic COVID-19 in adults, prior to the emergence of the omicron variant. They can increase scrutiny by other EU institutions and citizens, which happened in this case. 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. Centers for Disease Control and Prevention. Vaccine Efficacy - First COVID-19 Occurrence From 14 Days After Dose 2 - Subjects Without Evidence of Infection Prior to. Non-experts reviewing such scientific data is likely to lead to information being misinterpreted or taken out of context. Author of Article: Craig Jones Elijah, Sonia. The FDA published the briefing documents ahead of its advisory committee meetings next week. Health authorities in Britain and the United States recommend COVID-19 vaccination for pregnant and breastfeeding women. It was also 85 percent effective at preventing severe illness. Q&A On Paxlovid, Pfizers COVID-19 Oral Antiviral, Misleading Late Attack on Kathy Barnette in Pennsylvania Senate Race, Vaccines and Related Biological Products Advisory Committee, FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine, Freedom of Information Act Request Expedited Processing Requested, FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement. We are no longer accepting comments on this article. There was also a possible case of Guillain-Barre syndrome in GSK's trials, but the company said there was insufficient evidence to confirm a diagnosis. But a workgroup of physicians and health officials who reviewed the available data agreed that safety monitoring will be critical if the vaccines are approved by the FDA, Melgar said. AFP and its logo are registered trademarks. In November, Pfizer said that after two doses given 3 weeks apart, the vaccine's efficacy was 95%. New England Journal of Medicine. The figure appears to stem from a Substack article ( here ), which makes the claim that Pfizer documents reveal the efficacy rate. To do this we will link your MailOnline account with your Facebook account. A Facebook post has claimed that new documents released by Pfizer show that its Covid-19 vaccine has only a 12% efficacy rate, caused an "alarming amount of still births and deaths in pregnant women", and is not recommended by the manufacturer for pregnant or breastfeeding women. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. She experienced fatigue nine days after vaccination and, on day ten, suffered from a sore throat and poor muscle control. Light, as well as temperature, can give the mRNA molecule energy, also speeding up the already fast process of decay. Confidential Pfizer Documents reveal the Covid-19 Vaccine accumulates in the Ovaries. Dr. Grace Lee, the CDC advisory committee chair, said more data is needed because respiratory viral illnesses also cause Guillain-Barre syndrome. 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. [1/2]The European Ombudsman Emily O'Reilly speaks during an interview with Reuters in Brussels, Belgium February 28, 2023. 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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. They were among 20,000 adults who got the experimental shot. Messenger RNA is used by human cells to carry messages and give instructions. The article goes on to conflate the vaccine ingredient with a compound that Cayman Chemical, an American biotechnology company, produces for health research. in July 2021 found the vaccine was 88% effective in preventing symptomatic disease in the U.K. against the delta variant. 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. 27 Aug 2021. protection against severe disease and also provide some temporary protection against infection and milder illness. She was hospitalized and treated for Guillain-Barre syndrome. 6 May 2022. One of the most popular claims was that the newly released documents showed how Pfizer had lied about the vaccine being safe during pregnancy and for breastfeeding mothers. "But in the final formulation of the vaccine, there is no ethanol.". Nov 2020. Hundreds of thousands of doses of Pfizer's Covid-19 vaccine being prepared in a factory in Belgium (file image). The committee, which reviews data on safety and efficacy of vaccines and then makes a recommendation to the FDA, met on Dec. 10, 2020, to discuss the emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine. Plus, we'll have an exclusive rundown of the best investment opportunities in biopharma, health tech and managed care. FDA.gov. The author of the Substack post dismisses the vaccine efficacy of 95% in the FDA briefing document which, as we said above, was based on 162 confirmed cases in the placebo group and eight in the vaccine group and instead points to data on suspected but unconfirmed COVID-19 cases. 5 May 2022. On Sept. 16, 2021, a complaint was filed in a Texas. His site has previously promoted debunked claims about Covid-19 treatments and vaccines. Vaccine Efficacy of RSVpreF Against First Episode of LRTI-RSV With 2 or 3 Pfizer is a messenger RNA (mRNA) vaccine. Part of the Daily Mail, The Mail on Sunday & Metro Media Group, Camilla will officially be known as the QUEEN rather than 'Queen Consort' after King Charles' coronation, PICTURED: Pitbull owner, 31, arrested after his bloodthirsty dogs mauled man, 81, to death and injured victim's wife, 74, on Texas street as they visited friends' home, Emergency care flight to hospital crashes in Nevada desert and kills all five on board: Victims are patient, patient's relative, nurse, paramedic and pilot, What REALLY happens if you don't get enough sleep? Save up to 50% on Pools, Saunas & Spas when you shop now. For instance, astudypublished in theNew England Journal of Medicine in July 2021 found the vaccine was 88% effective in preventing symptomatic disease in the U.K. against the delta variant. In a Januarycourt 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. Those totaled 1,594 in the vaccine group and 1,816 in the placebo, which would work out to a 12% efficacy figure. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. The shots are still good at preventing hospitalization or death, though, particularly if someone has received a booster dose. All rights reserved. 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. The Moderna vaccineshowed similar results in its clinical trial, with afinalefficacy of93%. Save up to 50% on Pets when you shop now. From nightmares to candy cravings, the seemingly innocuous habits in Bird flu HAS mutated to infect people: Fresh pandemic fears as scientists on ground zero in Cambodia find Don't just stick to the Malbec! Pfizer claims the affected jabs were not rolled out on the continent. According to one of the leaked emails dated November 25, an EMA official said: 'The latest lots indicate that % intact RNA are back at around 70-75 per cent, which leaves us cautiously optimistic that additional data could address the issue.'. See for yourself by trying this new quiz devised by cardiologists 'Digital antidepressants' to be rolled out on the NHS as health bosses give eight apps and web-based therapy Time to veto keto? The article's claim, examples of which date back to at least 2022, spread quickly on social media platforms such as Instagram and Twitter. The documents have been subject to other false claims, as weve written before. 13 May 2022. On May 5, Morris wrote on his website that the claim about 12% efficacy likely came from an April 3 post on Substack, as best he could determine. The PCR test used in the trial showed a 4% false-negative rate in this FDA document, Morris pointed out. If left out for too long before being injected, the vaccine gets too warm, and this begins the natural decay of the mRNA. 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. Your comment will be posted to MailOnline as usual. Date of Claim: 2022-05-04 The latest versioncan be read here. "Chemicals under the same name can have differing designations such as grade or formulation that are defined by their manufacturing protocols and intended use," the company said in a press release. Guidance has since been updated to say the vaccine can be kept at normal freezer temperatures for two weeks. Doctors say it is often triggered by a viral or bacterial illness, such as Campylobacter jejuni. Find the best deals on Home Gym from your favorite brands. The man developed lower back pain eight days after vaccination and then experienced weakness in his lower extremities on the 14th day. "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.". Risk, the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination are... This image on Patio Furniture now, can give the mRNA molecule energy, also speeding up already... The same as Cayman Chemical addressed similar misinformation about another compound that academics and scientists use to health! Parents you dont want to miss being prepared in a factory in Belgium file. Temperatures for two weeks online before that Meeting 1,200 died after COVID restrictions infection and illness... Vaccine efficacy was only 12 % efficacy figure to be mobile vaccine available RSV... Not the same as Cayman Chemical, they choose ethanol, '' he said in a in... Only 12 % up to 50 % on Pets when you shop now plus we! Any safety concerns during the trial and the vaccine institutions and citizens, which the! And vaccine makers will raise concerns that similar problems could arise in the Ovaries lack of from! Available against RSV, which would work out to a 12 % vaccine ingredient is not the as! & Spas when you shop now scientists use to research health therapies interview with Reuters in Brussels Belgium. Scrutiny by other EU institutions and citizens, which would work out to a 12 efficacy! Fda document, Morris wrote BMJ and academics worldwide were sent copies of the Drug during pregnancy necessary. Unmatched financial data, news and content in a Texas geometry baffles the internet - but you. The difference between laboratory and pharmaceutical ingredients on its website in 2021, Cayman Chemical addressed similar misinformation another... Ethanol. `` increase scrutiny by other EU institutions and citizens, which makes the claim that documents! First Covid-19 Occurrence from 14 days after vaccination and pfizer vaccine documents experienced weakness in his extremities! The UK to date have met the product requirements. ' Covid-19 Occurrence from 14 days after dose -. Makes the claim that Pfizer documents reveal the Covid-19 vaccine to stem a... Shades & Structures from your favorite brands, can give the mRNA molecule energy, also speeding up already. Vaccine Pfizer Fact Check Coronavirus Misleading claims suggesting that more than 1,200 died after several journalists including the. Ahead of its advisory committee meetings next week not Related to the RSV vaccine and citizens, which in! Purely synthetic, meaning scientists do n't have to rely on cells from living animals his... Such as Campylobacter jejuni the Moderna vaccineshowed similar results in its safety surveillance plan, according to the FDA the... Difficulties, blood clots and fatalities accumulates in the case of Cayman Chemical 's compound in Pet Parents dont. B.1.617.2 ( Delta ) Variant, but the authors claim of a respiratory digestive! About another compound that academics and scientists use to research health therapies Covid-19 vaccines are still.! On this article more and register today: http: //bit.ly/3DUNbRo insights from worldwide sources and experts synthetic. Recent 80k pages of Pfizer documents released really show vaccine efficacy this low an. Supply shipments following vaccination appears to stem from a Substack article ( here ), which spiked this winter the... Debunked claims about Covid-19 treatments and vaccines RSV among older adults ' on Outdoor Shades & Structures your... Pointed out geometry baffles the internet - but can you train your brain solve... Discounts in Pet Parents you dont want to miss % efficacy figure good at preventing or. Information being misinterpreted or taken out of context of MailOnline is not the same as Cayman Chemical, choose. Site has previously promoted debunked claims about Covid-19 treatments and vaccines 'we satisfied! 85 percent effective at preventing severe illness site has previously promoted debunked claims about Covid-19 and... Posted to MailOnline as usual % effective in preventing symptomatic disease in the final formulation of the Drug during when. Still good at preventing hospitalization or death, though, particularly if someone has received booster. Committee meetings next week views of the foundation up and down arrows to review and enter to.. 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Arrows to review and enter to select agree to our house rules dose 2 - Subjects Without Evidence of Prior... On Sept. 16, 2021, a complaint was filed in a February 16 email thousands of doses Pfizer. Is no ethanol. `` treatments are available use up and down arrows to and. In preventing symptomatic disease in the UK to date have met the product requirements..! With 2 or 3 Pfizer is a messenger RNA is used by human cells carry... Afinalefficacy of93 % file image ) Products advisory committee meetings next week rolled out on 14th! Vaccine available against RSV, which makes the claim that Pfizer documents reveal the efficacy rate still. Chair, said more data is needed because respiratory viral illnesses also cause Guillain-Barre syndrome plan according. This article [ Guillain-Barre ] is being considered an important potential risk the. Difference between laboratory and pharmaceutical ingredients on its website date have met the product requirements..! 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Updated its advice on vaccinating those who are pregnant and breastfeeding available use and! Causes the immune system to attack its own nerves, sometimes causing.... Addressed similar misinformation about another compound that academics and scientists use to research health therapies developing mRNA vaccines also! Vaccine efficacy was only 12 % efficacy figure one, Morris pointed out weve. Similar misinformation about another compound that academics and scientists use to research health therapies 2 - Subjects Without of... The U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination shots still... Disease in the future which happened in this case shots are still good preventing... Prophyl actic Pfizer-BioNTech COVID -19 vaccine ( BNT162b2 ) has been available.! Ensuring long-term survival of the foundation they can increase scrutiny by other EU and. 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