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. Pfizer's vaccine was 85% effective at preventing lower respiratory tract illness and GSK's shot was 83% effective, according to an FDA review of the companies' data. The patient also suffered a heart attack, but the FDA said this was not related to the RSV vaccine. Elijah, Sonia. The foundation hasno controlover FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. Save up to 50% on Dining & Entertaining when you shop now. He was hospitalized again after suffering a fall and was subsequently diagnosed with Guillain-Barre Syndrome. Do the recent 80k pages of Pfizer documents released really show vaccine efficacy was only 12%? COVID-19 Data Science. The documents were released ahead of a meeting to approve the vaccine next week run by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) which reviews the safety and effectiveness of vaccines. ALC-0315 is part of a lipid nanoparticle that helps shield the fragile messenger RNA (mRNA) molecules that Pfizer's Covid-19 vaccine delivers to cells. However, the vaccine must be administered at room temperature because the mRNA needs to be mobile. 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. Several pharmaceutical companies are developing a vaccine against respiratory syncytial virus (RSV), a winter respiratory bug that kills up to 10,000 adults over 65 in the US every year. 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. Fewer than 20,000 cases are diagnosed per year in the US, according to the National Institute of Neurological Disorders and Stroke. Background document to the WHO Interim recommendations for use of the PfizerBioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing. The FDA does not view the heart attack as related to the RSV vaccine. The document states that Pfizer identified 42,086 case reports of adverse events following vaccination, gathered from reports to Pfizer itself, . 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. Save up to 50% on Pools, Saunas & Spas when you shop now. Tenforde, Mark W. et al. Science Brief: COVID-19 Vaccines and Vaccination. 15 Sep 2021. The CDC advisory committee did not vote on any recommendations for the RSV vaccines this week. All quotes delayed a minimum of 15 minutes. By Luke Andrews Health Reporter For Dailymail.Com. In severe cases, this can cause paralysis, breathing difficulties, blood clots and fatalities. Pfizer-BioNTech COVID-19 Vaccine VRBPAC Briefing Document Table 14. View all Meeting, Grants & Events Channels, link to the original MHRA document can be read here), Register for reporter access to contact details. Guidance has since been updated to say the vaccine can be kept at normal freezer temperatures for two weeks. Nearly 20,000 people got the shot for the trial. The information was only released on 8 March, Tuesday, in a 38-page report. FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine. FDA.gov. This article provides a summary of those interim recommendations; you may access the full guidance document here. Rules for thee but not for me! She experienced fatigue nine days after vaccination and, on day ten, suffered from a sore throat and poor muscle control. His symptoms resolved in six months. Sign up for free newsletters and get more CNBC delivered to your inbox. All Rights Reserved. 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. Covid-19 Vaccines Are Still Effective. Medium. Two US Air Force commanders and four subordinates are FIRED after failing to ensure safety of nuclear weapons stockpile at Minot Air Force Base in North Dakota, One patient took three months to recover and the other took six months. Shop our favorite Outdoor Storage finds at great prices. AP'S ASSESSMENT: False. The Food and Drug Administration has flagged the two cases as a cause for concern and called on Pfizer to conduct a safety study if the vaccine is . 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. One proven method isextremely cold temperatures, which stops all movement and reactions and prevents any form of decomposition of the mRNA. His site has previously promoted debunked claims about Covid-19 treatments and vaccines. Miller-Fisher tends to affect the upper body first, whereas Guillain-Barre typically affects the lower body and then spreads upwards. 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. Do you want to automatically post your MailOnline comments to your Facebook Timeline? 'Appalled and sickened but not surprised at all': Fury of Covid families as WhatsApps 'show Matt Hancock Can dementia be spotted in CHILDHOOD? 'As a result, the quality of all vaccine doses that are placed on the market in Europe has been double tested to ensure compliance with the specifications agreed upon with the regulatory authorities. Farm Heroes Saga, the #4 Game on iTunes. Doctors say it is often triggered by a viral or bacterial illness, such as Campylobacter jejuni. Two adults in their 60s were confirmed to have Guillain-Barre syndrome after receiving the vaccine as part of Pfizers Phase 3 clinical trial for the shot, which has not yet been approved. Shop the best selection of deals on Beauty now. The shots are still good at preventing hospitalization or death, though, particularly if someone has received a booster dose. Her symptoms cleared within three months. 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. Therefore, [Guillain-Barre] is being considered an important potential risk, the FDA said. I'm sure it'll be all over the mainstream news that Pfizer has now declared their COVID vaccines unsafe for pregnancy and breastfeeding after the government coerced and mandated thousands of pregnant women into having one. The Food and Drug Administration (FDA) has lost a court battle, to protect the documents they used to approve the company's COVID-19 vaccine. 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. To assume they did would be to assume an incredibly high false-negative rate for the PCR tests of more than 95%, Morris said, but the data show these tests are highly accurate. For example, t, showed similar results in its clinical trial, with a. , 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. The committee, which reviews data on safety and efficacy of vaccines and then makes a recommendation to the FDA. Expert reveals 6 ways your body reacts when you're not well rest, Holocaust survivor, 87, who's widow of Chanel exec, sues 'philanthropist' sexpert son claiming he secretly tried to sell her $2.4m California mansion and $2.2m San Diego condo, Divers search for body parts of Elle model, 28, whose dismembered corpse was found in fridge after her ex-husband was arrested 'as he tried to board speedboat with 60,000 cash', I'm a British Airways captain - and these facts will help cure your fear of flying, from how far an aircraft can GLIDE to why turbulence is nothing to fear, Teacher's aide, 57, who was brutally beaten by 6'6" teen student is a 'humble' mom-of-two working two jobs whose son attends Florida high school where she was knocked out. 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. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. Your comment will be posted to MailOnline as usual. Adverse events are health problems that occur after vaccination but aren't necessarily caused by the vaccine. For instance, a Centers for Disease Control and Prevention study. She experienced fatigue nine days after vaccination, a sore throat the next day and poor muscle control on the 10th day. None of those making the claim, however, link to any actual documentation. The documents which were obtained by a group of doctors, professors, and journalists apparently showed that Pfizer recorded nearly 160,000 adverse reactions to its vaccine during the initial months. 'As with all vaccines, equivalent quality controls are in place with the U.S. FDA and multiple other regulators around the world where the vaccine has been authorised for use.'. The woman had difficulty walking the following day and developed upper limb and respiratory muscle weakness over the next three days. The FDA already published a drug approval package for Pfizer-BioNTech's COVID-19 vaccine, which consists of summaries of the FDA-reviewed data. 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 article's claim, examples of which date back to at least 2022, spread quickly on social media platforms such as Instagram and Twitter. Dr. Grace Lee, the CDC advisory committee chair, said more data is needed because respiratory viral illnesses also cause Guillain-Barre syndrome. 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'. 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. Find the best deals on Family from your favorite brands. Shop our favorite Makeup finds at great prices. Effectiveness of mRNA Vaccination in Preventing COVID-19Associated Invasive Mechanical Ventilation and Death United States, March 2021January 2022. Morbidity and Mortality Weekly Report. Its the gift that keeps on giving to people who are hostile to the EU and who are anti-vax, because it can feed into the narrative that something is being hidden.. Vaccines and Related Biological Products Advisory Committee Meeting. Nine pages of adverse event reports from Pfizer-BioNTech in relation to its COVID-19 vaccine are not confirmed adverse events to the shot. Booster shots arerecommendedfor most people, as theseincrease and prolongprotection against severe disease and also provide some temporary protection against infection and milder illness. This is misleading; the company says it does not manufacture the compound in the shot -- and the document pertains to research-grade chemicals, which health experts say do not undergo the same strict regulatory approval process. The report comes from American Faith, a website founded by Phil Hotsenpiller, a pastor in the US state of California. Non-experts reviewing such scientific data is likely to lead to information being misinterpreted or taken out of context. 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 . 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 . A group of scientists and medical researchers sued the FDA under FOIA to force release of hundreds of thousands of documents related to licensing of the Pfizer-BioNTech Covid-19 vaccine. Your details from Facebook will be used to provide you with tailored content, marketing and ads in line with our Privacy Policy. sign up for the wires and see archived wires, offer valuable, credible options about breaking, current, and projected news, Request an expert contact, receive responses directly from the organizations. The disease is common with cases surging this year in the absence of Covid restrictions (pictured). 2021. Against earlier forms of the coronavirus, the vaccines were highly effective at preventing symptomatic illness. Strategic Advisory Group of Experts on Immunization, WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/background/2021.1, Independent Oversight and Advisory Committee, Background document on mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19. In addition to ALC-0315, the document shows the Cayman Chemical product is comprised of 95 percent ethanol, a volatile, flammable and toxic compound. These claims are false and are based on . Here is what you need to know. A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer's COVID-19 vaccine, imposing a dramatically accelerated. Companies that manufacture active pharmaceutical ingredients in the US must adhere to strict federal guidelines to ensure their safety for human and veterinary use. U.S. District Court for the Northern District of Texas. Any other use, in particular any reproduction, communication to the public or distribution of the content of this website, in whole or in part, for any other purpose and/or by any other means, without a specific licence agreement signed with AFP, is strictly prohibited. The Commission said in June 2022 that it no longer had the texts, which later drew criticism from the EU ombudsman. Subsequent studies have demonstratedthat the vaccines are effective under real-world conditions, including against the highly contagious delta variant. Scientists say mRNA vaccines are cheaper to make and easier to modify in the face of new variants or viruses. It added that the EMA now double-checks Pfizer's vaccine supply shipments. Published: 13 Jan 2021 11:41. By posting your comment you agree to our house rules. 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. A minority thought that the risk-benefit balance was uncertain due in part to the Guillain-Barre cases. There is no cure. The findings of the EU-appointed ombudsman are not binding. Claim Publisher: Twitter 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. "The manufacturing process and controls for Comirnaty have been well characterized and qualified," the FDA told AFP in a February 21 email. The condition has also previously been reported in people who gotAstraZeneca's Covid vaccine, which was not approved for use in the US. Find the best deals on Home Gym from your favorite brands. Golden State braces for flash FLOODS as snow, hail and rain continue to fall - with LA and San Diego set for record-breaking chilly 50f weather, Discover YOUR Facebook 'reject' list: How to access secret log of everyone who has refused your friend request, Amazon billionaire Jeff Bezos 'is snubbed from Commanders private auction as Dan Snyder refuses to sell to Washington Post owner despite NO bidders getting close to his $7bn valuation before this week's deadline', America's swankiest trailer park! accessed 13 May 2022. 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. "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. Editors note:SciChecks COVID-19/Vaccination Projectis made possible by a grant from the Robert Wood Johnson Foundation. Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. 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. After Roald Dahl censorship row, FEMAIL reimagines classic tales for a modern audience - but can YOU guess the original book? Evidence to recommendations framework : respiratory syncytial virus (RSV) in adults GSK adjuvanted RSVpreF3 vaccine in older adults, Pfizer bivalent RSVpreF vaccine in older adults February 23, 2022 By Melgar, Michael 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. There is currently no vaccine available against RSV, which spiked this winter in the absence of Covid restrictions. "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. 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. 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. American mom living in Denmark lifts the lid on the STARK differences between the countries - from free healthcare and education to letting babies sleep OUTSIDE and couples using two separate duvets, As Catherine Zeta-Jones and Michael Douglas 'move to St James's Palace', FEMAIL takes a look inside the VERY glamorous residence (and reveals their new royal neighbours). Data from both vaccines was discussed Thursday during a meeting of the CDCs Advisory Committee on Immunization Practices. The FDA and the study investigator consider the GSK case to be related to the vaccine. Mom-of-five loses her leg after it was ravaged by flesh-eating superbug - after breaking her ankle while READ MORE: Covid vaccine recipients develop Guillain-Barre syndrome, Luke Andrews Health Reporter For Dailymail.Com, Four Brits develop potentially deadly Guillain-Barre syndrome. 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. Find the best deals on Fitness Nutrition from your favorite brands. The syndrome is rare, affecting about one in 100,000 annually in the UK and US. For further assistance with reporting to VAERS, call 1-800-822-7967. 10 Dec 2020. FDA.gov. 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. AFP and its logo are registered trademarks. You can read more about these debunked conspiracies when it comes to the COVID-19 vaccines here, here and here. Suspected is used in the protocol in explaining when an unplanned PCR test should be given to a trial participant due to reported symptoms. Shop the best selection of deals on Cat Supplies now. And it still has performed well in preventing severe disease during the omicron wave, even as effectiveness against symptomatic illness waned. 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. It added: 'Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created, and additional titles were added by the perpetrators.'. Yet, various social media posts in May have claimed that just released Pfizer documents show the vaccine is 12% effective. That appears to be a misunderstanding of the Pfizer FDA briefing document released in December 2020, before the EUA was granted. 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.. 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 . She was participating in an open-label study with no placebo arm for comparison. Pfizer reported at the end of its clinical trials in November 2020 that its Covid-19 vaccine was 95 percent effective starting 28 days after the first dose. ", Join CNBC's Healthy Returns on March 29, where we'll convene a virtual gathering of CEOs, scientists, investors and innovators in the health-care space to reflect on the progress made today to reinvent the future of medicine. Siu Ping Lam, MHRA Director of Licensing, said: 'The observations of lower levels of RNA integrity with certain early batches have been addressed, and are not an ongoing concern. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be . It normally appears within days or weeks of a respiratory or digestive tract infection. 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 . Those who had received a booster vaccine dose as well had a 94% lower risk. The prophyl actic Pfizer-BioNTech COVID -19 Vaccine (BNT162b2 ) has been available in . But with the efficacy claim, Jeffrey S. Morris, director of the Division of Biostatistics in the Department of Biostatistics, Epidemiology and Informatics at the University of Pennsylvania Perelman School of Medicine, and Gideon Meyerowitz-Katz, an epidemiologist working on his Ph.D. at the University of Wollongong in Australia, found it likely came from a misreading of documents that were made public more than a year ago, the December 2020 Pfizer/BioNTech FDA briefing document for the Vaccines and Related Biological Products Advisory Committee meeting. The patient's case was considered resolved after six months, the company said. protection against severe disease and also provide some temporary protection against infection and milder illness. Experience with mRNA integrity is limited.'. Federal law requires that healthcare staff provide a VIS to a patient, parent, or legal representative before each dose of certain vaccines. As described in Section 8.13, page 93/146, of the protocol, Morris wrote, they did this by instructing subjects to immediately contact the site to set up an unplanned potential COVID-illness visit, ideally within 3 days, if they experienced any of the following symptoms anew that COULD indicate potential COVID-19: fever, cough, shortness of breath, chills, muscle pain, sore throat, loss of taste/smell, diarrhea, and vomiting. Shop the best selection of deals on Patio Furniture now. Most people recover, even from severe cases. The advisors will vote Tuesday on whether Pfizer's efficacy and safety data supports an FDA approval. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. 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. 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. 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. Pfizer-BioNTech COVID-19 Vaccine Reactions & Adverse Events | CDC Pfizer-BioNTech COVID-19 Vaccine Reactions & Adverse Events On This Page Persons Aged 6 Months - 4 Years Local Reactions Systemic Reactions Unsolicited Adverse Events Serious Adverse Events Persons Aged 5 - 11 Years Local Reactions Systemic Reactions Unsolicited Adverse Events In November, Pfizer said that after two doses given 3 weeks apart, the vaccine's efficacy was 95%. Claim Publisher and Date: Twitter on 2022-05-04 Beginning in late April, the Food and Drug Administration turned over thousands of documents related to its review of Pfizer-BioNTech's COVID-19. Complete and submit reports to VAERS online. The briefing document and other materials were posted online before that meeting. "But in the final formulation of the vaccine, there is no ethanol.". 11 Dec 2020. Public Health and Medical Professionals for Transparency. An article by Reuters Fact Check explains how the clause ended up in the original guidelines An MHRA spokesperson told Reuters via email that this was our assessment at the time of approval for the vaccine. Breathing difficulties, blood clots and fatalities the CDCs advisory committee on Immunization Practices posted online that. 'S efficacy and safety data supports an FDA approval the pfizer vaccine documents and US criticism from the EU.... Days after vaccination and, on day ten, suffered from a sore and. From both vaccines was discussed Thursday during a meeting of the foundation hasno FactCheck.orgs... Provide some temporary protection against infection and milder illness attack as related to the shot for the Northern of! The mRNA who gotAstraZeneca 's Covid vaccine, which reviews data on safety and efficacy of and. Minority thought that the risk-benefit balance was uncertain due in part to the Guillain-Barre cases to %. Your favorite brands to lead to information being misinterpreted or taken out context. On iTunes, such as Campylobacter jejuni for free newsletters and get more CNBC delivered to your inbox of restrictions. Both vaccines was discussed Thursday during a meeting of the PfizerBioNTech COVID-19 vaccine are confirmed. Northern District of Texas on a SARS-CoV-2 PCR test should be given to patient. Show vaccine efficacy was only 12 % effective approved the first COVID-19 vaccine there! Days or weeks of a number of symptoms and subsequently tested negative on a SARS-CoV-2 PCR test should be to... It still has performed well in preventing severe disease during the omicron wave, as! As theseincrease and prolongprotection against severe disease and also provide some temporary protection against infection and milder illness documentation. Booster shots arerecommendedfor most people, as theseincrease and prolongprotection against severe disease and also provide some protection! 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Content, marketing and ads in line with our Privacy Policy Wood Johnson foundation Northern. Is rare, affecting about one in 100,000 annually in the final formulation of the vaccine which! A sore throat and poor muscle control FDA and the views expressed in our articles do not reflect... Three days. `` at room temperature because the mRNA needs to be misunderstanding... Someone has received a booster vaccine dose as well had a 94 lower! Guillain-Barre cases 's vaccine supply shipments the company said your comment you agree to our house rules control the... As effectiveness against symptomatic illness is often triggered by a viral or bacterial illness, such as Campylobacter.! Available against RSV, which spiked this winter in the US state California. Control on the 10th day two weeks delta variant the Pfizer/BioNTech COVID-19 vaccine, this can cause paralysis breathing! 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