Help us create a more trustworthy Internet! There are about 28 million children between ages 5 and 11 in the United States, well above the 17 million children between ages 12 to 17 who became eligible for the Pfizer vaccine d Mild: easily consolable; moderate: requiring increased attention; severe: inconsolable; crying cannot be comforted; Grade 4: emergency room visit or hospitalization, aAny fever= 38.0C While on the surface those numbers could be alarming, its critical to understand that an adverse event is simply an event that has occurred after vaccination it does not mean the vaccine necessarily caused the problem. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, accordingto the CDC. This was a global study in 18 countries and started in June 2020, so it spanned multiple RSV seasons in both the northern and southern hemisphere. According to Endpoints News, among the documents released, one shows a nearly $2.9 million user fee payment to FDA from Pfizer and others which show a fast track designation letter, which is not typically released, a confidential nonclinical overview for the vaccine, Pfizers request for a waiver from adding a suffix to the vaccines name, which is also not typically released, and a long list of anonymised trial subjects who didnt receive the vaccine as randomised. Pfizer's document released by the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination. 3.RESULTS 3.1.Safety Database 3.1.1.General Overview It is estimated that approximately doses of BNT162b2 were a Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain. Swiss athlete Sarah Atcho shared on Instagram that she now suffers from pericarditis, an inflammation of the membrane that covers the heart, which was caused after she received the 3rd dose of the Covid vaccine. b Mild: decreased interest in eating; moderate: decreased oral intake; severe: refusal to feed; Grade 4: emergency room visit or hospitalization Campbells video claiming that Pfizers document showed 1,223 [vaccine-]associated deaths received more than 760,000 views and 24,000 engagements on Facebook. The data request came from the Public Health and Medical Professionals, demanding more transparency, who sued the FDA under a Freedom of Information due to the FDAs initial request of only releasing a minimum of 500 pages a month. COVID-19 Vaccinations in the United States. COVID Data Tracker. By age group, 88.7% in the younger group (aged 18 to 55 years) and 79.7% in the older group (aged >55 years) reported at least one local reaction. 19 Apr 2021. Ever since the first vaccine was developed in 1796 to treat smallpox,1 several different methods have been created to develop successful vaccines. About Pfizer: Breakthroughs That Change Patients Lives , after review of the manufacturing process and ongoing trial results and safety monitoring. Updated December 18, 2020. Accessed 18 Mar 2022. Fever was more common after the second dose and in the younger group (15.8%) compared to the older group (10.9%). because its a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists. Learn about SARS-CoV-2, the coronavirus that causes COVID-19, what you can do to stay safe and prevent the spread, and our scientific efforts to help bring an end to the current global health crisis. As of March 1, 2022, the following secondary endpoints had not yet been analyzed: reduction of incidence of all CDI cases following the second and the third One grade 4 fever (>40.0C) was reported in the vaccine group. Such posts received more than 47,000 interactions on Facebook and Instagram, according to the social media analytics tool CrowdTangle. via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects. However, the time it takes to process them will vary depending on the complexity of the request, as the FOIA website explains. After more than 1 billion doses administered worldwide includingmore than325 million in the U.S. and more than a year of safety monitoring, thePfizer/BioNTech COVID-19 vaccine is considered to be very safe. c Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea. d Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization. Any health problem that happens after vaccination is considered an adverse event following immunization, the Centers for Disease Control and Prevention, . Associate Professor of Public Health and Community Medicine, Tufts University School of Medicine. Vaccine recipients reported similar rates of local reactions after dose 1 and dose 2, but slightly lower after dose 3. Its shocking. 28 Jul 2020. those posting alarming stories about the document appear to have ignored. All our print and online content always has been and always will be FREE OF CHARGE. At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. Burden of RSV in Infants cMild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea. N Engl J Med. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Study authors say these effects were similar to what Pfizer and Moderna reported in clinical trials before they were granted FDA authorization. Therefore, these reports dont establish a causal relationship between the events and the vaccine. All information these cookies collect is aggregated and therefore anonymous. Since the data doesnt provide evidence that the vaccine caused any new side effects or is unsafe, claims that Pfizer and the FDA tried to hide this information from the public are also unfounded. Far from proving that the Pfizer/BioNTech vaccine isnt safe, the Pfizer document is evidence of the vaccines continued safety, Beninger said. We strive to explain whether and why information is or is not consistent with the science and to help readers know which news to trust. DAmbrosio, Amanda. from Childrens Health Defense, Robert F. Kennedy Jr.s anti-vaccination organization, similarly highlights the appendix and calls the document a bombshell that should put an immediate end to the Pfizer COVID vaccines., John Campbell, a nurse educator in the U.K., whom weve written about, , also discussed the document in a popular YouTube. By signing up, you will create a Euro Weekly News account if you dont already have one. Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Bird Flu Deaths Prompt U.S. to Test Vaccine in Poultry, COVID Treatment in Development Appears Promising, Marriage May Help Keep Your Blood Sugar in Check, Getting Outdoors Might Help You Take Fewer Meds, New Book: Take Control of Your Heart Disease Risk, MINOCA: The Heart Attack You Didnt See Coming, Health News and Information, Delivered to Your Inbox. These reports alone thus are insufficient to demonstrate that the Pfizer-BioNTech COVID-19 vaccine caused any new side effects or is unsafe. But the assessments not there to show that they were causally related, he said. The posts incorrectly claim that it shows the vaccine is unsafe and is evidence that this was hidden from the public. Absolutely yes, categorically, no question, he said. 2020 Jul;146(1):e20193611. Why werent we made aware of these at the time? One year ago, these were side effects that Pfizer knew about, conservative commentator Liz Wheeler says in an Instagram post, before highlighting a long list of so-called adverse events of special interest in the documents appendix. Download our media pack in either English or Spanish. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. endstream endobj 401 0 obj <>stream Several months earlier, on Dec. 16, 2021,the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&Js. Pfizers analysis notes that the companys safety database contains cases of adverse events regardless of causality assessment and says that numerous factors can influence whether an adverse event is reported, and that the , spontaneous reporting system should be used for signal detection.. And many of the events are likely to be purely coincidental. Pfizer Inc. (NYSE: PFE) today announced positive top-line data from the Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) investigating its bivalent RSV prefusion vaccine candidate, RSVpreF or PF-06928316, when administered to pregnant participants to help protect their infants from RSV disease after birth. Disease or Condition of the Week - Respiratory Syncytial Virus Infection (RSV). This followed the FDAs November 2018 decision to grant Fast Track status to RSVpreF. Pfizer data submitted to FDA contains 8 pages of known side effects. The document is an analysis of adverse events, or health issues reported following vaccination, regardless of whether they were caused by the vaccine. The first pages of the document, too, explicitly address many of the limitations of adverse event reporting to help properly interpret the data limitationsthose posting alarming stories about the document appear to have ignored. i l%,$i3j!3S+ kx ;a/O.cUSk94o"yZwM=2zCj$,;iyQ|G Y CJCVOPvzO.N"'R\paJpumJ~g T` The analysis concludes that Pfizers post-marketing data confirms a favorable benefit: risk balance for its vaccine, and that the company will continue its monitoring to assure patient safety.. However, Zach Zalewski, PhD, JD, a regulatory strategy consultant at Avalere Health, warned that there is the potential of cherry picking information after the huge data release, which is set to conclude in the summer. The adverse event reports that Pfizer collected between December 2020 and February 2021 cant tell us whether the vaccine caused the adverse events. Published on: 11 Mar 2022 | Editor: Iria Carballo-Carbajal. Early evidence suggests these myocarditis cases are less severe than typical ones. Phone interview with FactCheck.org. Many posts also wrongly assume that a long list of health issues Pfizer is monitoring for occurred and were due to vaccination. Amongseveralothers, the list of signatories includes Idaho pathologist Dr. Ryan Cole, who has baselessly saidthat the vaccines cause cancer, and Dr. Stella Immanuel, who hasfalsely promotedhydroxychloroquine as a COVID-19 cure and has previouslyclaimedthat some medicines are made of space alien DNA. that the groups request would require releasing 80,000 pages a month, which the agency said had never happened before with any FOIA request, and was difficult if not impossible with its current staffers, who would need to go through the documents line by line and redact exempted material. One of the documents released was a 38-page safety surveillance report from the first three months post-authorization that included a nine-page appendix listing adverse events of special interest. 2017;5(10):e984-e991. 14 Mar 2022. The FDA did not oppose releasing the information, but denied the groups request for expedited processing, leading PHMPT to sue the agency in federal court in September, as MedPage Today hasexplained. The Pfizer logo on the outside of a building in Belgium. WebReport vaccine side effects toll-free at 1-800-822-7967 March 29, 2022. Ultimately, the claim that the documents show the vaccine is dangerous is simply baseless, as the documents dont demonstrate any safety issues with the COVID-19 vaccine. 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 companys COVID-19 vaccine. , have subsequently identified only a few, very rare adverse events. The majority of systemic events were mild or moderate in severity, after both doses. As weve already established, theres nothing to indicate that there was any identified safety issue, and therefore, theres no evidence that regulators failed to share any important safety information with the public. We would like to thank the pregnant women who volunteered for this trial, along with their infants, and all the investigators around the world who participated in the study for their contribution to this landmark research.. He also suggests Dr. , the acting FDA commissioner when the agency gave full approval to the Pfizer vaccine, was wrong to, that millions of people have already safely received COVID-19 vaccines., All of these posts misunderstand what is being reported in the Pfizer. Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 4 days after either dose and lasted a median duration of 1 day. PHMPT then posted the documents on its website. No bells palsy or anaphylaxis was reported among vaccine recipients in this age group. 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