The use of these complementary monitoring systems has provided robust and reassuring data," Matthew S. Krantz, MD, and Elizabeth J. Phillips, MD, with the Vanderbilt University School of Medicine in Nashville, said. You cannot call them vaccine-associated., This confusion about adverse events is common and has been a frequent issue before with people distorting data from the, in the U.S. to argue that vaccines are unsafe, as weve, , it should be said, reviews the adverse events in groups according to organ type, noting each time that the evidence does not suggest a new safety signal. Pfizer and BioNTechs two-dose Covid vaccine provided very little protection for children aged 5 to 11 during the wave of omicron infection in New York, according to a study published Monday. [emailprotected] , or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. Many posts also wrongly assume that a long list of health issues Pfizer is monitoring for occurred and were due to vaccination. The FDA proposed releasing 500 pages a month instead, which it said was the standard rate. 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. [emailprotected] Reports of lymphadenopathy were imbalanced with 6 more cases in the vaccine group (7) than the placebo group (1); lymphadenopathy is plausibly related to the vaccine. Just a sampling here phmpt.org/wp-content/upl 11:50 AM - 1 Mar 2022 2,385 Retweets 4,343 Likes As the title indicates, the document contains information about adverse events that occurred following vaccination, not vaccine side effects as many claimed. March 8, 2022 Side effects from the Pfizer and Moderna vaccines in the United States have largely been mild and short-lived, a large new study of the first 6 The group asked the FDA for all of its documents related to the Pfizer/BioNTech COVID-19 vaccine or. Injection site redness and swelling following either dose were reported less frequently than injection site pain. The list notes 1,291 different adverse events following the Pfizer Covid vaccine. To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. RSV is a contagious virus and a common cause of respiratory illness.1 The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for young infants, persons with certain chronic medical conditions, and older adults.2,3,4,5 In the United States alone, approximately 2.1 million outpatient visits and 58,000 hospitalizations due to RSV occur each year among children younger than five years old.6,7 Worldwide, RSV results in death of approximately 102,000 children annually, with about half of those in infants less than 6 months old and the vast majority in developing countries.8,9. Understanding Adverse Events and Side Effects. CDC. The potential side effects from pages 30-38 of Pfizer's data dump are: APPENDIX 1. Although talking about the Moderna vaccine, a viral post from Twitter user Louie Traub said: Im 41 and on now heart medication thanks to Moderna. 25 ways to protect yourself from illness. Expert groups continue to recommend use of the drug during pregnancy when necessary and in consultation with a doctor. 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). Through February 2021, it says, there were 42,086 reports of individuals reporting adverse events, including 1,223 deaths. b Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or hospitalization for severe vomiting. Among all study vaccine recipients asked to complete diaries of their symptoms during the 7 days after vaccination, 84.7% reported at least one local injection site reaction. And its FREE! &iDihFO6,(z4HQ8DRN|. 5 No Bells palsy, anaphylaxis or myocarditis was reported among vaccine recipients in this age group. Many people have reported side effects, such as headache, fatigue, and soreness at the injection site, that are generally mild to moderate and go away within a few days. Unleashing the next wave of scientific innovations, Research and Business Development Partnerships, results of the Phase 2b proof-of-concept study, https://www.cdc.gov/rsv/about/transmission.html, https://www.cdc.gov/rsv/factsheet-older-adults.pdf, https://www.cdc.gov/rsv/high-risk/infants-young-children.html, https://www.businesswire.com/news/home/20221101005117/en/, Understanding Six Types of Vaccine Technologies. 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. Additionally, the FDA and CDC have authorized and recommended the Pfizer booster for ages 5 and up at least five months after their primary two-dose series. The products discussed herein may have different labeling in different countries. 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.. While reports of vaccine side effects continue to roll in across the globe, the FDAs initial request of 75 years to release the data, which is linked to its decision in December 2020 to grant Pfizer-BioNTech Emergency Use Authorisation for its mRNA vaccine, was finally turned down and subsequently, a judge ordered the release of data to begin in March, citing the request as paramount to public importance. Pfizers confidential document shows adverse events reported following vaccination; it doesnt demonstrate that the vaccine caused the events or is unsafe. HealthFeedback. As of early April,the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Pfizer may have been the first company to deliver on the promises of former President Trumps Operation Warp Speed, but it was an exceedingly rocky road for the 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. , before highlighting a long list of so-called adverse events of special interest in the documents appendix. 2017;5(10):e984-e991. The pre-planned, interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints. [8acf;-.6-v]\)puZ$ir}WvXJYp. 3.RESULTS 3.1.Safety Database 3.1.1.General Overview It is estimated that approximately doses of BNT162b2 were Data source: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA. . COVID Data Tracker. The Express article also said: It is the first time the public are allowed to access the data Pfizer submitted to FDA from its clinical trials in support of a Covid-19 vaccine license [sic].. c Mild: increased or prolonged sleeping bouts; moderate: slightly subdued interfering with daily activity; severe: disabling; not interested in usual daily activity; Grade 4: emergency room visit or hospitalization People across the globe are currently scrutinising the huge amount of data after the hashtag #VaccineSideEffects began trending on Twitter. However, their reactions to vaccination are expected to be similar to those of young adults who were included. All of this comes at ZERO cost to our readers. Page 6 of the document explicitly states: An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AE was caused by the drug; rather, the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication., The FDA release was a response to a Freedom of Information Act (FOIA) request by the group Public Health and Medical Professionals for Transparency filed in September 2021, demanding the data that Pfizer submitted to the FDA as part of the license application. 16 Mar 2022. At that pace, all of the information will be released by the end of the summer. endstream endobj 399 0 obj <>stream Pfizers investigational RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the viral fusion protein (F) that RSV uses to enter human cells. after the agency gave full approval to the vaccine. View source version on businesswire.com: https://www.businesswire.com/news/home/20221101005117/en/, Media Contact: The FDA turned over thousands of documents related to its review of RSV bronchiolitis is the leading cause of infant hospitalization due to viral respiratory illness, characterized by respiratory distress that can result in death. The information contained in this release is as of November 1, 2022. March 01, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a safety ; 1Y/%-p /=p8gcHm>=vxo4>i7}fY4tM>:WP8.=\pW'-Ide=ksD(sg"V=stream A maternal vaccine with high efficacy that can help protect infants from birth could substantially reduce the burden of severe RSV among newborns through six months of age, and, if approved by regulatory authorities, will likely have a significant impact on disease in the U.S. and globally.. Any health problem that happens after vaccination is considered an adverse event following immunization, the Centers for Disease Control and Preventionexplains. Rather than producing 500 pages a month the FDA's proposed timeline he ordered the agency to turn over 55,000 a month. This confusion about adverse events is common and has been a frequent issue before with people distorting data from theVaccine Adverse Event Reporting Systemin the U.S. to argue that vaccines are unsafe, as wevewrittenrepeatedlybefore. DAmbrosio, Amanda. Because a variety of health problems, including death, occur in the population every day, its expected that many of these will be reported after vaccination, even if they have nothing to do with the vaccine. But those arent dangerous and are signs that the vaccine is working and the body is beginning to mount a protective immune response. Based on this document, multiple posts and memes (see examples here, here, and here) claimed that the Pfizer-BioNTech COVID-19 vaccine caused a lengthy list Supported by WP Advisor. 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. Lymphadenopathy was reported by 2 (0.2%) vaccine recipients 6-23 months of age, 1 (0.1%) vaccine recipient 2 4 years of age, and no placebo recipients. Most SAEs were gastrointestinal or respiratory infections/illnesses that occur commonly in this age group. aMild: 0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only) Jaramillo, Catalina. Local reactions were reported by half (48%) of vaccine recipients and at higher rates than placebo recipients. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. The J&J vaccine has also been linked to an increased risk of Guillain-Barr Syndrome, a rare disorder in which the immune system attacks nerve cells. 11 Dec 2020. , Theyre temporally associated, thats the reason why they were reported. The most commonly observed adverse events were consistent with those reported as local and systemic reactions and/or were consistent with events frequently reported in this age group, including infections and injuries, that were not considered related to vaccination. The median onset of local reactions in the vaccine group was 1 to 2 days after either dose and lasted a median duration between 1 and 2 days. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain or no side effects at all. h242U0P042S02P+-(] h V Currently there is no vaccine to prevent RSV. Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. 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.. V-safe is a voluntary, smartphone-based system set up in 2020 specifically for monitoring reactions to COVID-19 and health effects after vaccination. A flurry ofarticlesandvideosonlineare now misinterpreting a Pfizerdocument released by the FDA as part of a Freedom of Information Act request. After the FDA denied it, the group filed suit in the U.S. District Court for the Northern District of Texas to seek this expedited processing, arguing that their request was a top priority. One clue comes from its formatting, he said. More serious side effects, The vaccine was first granted an emergency use authorization by the FDA in, , based on a large phase 3 randomized controlled trial and other studies. Most reported cases following J&J vaccination have occurred in men 50 years old and older. Fatigue, headache, muscle pain Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain. At the recommendation of the DMC, and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer has stopped enrollment in the study. hLn0_OPi%@-Ks e*KY-&o"?yY5-XeB{,}y1YqP/ =rx!j[th$;pTN (Table 6). 28 Jul 2020. Many posts also err in their interpretation of the Pfizer documents appendix, which is an alphabetical list of 1,291adverse events of special interest. I used to be healthy, teach snowboarding and climb Colorados 14,000-foot peaks. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; including the risk that final results from the Phase 3 trial could differ from the interim data discussed in this release; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in any jurisdictions for RSVpreF for any potential indications (including the planned BLA submission in the U.S.); whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether RSVpreF will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of RSVpreF; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding RSVpreF and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. 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