Injection site redness and swelling following either dose were reported less frequently than injection site pain. aMild: 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20221101005117/en/, Media Contact: By Matthew Roscoe 08 March 2022 16:09. These findings should put an immediate end to the Pfizer COVID vaccines. The document was released by the FDA in response to a Freedom of Information Act request from Public Health and Medical Professionals for Transparency. Beninger, Paul. 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. z/|D;}"jwY9/#2Ht [0v34R)O`I32CMRf?vKe75y#junGxHXrV,oc`n`+haiEI/OFKB_l'gt=@HA67Snmyme9+;F]_ HJEeU&okH&6}4F5: :xM"3t|@l8[TJWYgr*XFe% %S5` aMild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). 3.RESULTS 3.1.Safety Database 3.1.1.General Overview It is estimated that approximately doses of BNT162b2 were Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period. 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. aAny fever= 38.0C 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. On Jan. 6, a judge in North Texas recognized the unduly burdensome challenges of the FOIA, but. Im 41 and on now heart medication thanks to Moderna. This is misleading for two reasons. h Health Feedback is a non-partisan, non-profit organization dedicated to science education. As its website explains, VAERS is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.. But, as well explain, the appendix is just a list of conditions Pfizer was monitoring for, and the document supports the vaccines continued safety. Of those, 313,499 (92.1%) were considered nonserious; 22,527 (6.6%) were serious, but did not include death; and 4,496 (1.3%) were deaths. 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. N Engl J Med. 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. Accessed 18 Mar 2022. At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. 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). 1 Centers for Disease Control and Prevention. 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. 2005 - 2023 WebMD LLC. https://www.cdc.gov/rsv/high-risk/infants-young-children.html. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Lancet 2022; 399: 2047-64. Researchers, led by Hannah G. Rosenblum, MD, CDCs COVID Response Team, looked at data collected through the Vaccine Adverse Event Reporting System (VAERS) and and a system called v-safe starting in December 2020 through the first 6 months of the US COVID-19 vaccination program. 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. 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. BJ4h:E`;k2nm@O.z 'JWPG1@#eij :zFC)6YNu}A.6za.q5z5LLhpZEu7 3 Centers for Disease Control and Prevention. 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. Investor Contact: . Our World in Data. Absolutely yes, categorically, no question, he said. Originally from the UK, Matthew is based on the Costa Blanca and is a web reporter for The Euro Weekly News covering international and Spanish national news. The remaining SAEs were considered by FDA to be unrelated to the study vaccine. 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 Among persons aged 1217 years, reactions after Pfizer-BioNTech booster vaccination were generally mild to moderate and transient; the frequency of local and Privacy Policy for more information about our privacy practices. 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. No grade 4 local reactions were reported. Overall, the median onset of local reactions in the vaccine group was 1 to 2 days after either dose, with a median duration of 1 day after onset. If transparency is what they want, transparency is what theyll get., Theres a risk of cherry picking and taking things out of context, Zalewski said. But the assessments not there to show that they were causally related, he said. Q: Is the use of acetaminophen during pregnancy linked to autism or ADHD? The challenge is to see whether the frequency of a particular event is elevated above the background rate, which could indicate a possible problem. , before highlighting a long list of so-called adverse events of special interest in the documents appendix. Accessed 18 Mar 2022. Saving Lives, Protecting People, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Considerations for Planning School-Located Vaccination Clinics, How Schools and ECE Programs Can Support Vaccination, Customizable Content for Vaccination Clinics, Best Practices for Schools and ECE Programs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services. Public Health and Medical Professionals for Transparencywebsite. Traubs tweet, which has been shared over 10k times on the platform, is not the only example of peoples blaming the Covid vaccines for the side effects they have suffered following the jab. 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. 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. The Burden of Respiratory Syncytial Virus Infection in Young Children. All rights reserved. (Table 5). Such posts received more than 47,000 interactions on Facebook and Instagram, according to the social media analytics tool CrowdTangle. Shortly thereafter, misleading or false claims began circulating online about the safety of the Pfizer/BioNTech vaccine using the documents, which our colleagues at Health Feedback have alsoaddressed. Jan. 18, 2022, 1:00 AM. Got a news story you want to share? The list notes 1,291 different adverse events following the Pfizer Covid vaccine. 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. Therefore, these reports dont establish a causal relationship between the events and the vaccine. As Health Feedback explained in earlier reviews (here, here, here, and here), these surveillance systems help health authorities identify safety signals that may indicate a problem with the vaccine and require further investigation, such as a disproportionately high number of a particular adverse event. WebThe overall incidence of unsolicited non-serious adverse events from dose 1 to data cutoff (April 29, 2022) were similar in the vaccine and placebo groups in both age groups: 29.1% vs. 26.3% for the younger age group and 18.5% vs. 18.5% in the older age group, Redness was reported slightly more frequently in the older age group than the younger age group (10.9% vs 7.5% after dose 3). A popular video and other online posts, however, incorrectly imply that the vaccine caused the events. 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 hMo8 This data is presented in Table 11 and Table 12 immediately below this paragraph. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. 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. 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. Two serious adverse events were considered by U.S. Food and Drug Administration (FDA) as possibly related to vaccine: shoulder injury possibly related to vaccine administration or to the vaccine itself, and lymphadenopathy involving the axilla contralateral to the vaccine injection site. One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. 2023 EWN Media. At that pace, all of the information will be released by the end of the summer. As this review explains below, the cited document doesnt show known side effects of the Pfizer-BioNTech COVID-19 vaccine. There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults. ___________________________ Childrens Health Defense issued a related press release claiming that The potential for serious harm is very clear and that It would be criminal to expose infants and young children to this extremely risky product. Also, those who shouldnt receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine. The Johnson & Johnson vaccine has been linked to an, the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Pfizer's document released by the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination. In August 2021, it receivedfull approval, after review of the manufacturing process and ongoing trial results and safety monitoring. DAmbrosio, Amanda. WebPfizer has also taken a multiple actionsto help alleviate the large increase of adverse eventreports. 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. One vaccine recipient reported two SAEs (fever and pain in extremity requiring hospitalization) which were considered potentially related by the investigator and FDA. Infants were followed for at least one year for safety and efficacy, with over half of the infants followed for two years. Why werent we made aware of these at the time? Look at how many side effects, adverse events, were recorded before the end of February of last year, she said. The list of deadly adverse reactions of note is frankly breathtaking. The majority of systemic events were mild or moderate in severity, but there was a higher occurrence of grade 3 or higher reactions in the vaccine group. All of this comes at ZERO cost to our readers. 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, it continues. The first pages of the document, too, explicitly address many of the limitations of adverse event reporting to help properly interpret the data limitations. Similar claims also spread via the U.K. tabloid Express and the website Rebel News, identified as promoting propaganda and conspiracy theories by Media Bias/Fact Check, as well as video platforms. 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. The FDA proposed releasing 500 pages a month instead, which it said was the standard rate. Among all study vaccine recipients aged 1215 years, 90.9% reported at least one local injection site reaction in the 7 days after vaccination. +1 (212) 733-4848. And many of the events are likely to be purely coincidental. Although TTS remains rare, because of the availability of mRNA vaccines, which are not associated with this serious side effect, the FDA on May 5. the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&Js. This week, a 55 000-page set of documents revealed the Pfizer Covid-19 vaccine, Comirnaty, has 1,291 side effects. This data is presented in Table 8 below. The overall incidence of unsolicited non-serious adverse events from dose 1 to data cutoff (April 29, 2022) were similar in the vaccine and placebo groups in both age groups: 29.1% vs. 26.3% for the younger age group and 18.5% vs. 18.5% in the older age group, respectively. The average duration of lymphadenopathy was approximately 10 days. 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. The group asked the FDA for all of its documents related to the Pfizer/BioNTech COVID-19 vaccine oraround329,000 pages, plus other files fourdaysafter the agency gave full approval to the vaccine. The information was only released on Tuesday, 8 March, in a 38-page report. Among all study vaccine recipients aged 511 years, 86.2% reported at least one local injection site reaction in the 7 days after vaccination. Pre-planned safety reviews conducted at regular intervals throughout the duration of the study by the DMC also indicate the investigational vaccine is well-tolerated with no safety concerns for both the vaccinated individuals and their newborns. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Subscribe to our Euro Weekly News alerts to get the latest stories into your inbox! This particular document covers the first three months of the vaccines rollout, and incorporates adverse event reports from across the globe. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life. Redness and swelling were more common after dose 2 than dose 1 or 3. Of those reporting reactions after dose 1, about two thirds (68.6%) reported a reaction to one particular area of the body and 52.7% reported a reaction that spread to several places. 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. Help us create a more trustworthy Internet! Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. There is no specific treatment for RSV, only supportive care measures like oxygen and fluids. No serious adverse events were considered as possibly related to the 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. He also suggests Dr.Janet Woodcock, the acting FDA commissioner when the agency gave full approval to the Pfizer vaccine, was wrong tosaythat millions of people have already safely received COVID-19 vaccines.. An adverse event can be a true adverse reaction, also known as a side effect, that is related to the vaccine, or a coincidental event that happened following vaccination., Beninger said it was inaccurate for Campbell to say the reported deaths were associated with Pfizers vaccine. 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. The FDA proposed releasing 500 pages a month instead, which it said was the standard rate. Are the Vaccines Safe? Public Health and Medical Professionals for Transparency requested expedited processing of the FOIA request. 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