This is a bombshell, said Childrens Health Defense (CHD) president and 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. doi:10.1016/S2214-109X(17)30344-3. 3.RESULTS 3.1.Safety Database 3.1.1.General Overview It is estimated that approximately doses of BNT162b2 were 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. 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 After more than 1 billion doses administered, 325 million in the U.S. and more than a year of safety monitoring, the, Many people experience temporary symptoms, such as fever, headache or pain at the site of injection. This informationincluding product informationis intended only for residents of the United States. 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. Tuesday, Mar 1 2022 First Edition: March 1, 2022 Today's early morning highlights from the major news organizations. You can review and change the way we collect information below. Spencer, Saranac Hale and Angelo Fichera. 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. Idaho Doctor Makes Baseless Claims About Safety of COVID-19 Vaccines. FactCheck.org. All of this comes at ZERO cost to our readers. Campbells video claiming that Pfizers document showed 1,223 [vaccine-]associated deaths received more than 760,000 views and 24,000 engagements on Facebook. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. From v-safe reporting, researchers learned that more than half (about 71%) of the 7.9 million participants reported local or systemic reactions, more frequently after dose 2 than after dose 1. They help us to know which pages are the most and least popular and see how visitors move around the site. 7 Rha B, et al. 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. WebMD does not provide medical advice, diagnosis or treatment. 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` 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. So how would you say its safe, when this document is indicating theres been 1,223-associated deaths? he asks. I used to be healthy, teach snowboarding and climb Colorados 14,000-foot peaks. 11 Mar 2022. To understand why the claims are misleading, it is important first to understand the difference between an adverse event and a side effect. Fever was more common after the second dose and in the younger group (15.8%) compared to the older group (10.9%). 23 Aug 2021. The proportions of participants who reported at least 1 serious adverse event were 0.6% in the vaccine group and 0.5% in the placebo group. persons aged 1217 years in the United States doi: 10.1542/peds.2019-3611. But showing that a vaccine caused an adverse event requires more than simply observing that one event happened after vaccination. 16 Mar 2022. According to the CDC, TTS has occurred in around 4 people per million doses administered. You cannot call them vaccine-associated.. 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 This data is presented in Table 8 below. Public Health and Medical Professionals for Transparency requested expedited processing of the FOIA request. bMild: 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. Currently there is no vaccine to prevent RSV. Its shocking. Many posts also err in their interpretation of the Pfizer documents appendix, which is an alphabetical list of 1,291adverse events of special interest. There is no specific treatment for RSV, only supportive care measures like oxygen and fluids. 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. Accessed 18 Mar 2022. 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 The information was only released on Tuesday, 8 March, in a 38-page report. As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in . 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. In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants. But those arent dangerous and are signs that the vaccine is 2017;5(10):e984-e991. In a multistate analysis of 39,217 ED and UC encounters with COVID-19like illness among nonimmunocompromised patients aged 517 years through January 29, 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. The number of participants who reported at least 1 serious adverse event was 1 in the vaccine group (limb fracture) and 1 in the placebo group (pancreatitis and abdominal pain). 1 Centers for Disease Control and Prevention. 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. N Engl J Med. with the plaintiff, concluding the request was of paramount public importance. He set the deadline for the first tranche of documents for Jan. 31, with another 55,000 pages to be released every month. 3 Centers for Disease Control and Prevention. MATISSE is an ongoing randomized, double-blinded, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and immunogenicity of RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy. . COVID Data Tracker. But those arent dangerous and are signs that the vaccine is working and the body is beginning to mount a protective immune response. Accessed 18 Mar 2022. At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. These findings should put an immediate end to the Pfizer COVID vaccines. 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. Vaccine Adverse Event Reporting System (VAERS) and the U.K. Yellow Card Scheme. The paper prints over 150 news stories a week with many hundreds more on the web no one else even comes close. CDC twenty four seven. The information contained in this release is as of November 1, 2022. 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. This release contains forward-looking information about Pfizers respiratory syncytial virus vaccine candidate (RSVpreF), including its potential benefits and planned regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Instead, it collects data on adverse events reported following vaccination. Vaccines can give your body way to identify an infecting agent, and instructions on how to defeat itand potentially, avoid infecting others. The potential for serious harm is very clear, and those injured by the vaccines are prohibited from suing Pfizer for damages.. One vaccine recipient reported two SAEs (fever and pain in extremity requiring hospitalization) which were considered potentially related by the investigator and FDA. For example, political commentator Liz Wheeler claimed in this podcast that these were side effects that Pfizer knew about. Web01.31.2023 PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES FULL-YEAR 2023 FINANCIAL GUIDANCE 01.17.2023 Pfizer Expands An Accord for a https://www.cdc.gov/rsv/about/transmission.html. Understanding Adverse Events and Side Effects. CDC. In about one third of the reports, patients said they were unable to work or do normal activities after the second dose, while similar reports after the first dose came from 12% of patients.Fewer than 1% of participants needed medical care after dose 1 or 2 of the vaccine. Now, its hard climbing up a flight of stairs thanks to Vaccine Side Effects., I'm 41 and on now heart medication thanks to Moderna. 28 Jul 2020. (Table 5). Safety surveillance data in the Pfizers document shows harmful effects of the Pfizer-BioNTech COVID-19 vaccine. PHMPT then posted the documents on its website. 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. 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. Please get in touch if you have any comment or think there is an important claim or article that would need to be reviewed. The Childrens Health Defense notes that a 38-page report was also included within the documents that features an Appendix called: LIST OF ADVERSE EVENTS OF SPECIAL INTEREST. The list notes 1,291 different adverse events following the Pfizer Covid vaccine. Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period. 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. 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. hd_k0J[LP|ls)o!p9%Lp'{+a dh8_4qH i[53!zW.zrEIor[!h!7}SA5oZ=2r'3aR`jF'8e?r'ltM. 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. These cookies may also be used for advertising purposes by these third parties. 2023 EWN Media. endstream endobj 399 0 obj <>stream The only available preventive agent is recommended for use in limited settings in the highest-risk infants as a monthly injection with 5 doses administered during the RSV season, leaving most infants without protection. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. [8acf;-.6-v]\)puZ$ir}WvXJYp. Its worth noting that while Campbell calls the people who have joined PHMPT prestigious and highly qualified, the list is primarily notable for its inclusionof multiple individuals who have made dubious claims about COVID-19 or the vaccines. About Pfizer: Breakthroughs That Change Patients Lives 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. Center for Biologics Evaluation and Research. The data from ongoing safety monitoring of vaccinated people is reassuring and indicates that serious vaccine side effects are very rare. 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. In Viral Video, Doctor Falsely Touts Hydroxychloroquine as COVID-19 Cure. FactCheck.org. 7 Mar 2022. One year ago, these were side effects that Pfizer knew about, conservative commentator Liz Wheeler says in an Instagram. By signing up, you will create a Euro Weekly News account if you dont already have one. 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 All of these posts misunderstand what is being reported in the Pfizerdocument. who develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal. Within each age group, the frequency and severity of systemic adverse events was higher after dose 2 than dose 1. But the assessments not there to show that they were causally related, he said. The most common solicited systemic adverse reaction after any dose was irritability (43.6% 51.2%) among ages 6 23 months and fatigue (24.5% 29.7%) among ages 2 4 years. b Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization The potential side effects from pages 30-38 of Pfizer's data dump are: APPENDIX 1. WebUS Department of Health and Human Services/Centers for Disease Control and Prevention MMWR / March 4, 2022 / Vol. Anyone can submit a report to VAERS for any health problem that occurs after an immunization. The foundation hasno controlover FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. 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. In addition, reactogenicity data from adolescents aged 12-15 years were obtained and reviewed, and were similar to those from adults aged 18-55 years. (Table 6). Pain/tenderness at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. No serious adverse events were considered by FDA as possibly related to vaccine. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Covering the Costa del Sol, Costa Blanca, Almeria, Axarquia, Mallorca and beyond, EWN supports and inspires the individuals, neighbourhoods, and communities we serve, by delivering news with a social conscience. A: There is currently no strong evidence that acetaminophen use during pregnancy causes autism or ADHD in children. In the video, which garnered more than 1.5 million views in just three days, he incorrectly implies that the vaccine caused the reported health problems. posted on March 9. Data on systemic reactions were not solicited from persons aged 16-17 years. endstream endobj 403 0 obj <>stream No bells palsy or anaphylaxis was reported among vaccine recipients in this age group. In the video, Campbell himself acknowledges that he struggled to read the document. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Similarly, its not correct to call the adverse events side effects, as Wheeler did. But the appendix, Beninger said, was actually just a list of the things Pfizer was monitoring for not a list of health problems that have been observed after vaccination or that had been shown to be due to vaccination. Pfizers confidential document shows adverse events reported following vaccination; it doesnt demonstrate that the vaccine caused the events or is unsafe. HealthFeedback. Lancet 2022; 399: 2047-64. Are the Vaccines Safe? 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. CDC. 9 347 Release on the . 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. Accessed 18 Mar 2022. 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 posts incorrectly claim that it shows the vaccine is unsafe and is evidence that this was hidden from the public. 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. In March 2022, Pfizer announced RSVpreF received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract disease caused by RSV in individuals 60 years of age or older. Published on: 11 Mar 2022 | Editor: Iria Carballo-Carbajal. 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].. A popular video and other online posts, however, incorrectly imply that the vaccine caused the events. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. FDA. https://www.cdc.gov/rsv/factsheet-older-adults.pdf. Early symptoms of the condition, which is known as thrombosis with thrombocytopenia syndrome, or TTS, can appear as late as three weeks after vaccination andincludesevere or persistent headaches or blurred vision, leg swelling, and easy bruising or tiny blood spots under the skin outside of the injection site. 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 also, released summaries of the data it has reviewed, and the FOIA documents may not be material to an overall analysis of the vaccines safety and efficacy. Zach Zalewski, a regulatory strategy consultant at Avalere Health, told the outlet, Theres a risk of cherry picking and taking things out of context., COVID-19 vaccine doses administered by manufacturer. Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients. The median onset of local reactions in the vaccine group was 0 (day of vaccination) to 2 days after either dose and lasted a median duration between 1 and 3 days. No other systemic grade 4 reactions were reported. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Disease or Condition of the Week - Respiratory Syncytial Virus Infection (RSV). The fact that all of those reports were there is proof of nothing, it all needs to be assessed.. Some of the members of this group, which comprises mainly academics and physicians, have previously spread misinformation about COVID-19 vaccine safety (see examples here, here, and here). By Matthew Roscoe 08 March 2022 16:09. ; 1Y/%-p /=p8gcHm>=vxo4>i7}fY4tM>:WP8.=\pW'-Ide=ksD(sg"V=