The document is an analysis of adverse events, or health issues reported following vaccination, regardless of whether they were caused by the vaccine. Vomiting and diarrhea were exceptions, and similar between vaccine and placebo groups and regardless of dose. Fatigue, headache, chills, and new or worsened muscle pain were most common. As the title indicates, the document contains information about adverse events that occurred following vaccination, not vaccine side effects as many claimed. 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. Among all vaccine recipients, 66.6% reported at least one systemic reaction in the 7 days after vaccination. process to address current and emerging variants during the Fall season 2022. Subscribe to our Euro Weekly News alerts to get the latest stories into your inbox! Through February 2021, it says, there were 42,086 reports of individuals reporting adverse events, including 1,223 deaths. This study was initiated in September 2021 and remains ongoing. 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. Infants were followed for at least one year for safety and efficacy, with over half of the infants followed for two years. Beninger, however, said the FDA had been a bit tone deaf to whats going on around them, and said he thought that the agency should have been more attentive. Tuesday, Mar 1 2022 First Edition: March 1, 2022 Today's early morning highlights from the major news organizations. b Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization One vaccine recipient reported two SAEs (fever and pain in extremity requiring hospitalization) which were considered potentially related by the investigator and FDA. 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. 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. WebUS Department of Health and Human Services/Centers for Disease Control and Prevention MMWR / March 4, 2022 / Vol. 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].. 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. 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. , have subsequently identified only a few, very rare adverse events. RENOIR and MATISSE assessed severe LRTI differently among the distinct study populations of older adults and infants, respectively. The information is still valuable 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. 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. 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. 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 limited authorized use of the J&J vaccine to adults who either couldnt get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. They KNEW. "The safety monitoring of the mRNA COVID-19 vaccines stands out as the most comprehensive of any vaccine in U.S. history. Similarly, its not correct to call the adverse events side effects, as Wheeler did. 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. But, as well explain, the appendix is just a list of conditions Pfizer was monitoring for, and the document supports the vaccines continued safety. 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. ; 1Y/%-p /=p8gcHm>=vxo4>i7}fY4tM>:WP8.=\pW'-Ide=ksD(sg"V=40.0C) was reported in the vaccine group. 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. Learn about specific ways our research is leading to medicines and vaccines that will benefit patients around the world. FOIA requests allow the public to access records from any federal agencies, which are legally obliged to disclose any information requested with few exceptions. 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 Of the 298.79 million doses of mRNA vaccines administered in the U.S. during the study period, 340,522 reports were made to VAERS. RSV Transmission. USA As the war rages on in Ukraine and the eyes of the world are fixed on the tragic events in Europe, the US Food and Drug Administration (FDA) has slowly started to release Pfizer COVID-19 vaccine data to the public something that they had originally wanted until 2096 to do. Krantz and Phillips point out in a separate commentary that the v-safe reports of reactions are consistent with those reported from clinical trials and a real-life study in the United Kingdom. And many of the events are likely to be purely coincidental. The adverse event reports that Pfizer collected between December 2020 and February 2021 cant tell us whether the vaccine caused the adverse events. 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. 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. Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the six-month follow-up period. The majority of systemic events were mild or moderate in severity, after both doses. Injection site redness and swelling following either dose were reported less frequently than injection site pain. 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. 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. A popular video and other online posts, however, incorrectly imply that the vaccine caused the events. The median time to onset was 2-3 days after either dose and all cases resolved within 2 weeks. Pain/tenderness at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. endstream endobj 403 0 obj <>stream From the emergency authorization of the vaccine on 1 December 2020 through 28 February 2021, Pfizer collected a total of 42,086 adverse event reports. Another example is a YouTube video by John Campbell, a retired nurse practitioner who previously spread misinformation about COVID-19, as earlier reviews by Health Feedback documented. Why werent we made aware of these at the time? After dose 1, the older age group (2 4 years) reported pain/tenderness more frequently than the younger age group (6 23 months) (30.8% vs 16.6%); a similar pattern was observed after dose 2 and 3 (31.0% vs 15.0% and 26.7% vs 16.0%, respectively). Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability/incapacity. Accessed 18 Mar 2022. hd_k0J[LP|ls)o!p9%Lp'{+a dh8_4qH i[53!zW.zrEIor[!h!7}SA5oZ=2r'3aR`jF'8e?r'ltM. 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. Please get in touch if you have any comment or think there is an important claim or article that would need to be reviewed. You will be subject to the destination website's privacy policy when you follow the link. Review our The total number of doses shipped around the world in He also said that Woodcock was completely right to say that millions of COVID-19 vaccine doses had been administered safely. But these claims are misleading. Specifically, it mentions incomplete clinical information and external factors that might influence reporting, such as the seriousness of the reaction and awareness by health professionals and consumers. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. 1 Centers for Disease Control and Prevention. 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. V-safe is a voluntary, smartphone-based system set up in 2020 specifically for monitoring reactions to COVID-19 and health effects after vaccination. 2005 - 2023 WebMD LLC. Privacy Policy for more information about our privacy practices. who develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. FDA spokesperson. Redness and swelling were slightly more common after dose 2. Public Health and Medical Professionals for Transparencywebsite. No other systemic grade 4 reactions were reported. Updated December 18, 2020. 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. 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. 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. Maternal participants were followed for safety through vaccination and for six months after delivery. hV_o0*~lH$Hk;%: /EJ 5~wRYO:l|www0jJus%..%el^0R$ a2CM 9nRPe.=I~8.3vsN#UpIcVqa`]v (7;]QIgmTv~M`=WkE2 67?iY)l3LVn$8(sXc_R (i>#$#8reCy\$h6"o#U%\5}$!~D_u#U[+Nc*-DpDB=AK2Jtin b5p)0 L6PA3muD)=#or%m={-jypzU!a:f.Pt;1+?R Download our media pack in either English or Spanish. Idaho Doctor Makes Baseless Claims About Safety of COVID-19 Vaccines. FactCheck.org. COVID-19 Vaccinations in the United States. COVID Data Tracker. endstream endobj 402 0 obj <>stream In the video, Campbell himself acknowledges that he struggled to read the document. 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