RENOIR and MATISSE assessed severe LRTI differently among the distinct study populations of older adults and infants, respectively. Respiratory Syncytial Virus Infection (RSV). A Project of The Annenberg Public Policy Center, This article is available in both English and Espaol, No vaccine or medical product is 100% safe, but the. Theyre not presented in a massive alphabetical listing from A to Z.. 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. In a Januarycourt order, US District Judge Mark Pittman of the Northern District of Texas required the FDA to release around 12,000 documents immediately, and then 55,000 pages a month until all documents are released totaling more than 300,000 pages, On March 1, the FDA finally produced its first 10k pages of Pfizer clinical trial documents and after securing the release of the data, Aaron Siri, a lawyer working on the case told Endpoints News, Our job was to get the documents. To date, Pfizer has onboarded approximately additional full-time employees (FTEs). 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. (Table 5). 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. 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). 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 of serious side effects, ranging from epilepsy to liver injury to autoimmune diseases. 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. 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. Im 41 and on now heart medication thanks to Moderna. SOURCE: John Campbell, Liz Wheeler, Social media users, Children's Health Defense, Facebook, Instagram, The Liz Wheeler Show, YouTube, 3 Mar. The FDA turned over thousands of documents related to its review of , or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. Among persons aged 1217 years, reactions after Pfizer-BioNTech booster vaccination were generally mild to moderate and transient; the frequency of local and On March 2, 2022, Pfizer announced that its vaccine candidate received Breakthrough Therapy Designation from the FDA for the prevention of RSV-associated lower respiratory tract disease in infants up to six months of age by active immunization of pregnant women. Accessed 18 Mar 2022. CDC. Within each age group, the frequency and severity of systemic adverse events was higher after dose 2 than dose 1. Side effects reported with the vaccine include: There is a remote chance that the vaccine could cause a severe allergic reaction A severe allergic reaction would ?,Z2/Il!p\_jef|*s8lgvgJ8YaDAU UM#2xtZmY+>n V:2'm\B=6m6sU.-d0o)|]|*0m vE|t Among a safety expansion cohort (over 2250 children randomized 2:1 vaccine to placebo), 6 participants (0.4%) in the vaccine arm and 3 participants (0.4%) in the placebo arm had events of lymphadenopathy. doi:10.1016/S2214-109X(17)30344-3. On 23 August 2021, the U.S. Food and Drug Administration (FDA) granted the first approval for a COVID-19 vaccine to Pfizer and BioNTech. 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. Some posts even seemed to suggest, on the basis of no evidence, that the FDA tried to minimize the impact of the data by choosing to release the information during the Russian invasion of Ukraine. 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. Webprocessing colleagues. One grade 4 fever (>40.0C) was reported in the vaccine group. At that pace, all of the information will be released by the end of the summer. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. RSV in Infants and Young Children. Fever was more common after the second dose and in the younger group (15.8%) compared to the older group (10.9%). PHMPT then posted the documents on its website. FOIA requests allow the public to access records from any federal agencies, which are legally obliged to disclose any information requested with few exceptions. 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. This is a bombshell, said Childrens Health Defense (CHD) president and general counsel Mary Holland. After this important discovery, Pfizer tested numerous versions of a stabilized prefusion F protein and identified a candidate that elicited a strong anti-viral immune response in pre-clinical evaluations. Vomiting and diarrhea were exceptions, and similar between vaccine and placebo groups and regardless of dose. Because if we were aware of them at the time, we could have had an index of suspicion for them and kept an eye out for them.. These cookies may also be used for advertising purposes by these third parties. Far from proving that the Pfizer/BioNTech vaccine isnt safe, the Pfizer document is evidence of the vaccines continued safety, Beninger said. No vaccine or medical product is 100% safe, but the safety of vaccines is ensured 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. Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients and was slightly more common after dose 2. This data is presented in Table 7 below. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. The Pfizer logo on the outside of a building in Belgium. 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. 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. Many social media users misrepresented this scheduling dispute as an attempt by the FDA to conceal the vaccine data or delay its release, even though the agency never opposed releasing this information. All of this comes at ZERO cost to our readers. The median onset for most systemic events in the 6 23 month age group was 2 days after any dose and all events resolved with a duration of 1 to 2 days after onset. . Our World in Data. Overall, 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 2 days. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. 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. No other systemic grade 4 reactions were reported. 2009; 360:588-598. 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. Respiratory Syncytial Virus Infection (RSV) Older Adults are at High Risk for Severe RSV Infection Fact Sheet. 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. endstream endobj 400 0 obj <>stream Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period. https://www.cdc.gov/rsv/index.html. Any health problem that happens after vaccination is considered an adverse event following immunization, the Centers for Disease Control and Preventionexplains. The document is an analysis of adverse events, or health issues reported following vaccination, regardless of whether they were caused by the vaccine. 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). Of Campbell, Beninger said, His comments are very superficial and a lot of it is quite naive. On Jan. 6, a judge in North Texas recognized the unduly burdensome challenges of the FOIA, but sided 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. 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. RSV bronchiolitis is the leading cause of infant hospitalization due to viral respiratory illness, characterized by respiratory distress that can result in death. Pain/tenderness at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. 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. release syndrome;Cytokine storm;De novo purine synthesis inhibitors Some people have no side effects. As its website, , 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., Anyone can submit a report to VAERS for any health problem that occurs after an immunization. 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. The list notes 1,291 different adverse events following the Pfizer Covid vaccine. 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. 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. Evidence Still Lacking to Support Ivermectin as Treatment for COVID-19. FactCheck.org. REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021. Pfizer. No Bells palsy, anaphylaxis or myocarditis was reported among vaccine recipients in this age group. 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. 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). 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. However, the time it takes to process them will vary depending on the complexity of the request, as the FOIA website explains. But, as well explain, the appendix is just a list of conditions Pfizer was monitoring for, and the document supports the vaccines continued safety. Data on local reactions were not solicited from persons aged 16-17 years. 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 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. endstream endobj 404 0 obj <>stream CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. A popular video and other online posts, however, incorrectly imply that the vaccine caused the events. Now, its hard climbing up a flight of stairs thanks to, Thank you for taking the time to read this article, do remember to come back and check, UPDATE: At least 29 dead and 85 injured after two trains collide and burst into flames in Tempe, Greece, BREAKING: Missing baby of Constance Marten and her partner Mark Gordon found, King Charles evicting Harry and Meghan from Frogmore Cottage, Jeremy Clarkson axed as ITV host following Meghan Markle comments, Hotel rooms from just 19 as Travelodge announces plans to expand its portfolio in Spain. No grade 4 local reactions were reported. As MedPage Today hasexplained, the FDA hasalreadyreleased 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.. One clue comes from its formatting, he said. Accessed 18 Mar 2022. 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.