WebUS Department of Health and Human Services/Centers for Disease Control and Prevention MMWR / March 4, 2022 / Vol. This informationincluding product informationis intended only for residents of the United States. 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. Findings of the study, compiled after nearly 300 million doses were administered, were published online in The Lancet Infectious Diseases. 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. Reports of lymphadenopathy were imbalanced. But, as well explain, the appendix is just a list of conditions Pfizer was monitoring for, and the document supports the vaccines continued safety. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. Maternal participants were followed for safety through vaccination and for six months after delivery. Pfizer intends to submit these results for peer-review in a scientific journal. %PDF-1.6 % 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. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. 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. 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. b Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe pain at the injection site. Redness and swelling were slightly more common after dose 2. Anyone can submit a report to VAERS for any health problem that occurs after an immunization. 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, 16 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 Redness was reported slightly more frequently in the older age group than the younger age group (10.9% vs 7.5% after dose 3). Reports of lymphadenopathy were imbalanced with 58 more cases in the vaccine group (64) than the placebo group (6); lymphadenopathy is plausibly related to the vaccine. FOIA requests allow the public to access records from any federal agencies, which are legally obliged to disclose any information requested with few exceptions. More are joining each month with an expected total of more than additional resources by the end of June 2021. RSV bronchiolitis is the leading cause of infant hospitalization due to viral respiratory illness, characterized by respiratory distress that can result in death. Just a sampling here phmpt.org/wp-content/upl 11:50 AM - 1 Mar 2022 2,385 Retweets 4,343 Likes , after review of the manufacturing process and ongoing trial results and safety monitoring. Got a news story you want to share? This is misleading for two reasons. Of Campbell, Beninger said, His comments are very superficial and a lot of it is quite naive. 1 Centers for Disease Control and Prevention. RSV in Infants and Young Children. DAmbrosio, Amanda. 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. No grade 4 local reactions were reported. Accessed from Public Health and Medical Professionals for Transparency, Evidence Still Lacking to Support Ivermectin as Treatment for COVID-19, Understanding Adverse Events and Side Effects, FDA Begins Releasing Pfizer COVID Vax Documents, Pfizers confidential document shows adverse events reported following vaccination; it doesnt demonstrate that the vaccine caused the events or is unsafe, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, Idaho Doctor Makes Baseless Claims About Safety of COVID-19 Vaccines, Polio Vaccine Is a Four-Shot Series, Contrary to Greene Comments, Zelensky Remains in Ukraine, Despite False Claims on Social Media, In Viral Video, Doctor Falsely Touts Hydroxychloroquine as COVID-19 Cure.. The term adverse event describes any health problem that occurs after vaccination, regardless of whether the vaccine caused it. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. As the title indicates, the document contains information about adverse events that occurred following vaccination, not vaccine side effects as many claimed. By Matthew Roscoe 08 March 2022 16:09. The Burden of Respiratory Syncytial Virus Infection in Young Children. ,7";b=b}seEu!EdMScqGf(d1PN{0rrs:0J,p va4y`XtHvaMwltiO1ug1eg(sra[byWb!6e;r Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 2 days after either dose and lasted a median duration of 1 day. Pain/tenderness at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. Accessed 18 Mar 2022. Among all study vaccine recipients aged 511 years, 86.2% reported at least one local injection site reaction in the 7 days after vaccination. Instead, it collects data on adverse events reported following 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. As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in . All of these posts misunderstand what is being reported in the Pfizerdocument. 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 document doesnt disclose the total number of people who had received the vaccine at the time the document was published. 398 0 obj <>stream Fever was more common after the second dose than after the first dose. The Pfizer logo on the outside of a building in Belgium. At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. 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. The law requires federal agencies to first respond to requests within 20 business days. 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. In the video, Campbell himself acknowledges that he struggled to read the document. 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. The challenge is to see whether the frequency of a particular event is elevated above the background rate, which could indicate a possible problem. After more than 1 billion doses administered worldwide includingmore than325 million in the U.S. and more than a year of safety monitoring, thePfizer/BioNTech COVID-19 vaccine is considered to be very safe. 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 release syndrome;Cytokine storm;De novo purine synthesis inhibitors @_en~v&;Fh4;0~(yb12Xq$f2Ei8)n{Byy]7mvHLej :H*zBQ e/K%T&D23T{eE)p3C?% ~ Data on local reactions were not solicited from persons aged 16-17 years. hLn0_OPi%@-Ks e*KY-&o"?yY5-XeB{,}y1YqP/ =rx!j[th$;pTN 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. We would like to thank the pregnant women who volunteered for this trial, along with their infants, and all the investigators around the world who participated in the study for their contribution to this landmark research.. Data on systemic reactions were not solicited from persons aged 16-17 years. 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 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. 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. Maternal participants 49 years of age were randomized in a 1:1 ratio to receive a single dose of either 120 g of Pfizers RSVpreF or placebo during the late second to third trimester of their pregnancy. Now, it's hard climbing up a flight of stairs thanks to #VaccineSideEffects pic.twitter.com/B0P8SXqQo5, Louie Traub (@louietraub) March 7, 2022. endstream endobj 399 0 obj <>stream Accessed 18 Mar 2022. https://www.cdc.gov/rsv/index.html. 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.. The released Pfizerdocument, 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. 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. 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. Some people have no side effects. FDA. Another monitoring system is the CDCs Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. to identify adverse events related to vaccination in near real time. Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period. This includes significant technology enhancements, and process Accessed 18 Mar 2022. We depend on your support to operate. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. 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. 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. Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. The reason that the documents were released on 1 March 2022 is because the court order itself set the due date on or before March 1, 2022. The most common serious adverse events in the vaccine group which were numerically higher than in the placebo group were appendicitis (7 in vaccine vs 2 in placebo), acute myocardial infarction (3 vs 0), and cerebrovascular accident (3 vs 1). Many posts also err in their interpretation of the Pfizer documents appendix, which is an alphabetical list of 1,291adverse events of special interest. We routinely post information that may be important to investors on our website at www.Pfizer.com. The proportions of participants who reported at least 1 serious adverse event were 0.4% in the vaccine group and 0.2% in the placebo group. Accessed from Public Health and Medical Professionals for Transparencywebsite. 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. 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. Investor Contact: After the FDA began releasing Pfizers documents, these earlier claims merged with those questioning vaccine safety (see examples here and here). i7U cO[m,a4DmRXCu<9:GWR/9!iS:tPk~z3V/QZ47qa`Dj x-WWPDg5TOpS_NRu&701 E58jT5*>ruZM'b blj|"Aw\O&^ggl`VmgM4`]3hv4IS$^{gY0Q]4A{yA301|jQ& Why werent we made aware of these at the time? 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. 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