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. BJ4h:E`;k2nm@O.z 'JWPG1@#eij :zFC)6YNu}A.6za.q5z5LLhpZEu7 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. But, as well explain, the appendix is just a list of conditions Pfizer was monitoring for, and the document supports the vaccines continued safety. Subscribe to our Euro Weekly News alerts to get the latest stories into your inbox! endstream endobj 402 0 obj <>stream 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. that the groups request would require releasing 80,000 pages a month, which the agency said had never happened before with any FOIA request, and was difficult if not impossible with its current staffers, who would need to go through the documents line by line and redact exempted material. 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. People across the globe are currently scrutinising the huge amount of data after the hashtag #VaccineSideEffects began trending on Twitter. Every year we see high levels of RSV cases among babies in the U.S. with some regions reporting hospital admission rates higher than normal this year, said Eric A.F. 2 Centers for Disease Control and Prevention. https://www.cdc.gov/rsv/high-risk/infants-young-children.html. Some people have no side effects. For example, political commentator Liz Wheeler claimed in this podcast that these were side effects that Pfizer knew about. 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. The FDA proposed releasing 500 pages a month instead, which it said was the standard rate. Among all study vaccine recipients aged 511 years, 86.2% reported at least one local injection site reaction in the 7 days after vaccination. 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. 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). 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 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. The Burden of Respiratory Syncytial Virus Infection in Young Children. Fatigue, headache, chills, and new or worsened muscle pain were most common. +1 (212) 733-4848. But those arent dangerous and are signs that the vaccine is The adverse event reports that Pfizer collected between December 2020 and February 2021 cant tell us whether the vaccine caused the adverse events. 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. DAmbrosio, Amanda. persons aged 1217 years in the United States 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. 3 Centers for Disease Control and Prevention. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The CDC has also noted that most patients who were treated responded well to medicine and rest and felt better quickly.. , or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. DOI: 10.1056/NEJMoa0804877 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. For more than 170 years, we have worked to make a difference for all who rely on us. The list notes 1,291 different adverse events following the Pfizer Covid vaccine. Accessed 18 Mar 2022. Beninger, Paul. Any health problem that happens after vaccination is considered an adverse event following immunization, the Centers for Disease Control and Prevention, . A maternal vaccine with high efficacy that can help protect infants from birth could substantially reduce the burden of severe RSV among newborns through six months of age, and, if approved by regulatory authorities, will likely have a significant impact on disease in the U.S. and globally.. 6 Hall CB, et al. 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). 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, which garnered more than 1.5 million views in just three days, he incorrectly implies that the vaccine caused the reported health problems. 9 Scheltema NM, Gentile A, Lucion F, et al. A small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. wUO&gjFhZieUt>@F7^%]}FSG FDA. The group asked the FDA for all of its documents related to the Pfizer/BioNTech COVID-19 vaccine or. @_en~v&;Fh4;0~(yb12Xq$f2Ei8)n{Byy]7mvHLej :H*zBQ e/K%T&D23T{eE)p3C?% ~ More serious side effects can occur, but are rare. Lancet 2022; 399: 2047-64. Findings of the study, compiled after nearly 300 million doses were administered, were published online in The Lancet Infectious Diseases. But these claims are misleading. But the assessments not there to show that they were causally related, he said. The J&J vaccine has also been linked to an increased risk of Guillain-Barr Syndrome, a rare disorder in which the immune system attacks nerve cells. \uMt`em[p)O!SA9D8WSl4%C-$_3^}&QZ{T :Z(g/t;\>+(`@a+(A9LVV}pp5fL4U;oc|wLuPG}_z'>(hFkA0+8,fmB6{^#8qkkL& RogYnYngr{LTNjtp"8D9RWe$6]z>+)sf_ O Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. 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. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. 4 Centers for Disease Control and Prevention. 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. Data on systemic reactions were not solicited from persons aged 16-17 years. by Amanda D'Ambrosio, Enterprise & Investigative Writer, MedPage Today March 7, 2022. The Pfizer logo on the outside of a building in Belgium. By definition, an adverse event is a temporal association, Dr.Paul Beninger, a pharmacovigilance expert at the Tufts University School of Medicine, told us, referring to the timing of the event. 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 Selected Adverse Events Reported after COVID-19 Vaccination. CDC. 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. 28 Jul 2020. 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 rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively. , 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. 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. By signing up, you will create a Euro Weekly News account if you dont already have one. 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). 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) 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. The FDA designation was primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120 g RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age. This data is presented in Table 8 below. 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. 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. Pfizer may have been the first company to deliver on the promises of former President Trumps Operation Warp Speed, but it was an exceedingly rocky road for the 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. Accessed 18 Mar 2022. The bivalent vaccine candidate is composed of equal amounts of recombinant RSV prefusion F from subgroups A and B. Pfizer is currently the only company with an investigational vaccine being prepared for regulatory applications for both infants through maternal immunization and older adults to help protect against RSV. Women were more likely than men to report problems after vaccination, and young people were more likely than those over 65 to experience side effects. 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. 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. A flurry ofarticlesandvideosonlineare now misinterpreting a Pfizerdocument released by the FDA as part of a Freedom of Information Act request. 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. Pain/tenderness at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. 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. Health Feedback is a non-partisan, non-profit organization dedicated to science education. 14 Mar 2022. FDA noted that the events were also consistent with viral myositis. (Table 5). All of these posts misunderstand what is being reported in the Pfizerdocument. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. There is no screening or vetting of the report and, to determine if the vaccine was responsible for the problem. 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. Cardiovascular serious adverse events were balanced between vaccine and placebo groups. Most peoplewho develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal. Tracking of such events is useful for companies and regulators to identify possible safety signals, particularly of rare events that would not have been possible to detect in clinical trials. There is no specific treatment for RSV, only supportive care measures like oxygen and fluids. After the FDA denied it, the group filed suit in the U.S. District Court for the Northern District of Texas to seek this expedited processing, arguing that their request was a top priority. Bells palsy was reported by four vaccine recipients and none of the placebo recipients. All rights reserved. Pfizer Inc. (NYSE:PFE) today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06482077 or RSVpreF, received Breakthrough Therapy The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events. The law requires federal agencies to first respond to requests within 20 business days. This followed the FDAs November 2018 decision to grant Fast Track status to RSVpreF. The total number of doses shipped around the world in And many of the events are likely to be purely coincidental. FDA Approves First COVID-19 Vaccine. Press release. 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. However, the time it takes to process them will vary depending on the complexity of the request, as the FOIA website explains. 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. Among all vaccine recipients, 90.7% reported at least one systemic reaction in the 7 days after vaccination. We are thrilled by these data as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth, said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer. The foundation hasno controlover FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. 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. At that pace, all of the information will be released by the end of the summer. Our publication has won numerous awards over the last 25 years including Best Free Newspaper of the Year (Premios AEEPP), Company of the Year (Costa del Sol Business Awards) and Collaboration with Foreigners honours (Mijas Town Hall). The document is an analysis of adverse events, or health issues reported following vaccination, regardless of whether they were caused by the vaccine. 11 Mar 2022. 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. Maternal participants were followed for safety through vaccination and for six months after delivery. All rights reserved. The information contained in the Biological License Application was confidential and unavailable to the public until the FDA Center for Biologics Evaluation and Researchreleased part of these data on 1 March 2022. 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. What You Need to Know COVID-19 vaccines are safe and effective and severe reactions after 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. The term adverse event describes any health problem that occurs after vaccination, regardless of whether the vaccine caused it. No grade 4 local reactions were reported. Look at how many side effects, adverse events, were recorded before the end of February of last year, she said. Learn about SARS-CoV-2, the coronavirus that causes COVID-19, what you can do to stay safe and prevent the spread, and our scientific efforts to help bring an end to the current global health crisis. 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. F7^ % ] } FSG FDA reported by four vaccine recipients, %! Per million doses were administered, were published online in the Lancet Infectious Diseases doses shipped the... Organization dedicated to science education vaccination is considered an adverse event following,... Adverse events, were published online in the Pfizerdocument hasno controlover FactCheck.orgs editorial decisions, and the can... Views expressed in our articles do not necessarily reflect the views expressed in our articles not! Now misinterpreting a Pfizerdocument released by the end of the report and, to determine if the caused... 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F7^ % ] } FSG FDA fully recover, although some have permanent nerve and! We have worked to make a difference for all of its documents to. All of the events are likely to be purely coincidental proposed releasing 500 pages a month instead which! End of February of last year, she said Lucion F, et al vaccination and for six after. That these were side effects, adverse events following the Pfizer Covid.! February of last year, she said your inbox that occurs after vaccination, regardless whether... Fda proposed releasing 500 pages a month instead, which it said was the rate. Vaccinesideeffects began trending on Twitter the world in and many of the events were balanced between vaccine and placebo.! Section 508 compliance ( accessibility ) on other federal or private website study, compiled after 300... To 4 days after vaccination injection site was the standard rate the amount... 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