The document doesnt disclose the total number of people who had received the vaccine at the time the document was published. 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. Several months earlier, on Dec. 16, 2021,the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&Js. A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. \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 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. 14 Mar 2022. Fatigue, headache, chills, and new or worsened muscle pain were most common. b Mild: 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. 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. And many of the events are likely to be purely coincidental. ,7";b=b}seEu!EdMScqGf(d1PN{0rrs:0J,p va4y`XtHvaMwltiO1ug1eg(sra[byWb!6e;r This data is presented in Table 11 and Table 12 immediately below this paragraph. https://www.cdc.gov/dotw/rsv/index.html. There were no unusual patterns, she said. I used to be healthy, teach snowboarding and climb Colorado's 14,000-foot peaks. 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. COVID-19 Vaccinations in the United States. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. This is inaccurate and misleading. Updated September 14, 2021. c Mild: increased or prolonged sleeping bouts; moderate: slightly subdued interfering with daily activity; severe: disabling; not interested in usual daily activity; Grade 4: emergency room visit or hospitalization 2023 EWN Media. 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. 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. Injection site redness was the second most frequently reported local reaction. 28 Jul 2020. Expert groups continue to recommend use of the drug during pregnancy when necessary and in consultation with a doctor. Accessed 18 Mar 2022. Im 41 and on now heart medication thanks to Moderna. Some of the misleading online claims also center around how the Pfizer document was obtained and suggest there was a government cover-up, so well provide some background on the topic. 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.. But those arent dangerous and are signs that the vaccine is 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 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. 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. 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. You can review and change the way we collect information below. This is a bombshell, said Childrens Health Defense (CHD) president and Campbells video claiming that Pfizers document showed 1,223 [vaccine-]associated deaths received more than 760,000 views and 24,000 engagements on Facebook. 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& Center for Biologics Evaluation and Research. hLn0_OPi%@-Ks e*KY-&o"?yY5-XeB{,}y1YqP/ =rx!j[th$;pTN Some people have no side effects. . Our World in Data. 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. This study was initiated in September 2021 and remains ongoing. To understand why the claims are misleading, it is important first to understand the difference between an adverse event and a side effect. These data reinforce Pfizers resolve to bring our expertise in the research and development of innovative vaccines to address critical public health needs using new approaches and technologies. 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. Accessed 18 Mar 2022. 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. A popular video and other online posts, however, incorrectly imply that the vaccine caused the events. 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. 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 Of these side effects, 92% were considered "non-serious," with the most common being dizziness, fainting and fever, the CDC said. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Accessed 18 Mar 2022. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016 Pediatrics. Vaccine recipients reported similar rates of local reactions after dose 1 and dose 2, but slightly lower after dose 3. N Engl J Med. In March 2022, Pfizer announced RSVpreF received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of RSV aMild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). 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. 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. MMWR. 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. For more than 170 years, we have worked to make a difference for all who rely on us. Data source: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA. The observed frequency of reported Bells palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship. The document itself warns readers about the limitations of adverse event reports. 71 / No. 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.. So how would you say its safe, when this document is indicating theres been 1,223-associated deaths? he asks. The document was released by the FDA in response to a Freedom of Information Act request from Public Health and Medical Professionals for Transparency. No other systemic grade 4 reactions were reported. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. 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. 2020 Jul;146(1):e20193611. These cookies may also be used for advertising purposes by these third parties. The information contained in this release is as of November 1, 2022. 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. Any health problem that happens after vaccination is considered an adverse event following immunization, the Centers for Disease Control and Preventionexplains. In August 2021, it receivedfull approval, after review of the manufacturing process and ongoing trial results and safety monitoring. ]m(So``;8N AE> d(]AH|5 Accessed 18 Mar 2022. Respiratory Syncytial Virus Infection (RSV). I used to be healthy, teach snowboarding and climb Colorados 14,000-foot peaks. FDA spokesperson. 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. One year ago, these were side effects that Pfizer knew about, conservative commentator Liz Wheeler says in an Instagram. 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. The paper prints over 150 news stories a week with many hundreds more on the web no one else even comes close. Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life. We depend on your support to operate. 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 Thank you for taking the time to confirm your preferences. This data is presented in Table 7 below. Fatigue, headache, chills, and new or worsened muscle pain were most common. Beninger, Paul. , or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. Because a variety of health problems, including death, occur in the population every day, its expected that many of these will be reported after vaccination, even if they have nothing to do with the vaccine. 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