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    stanford, ucla study finds excess risk of serious adverse events from pfizer, moderna covid jabs

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    Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials by Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, Peter Doshi :: SSRN

    Introduction: In 2020, prior to COVID-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list

    Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials

    JVAC-D-22-01206

    22 Pages Posted: 1 Jun 2022

    See all articles by Joseph Fraiman

    Joseph Fraiman

    Louisiana State University - Lallie Kemp Regional Medical Center

    Juan Erviti

    Navarre Health Service

    Mark Jones

    Bond University - Institute for Evidence-Based Healthcare

    Sander Greenland

    University of California, Los Angeles (UCLA) - Jonathan and Karin Fielding School of Public Health

    Patrick Whelan

    University of California at Los Angeles

    Robert M. Kaplan

    Stanford University

    Peter Doshi

    University of Maryland - School of Pharmacy

    Abstract

    Introduction: In 2020, prior to COVID-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We leveraged the Brighton Collaboration list to evaluate serious adverse events of special interest observed in phase III randomized trials of mRNA COVID-19 vaccines.

    Methods: Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines (NCT04368728 and NCT04470427), focusing analysis on potential adverse events of special interest identified by the Brighton Collaboration.

    Results: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).

    Discussion: The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes such as hospitalization or death.

    Note:

    Funding Information: This study had no funding support.

    Declaration of Interests: JF, JE, MJ, SG, PW, RK: none to declare. PD has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the FDA (through University of Maryland M-CERSI; 2020), Laura and John Arnold Foundation (2017-22), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014-16), Cochrane Methods Innovations Fund (2016-18), and UK National Institute for Health Research (2011-14); was an unpaid IMEDS steering committee member at the Reagan-Udall Foundation for the FDA (2016-2020) and is an editor at The BMJ. The views expressed here are those of the authors and do not necessarily reflect those of their employers.

    Keywords: SARS-CoV-2, COVID-19, Vaccines, COVID-19 vaccines, mRNA vaccines, Pfizer-BioNTech COVID-19 vaccine BNT162b2, Moderna COVID-19 vaccine mRNA-1273, NCT04368728, NCT04470427, serious adverse events, adverse events of special interest, Brighton Collaboration, Coalition for Epidemic Preparedness Innovations, Safety Platform for Emergency vACcines

    Suggested Citation

    Fraiman, Joseph and Erviti, Juan and Jones, Mark and Greenland, Sander and Whelan, Patrick and Kaplan, Robert M. and Doshi, Peter, Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials. JVAC-D-22-01206, Available at SSRN: https://ssrn.com/abstract=4125239

    Joseph Fraiman

    Louisiana State University - Lallie Kemp Regional Medical Center ( email )

    Independence, LA United States

    Juan Erviti

    Navarre Health Service ( email )

    Mark Jones

    Bond University - Institute for Evidence-Based Healthcare ( email )

    Sander Greenland

    University of California, Los Angeles (UCLA) - Jonathan and Karin Fielding School of Public Health ( email )

    Patrick Whelan

    University of California at Los Angeles ( email )

    Robert M. Kaplan

    Stanford University ( email )

    Stanford, CA 94305 United States

    Peter Doshi (Contact Author)

    University of Maryland - School of Pharmacy ( email )

    Source : papers.ssrn.com

    Stanford, UCLA Study Finds "Excess Risk Of Serious Adverse Events" From Pfizer, Moderna COVID Jabs

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    Stanford, UCLA Study Finds "Excess Risk Of Serious Adverse Events" From Pfizer, Moderna COVID Jabs

    An "absolute risk increase of 12.5 per 10,000" vaccinated individuals vs. the placebo group...

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    Stanford, UCLA Study Finds "Excess Risk Of Serious Adverse Events" From Pfizer, Moderna COVID Jabs | ZeroHedge

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    A preprint study that has not yet undergone peer review has found that there were 'serious adverse events of special interest' when performing a secondary analysis of vaccine injuries reported in the Phase III randomized clinical trials of both Pfizer and Moderna's Covid-19 jabs. A team of researchers from across the globe - including Stanford University, UCLA, Louisiana State University, and the University of Maryland School of Pharmacy applied a new method of analysis to the Phase III results.

    A preprint study that has not yet undergone peer review has found that there were 'serious adverse events of special interest' when performing a secondary analysis of vaccine injuries reported in the Phase III randomized clinical trials of both Pfizer and Moderna's Covid-19 jabs.

    A team of researchers from across the globe - including Stanford University, UCLA, Louisiana State University, and the University of Maryland School of Pharmacy applied a new method of analysis to the Phase III results.

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    Vaccination against COVID

    A Stanford study finds that the mRNA vaccines, Pfizer and Moderna, offer strong protection against the California variant of the coronavirus.

    News Story

    Vaccination against COVID-19 prevents breakthrough infections, Stanford researchers find

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    A Stanford study finds that the mRNA vaccines, Pfizer and Moderna, offer strong protection against the California variant of the coronavirus.

    July 6, 2021 - By Janelle Weaver

    A study of workers at Stanford Health Care found that the mRNA vaccines offered a high level of protection, even against a widely circulating variant.

    More than 99% of Stanford Health Care employees resisted breakthrough infections after receiving at least one dose of an mRNA-based vaccine for COVID-19, according to researchers at the Stanford School of Medicine.

    Between Dec. 18, 2020, and April 2, 2021, at least 23,090 employees at Stanford Health Care received one or two doses of the Pfizer or Moderna vaccine. During that period, 189 of vaccinated individuals tested positive for SARS-CoV-​2, which causes COVID-19. By contrast, at least 660 of approximately 6,910 — nearly 10% — of unvaccinated workers became infected with the coronavirus.

    Sixty percent, or 114, of the breakthrough infections occurred two weeks or less after the first shot. An additional 49 (26%) cases emerged more than two weeks after the first dose and less than two weeks after the second dose. Taken together, 86% of the individuals who tested positive after vaccination did so before immunity fully developed.

    “These findings add to the mounting evidence demonstrating that vaccination is extremely effective at preventing COVID-19 infection,” said Marisa Holubar, MD, a clinical associate professor of infectious diseases. “The results also highlight the need to observe strict precautions until full immunity is achieved.”

    Among all post-vaccine cases, only 26 (14%) emerged more than two weeks after the second dose. That is, approximately 0.1% of employees who completed the two-shot series tested positive for the coronavirus more than two weeks after full vaccination. Additional results suggest that mRNA-based vaccines work well against the California variant. The researchers were not able to determine how well the vaccines hold up against the delta variant, as their study ended before it had gained a foothold in the United States.

    Marisa Holubar

    A look at variants

    “Our study is the first to look closely at the mutations in the post-vaccine viruses and compare them with the strains contemporaneously circulating in the population,” said Julie Parsonnet, MD, the George DeForest Barnett Professor in Medicine and a professor of epidemiology and population health. “This is also the largest study I’m aware of looking at mutations in post-vaccine cases.”

    The study was published online June 17 in Holubar and Parsonnet are co-senior authors. The lead author is Karen Jacobson, MD, a postdoctoral scholar in infectious diseases.

    Evidence from clinical trials has suggested that the Pfizer and Moderna vaccines are approximately 95% effective at preventing COVID-19 illness. But according to Parsonnet, drugs and vaccines rarely work as well in real life as they do in the original clinical trials. In addition, little is known about how effectively COVID-19 vaccines protect against new genetic variants. “We just wanted to see how well the vaccine was working with heath care personnel and to confirm efficacy,” Parsonnet said. “As the new variants appeared, it became more important to figure out how they responded.”

    During the new study, a variant called B.1.427/B.1.429, or epsilon, was rapidly spreading in California and becoming the dominant virus in circulation. Other research has shown that it is associated with an approximately 20% increase in transmission. But the researchers found no evidence that the mRNA-based vaccines are less effective against the epsilon variant. Approximately 40% of health care personnel who tested positive for the coronavirus had this variant, regardless of whether they had been vaccinated. The similar proportion of variants among vaccinated and unvaccinated individuals suggests that the epsilon variant is no more likely to break through vaccine protection.

    Julie Parsonnet

    Monitoring new variants

    “It is a relief to see that in a real-world population, vaccinated individuals were not more at risk for this variant than those who remain unvaccinated,” Jacobson said. “We will continue to monitor COVID-19 infections in our vaccinated populations as more variants emerge.”

    Even though 86% of breakthrough infections produced symptoms, post-vaccine cases led to only two hospitalizations during the early post-vaccination period and no deaths. “Right now, we are happy that the virus is so well controlled in our highly vaccinated population,” Parsonnet said.

    Source : med.stanford.edu

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