viernes, 26 de julio de 2024
Call for Papers: Supplemental Issue of Prevention Science Structural Approaches to Youth Violence Prevention: Addressing Racism and Discrimination Released: May 31, 2024 Letters of intent due: September 30, 2024
https://nimhd.nih.gov/about/publications/call-for-papers-supplemental-issue-of-prevention-science.html?utm_medium=email&utm_source=govdelivery
Submit Your Letter of Intent by September 30, 2024
NIMHD is inviting researchers to contribute to an upcoming supplemental issue of the journal Prevention Science. This supplemental issue will focus on youth violence prevention interventions that address structural racism and discrimination, and other structural factors and social determinants.
Topics of Interest:
Empirical research on the impact of interventions on individual, community, social, and structural factors.
Prospective intervention studies and natural policy experiments at local, state, regional, or national levels.
Conceptual papers that describe current challenges and viable solutions to implementing sustainable multilevel, multisectoral interventions that address social and structural factors that place youth at highest risk for violence as well as those that address disparities in youth violence.
Authors interested in contributing should submit a letter of intent by September 30, 2024.
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry July 2024
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory?utm_medium=email&utm_source=govdelivery
FDA issued the final guidance Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.
The guidance includes recommendations for sponsors and other interested parties proposing to use data from electronic health records (EHRs) or medical claims to help support a new use of an FDA-approved drug or biological product or to help support or satisfy post-approval study requirements.
FDA issued the draft version of the guidance in September 2021 and considered public comments when finalizing the guidance. Changes from the draft to the final guidance include:
clarifying the considerations for selecting study variables for validation, and the extent of effort needed for validation;
noting that choice of a reference standard for validation may vary according to study-specific factors;
recommending the use of quantitative approaches to demonstrate whether and how study findings might be impacted if certain key study variable(s) are misclassified; and
removing from the glossary defined terms that are generally understood and transferring other relevant definitions from the glossary to the text in the guidance.
The US will pay Moderna $176 million to develop an mRNA pandemic flu vaccine
https://apnews.com/article/bird-flu-moderna-vaccine-mrna-pandemic-7f15d8d274a24d89fa86e2f57e13cbff?utm_campaign=KFF-Misinformation-Trust&utm_medium=email&_hsenc=p2ANqtz-8mc8JHBVrDPYVczvTd5gt_78yBdcRIyAaoV9WwpuhPKptDODS2SjkYKCzLgW-GAPPKjSO1aZAelDF_ARa8-amU2kZcqw&_hsmi=317302400&utm_content=317302400&utm_source=hs_email
Bird Flu: H5N1 bird flu has continued infecting animals throughout the U.S., and, as of July 21, 10 human cases have been reported in the U.S. In July, news outlets reported that Moderna is developing an mRNA bird flu vaccine that can be distributed if further human outbreaks occur. Most of the 42,000 posts, articles, comments and videos mentioning bird flu and Moderna in the past 30 days were published immediately following the announcement. Some of the most popular social media posts falsely claim that bird flu is a “hoax” designed to make money for pharmaceutical companies or that bird flu vaccines are part of a “depopulation plan.”
https://www.cdc.gov/bird-flu/spotlights/h5n1-response-07192024.html?utm_campaign=KFF-Misinformation-Trust&utm_medium=email&_hsenc=p2ANqtz--l6WfdVFESnNwlD2yn6A0AgSmeNmtViLPC4hRW-wT37KyfzfBfTuTFTOVLZXWPWRSwL3RH17r0tls_Q3FZsB4Vp4F3cw&_hsmi=317302400&utm_content=317302400&utm_source=hs_email
Kansas Cites Misleading Claims About Vaccine Safety in Lawsuit Against Pfizer
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-adds-warning-about-rare-heart-inflammation-pfizer-moderna-covid-vaccines-2021-06-26/?utm_campaign=KFF-Misinformation-Trust&utm_medium=email&_hsenc=p2ANqtz-9WIR3bENt_oVvVDx_jrd1V8ZZvJnHfFSnPR1YHiEfVGJKG6iAU0OLMK3sqgYGq15fF1HbIdhYu1Dw9h9OylvrefuiYrg&_hsmi=317302400&utm_content=317302400&utm_source=hs_email
Kansas Cites Misleading Claims About Vaccine Safety in Lawsuit Against Pfizer
Kansas Attorney General Kris Kobach filed a lawsuit against Pfizer last month, resurfacing false claims about vaccine safety. Kobach accuses Pfizer of downplaying potential risks such as myocarditis and pregnancy complications, citing misinformation to support the lawsuit. However, the chance of developing myocarditis after vaccination is rare and the FDA already issued a myocarditis warning last year. Studies also show that the COVID-19 vaccine does not increase the risk of miscarriage.
https://www.nature.com/articles/s41598-024-57880-8?utm_campaign=KFF-Misinformation-Trust&utm_medium=email&_hsenc=p2ANqtz-_EOmNSLrzqj8lV2SAK8ylavkqiTbRV4Fh93CJIJTws4EZ3Y6dnpR-St9J4gwE6wh7UTsAUM8UQ6YQEZIHpWB_rtPMV-w&_hsmi=317302400&utm_content=317302400&utm_source=hs_email
Following the announcement of the lawsuit, there was a spike in social media posts about Pfizer. The top five posts came from accounts known for opposing vaccines, and they all expressed distrust of Pfizer. Some of these posts and comments echoed the lawsuit’s false claim that COVID-19 vaccines carry a high risk of heart inflammation. For example, one post said “...it's definitely not normal for children to have heart attacks. I'm so happy I stayed strong and refused to put this in my family.” Many posts also suggested that pharmaceutical companies should be held accountable for alleged wrongdoing. Another post said, “Every state has to hold these companies accountable for injecting poison into people’s bodies.”
https://www.factcheck.org/2023/04/scicheck-no-evidence-excess-deaths-linked-to-vaccines-contrary-to-claims-online/?utm_campaign=KFF-Misinformation-Trust&utm_medium=email&_hsenc=p2ANqtz--4ANG1AvxvhEYXEMeZ-1PBnDSqB7MuHm-I9DPFak31I3SO4BqD76oCXdNliWnKDqqdmOa4vmCHLVaP_K0wn4P7l0ClDw&_hsmi=317302400&utm_content=317302400&utm_source=hs_email
The false narratives suggest that vaccine opponents are leaning on years-old talking points to discourage COVID-19 vaccination, despite extensive research showing that COVID-19 vaccines have not caused mass death and that heart inflammation is much more common and more severe after a COVID-19 infection, not vaccination. We expect vaccine opponents to continue recycling false claims when major COVID-19 related news occurs.
https://publicgoodnews.com/2023/12/25/myocarditis-facts-covid-19-vaccines-fact-check/?utm_campaign=KFF-Misinformation-Trust&utm_medium=email&_hsenc=p2ANqtz--ba3qxmMBxj0d8M9fPoK3nIr5sMnDOQ1dZxYP0pYFhWRVl2nXk0pf5tNwpEKmQ-zz2dWLpQktcR1fNpE1O5fuehgyFzA&_hsmi=317302400&utm_content=317302400&utm_source=hs_email
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