TrialSiteNews

Flávio Cadegiani is a medical doctor and board-certified endocrinologist with a master's and Ph.D. in clinical endocrinology. He is the founder of the Corpmetria Institute in Brazil and has more than 35 publications in PubMed. He is well known for his research on androgens and COVID-19 and endocrine-related therapies.

Join The Conversation! | https://trialsitenews.com/ Recently, a team of researchers from France’s National Health Insurance program launched a population-wide study to investigate the risks of myocarditis and pericarditis due to COVID-19 vaccination. Tapping into a suite of nationwide hospital discharge and vaccine databases, the group analyzed 1,612 cases of myocarditis and 1,613 cases of pericarditis identified in the European nation from May 12, 2021, to October 31, 2021. Conducting a retrospective matched case-control series studies, the team discovered the risk for both myocarditis and pericarditis spiked the first week after vaccination. The increase in these cardiovascular-based adverse events increased even further after the second dose. Comparing both Pfizer/BioNTech (BNT162b2) and Moderna (mRNA-1273) mRNA vaccines, the study results, peer-reviewed and published in the journal Nature, indicate both mRNA vaccines introduce greater risk for myocarditis with the Moderna vaccine as compared to the Pfizer-BioNTech product. TrialSite News Crowdfunding Link | https://www.picmiicrowdfunding.com/deal/TrialSite%20News/

Join The Conversation! | https://trialsitenews.com/ Sonia Elijah from Trial Site News interviews Dr David Wiseman, who critically evaluates the "imprecise and unstable" data that the FDA relied on to authorize the Pfizer and Moderna COVID-19 vaccines for children as young as six months old. Wiseman also provides an illuminating review of the pivotal VRBPAC meeting of June 14-15, 2022. Referenced FDA Video: Vaccines and Related Biological Products Advisory Committee – 6/15/2022 | https://www.youtube.com/watch?v=Ixm4UmldTGQ

Join The Conversation! | https://trialsitenews.com/ Despite 95%+ full vaccination of adult populations in Australia, TrialSite has continued to report on surges in new COVID-19 cases, hospitalizations, and deaths. It is a disturbing situation that the mainstream press either completely ignores or summarily embraces as a context to promote further vaccination as the only answer. But is this an evidence-based approach to the problem? TrialSite reported that in the first 14 weeks of 2022, Australian fatalities due to COVID-19 were double that of 2020 and 2021 combined, despite near universal vaccination. By January 2022, TrialSite updated the global audience that in Australian states including New South Wales or “NSW,” the new increasingly Omicron-based cases were surging. TrialSite reviewed the latest data. Now, with a surge in B.4 and B.5 Omicron subvariants which more evade vaccine induced antibodies, a disturbing number of deaths are reported daily. What’s the level of protection the vaccines are affording to the population of NSW now that these subvariants circulate through this southeastern part of Australia?

Alexandra Latypova ("Sasha") is a retired pharmaceutical industry executive and entrepreneur. She holds an MBA degree from Dartmouth College and spent approximately 25 years in pharmaceutical research and development. Sasha later co-founded several clinical research organizations working as a contractor for about 60 pharmaceutical companies worldwide and was involved in the design, execution, data collection, analysis and submission of data to the FDA on hundreds of clinical trials. She also interacted with the FDA as part of the scientific consortium that developed new guidance for cardiovascular safety assessments of drugs and worked in all therapeutic areas and in many countries. Sasha currently holds board positions with several medical device and health care companies and volunteers for community and charitable organizations. You can follow Sasha on Bitchute here: https://www.bitchute.com/channel/7dNrFbLeGSev/

Shabnam Palesa Mohamed in a riveting conversation with South Africans, advocate Sabelo Sibanda, attorney Pearl Kupe, and activist Conel Loggenberg, some of the many people using law and activism to defend rights during C19. Hear what they think abut the state of justice in South Africa, specific C19 legal cases, the role of Big Pharma, and what is to be done about the apparent failures of the legal system. #CATalyst #TrialSiteNewsAfrica #TrialSiteNews #SouthAfrica #Law

When it comes to our health and well-being no one deserves to be dismissed, censored, or gaslit by the medical community. Let’s face it, the trajectory of the way medicine is being approached today is concerning, and no patient, no matter how rare their case may be, should be swept aside. If we want to collectively leave future generations better off in terms of health, we cannot ignore troubling-yet-true information. If our goal in science is to champion medical breakthroughs that truly heal via state-of-the-art research and innovation, then we need to first understand the full picture. We need to welcome an open dialogue with open arms and open-minds and keep the Hippocratic oath at the forefront of our medical mission.

Shabnam Palesa Mohamed in a riveting conversation with South Africans, advocate Sabelo Sibanda, attorney Pearl Kupe, and activist Conel Loggenberg, some of the many people using law and activism to defend rights during C19. Hear what they think abut the state of justice in South Africa, specific C19 legal cases, the role of Big Pharma, and what is to be done about the apparent failures of the legal system. #CATalyst #TrialSiteNewsAfrica #TrialSiteNews #SouthAfrica #Law

Join The Conversation! | https://trialsitenews.com/ Trial Site News recently were able to review leaked internal emails from the European Medicines Agency (EMA) and meeting report between the agency and Pfizer. The EMA oversees the evaluation and supervision of medicinal products for the European Union. Like other regulatory health bodies, its main responsibility is to protect and promote public health. Snapshots of internal EMA email correspondence; a November 26, 2020, PowerPoint presentation from a pivotal meeting between Pfizer and the agency, as well as a confidential 43-page Pfizer report were provided by an anonymous source because of their trust in Trial Site’s commitment to transparency, accessibility, and accountability in furtherance of a highly ethical, quality-focused and public health-centric biomedical research industry. Article Link | https://www.trialsitenews.com/a/what-the-leaked-ema-emails-docs-reveal-major-concerns-with-pfizer-c-19-vaccine-batch-integrity-and-the-race-to-authorise-cdda0ba2

Join The Conversation! | https://trialsitenews.com/ Pfizer has proposed in their defense in a lawsuit charging them with vaccine study fraud that there cannot be any legal culpability associated with the charged violations associated with certifications to the federal government as part of their contract in response to the COVID-19 pandemic. Why? Because a federal contract status offers them immunity from such claims. As part of the whistleblower Brook Jackson’s lawsuit against Pfizer, the pharmaceutical company seeks to dismiss the case. Article Link | https://www.trialsitenews.com/a/pfizer-defense-against-vaccine-fraud-case-the-governments-given-us-a-pass-from-the-normal-procurement-rules-02546b23

Join The Conversation! | https://trialsitenews.com/ South Africa’s drug regulator has terminated its controversial COVID-19 ivermectin program. The South African Health Products Regulatory Authority (SAHPRA) will no longer allow importation of unrecovered ivermectin products, nor can health facilities hold bulk ivermectin stock in anticipation of prescriptions for the unregistered products. The controversial “Section 21” approval program is gone, and with it, a piece of South African history. And now, Culminating with this victorious lawsuit with bittersweet real-world implications, SAHPRA has appeared to pound the last nail in ivermectin’s COVID-19 coffin. At least in this part of the world.

Join The Conversation! | https://trialsitenews.com/ Are the Department of Defense COVID-19 vaccine mandates unconstitutional and unlawful because the vaccines remain experimental—e.g., investigational products—thus requiring informed consent? The plaintiffs of a recently filed lawsuit allege that the COVID-19 vaccines from both Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) remain experimental and that no vaccines should be mandated without informed consent based on multiple federal statutes raising such requirements for “unlicensed product,” including 10 U.S.C. § 1107a and 21 U.S.C. § 360bbb-3 or the “Informed Consent Laws.” The mandates were issued by the Secretary of Department of Defense (DoD) Lloyd Austin, III, who is named as the defendant in this case as is Janet Woodcock, Principal Deputy Commissioner with the U.S. Food and Drug Administration (FDA), and Xavier Becerra, Secretary of the Department of Health and Human Services.

Join The Conversation! | https://trialsitenews.com/ Hedley Rees is a drug development expert and author. Rees is the Managing Consultant at PharmaFlowLimited, a UK-based consultancy specializing in supply chain management within the pharmaceutical and life science sectors. Clients range from large pharmaceutical companies to emerging biotech, and also include investors, lawyers, other consultancies, facility design and build specialists, and third-party logistics providers. Assignments span preclinical, clinical, and commercial supply chains up to complex multi-product networks covering global territories.

Join The Conversation! | https://trialsitenews.com/ In what can only be called a coincidence, in 2019, the U.S. Food and Drug Administration (FDA) approved the Jynneos Smallpox Monkeypox Vaccine, which is live and non-replicating for the prevention of smallpox and monkeypox disease in adults aged 18 and above determined to be at high risk for these viral infections in what appears to represent the first outbreak outside of Africa now unfolding. The only current FDA-approved vaccine for the prevention of monkeypox disease anticipated the first outbreak by just a couple years as monkeypox is now under investigation in several European nations as well as America, Canada, and Australia report health authorities and local media.

Join The Conversation! | https://trialsitenews.com/ A team of researchers from various institutes within the National Institutes of Health (NIH) led by corresponding author Avindra Nath, a senior investigator and clinical director at the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, have reported on study results associating the COVID-19 vaccines with neuropathic side effects. This observational and yet to be reviewed study should not be cited as evidence until it is formally peer reviewed. Moreover, the authors declare that more time is necessary for scientists and physicians to determine the true nature of any causal relation between the COVID-19 vaccines and neuropathies. The results are posted in medRxiv. Study Link | https://www.medrxiv.org/content/10.1101/2022.05.16.22274439v1

Join The Conversation! | https://trialsitenews.com/ A scientist and expert witness shared with TrialSite News a recent legal case involving a 22-year Navy enlisted LT. The winning law firm, R Davis Younts Esquire, reports that on May 20, 2022, a Board composed of three Navy officers found that the firm’s client, LT Bill Moseley, did not commit misconduct by refusing a COVID-19 injection and found unanimously that LT Moseley should be retained in the United States Navy.

Join The Conversation! | https://trialsitenews.com/ The Centers for Disease Control and Prevention (CDC) convened a meeting of their Advisory Committee on Immunization Practices (ACIP) after an Emergency Use Authorization (EUA) amendment was issued by the U.S Food and Drug Administration (FDA) on May 17. This amendment expands the eligibility for the Pfizer-BioNTech COVID-19 vaccine booster dose for children ages 5 to 11 years at least five months after completion of a primary series. Responding to the policy question posed by the CDC, and “based on the balance of benefits and risks,” ACIP voted in favor of the following Interim Recommendation: “A single Pfizer-BioNTech COVID-19 vaccine booster dose is recommended for persons ages 5-11 years at least 5 months after the primary series, under the FDA’s Emergency Use Authorization.” Article Link | https://www.trialsitenews.com/a/cdc-greenlights-pfizer-biontech-mrna-booster-dose-for-children-aged-5-to-11-years-on-limited-evidence-33d64f9e

Join The Conversation! | https://trialsitenews.com/ The World Health Organization (WHO), through the International Health Regulations (IHR), is in the process of being given more authority over people’s health. So the question has now been raised… Does this represent a global power grab or simply a rational measure to better synchronize national health agencies? We discuss! Special Guest: Shabnam Palesa Mohamed Link: https://www.trialsitenews.com/p/shabnam Twitter: https://twitter.com/ShabnamPalesaMo

Hedley Rees is a drug development expert and author. Rees is the Managing Consultant at PharmaFlowLimited, a UK-based consultancy specializing in supply chain management within the pharmaceutical and life science sectors. Clients range from large pharmaceutical companies to emerging biotech, and also include investors, lawyers, other consultancies, facility design and build specialists, and third-party logistics providers. Assignments span preclinical, clinical, and commercial supply chains up to complex multi-product networks covering global territories.

Join The Conversation! | https://trialsitenews.com/ Neuron23, a biotech company focused on developing precision medicines for neurological and immunological diseases, has been receiving support from Westlake Village BioPartners and Kleiner Perkins for series A and B of drug development. However, as for the most recent round of funding, they got a huge boost from a reputable investor, the SoftBank Vision Fund. The SoftBank Vision Fund, a sub-category of SoftBank Group Corp., invested a whopping 100 million dollars into the series C, accounting for nearly half of the 213.5 million in total financing. With this funding, the young biotech company now plans for a clinical trial by the end of the year.

Join The Conversation! | https://trialsitenews.com/ Israeli researchers tracking COVID-19 vaccination investigated the benefits of a fourth dose of BNT162b2, Pfizer-BioNTech's mRNA vaccine in an effort to reduce the strains on the Israeli healthcare system brought by the Omicron (B.1.1.529) strain of COVID-19. The fourth booster dose was authored for persons aged 60 and above as well as high-risk populations and healthcare workers if over four months had passed since receiving a third (booster) dose. Tapping into the national database from the Israeli Ministry of Health, the team represented by corresponding author Dr. Yair Goldberg with Technion—Israel Institute of Technology sought to better understand the effectiveness of the fourth booster dose as compared to only three doses against confirmed infection as well as severe illness in a targeted study population of Israel-based elderly individuals. They found, unfortunately, that the durability of the BNT162b2 product remains a problem, given vaccine effectiveness wanes rapidly starting at week 5 after administration. While the protection against severe disease held, the study team only evaluated the product for six weeks which is, frankly, a serious limitation. The authors acknowledge a “modest” benefit to a fourth dose while not delving into other considerations such as safety.

Join The Conversation! | https://trialsitenews.com/ Deaths are on the rise in China as the Omicron-driven surge continues unabated in infectious hot spots. Places such as Shanghai, over the last several weeks have witnessed an unprecedented city-wide lockdown of nearly 26 million people. The failings of China’s pandemic management continue, including the recent disclosure that municipal health workers bundled up for dead an elderly person. However, at a morgue located in the Shanghai Xinchangzheng welfare hospital, the person was discovered to be still alive. Multiple media such as CBS News report that the ongoing zero-tolerance policy and existing lockdowns are making the Chinese and world economy pay dearly. Article Link | https://www.trialsitenews.com/p/trialsitenews/chinas-relentless-war-on-covid-19-has-causalitiesthe-people-economy-domestically-beyond-70a93fa9

Join The Conversation! | https://trialsitenews.com/ Parents of two Kentucky young boys recently sued the national pharmacy CVS for malpractice and other causes of action as the kids, 8 and 10 years of age, were mistakenly given COVID-19 vaccines instead of the standard flu shot this past October. The two boys received adult doses while the jab wasn’t authorized for children ages 5 to 11 till later in October. The lawsuit was just filed on February 1, 2022, in a Kentucky district court. CVS acknowledged the mistake, sharing with local media (WDRB) that the pharmacy notified the parents once they were aware of the mistake. Both children have experienced side effects from the COVID-19 vaccines while the parents fear the boys could suffer from mental damage. Article Link | https://www.trialsitenews.com/p/trialsitenews/two-parents-sue-cvs-their-2-young-boys-mistakenly-given-adult-dose-of-covid-19-vaccine-instead-of-seasonal-flu-shot-84eb0788

Join The Conversation! | https://trialsitenews.com/ The Scandinavian country became the first country to cease all pandemic restrictions by February 1st, as it notified its population that COVID-19 was no longer a critical threat. After all, with a highly vaccinated population, recognition of robust natural immunity for those already infected, waning infections, and stabilized rate of hospitalizations the Danish Health Authority made the move to essentially transition their nation to the endemic stage of COVID-19 as the virus was essentially in control. Now, reports are that the Danish government has decided to cease its COVID-19 vaccination program starting May 15, 2022. However, public health officials stand ready to reactivate the vaccine program after the summer, as Scandinavia enters its chilly fall and dreary and cold winter. Article Link | https://www.trialsitenews.com/p/trialsitenews/danish-health-authority-to-cease-all-covid-19-vaccinations-by-may-15at-least-for-a-while-440dc4cd

Michael Alexander talks about the WHO's power grab, crackdown on physicians who challenge the COVID narrative, and a trucker's convoy update. Michael Alexander is co-chair of the law and activism committee of the World Council for Health and a constitutional litigator at the Justice Center for constitutional freedoms. He has had a distinguished career in Toronto Canada where he served as litigation counsel and advisor to private equity firms and acted as senior counsel to a boutique litigation firm that specializes in administrative, regulatory and constitutional law. Michael has appeared at all levels of the court system, including the Supreme Court of Canada, and has been actively involved in public affairs...