Latest news with #VAERS
Yahoo
02-06-2025
- Health
- Yahoo
‘Stealthy' Endocrine Effects of the COVID Vaccine Discussed in the Journal of American Physicians and Surgeons
TUCSON, Ariz., June 02, 2025 (GLOBE NEWSWIRE) -- Endocrine effects that may result from vaccination are deceptively subtle at their onset. Hence, robust and sensitive pharmacovigilance is needed to discover them, writes Jane Orient, M.D., in the summer issue of the Journal of American Physicians and Surgeons. As of Mar 20, 2023, more than 13 billion COVID-19 vaccine doses had been administered worldwide. Vaccine proponents argue that with such huge numbers of vaccinations, a clear signal for endocrinological complications should be detected by current vaccine surveillance. This has not occurred, but not necessarily due to the absence of adverse endocrine events, Dr. Orient writes. There are two approaches to surveillance, she explains: the adverse events of special interest (AESI) method and organ systems-based surveys. The AESI approach focuses on a few events selected based upon their severity, biological plausibility, and previous association with vaccines. Organ systems-based surveys examine systematically any potential side effects that could affect vital organs. The article summarizes the major vaccine safety monitoring systems, including: the U.S Vaccine Adverse Event Reporting System (VAERS), the EU's EudraVigilance System, the Vaccine Safety Datalink (VSD), V-safe, and the Biologics Effectiveness and Safety System (BEST). These systems rely on the AESI approach due to its low cost and simplicity. However, this method is neither sufficiently robust nor sensitive to detect subtle signs of initial endocrine side effects, Dr. Orient writes. 'In fact, one can argue that overreliance on this method can guarantee that virtually none of the endocrine complications of COVID-19 vaccine will be detected.' Induction of autoimmunity is a well-recognized mechanism for vaccine adverse effects. The cause of many endocrine conditions, including diabetes mellitus and thyroid, adrenal, and pituitary diseases, involves autoimmune mechanisms as well. Unsurprisingly, there are published case series and reviews demonstrating association between vaccinations and endocrine disorders, Dr. Orient states. Those phenomena are overlooked by the AESI approach because it lacks needed sensitivity. 'A potential disaster of yet undetected endocrine side effects of the vaccine is likely unfolding surreptitiously,' she concludes, and 'clinicians need to have a high index of suspicion for this problem in their patients.' The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943. Contact: Jane M. Orient, M.D., (520) 323-3110, janeorientmd@
Gulf Insider
28-05-2025
- Health
- Gulf Insider
Rogan & Rodgers Unleash Big Pharma's Worst Nightmare...
When Joe Rogan sat down with Aaron Rodgers, the conversation quickly turned to one of the most polarizing topics in modern medicine: instead of retreading old ground, they zeroed in on one of the most overlooked—and deeply disturbing—double standards of the pandemic. Rogan opened the door with a brutally simple observation. 'You're not even supposed to eat sushi while you're breastfeeding,' he said. 'Because you could get some sort of a parasite. And yet, you're going to take pregnant women and dose them up with this experimental vaccine.' He didn't stop there. 'There was no studies on whether or not women were getting damaged by this.' Rodgers chimed in to confirm what many already suspected: 'No studies got released.' That silence, wasn't due to a lack of data—but a refusal to release it. And now, as Rogan pointed out, the consequences are finally starting to come into view. 'Now there's some study that it's destroying their eggs.' Rodgers added, 'That, the cancers, turbo cancers, people dropping, kids dropping.' Rogan let it sit for a beat before saying what many are thinking: 'Yeah, it's all very dark, dude.' They quickly shifted to the broader vaccine schedule for children—and what they see as a runaway system with no brakes and no accountability. Today, American kids receive 72 doses of 17 vaccines between birth and age 18. Just to enroll in kindergarten, they're hit with 29 doses of 9 different vaccines. Daycare kids face multiple rounds of 13. And few parents even realize this. Rogan questioned the logic behind that kind of medical regimen, especially when it comes to the very first days of life. 'Why would you give a baby a Hep B shot on DAY ONE for a sexually transmitted disease? Totally unnecessary and crazy.' He also took aim at the fear-driven messaging around diseases like tetanus. 'Tetanus is not dangerous. If you have an open wound with tetanus, you just wash it out and you won't get tetanus. The number of cases? ZERO.' Rodgers, echoing a frustration felt by many parents, said the entire system has moved far from informed consent—and deep into financial conflicts of interest. Doctors aren't just recommending vaccines, he argued—they're being paid to. Behind it all, they pointed to a turning point in 1986, when the federal government passed the National Childhood Vaccine Injury Act. That legislation gave vaccine manufacturers blanket immunity from lawsuits, effectively removing the last guardrail. Since then, chronic illness among children has skyrocketed. Coincidence? They don't think so. But it was what came next that was truly disturbing. This was a bombshell and there is no denying it anymore. Rogan brought up a recent study he had just sent to his producer, Jamie. The analysis drew from adjusted VAERS data, MIT research, and findings from the Florida Department of Health—and the numbers were staggering. 'I just sent Jamie this study. VAERS adjusted data, and other derived from the MIT, Florida Department of Health study findings that yield a conservative range of 470,000 to 600,000 American deaths from the Covid-19 mRNA shots.' Rodgers, almost in disbelief, responded, 'That's it?' Rogan nodded. 'Well, just that alone. That's a lot of people, man.' And then he dropped a jaw-dropping comparison: 'More than World War I, World War II and Vietnam combined.' He clarified that the estimate referred to Pfizer alone—not even counting Moderna. 'Pfizer alone likely killed over 470,000 Americans.' 'They found a 36% increase in all cause mortality among Pfizer recipients versus Moderna.' Rodgers, deadpan and sarcastic, delivered the line that said it all: 'Yeah, but they saved MILLIONS!' They wrapped the conversation taking aim at the narrative itself—the one that turned vaccine skeptics into public enemies. Not because they were wrong. Because they were inconvenient. Rogan called it out. 'You start talking to them about the possibilities that these things caused all these problems, and their eyes glaze over.' 'They're like, Oh! Where are you hearing this?' His response flipped the script: 'Where are you hearing that it's not the case?' 'And why are you so confident to say that this is what happened?' Then he questioned the sacred cow of COVID rhetoric: ''The Covid vaccine saved millions of lives.' How do you know that?' But when it comes to the damage? 'How many do you think got fucked up by it? I know a lot of people that got fucked up by it—and most people do too. They just don't want to admit it.' Rodgers hit back at the fear machine: 'Why were they trying so hard to scare the shit out of everybody? Tell me that.' 'Why did they have fucking death tolls on the news stations?' Then he followed the money. 'There's a ton of money.' 'Doctors get huge bonuses for fully vaccinated kids. That's the truth.' And finally, he hit the core issue: 'Instead of attacking the person that says that, isn't it something you should look into?' 'Is that a conflict of interest? Should be.' Also read: $67 In France And $798 In US – Why Prescription Drug Prices Are So High In America
Medscape
14-05-2025
- Health
- Medscape
Suspend Use of Chikungunya Vaccine in Adults Aged 60+
Healthcare providers should pause in their use of the chikungunya live vaccine (Ixchiq) while investigation of serious neurologic, cardiac, and other adverse events in vaccine recipients is ongoing, according to a safety communication issued jointly by the US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC). A total of 17 serious adverse events, two of which resulted in deaths, have been reported as of May 7, 2025, according to the communication. The events occurred in adults aged 62-89 years who received the live chikungunya vaccine worldwide during postmarketing availability. Six of the events occurred in the United States. Most of the serious adverse events associated with the chikungunya vaccine in the United States and overseas that have been reported to the Vaccine Adverse Event Reporting System (VAERS) have occurred in patients with underlying medical conditions and may not be causally linked to the vaccine, according to the communication. Some of the serious adverse events reported are consistent with complications from chikungunya disease, and the FDA-approved vaccine prescribing information warns that severe or prolonged chikungunya-like adverse reactions may occur. In clinical trials comparing the vaccine with placebo, severe chikungunya-like reactions were observed in 1.6% of vaccine patients vs none of placebo patients. Postmarketing reports of adverse events included one death from encephalitis. The FDA approved the vaccine for the prevention of chikungunya virus in adults aged 18 years or older who are at increased risk for exposure, and the vaccine contains a live, though weakened, version of the virus, according to the communication. Approximately 80,000 doses of the vaccine have been distributed worldwide to date. The FDA and CDC will continue to evaluate postmarketing safety reports, and the agencies recommend that healthcare providers refrain from administering the vaccine to adults aged 60 years or older while the investigations are ongoing. Healthcare providers are advised to report any adverse events in recipients of the chikungunya vaccine to VAERS.
Yahoo
12-05-2025
- Health
- Yahoo
FDA follows EMA in limiting use of Valneva shot
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use of Valneva's chikungunya vaccine in people at least 60 years of age. The recommendation announced Monday comes days after the European Medicines Agency temporarily suspended use of the vaccine, known as Ixchiq, in those over 65 pending an investigation. A committee advising the CDC previously suggested a precaution for use in a similar age group. The FDA and CDC have upheld recommendations for use in adults between 18 and 60 years of age, while the EMA still endorses the shot for individuals between 12 and 64. Ixchiq in November 2023 became the first shot approved in the U.S. to prevent illness from the chikungunya virus, which is typically transmitted through the bites of infected mosquitos. While the most common symptoms are fever and joint pain, the disease can also have lasting and potentially debilitating effects in some people, such as young children and the elderly. The shot was cleared in Europe in June 2024. But its use has since been dialed back there and now the U.S. In a statement Friday, the FDA noted how postmarketing reports have uncovered 17 serious adverse events, including two deaths, in vaccinated adults between the ages of 62 and 89. Most occurred in people with underlying health conditions and were reported to the Vaccine Adverse Event Reporting System, or VAERS. Six involved people in the U.S., according to the agency. The FDA said adverse events reported to VAERS may not be related to vaccination. In its own statement, Valneva said it is working with health authorities to review the data and anticipates 'formal reviews' of the safety reports everywhere its shot is available. Vaccine reviews and regulatory updates are facing additional scrutiny under new leadership at the FDA and Department of Health and Human Services. So far, the regulator has delayed approval decisions involving shots from Novavax and Moderna, in each case requesting more data. VAERS, a reporting system that monitors safety signals in vaccines available in the U.S., has also been targeted by new HHS leadership. In a previous email to BioPharma Dive, HHS spokesperson Andrew Nixon called VAERS inadequate.
Yahoo
01-05-2025
- Health
- Yahoo
RFK Jr to require all new vaccines to undergo placebo testing
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is requiring all new vaccines to undergo placebo-controlled trials in a policy change the agency described as a "radical departure from past practices." "Under Secretary Kennedy's leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices," an HHS spokesperson said to Fox News Digital on Thursday. HHS suggested that childhood-recommended vaccines listed under the Center for Disease Control and Prevention, for instance, should be tested. "Except for the COVID vaccine, none of the vaccines on the CDC's childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products," the HHS spokesperson said. Robert F. Kennedy Jr: Measles Outbreak Is A Call To Action For All Of Us Placebo testing, which involves volunteers receiving dummy injections such as saline shots, is already a common practice for new pathogens. Updated versions of proven protective immunizations, however, often do not undergo new placebo trials and are instead tested against existing vaccines. Read On The Fox News App Some health experts have raised concerns about conducting placebo trials, arguing that such tests could expose people to illnesses that otherwise could have been prevented. "Vaccine trial design can raise challenging ethical questions, especially regarding the use of placebo controls when an efficacious vaccine exists," a 2014 World Health Organization report published on the National Institutes of Health's website says. The risks of using a placebo control may be ethically justified even when an efficacious vaccine exists if the trial is "in settings where vaccine supplies are limited, where vaccines remain investigational and/or where public health recommendations for use of these vaccines have not been made," according to an article from the European Society of Clinical Microbiology and Infectious Diseases, also on the NIH website, citing a trial from a pharmaceutical company. Watch Full Interview With Dr. Marc Siegel And Rfk Jr. On Fox Nation HHS also claimed that the CDC has not been monitoring vaccine complications adequately, and criticized its current surveillance system. "The CDC's former practice of suppressing information about vaccine injuries has badly eroded trust in our public health agencies," the agency said. "The CDC's own research has shown that the post-licensure surveillance system, VAERS, captures fewer than 1% of vaccine injuries," the HHS spokesperson said. "It's a system that was designed to fail. The Vaccine Safety Datalink (VSD) — intended as a backup to VAERS — is virtually unusable for serious research. Both systems have become templates of regulatory malpractice." Kennedy, who has repeatedly said vaccines are not adequately tested for safety, is calling for greater transparency in its testing and approval process. "Secretary Kennedy's HHS has pledged radical transparency to the American public," the spokesperson said. "This means being honest and straightforward about what we know — and what we don't know — about medical products, including vaccines." "HHS is now building surveillance systems that will accurately measure vaccine risks as well as benefits — because real science demands both transparency and accountability," the spokesperson article source: RFK Jr to require all new vaccines to undergo placebo testing
