FDA

FDA Official Demands YouTube Video Removal, Fuels Censorship Concerns

The FDA’s chief vaccine regulator, Vinay Prasad, demanded the removal of six YouTube videos featuring himself, which were hosted on a channel run by Dr. Jonathan Howard, a critic of medical misinformation. Howard’s entire channel, containing numerous videos of doctors and commentators, was subsequently deleted by YouTube, citing copyright infringement. Howard stated his intention was to preserve public comments made by these individuals during the early pandemic. The videos were a collection of public statements. A spokesperson for the FDA stated Howard’s actions constituted copyright violation and that the videos remain available on Prasad’s podcast channel.

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FDA Approves Limited COVID Shots Under Kennedy Jr. Framework: Access Concerns Rise

The FDA has approved the latest round of Covid vaccines but with new limitations, rescinding broad emergency use authorizations and narrowing eligibility. The agency now only clears the shots for those at higher risk of severe illness, including individuals aged 65 and older and younger adults with underlying conditions. This shift follows efforts by Health and Human Services Secretary Robert F. Kennedy Jr. to alter U.S. immunization policies, leading to a break from previous recommendations of annual shots for all Americans. The new restrictions have drawn criticism from medical organizations like the American Academy of Pediatrics, who worry about limiting access to vaccines for vulnerable populations such as infants, toddlers, and pregnant women.

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Radioactive Shrimp Recall: FDA Warns Consumers After Cesium Contamination

Southwind Foods, a California-based seafood company, has issued a voluntary recall of a limited quantity of frozen shrimp products due to potential exposure to Cesium-137 (Cs-137), a radioactive material. The recalled shrimp, distributed between July 17 and August 8 to several states, include brands like Sand Bar and Best Yet. This recall follows a similar one from an Indonesian company, with the FDA actively investigating the source of the contamination, and the public is advised to discard or return the recalled shrimp to the point of purchase due to potential health risks from exposure.

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FDA Warns Against Eating Walmart Shrimp Due to Radioactive Contamination

The FDA is sounding the alarm, and it’s about something you might not expect: potentially radioactive shrimp sold at Walmart. This isn’t some obscure conspiracy theory; it’s a real warning, based on investigations into imported frozen shrimp. The story starts with U.S. Customs and Border Protection detecting Cesium-137 (Cs-137), a radioactive isotope, in shipping containers at several U.S. ports. The FDA got involved, and their tests confirmed the presence of this radioactive material in some frozen shrimp products. It’s a situation that’s raised a lot of questions, and understandably, some concerns.

The primary focus of the FDA’s warning is on certain lots of Great Value brand raw frozen shrimp, specifically those imported from an Indonesian firm, PT.… Continue reading

Pfizer Vaccine for Young Children: FDA Review Fuels Controversy Amidst Political Donations and Doubts

According to an email, the FDA may not renew Pfizer’s pediatric Covid vaccine authorization for the upcoming respiratory season, potentially removing the only vaccine for children under five. This decision would necessitate Moderna to increase its supply, although its vaccine is currently only approved for children with specific health conditions. The CDC is actively engaged in discussions with Moderna, focusing on addressing possible supply gaps and ensuring availability. This development occurs amid already low vaccination rates for children and ongoing concerns about the long-term effects of Covid.

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High Noon Seltzer Recall After Celsius Cans Mislabeled

High Noon has voluntarily recalled specific 12-pack cases of its Beach Variety vodka seltzer due to mislabeling, with some cans incorrectly labeled as Celsius energy drinks. This labeling error, stemming from the can supplier, poses a risk of accidental alcohol ingestion. The recall involves two production lots of the product, which were distributed to retailers across several states including Florida, New York, and Wisconsin, between July 21st and July 23rd. The FDA has reported no related illnesses or adverse events at this time.

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New HIV Prevention Drug Approved, Promises Global Impact

The FDA has approved lenacapavir, marketed as Yeztugo, a groundbreaking twice-yearly injection offering nearly complete protection against HIV. This capsid inhibitor, recognized as a major scientific breakthrough, has the potential to end the 44-year-long epidemic. To ensure global access, the manufacturer has entered royalty-free licensing agreements with generic drug producers and will supply the drug at no profit to countries in need, in partnership with the Global Fund. This preventative medication aims to transform HIV prevention by addressing adherence and stigma challenges associated with previous PrEP regimens.

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FDA Official’s Restrictions on COVID Vaccines Spark Controversy, Raise Questions

Newly released FDA documents reveal that the government’s top vaccine official, Dr. Vinay Prasad, under Health Secretary Robert F. Kennedy Jr., restricted the approval of two COVID-19 vaccines, Novavax and Moderna, overriding recommendations from government scientists. These scientists had initially planned to approve the shots for individuals 12 and older, concluding the benefits outweighed the risks. However, Prasad decided to limit the vaccines to those at higher risk, such as seniors and those with underlying medical conditions, citing concerns about potential side effects and reconsidering the benefits in light of changing infection rates. This decision is part of a series of vaccine restrictions imposed by officials under Kennedy.

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Trump Vaccine Policy Restricts COVID Shot Access

The Trump administration announced a significant policy shift, eliminating routine annual COVID-19 vaccinations for healthy younger adults and children. This new FDA framework mandates extensive clinical trials before approving updated vaccines for this group, prioritizing those 65 and older or with underlying health conditions. The decision raises concerns about vaccine accessibility and potentially contradicts established FDA procedures by preemptively influencing the CDC’s advisory panel. This approach marks a departure from the previous “one-size-fits-all” strategy and aligns with a more restrictive stance on COVID-19 vaccination.

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RFK Jr. Orders Mifepristone Review Amidst Anti-Abortion Push

US Health Secretary Robert F. Kennedy Jr. has directed the FDA to review mifepristone regulations based on new data from a flawed, non-peer-reviewed analysis. This analysis, promoted by anti-abortion groups, alleges higher complication rates than previously known, prompting calls to reinstate prior restrictions or remove the drug entirely. The data significantly overstates risks, including misclassifying ectopic pregnancies as complications of mifepristone. Anti-abortion groups intend to use this analysis to pressure the FDA and lawmakers to severely limit mifepristone access, potentially through ending telemedicine prescriptions as a first step. Despite over 100 studies confirming mifepristone’s safety and effectiveness, this campaign aims to significantly restrict access to the abortion pill.

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