Tag: human experimentation

FDA approves new genetically modified pig for allergy-free medical and food products

The US Food and Drug Administration said Monday it has approved a genetically modified pig whose body doesn’t make a component that can trigger allergies in people.The pigs should produce meat that is safe to eat, and organs and tissues safe for transplants and for the other biomedical uses for people allergic to the compound — a sugar found on the surface of animal cells known as alpha-gal, the FDA said.

It might help people who have an allergy to alpha-gal– an allergy sometimes triggered by a tick bite.”Today’s first ever approval of an animal biotechnology product for both food and as a potential source for biomedical use represents a tremendous milestone for scientific innovation,” said FDA Commissioner Dr. Stephen Hahn.The pigs, licensed to Revivicor Inc., a subsidiary of United Therapeutics, are called GalSafe pigs. Revivicor is a spinoff from PPL Therapeutics, which produced the first mammal cloned from an adult mammal: Dolly the sheep, in 1996.Products made from their bodies can be safely used by people with alpha-gal syndrome, FDA officials told a media briefing. These might include the blood thinner heparin, made from pig intestines, as well as tissue or organ transplants.A company called Xenotherapeutics has three patients enrolled in a Phase 1 safety trial of using skin from GalSafe pigs for skin grafts to treat burn victims with alpha-gal allergies. The company is working to enroll three more in the trial at Massachusetts General Hospital.

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Vaccine Safety to Remain Unclear Until Millions Get Their Shots

Monitoring Covid-19 vaccines for safety issues will fall to a group of U.S. health agencies that also will have a hand in their rollout, a potential hurdle in persuading skeptics to get the shots, say former government officials who helped control an outbreak a decade ago.

The Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Veterans Affairs and other health agencies all have separate systems to track side effects and safety in people who get the first shots. But there are concerns the groups advising the agencies on all aspects of a vaccine may face public skepticism over their safety assessments at a time when vaccine hesitancy is a major concern.

“The same advisory committee that told them to get it are telling them it’s OK,” said Daniel Salmon, the director of vaccine safety for the National Vaccine Program Office during the 2009 H1N1 swine flu outbreak. “What are the optics of that?”

There’s also worry that a lack of unified oversight could make it more difficult to document and quickly act on safety issues. Meanwhile, the stalled presidential transition could complicate efforts even further, said Jesse Goodman, who led the FDA office that handled vaccines during the 2009 H1N1 outbreak.

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The Johns Hopkins, CDC Plan to Mask Medical Experimentation on Minorities as “Racial Justice”

The main focus of this allocation strategy is to deliver vaccines first to racial minorities but in such a way as to make those minorities feel “at ease” and not like “guinea pigs” when receiving an experimental vaccine that those documents admit is likely cause “certain adverse effects…more frequently in certain population subgroups.” Research has shown that those “subgroups” most at risk for adverse effects are these same minorities.

The documents also acknowledge that information warfare and economic coercion will likely be necessary to combat “vaccine hesitancy” among these minority groups. It even frames this clearly disproportionate focus on racial minorities as related to national concerns over “police brutality,” claiming that giving minorities the experimental vaccine first is necessary to combat “structural racism” and ensure “fairness and justice” in the healthcare system and society at large.

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