Small RFKs require placebo control new vaccine: lens

New demand for vaccine research may delay the availability of new vaccines. Aire Image/Torque RF/Getty Image Closed subtitles

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Aire Image/Torque RF/Getty Image

The Trump administration plans to impose new testing requirements on new vaccines, which could delay the next round of Covid-19-19-19-19 and complicate approvals of other vaccines.

According to a statement by Secretary of Health and Human Services Robert F. Kennedy Jr., the government will require testing of all new vaccines in order to put in a substance called a placebo before available inert substances, which is “fundamental to past practices.”

The latest statement has raised an alarm from vaccine experts that Kennedy may have further damaged the confidence and availability of vaccines.

"I think Robert F. Kennedy Jr.," said the doctor. Paul Offita vaccine expert at the University of Pennsylvania. "He is an anti-vaccine activist, he is a scientific denier who will do everything he can to remove the vaccine infrastructure in this country. Robert F. Kennedy Jr is a dangerous person."

The government maintains this new requirement to ensure vaccines are safe. However, vaccine experts have objected to the claim that the main vaccine that has not been tested for placebo. They also questioned the definition of what constitutes a new vaccine. The ingredients in some vaccines are regularly updated, such as COVID lenses, to better match strains of the circulating SARS-COV-2 virus without fundamentally changing the vaccine itself. The flu vaccine has been like this for a long time.

"Kennedy's HHS has committed to providing fundamental transparency to the American public. This means being honest and direct about what we know and what we don't know, including vaccines," Nixon said.

He also claimed: “No vaccines were tested against inert placebo except for accessing vaccines on the CDC recommended timeline, meaning we know very little about the actual risk profile of these products.”

Nixon also questioned the reliability of the existing vaccine surveillance program, which he described as “regulatory malfeasance.”

Changes in standards may delay future co-shooting

While the government has not explicitly named the COVID vaccine, Nixon said any update to the Covid vaccine could make it a new vaccine that requires that test.

"As we said before, four years ago trials are no longer sufficient for people without natural immunity. The four-year-old trial is not a blank check for new vaccines that have no clinical trial data every year, the same as influenza that has been tested with over 80 years of experience and testing," Nixon said in a statement that he has issued a statement. Washington Post. “The public should have science of transparency and golden standards, especially in evolving products.”

He also mentioned Recent Comments Food and Drug Administration Commissioner Marty Makary said the vaccine should be considered as a new vaccine.

"Makary shows that major updates to existing vaccines, such as those that address seasonal strain changes or antigen drifts, may be seen as 'new products' that require additional clinical evaluation," Nixon wrote. "He stressed the need for strong data to support vaccine approval, stressed that's not allowing blankets of opinion, but wanting to see some good data."

These moves are when vaccination rates have dropped and diseases such as measles have broken out. Olit and others say Calved is still killing hundreds of Americans a week and the next pandemic could hit at any time.

"When it comes to vaccines, he seems to be in full attack mode. This is also so self-defense to our country and the world," the doctor said. Peter Hotelza vaccine researcher at Baylor College of Medicine in Houston. “This is absolutely dangerous.”

Placebo-controlled vaccine trials are common

OFFIT, Hotelz and others say that testing vaccines with placebo is a “radical start” and that children’s vaccines are not evaluated in this way. Scientists often test new vaccines and drugs for placebos to see if they are safe and effective.

"It is said that the blanket statement for no conventional vaccine tested for placebo is incorrect," Dr. Dr. said. Jesse Goodmannow a former Food and Drug Administration vaccine regulator at Georgetown University. “The placebo trial has been conducted.”

These include the initial co-coil vaccine, which was evaluated in large, well-designed placebo-controlled trials to assess its safety and effectiveness. Goodman and others say these trials and subsequent surveillance clearly show that the common vaccine, as well as all other vaccines on the market, are safe and effective.

Given how much immunity people have at this point, any new placebo trial will have to be huge, meaning that this will be very expensive and will take too long to make the newer vaccine available in time next fall and winter.

“When you complete these studies, the strain will develop, and the research you just did will be less stressful,” Goodman said. “You will deliberately create a situation where you may be using a vaccine that is not good for no reason.”

"This will basically be the secret to paralysis," Hotez said.

Furthermore, experts say it is unethical to give someone a placebo to protect them from potentially deadly diseases when an effective vaccine is already present.

"Are they really going to do a placebo-controlled trial where a group of people don't get the vaccine, knowing that the virus will cause infections and diseases, including those with serious illnesses in anyone?" Offit said. "So, it's not a moral trial." ”