Secretary of Health Robert F. Kennedy Jr.
“All new vaccines will be tested for safety in placebo-controlled trials before approval,” said Andrew Nixon, a spokesman for the Department of Health and Human Services, in a statement, saying the move was a “radical departure” from existing standards.
Even though modern studies usually use placebo, An exception is Covid Booster Shots, which has been authorized to target new strains of the virus without human trials. It is unclear how the announcement will affect the availability of the common vaccine expected to be updated in the fall.
Mr. Kennedy announced Thursday that it would be turbocharged for the National Institutes of Health, developing new co-transmissions, bird flu and seasonal flu.
A statement from the Department of Health and Human Services said the new vaccine development program will involve methods other than mRNA technology used to develop the major common vaccines already in use. mRNA lenses have always been the subject of conspiracy theories, and Mr. Kennedy has strongly criticized them.
Taken together, these moves suggest that Mr. Kennedy will involve details of vaccine development, which is probably his efforts to become one of the most critics of U.S. immunity supervision in decades.
While some scientists say it is necessary to fully understand the possible unexpected effects of vaccines, they also warn that doing so delays approval of lifesaving footage and could endanger public health.
In recent years, Mr. Kennedy’s activism has included applying to the Food and Drug Administration for withdrawing common vaccines from the market during the pandemic. He also urged the FDA not to authorize children to shoot.
When asked how the new testing policy will affect Covid Booster shooting, Nixon suggested that new trials could be requested. Although the FDA-authorized vaccine was initially studied in large-scale trials for placebos, Mr. Kennedy and others criticized the lack of clinical trials for boosters.
“As we said before, four years ago trials have no longer tried enough for people without natural immunity,” Nixon said. “Without clinical trial data, a four-year trial is not a blank check for new vaccines, unlike more than 80 years of trials and testing. The public should have the science of transparency and gold standards – especially in evolving products.”
Pfizer and Moderna, the maker of mRNA Covid lenses, did not immediately respond to requests for comment. The Washington Post first reported on policy changes.
Dr. Ofer Levy, a Harvard vaccine researcher and a member of the FDA Vaccine Advisory Committee, said exploring the possible unexpected effects of vaccines will be a valuable effort. But officials must “pierce the needle” to ensure it is protected from Kuved with a kind of protection that does not render older and immune-depressed people.
He said leaving a group makes the placebo vulnerable to a common attack, raising ethical issues that need careful consideration. He said it would be “unacceptable” to insist on renewed Covid lenses.
“Thousands of people can die without protecting Kuved,” Dr. Levi said.
Since September, the Centers for Disease Control and Prevention has reported about 23,000 deaths from Covid, with as many as 1,000 per week in the month and January. Nevertheless, according to the CDC
Mr. Kennedy’s familiarity with the issue is at least in part due to his comments on decades-old vaccine approvals, including polio vaccines and measles, mumps and rubella vaccines. He also helped to represent the plaintiff in the lawsuit against the manufacturer.
He and the organization he formed once led the health defense of children, repeatedly complaining that the vaccine was not tested in clinical trials when it was developed. The organization uses polio, hepatitis and meningitis vaccines as examples, introduced decades ago.
“The placebo was tested,” Mr. Kennedy said in a podcast in January 2020.
However, this is not entirely true. Cancer drugs and other drugs authorized under the FDA Accelerated Approval Program are authorized periodically after a placebo trial. New vaccines have been tested for placebos (such as saline injections) or inert substances (such as inert substances) against vaccines for other diseases, including vaccines for interconnected substances.
However, the approved vaccine is compared with the existing ones in clinical trials because it considers that vaccines that are effective in patients, including infants, are considered immoral.
“We need placebo-controlled trials of most vaccines, sometimes inert placebo, sometimes an irrelevant vaccine,” said Dr. Peter Marks. “It is incorrect to claim that we have not yet conducted a randomized trial of pediatric vaccines for COVID.”
Mr. Kennedy has also raised questions about tests for many who think are reasonable placebos: the same formula, but no immune-activated drugs. Mr Kennedy pointed out that this practice leaves uncertainty about whether the ingredients in the formula will cause harm.
The National Institutes of Health will develop new technologies to manufacture influenza and coronavirus vaccines to prevent the announcement of biology, which appears to be an mRNA vaccine technology designed to replace the targets of critics, including the health minister.
The department said this “next-generation vaccine platform” will be “fully government-owned.” NIH helped develop the mRNA platform, and vaccine maker Moderna paid hundreds of millions of dollars to the government to license key patents for the vaccine, although the company and the government later fell into controversy over patent rights.
The mRNA platform relies on a small portion of genetic codes that have spawned online rumors and conspiracy theories that it is used to insert microchips into vaccine recipients. In contrast, the new platform will rely on a more traditional vaccine development approach that uses inactivated viruses to trigger an immune response.
The department said the new platform will be developed using beta-pyruvate, which is already an integral part of vaccine development, but the Environmental Protection Agency is considered a hazardous substance when people are exposed to high doses.
