Health Minister Robert F. Kennedy Jr. He announced a plan that would require placebo -controlled studies for all new vaccines, surprising some experts who noted that these tests are already taking place.
In a statement, Andrew Nixon, a spokesman for the Ministry of Health and Human Services, said that “all new vaccines will undergo safety testing tests” prior to approval and called the “radical departure” move from existing standards.
Modern studies tend to use placebos. One exception was Covid Booster shots, which have been authorized without human tests to target new strains of the virus as it has evolved. It is not clear how the announcement will affect the availability of Covid vaccines that are expected to be informed of the fall.
Mr Kennedy also announced an effort on Thursday for National Institutes of Health to swirl the development of new vaccinations for Covid, bird flu and seasonal flu.
The new vaccine development initiative will include methods different from the MRNA technology used to develop the dominant Covid vaccines already used, a statement from the Department of Health and Human Services said. MRNA shots have been the subject of conspiracy theories and Mr Kennedy has strongly criticized them.
Overall, the moves suggest that Mr Kennedy will be very much in the details of the development of the vaccine, an attempt to be informed since his decades as one of the most vocal critics of immune surveillance.
Although some scientists say that trying to fully understand the possible unexpected effects of vaccines is worthwhile, they also warn that in the way it delaying the approval of life shots could endanger public health.
Mr Kennedy’s activism in recent years has included applications for the Food and Drug Administration to pull the Covid vaccine from the market in 2021 during a deadly phase of the pandemic. He also called on the FDA not to authorize Covid shots for children.
Asked how the new test policy would affect Covid Booster shots, Mr Nixon suggested that new tests could be requested. Although vaccines approved by the FDA were initially studied in major tests against Placebos, Mr. Kennedy and others have criticized the lack of clinical trials for amplifiers.
“As we said earlier, tests from four years before people without natural immunity are no longer enough,” Mr Nixon said. “A four -year test is also not a blank check for new vaccines each year without clinical trial data, as opposed to the shooting of the influenza tested and tested for more than 80 years.
Pfizer and Moderna, manufacturers of MRNA Covid shots, did not immediately respond to requests for comments. The Washington Post mentioned the policy shift for the first time.
Dr. Ofer Levy, a Harvard vaccine researcher and a member of the FDA vaccine advisory committee, said the investigation of possible unexpected effects on vaccines would be a valuable effort. But he said that officials had to “screw the needle” to be sure that it is not left out that it did not leave larger and immunosuppressive people unprotected than Covid.
He said that leaving a team that received the placebo vulnerable to Covid raises moral concerns that should be carefully examined. Occupation of the authorization for updated Covid shooting would be “unacceptable”, he said.
“Tens of thousands of people can die without protection from Covid,” said Dr. Levy, who founded a company working on an opioid vaccine.
Disease Control and Prevention Centers reported about 23,000 deaths from Covid since September, with 1,000 per week and January. Still, the intake of covid amplifiers was low: about 23 % of adults got the updated Covid shot released in the fall, according to CDC
Mr Kennedy’s familiarity with the issue comes at least in part from the revisions of the approvals of decades of age, including the polio and measles vaccine, the Red Mumps vaccine. It has also helped to represent the plaintiffs in lawsuits against manufacturers.
He and the organization he founded and once led, defending children’s health, have repeatedly complained that vaccines are not tested against virtual materials in clinical trials when developing. The body mentioned the vaccines of polio, hepatitis and meningitis as examples, all the vaccines admitted decades ago.
“Any other medicine is tested against a placebo,” Mr Kennedy told a podcast in January 2020, claiming that vaccines are relieved of this requirement.
This, however, is not absolutely right. Cancer medicines and other medicines allowed under the FDA accelerated approval program are regularly authorized after placebo -free tests. And new vaccines, including Covid vaccines, were tested against virtual material – inactive substances, such as saline infusion or in some cases against vaccines for other diseases.
However, new formulations already approved vaccines are compared to those found in existing vaccines in clinical trials, as it will be considered unethical to withhold effective vaccines from patients, including infants.
“We have demanded placebo -controlled testing for most vaccines and are sometimes inactive placebo and sometimes an irrelevant vaccine,” said Dr. Peter Marks, who was the senior employee of the Food and Drug Service vaccine until forced. “The claim that we have not done randomized tests for pediatric vaccines other than Covid is not correct.”
Mr Kennedy has also caused concerns in the past about testing a vaccine against what many consider a reasonable placebo: the same type, but without immune factors. Mr Kennedy noted that practice leaves uncertainty about whether the components of the formula could cause harm.
The announcement that the National Institutes of Health will develop new technology for the manufacture of influenza and crown vaccines to prevent pandemics, with the aim of displacement of MRNA vaccine technology aimed at critics, including Health Secretary.
This “next generation vaccine platform” would be “fully government”, the department said. NIH has helped develop the MRNA platform and the Moderna vaccine manufacturer paid the government hundreds of millions of dollars to grant permission to a basic patent in the vaccine, although the company and government later received a disagreement on diplomas.
The MRNA platform is based on small pieces of genetic code, which created rumors on online and conspiracy theories used to introduce microchip into vaccine recipients. The new platform, on the other hand, will be based on a more traditional method of vaccine development, which uses inactivated viruses to cause immune response.
The department said the new platform would be developed using beta-bubble, which is already a component of vaccine development, but is considered a dangerous substance by the environmental protection service when people are exposed to it in large doses.
