A new requirement for vaccine studies could delay the availability of new vaccines.
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The Trump administration plans to impose a new test requirement for new vaccines – a request that could delay the availability of the next series of COVVI -19 vaccines and complicate the approval of other vaccines.
The administration will require that all new vaccines be tested against an inert substance known as a placebo before being able to be made available, which is a “radical difference in past practices”, according to a press release from Andrew Nixon, spokesperson for Robert F. Kennedy Jr., Secretary of Health and Human Services.
The last statement sparked an alarm among the experts in vaccines that this could be another stage of Kennedy to undermine the confidence and availability of vaccines.
“I think that is the interest of Robert F. Kennedy Jr. to make vaccines more expensive, less available and more feared,” said Dr. Paul offerAn expert in vaccines from the University of Pennsylvania. “It is an anti-Vaccin activist, a denial of science that will do everything he can to demolish the infrastructure in this vaccine country. Robert F. Kennedy Jr is a dangerous man.”
The administration maintains that this new requirement aims to ensure that vaccines are safe. But vaccine experts dispute the assertion that key vaccines were not tested against a placebo. They also dispute the definition of what constitutes a new vaccine. The ingredients of certain vaccines, such as the counted plans, have been updated regularly to better correspond to the strains of the Sars-Cov-2 virus in circulation, without fundamentally changing the vaccines themselves. This has long been the case with influenza vaccines.
“Secretary Kennedy’s HHS has promised radical transparency to the American public. It means being honest and direct on what we know – and what we do not know – on medical products, including vaccines,” said Nixon.
He also said that “with the exception of the cocvid vaccine, none of the vaccines on the calendar recommended by the childhood of the CDC has been tested against an inert placebo, which means that we know very little the real risk profiles of these products.”
Nixon has also questioned the reliability of existing vaccine monitoring programs, which he described as a “regulatory professional fault”.
The change of standard could delay the future shots cow
Although the administration has not specifically appointed coastal vaccines, Nixon indicated that any cocvid vaccines could make new vaccines that would require this test.
“As we said before, trials of four years ago have been conducted in people without natural immunity is no longer enough. A four -year trial is not a white check for new vaccines each year without clinical trial data, unlike the influenza vaccine that has been judged and tested for more than 80 years,” said Nixon in a statement he had sent earlier The Washington Post. “The public deserves transparency and standard science – in particular with evolving products.”
He also referred to recent comments From the Food and Drug Administration Commissioner, Marty Makary, indicating that covid vaccines should be considered new vaccines.
“Makary said that important updates from existing vaccines – such as those dealing with seasonal strain or antigen drift changes – can be considered” new products “requiring additional clinical evaluation,” Nixon wrote. “He underlined the need for robust data to support the approvals of vaccines, highlighting:” Rather than allowing this vacuum to be filled with opinions, I would like to see good data. “”
The movements are worrying at a time when vaccination rates are already falling and diseases like measles are experiencing epidemics. Covid still kills hundreds of Americans every week, and the next pandemic could knock at any time, say Offer and others.
“It seems to be in complete attack mode with regard to vaccines. And it is so self-defusing for our country and in the world,” explains DR Peter HoozVaccinal researcher at the Baylor College of Medicine de Houston. “It’s absolutely dangerous.”
Placebo controlled vaccine trials were common
Offer, Hotz and others challenged the assertion that the test of vaccines against a placebo is a “radical start” and that infant vaccines have not been evaluated in this way. Scientists regularly test new placebos vaccines and drugs to see if they are safe and effective.
“The general declaration that none of the routine vaccines has never been tested against placebo is incorrect,” said Dr. Jesse GoodmanA former regulator of the Food and Drug Administration vaccine now at Georgetown University. “Placebo tests have been carried out.”
This includes the original coated vaccines, which have been assessed in large, well -designed placebo trials that have evaluated their safety and efficiency. These trials, as well as subsequent surveillance, have clearly shown that co -via vaccines as well as all other plans on the market are safe and effective, say Goodman and others.
Given the amount of immunity at this stage, all new placebo tests for update vaccines should be enormous, which means that it would be prohibitive and would take too much time to make the updated vaccines available in time for autumn and next winter, they say.
“As you did these studies, the tension would have evolved and the study you just made is a tension that is not as good,” explains Goodman. “You would deliberately create a situation where you would probably use less good vaccines – and without reason.”
“It would be essentially a paralysis recipe,” said Hooz.
In addition, experts say that giving someone a placebo to protect them from a potentially fatal disease when an effective vaccine already exists would be contrary to ethics.
“Do they really have a placebo controlled test where a certain group of people do not receive this vaccine, knowing that the virus can cause an infection and a disease, including a serious illness in anyone? Anyone can be shot down by this virus,” said Offer. “It is therefore not an ethical essay.”
