The early deployment of updated COVID vaccines this fall could be at risk after a change by the Secretary of Human Health and Services, Robert F. Kennedy Jr., in how vaccines are tested, experts say.
According to Kennedy’s change, according to an HHS spokesman, all new vaccines must go through placebo -controlled clinical trials, where some people receive real shot and others get something inactive, such as a saline shot, to compare the results.
Executing tests that include a placebo group is already routine for most new vaccines.
The original COVID vaccines, of Pfizer and Modern, approved at the end of 2020, went through controlled tests with placebo. But as the virus continued to mutate and the vaccines should be updated so that they coincide with the circulating tension, the medication manufacturers moved to a model similar to a flu vaccine, using smaller studies to prove how well the updated shots triggered an immune response against the variant in question.
Like the annual flu vaccine, updated COVID vaccines were not treated as completely new products, since they still used the same formula, with only an adjustment to the voltage that the vaccine would point. Arnm Covid vaccines were designed so that this change was particularly easy to make, in case the shots should be updated quickly.
Quickly, in this case, it turns out to be several months. To have enough Covid doses for autumn, vaccine creators are told what to point out in spring.
The Vaccine Advisory Committee of the Food and Drug Administration is expected to meet in May or June to make a recommendation on what strains should be included in the next round of shooting. A person familiar with the matter, who was not authorized to speak publicly, said the FDA had planned to schedule a meeting for May 22. An HHS spokesman declined to comment on the date of the meeting.
If the FDA considers that updated Pfizer and modern vaccines are “new”, which require new tests, it is extremely unlikely that the doses are ready for autumn, experts said.
Dr. Paul Offit, director of the Vaccine Education Center of the Filadelphia Children’s Hospital and member of the FDA Vaccine Advisory Committee, said the change would almost surely delay the launch of the updated PFIZER and modern shots for “months”, since drug manufacturers would take time to design the new essays and registration participants.
That would only be the beginning: drug manufacturers would have to execute the real essay, which would take several months, at least, and analyze the results.
Even Covid vaccines, which were acclaimed as “the most successful government science program” due to the speed with which Dr. Alex Greninger, a professor of medicine and laboratory pathology at UW Medicine in Seattle, was developed, it still took at least about six months to execute their phase 3 tests.
The HHS spokesman did not answer a question about whether Pfizer and Modern vaccines would require new clinical trials.
However, the spokesman said in a statement that “the FDA Commissioner, Dr. Marty Makary, has indicated that significant updates to existing vaccines, such as those that address seasonal voltage changes or antigenic drift, can be considered ‘new products’ that require additional clinical evaluation.”
“As we have said before, the rehearsals of four years ago in people without natural immunity are no longer enough,” said the spokesman. “A four -year trial is not a blank verification for new vaccines every year without clinical trial data,” they said, and added that the flu vaccine would be exempt from the new rule, because “it has been judged and tested for more than 80 years.”
The FDA has already delayed the approval of the Updated Covid Vaccine of Novavax, which requires the company to perform a new clinical trial because the strain included in the shot differs from what was originally authorized.
Vaccine experts criticized the new requirements.
It is “little ethical,” said Seth, noting that he is generally frowned upon in the scientific community to give someone a placebo when an approved product already exists that can protect them.
Dr. Stanley Plotkin, a pediatrician who played a key role in the development of the rubella vaccine, said the movement would not make “meaning.”
“What would be reasonable is to compare the old vaccine with the new vaccine to see if the new vaccine offers better immunological responses,” Plotkin said. “We have vaccines against Covid, where we have quite concrete ideas about what works and what does not work. We know they are not perfect, but we have vaccines that we know they work.”
Pfizer and Modern spokesmen did not immediately respond to comments requests.
The former government officials have said that the HHS, under the Kennedy, was moving to the approvals of slow -off vaccines, even imposing new regulatory obstacles to medication manufacturers, such as changing the requirements for approval or looking for additional clinical trial data.
Vaccine experts also fear that the change of rules will be part of a broader Kennedy effort to sow distrust of vaccines and limit public access to them.
“The objective is to make vaccines more onerous, more burdensome to prove by mentioning this type of false security concerns or false efficacy problems,” said Offit.
Dr. Sean O’Leary, president of the Infectious Diseases Committee of the American Academy of Pediatrics, said it is unlikely that change affects new vaccines. But it could have important implications for vaccines that may require updates in addition to COVID, such as RSV, since placebo tests are expensive and take much more to drive.
“It really is not feasible and would lead to many hospitalizations and deaths,” O’Leary said.
Plotkin added that vaccines that develop for infections that are incurable, such as HIV, can also be at risk.
“I guess you wanted to develop a new HIV vaccine?” asked. “Would you make a controlled judgment with a placebo in that situation? I mean exposing children to a disease that is very serious without offering them anything.”
