NBC News
Updated vaccines against COVID-19 for this fall could be in danger after a change introduced by the Secretary of Human Health and Services (HHS), Robert F. Kennedy Jr., in the way in which vaccines are approved, according to experts.
According to an HHS spokesman, with the change introduced by Kennedy, all new vaccines must be subjected to controlled clinical trials with placebo, in which some people receive the real vaccine and others receive an inactive product, such as an injection of saline solution, to compare the results.
The realization of trials that include a placebo group is already a common practice for most new vaccines.
Original vaccines against COVID-19, from Pfizer and Modern, approved by the late 2020s, were subjected to placed controlled tests. However, as the virus continued to mutate and it was necessary to update vaccines to adapt them to circulating strain, medication manufacturers went to a model similar to flu vaccines, in which they use smaller studies to check the effectiveness of updated vaccines when it comes to triggering an immune response against the variant in question.
Like the annual flu vaccine, updated vaccines against COVID-19 were not treated as completely new products, since They continued using the same formulawith only a small adjustment in the strain to which the vaccine was headed. RNM vaccines against COVID-19 were designed so that this change was especially easy to perform, in case it is necessary to quickly update vaccines.
In this case, “quickly” has turned out to be several months. To have enough doses of vaccines against COVID-19 lists for autumn, vaccine manufacturers are communicated in spring what strain they should attack.
The Advisory Committee on Vaccines of Food and Drug Administration (FDA) is expected to meet in May or June to recommend what strains should be included in the next round of vaccines. A person familiar with the matter, who was not authorized to speak publicly, said that the FDA had planned to hold a meeting on May 22. An HHS spokesman refused to comment on the date of the meeting.
If the FDA considers that updated Pfizer and modern vaccines are “new” products that require new trials, it is very unlikely that the doses are ready for autumn, according to experts.
Dr. Paul Offit, director of the Vaccine Education Center of the Chiladelphia Children’s Hospital and member of the FDA Vaccines Advisory Committee, declared that the change would almost surely delay the launch of the updated PFIZER and modern vaccines in “months”, since pharmaceutical companies would need time to design the new rehearsals and recruit participants.
That would only be the beginning: the pharmaceutical companies would have to carry out the essay itself, which would have at least several months, and analyze the results.
Even vaccines against COVID-19, which were acclaimed as “The most successful government scientific program” Because of the speed with which they developed, according to Dr. Alex Greninger, professor of Laboratory Medicine and Pathology at the UW Medicine in Seattle, it took at least six months to complete phase III tests.
The HHS spokesman did not answer directly to the question of 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 the significant updates of existing vaccines, such as those that address seasonal changes of strains or antigenic drift, can be considered ‘new products’ that require an additional clinical evaluation.”
“As we have said before, the essays carried out four years ago in people without natural immunity are no longer enough,” said the spokesman. “An essay of four years is not a blank check for new vaccines every year without clinical trial data,” he added, and pointed out that the flu vaccine would be exempt from the new standard, since “it has been tested and proven for more than 80 years.”
The FDA has already delayed the approval of the updated vaccine against the NOVAVAX COVID-19, demanding the company to carry out a new clinical trial because the strain included in the vaccine differs from the authorized authorized originally.
Vaccine experts criticized the new requirements.
It is “little ethical,” said Offit, noting that, in general, the scientific community disapproves of administering a placebo to someone when there is already an approved product that can protect it.
Dr. Stanley Plotkin, a pediatrician who played a key role in the development of the rubella vaccine, said the measure “makes no sense.”
“The reasonable thing would be to compare the old vaccine with the new one to see if the latter offers better immunological responses,” said Plotkin. “We have vaccines against COVID-19, about which we have quite concrete ideas in terms of what works and what we do not know that they are not perfect, but We have vaccines that we know work”
Pfizer and Modern spokesmen did not respond immediately to comments requests.
Former government officials have affirmed that HHS, under the direction of Kennedy, was taking measures to slow down vaccine approval, among other things by imposing new regulatory obstacles to medication manufacturers, such as changing the requirements for approval or requesting additional data on clinical trials.
Vaccine experts also fear that the change of regulations will be part of a broader Kennedy initiative to sow distrust of vaccines and limit public access to them.
“The objective is to make vaccines more expensive to manufacture and more expensive to prove, raising this type of false concerns about their safety or effectiveness,” said Offit.
Dr. Sean O’Leary, president of the Infectious Diseases Committee of the American Pediatrics Academy, declared that change is unlikely to affect totally new vaccines. However, it could have important repercussions in vaccines that may need updates-in addition to those of the COVID-19, those of the VRS-since the rehearsals with placebo are expensive and require much longer.
“It is really not feasible and would cause many hospitalizations and deaths,” said O’Leary.
Plotkin added that vaccines that are being developed for incurable infections, such as HIV, could also be in danger.
“Suppose you want to develop a new HIV vaccine,” he asked. “Would a placebo controlled trial be done in that situation? I mean expose children to a very serious illness without offering anything in return”
