The Food and Drug Administration provides major changes for the way vaccines are transported and which will be able to obtain the photos updated this fall.
In an article published Tuesday in the New England Journal of Medicine, the FDA commissioner, Dr. Marty Makary, and Dr. Vinay Prasad, the new FDA vaccine chief, wrote that any new cocvid vaccine must now undergo a real vaccine, while others get an inactive substance like a saline, to compare the results.
During a planned meeting of the FDA vaccine panel on Thursday, the agency’s advisor is expected to advise vaccines that tend to target for new blows. The new clinical trial requirement should not affect the deployment of autumn for the elderly and other people at high risk of serious illness because the drug manufacturers are exempt from additional tests for these groups.
Makary and Prasad said in a question and answer session later on Tuesday that annual shots for healthy children and adults would no longer be systematically approved. They also suggested that vaccines cannot be updated each year.
“Instead of having a covid strategy that is from year to year, why don’t we let science tell us when we should change?” Said Prasad. “The virus has no calendar.”
Previously, updated covid vaccines had been erased by the FDA similar to the flu vaccines.
The original cocovated blows of Pfizer and Moderna, approved at the end of 2020, underwent tests controlled by placebo. Then, the manufacturers of drugs went to smaller studies to test to what extent the updated shots have triggered an immune response against current variants circulating in the United States
In the journal article, Makary and Prasad questioned the flu vaccine model, noting that only a quarter of people in the United States obtain updated photos each year, including less than a third of health workers.
In comparison, approximately 75% of health workers receive vaccines against seasonal flu, according to data from centers for Disease Control and Prevention.
The covid shooting policy, wrote the officials: “has sometimes been justified by arguing that the American people are not sufficiently sophisticated to understand the recommendations based on age and risks.”
“We reject this view,” they added.
Dr. Jesse Goodman, professor of medicine and infectious diseases at the University of Georgetown and former FDA chief scientist, agreed that people can understand their own health risks, but were skeptical about the new approach of the agency, saying that it limits the “freedom to choose” people.
“What about people with parents / roommates at high or high-risk risks?”, He wrote in an email. “What about people who are not at increased risks of serious illnesses who wish to reduce their risk of infection or labor leave?” Asked Goodman.
During the webdiffusion, Prasad said “there is no high-quality evidence that you get a booster to visit your grandmother protects your grandmother.”
Who can get the co -vored photos?
As part of the new FDA directives, drug manufacturers will have to organize new trials that follow participants for at least six months.
The main objective of the trials should be to show that the shots help prevent the symptomatic cocoat, have written those responsible, with data showing at least 30% of efficiency. People who have had coated sites in the past should always be included in the trial to better reflect the general population, they said.
Drug manufacturers can always use smaller studies, called immunogenicity studies, to obtain the approval of adults aged 65 and over, as well as children and adults with at least one medical condition that presents them at a higher risk of covid.
The FDA said that many people were considered high -risk, including pregnant women and people with obesity or who have mental health problems such as depression. Other conditions related to a serious covidal disease include diabetes, heart disease and asthma.
“In the end, these studies alone can realize that the American rehearsal strategy in perpetuity is based on evidence,” the officials wrote.
Estimates, they said, suggest that 100 to 200 million Americans will have access to updated vaccines.
The FDA’s mandate occurs before the meeting of the Vaccines Consultative Committee on Thursday, where external experts will discuss the strains should be included in the next series of coated plans.
In information documents published on Tuesday, FDA staff wrote that updating vaccines to make the strains in circulation more closely in circulation could “provide additional advantages” in anticipation of an increase in autumn and winter cases.
The change means that it will be almost impossible for Pfizer and Moderna to finish the new tests in time for the fall season. In addition to managing the trials, drug manufacturers will always have to design the trials and register participants, which can also take several weeks or months.
The data should then be analyzed and signed by the FDA.
Nor is we knowing what change will mean for healthy children and adults who want to get updated photos.
Dr. Paul Offer, director of the Vaccine Education Center at the Philadelphia Children’s Hospital and member of the FDA vaccines, said that people considered to be “at low risk” can still be injured by the virus.
“The low risk does not mean any risk,” he said. “I mean that anyone can be hospitalized and killed by the virus.”
Goodman asked why the FDA brought the change instead of the CDC’s independent advisory committee, known as the advisory committee of vaccination practices, which generally makes recommendations on which should obtain the covored plans.
“It is not clear why there was an imperative reason for the FDA to intervene and pre-empt this usual and public advisory process,” he said.
Kennedy’s influence on vaccine rules
A modification of the way the coated vaccines are updated were expected. Earlier this month, the Secretary of Health and Social Services, Robert F. Kennedy Jr., demanded that all new vaccines should undergo clinical trials controlled by placebo.
Until Tuesday, it was not clear if HHS considered the update shots of Pfizer and Moderna, the “new vaccines”, requiring new clinical trials.
The former government’s health officials feared that the FDA, under Kennedy, will move towards the approvals of slowly close -up vaccines.
During the weekend, the FDA approved the Novovax vaccine after weeks late. In an unexpected tour, however, the agency has limited the use of shooting to people 65 and more and adolescents and adults with at least one medical condition that puts them at risk of serious illness. As a rule, it is the CDC that makes recommendations that should obtain vaccines.
Makary had warned against changes in how the vaccines are tested and approved, saying last week that the agency “would soon trigger a massive framework”.
Kennedy has long opposed the vaccines, the firing of which is coche.
In 2021, he submitted a petition of citizens requesting that the FDA revokes the authorization of the hairstyle vaccines.
The same year, he described the shots coded as “the deadliest vaccine ever made”, citing rare cases of myocarditis in young men. Studies reveal that the risk of myocarditis is higher – and generally more serious – in people with an infection wearing only after the vaccine.
Last week, during an audience of the Senate, Education, Labor and Pensions Committee, Kennedy also wrongly warned that the only vaccines tested against a placebo were the couples.
This decision prompted the chairman of the committee, Bill Cassidy, R-La., Then paused at the hearing to correct the Secretary of Health.
“For the record, this is not true. Rotavirus, measles and HPV vaccines have been (evaluated compared to a placebo) and certain vaccines are tested against the previous versions. So, for the record, to settle this straight,” said Cassidy.
Kennedy is not the sole health manager to have criticized coastal vaccines. Makary, Prasad, Dr. Tracy Beth Hoeg, special advisor to Makary, and Dr. Jay Bhattacharya, chief of the National Institutes of Health, also.
