The Secretary in the United States of Health and Social Services, Robert F. Kennedy Jr., announced Tuesday that the COVVI-19 vaccine will no longer be part of the vaccines recommended for pregnant women and healthy children in the United States Centers for Disease Control and Prevention.
THE vaccination calendar Published online had not changed halfway through.
Kennedy announced the unusual step in a video Published on social networks. He was flanked by the American Commissioner of Food and Drug Administration, Dr. Marty Makary and the director of the National Institutes of Health, Dr. Jay Bhattacharya.
“To date, the vaccine is coded for healthy children and healthy pregnant women has been removed from the vaccination calendar recommended by the CDC,” said Kennedy. “Last year, the Biden administration exhorted healthy children to get another covid shot, despite the lack of clinical data to support the repeated recall strategy in children.”
Kennedy did not propose any scientific evidence to justify the change in recommendations.
But experts say that change will have devastating consequences, especially for pregnant women and their babies. Both are considered At a higher risk of serious complications of COVVI-19 infections. Studies have found This COVVI-19 vaccination reduces the risk of hospitalization for pregnant women and infants under 6 months of age.
“This takes place in what we know about security as well as the advantages of COVVI-19 vaccination for young children and pregnant women,” said a person familiar with CDC deliberations on his vaccine recommendations, who asked not to be appointed for fear of reprisals.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement on Tuesday that “science has not changed. It is very clear that the infection codes during pregnancy can be catastrophic and cause major disability, and this can cause devastating consequences for families. The cocvid vaccine is safe during pregnancy and vaccination can protect our patients and children. ”
“In fact, growing proofs show how vaccination during pregnancy protects the child after birth, with The vast majority of hospitalized infants Less than six months – those who are not yet eligible for vaccination – born of non -vaccinated mothers, “added Fleischman.
Kennedy’s decision can affect insurance coverage as well as the government’s purchase of the shots, experts said.
“The result will be that COVVI-19 vaccines are less affordable and less available,” said Dr. Paul Offit, pediatrician and director of the Vaccines Education Center at the Philadelphia Children’s Hospital.
The announcement contrasts strongly with what Kennedy has said since he became secretary of the HHS. “I have always said during my campaign – and each party, each public declaration that I made – I will not remove the vaccines from people to them”, he said to CBS in April. “What I’m going to do is make sure we have a good science so that people can make an informed choice.”
But, Offer said on Tuesday, “he lied, because that’s exactly what he does. He takes them.”
By announcing the change, Kennedy has circumvented the normal government process to assess and recommend vaccines for Americans.
As a rule, the FDA assesses the safety and efficiency of vaccines by examining clinical trial data and other research. Once the FDA has approved a vaccine, the CDC and its independent vaccination expert committee, called the advisory committee on vaccination practices or the AIPI, recommend how a vaccine should be used, including which should obtain them and the frequency to which they are necessary. The CDC does not have to accept the recommendations of the APIP, but it generally does.
The recommendations of the AIPI have a regulatory weight. Upon virtue of the Act respecting affordable care, insurance companies must cover vaccines for adults if they have been recommended by the ACIP. The Advisory Committee also votes on the question of whether vaccines should be added to the federal vaccines program for children, which provides vaccines to children who are unable to afford it otherwise.
The revocation of the CDC recommendations for pregnant women and healthy children raises questions about insurance coverage and government purchases of COVVI-19 vaccines for these groups.
Health insurance companies can decide to cover COVID-19 themselves, even without formal recommendation of the CDC. It is likely that they do it, since scientific evidence supports vaccines as safe and effective, according to a person familiar with the legal ramifications of the deletion of the CDC recommendation, which asked not to be appointed for fear of reprisals.
This could mean that the Vaccines for Children program will not cover the gunshots, however, said the person.
The Society for Infectious Diseases, a professional organization, said that the decision could make more difficult for millions of Americans to obtain vaccines.
“IDSA strongly urges insurers to maintain the coverage of COVVI-19 vaccines so that all Americans can make the best decisions to protect themselves and their families against serious illnesses, hospitalization and death,” said group president, Dr. Tina Tan, in a statement. “IDSA also urges Congress to propose significant and necessary monitoring to guarantee the appropriate decision -making processes at the Ministry of Health and Social Services, which will have an impact on people of all ages.”
Other experts said Kennedy’s announcement could be challenged in court.
“It’s really poor administrative procedure,” wrote Dorit Reiss, professor of law at the University of California in San Francisco in a post on social networks.
“Under administrative law, avoiding being found arbitrary and capricious, the decision of an agency must meet certain criteria, in particular by explaining the conclusion of the facts of the agency, a link between facts and decisions, etc.”, wrote Reiss. “A one -minute video on Twitter does not quite take you.”
CDC vaccine advisers had already considered a change in the country’s COVVI-19 vaccine recommendations. Instead of the general recommendation according to which every 6 months and more should obtain a updated annual shot, the Committee assesses the opportunity to make recommendations more based on targeted risks, which include everyone aged 65 and over and those with a compromised immune function.
During an April meeting, a majority of members of the working group studying the change said that they had supported the narrowing of the recommendation. The full committee planned to vote on its next meeting in June.
Instead, Makary and Dr. Vinay Prasad, director of the Center for Biologics Evaluation and Research of the FDA, wrote an editorial in the New England Journal of Medicine to announce a change in the way the FDA would approve the COVVI-19 vaccines. The agency said it would require placebo -controlled clinical trials before it contains new vaccines for healthy children and adults 64 and under.
“Although the rapid development of several COVVI-19 vaccines in 2020 represents a major scientific, medical and regulatory realization,” wrote Makary and Prasad, “the benefit of the repeated dose-especially in low-risk people who may have already received multiple doses of COVVI-19 vaccines, had several covid-19 infections, or both-is uncertain.”
They said the new policy would encourage pharmaceutical companies to generate additional evidence to prove that young adults and healthy children benefit from blows.
Dr. Peter Hooz, Director of Vaccine Development in Texas Children’s Hospital, said this decision seems to go against the Ideals of the Freedom of Health Movement that Kennedy represents.
“This removes the decision from the parents and their pediatricians and is rather a decision now made by the great government – the opposite of the freedom of health adopted by Maha,” said Hooz, using the acronym of Make America Healthy again.
Experts say that although the benefits of COVVI-19 vaccination for pregnant women are clear, evidence is more troubled for children, mainly because there are fewer studies in this age group.
During its last meeting in April, the CDC vaccine advisory committee heard evidence that children represented approximately 4% of all COVVI-19 hospitalizations in last fall and the winter respiratory viruse season.
COVVI-19 hospitalization rates are the highest for the youngest age groups, with babies of less than 6 months at the highest risk. Maternal vaccination can however reduce this risk.
The Committee has also heard evidence on the risk of myocarditis or cardiac inflammation, which is very rarely associated with COVVI-19 vaccination. Myocarditis rates have dropped regularly, and in the fall and last winter, there were only five cases checked in people aged 12 to 40 within 21 days of a COVID-19 PFIZER shot. The researchers, however, saw the same number of cases in a comparison group, which led them to conclude that there was no increased risk of myocarditis associated with COVVI-19 vaccines last season.
Despite this, the FDA has compulsory vaccines Pfizer and Moderna to extend warning labels on their COVVI-19 vaccines on the risk of myocarditis.
