Federal civil servants can limit the recommendations for the Covid vaccine
This autumn, only older Americans and people with chronic health problems can be asked to receive the Covid shot – provided that the vaccine is available at all.
For years, scientific advisors for the control and prevention of diseases have been discussing whether the Americans should continue to recommend 6 months aged at the age of older Americans or to switch to a so -called risk -based strategy that is only the most at risk, as in most other countries.
The advisors are expected to make a path forward at a meeting in June. But the debate may have become irrelevant. New requirements for clinical tests from vaccines that were announced at the beginning of this month can delay the availability of recordings that were previously updated annually without complicated studies.
“Significant updates of existing vaccines – e.g.
This category includes the Covid shots and “May”, according to Andrew Nixon, a spokesman for HHS, even includes the seasonal flu vaccine.
The Food and Drug Administration has already asked Novavax for more clinical data before you agree to your Covid vaccine. (Currently it is an emergency permit for people aged 12 and over, not full approval.)
“We would like to see vaccines that are available for people with high risk, and at the same time we want good science, some good clinical data,” said Dr. Marty Makary, who heads the agency, reporters at a conference on Thursday.
The officials in Washington also asked great questions from CDC scientists about Covids toll at children under the age of 12, an indication that they may consider the use of the vaccine in this age group, according to an official who did not want to be identified for fear of retaliation.
The Wall Street Journal reported on Thursday that HHS is planning to no longer recommend the Covid vaccine for children and pregnant women, and cited people who are familiar with the matter.
In May 2021, Robert F. Kennedy Jr. tried to emphasize the approval for the shots in a petition to the FDA, which he wrongly said that vaccines had killed more people than the virus.
The executives that he in the agencies he leads, including Dr. Makary, installed, were also pronounced critics of annual covid recordings, especially for children.
The latter agree on many public health experts, including some advisors to the federal authorities. For years she has been suggesting that annual booster recordings could only offer marginal benefits relatively younger, healthy Americans.
“I think what Dr. Makary says is that the vaccine may not add as much if everyone already has an immunity against the virus, or may only add something in certain subpopulations,” said Dr. Philip Krause, a former FDA vaccine regulatory authority. “I think it's a reasonable question to know the answer.”
(Dr. Krause resigned from the FDA in autumn 2021 because he believed that there was not enough evidence to support Covid Booster shots for adults.)
The CDC already collects data on the advantages of the Covid vaccines that have decreased over time because more Americans gain greater immunity against the coronavirus.
However, the vaccine should be available to some people, including adults aged 75 and over, who have a high risk, such as Dr. Krause and other experts found.
“In my opinion, the data of the CDC provides quite strong evidence that there are some people who still benefit a lot from the vaccines,” he said. “There are still more fatal deaths than we want.”
Mr. Kennedy incorrectly claimed that none of the vaccines that were routinely offered for children was tested in placebo clinical exams, which was tested by several groups of scientists and by Senator Bill Cassidy, Republican of Louisiana, for a strong refusal of Louisiana, whose coordination of Mr. Kennedy's nomination is Health secretary of the healthcare system.
Some experts fear that the new federal limits are only the first steps in a campaign to undermine the use of all vaccines, including those in the immunization plan in childhood by increasing doubts about their security and imposing requirements for companies to continue.
“I think
Tara Smith, epidemiologist at Kent State University College of Public Health, who follows the anti-Accycine movement, said that there were jubilation between some groups that all vaccines, including decades of flu vaccine, could be questioned.
“I think everything is a goal,” she said.
Covid's deaths have dropped every year since the beginning of pandemic, although there were still around 1,000 deaths per week in the last winter summit. The vast majority occurred in adults from the age of 75.
At the beginning of this month, Federal Officials of the CDC sent an urgent application to the annual number of deaths in connection with Covid in children under the age of 12, according to an official with knowledge of the matter.
At the end of August, the agency reported 150 pediatric deaths, a number that is comparable to the deaths of children in a typical flu season.
“I think we all support the pediatric use of flu vaccine,” said Michael Osterholm, an expert in infectious diseases at the University of Minnesota. If Covid is roughly as risky for children, “it is difficult for me not to at least allow the vaccine available.”
The number of deaths in children only seems to be low compared to deaths in adults, said Sean O'Leary, chairman of the committee for infectious diseases of the American Academy of Pediatrics.
“This is the wrong way to look at it because pediatric deaths are actually quite rare,” he said. If the vaccine were completely withdrawn for small children, “I would have a big problem with it. These children have a higher risk of hospital stays.”
Dr. Krause said he was confused that the pediatric vaccine was not fully approved by the emergency permit, while the FDA was fully approved years ago
It may be that the FDA has access to data you have prevented from approving the shot, he said. “Apart from that, there are probably some children who would benefit from the vaccine,” he said.
The FDA did not work out about the additional tests of COVID vaccines. However, officials may offer clarity before the agency's scientific advisors meet next week to discuss vaccines for autumn.
It would be unethical to offer the participants a placebo in a randomized study if the virus still represents risks. And the results of new attempts would not be available in time for autumn, according to experts.
“In order to create new requirements for vaccines, there should be evidence that this would have an advantage for the public,” said Dr. Eric Rubin, one of the FDA consultants and editor -in -chief of the New England Journal of Medicine.
“Of course, the problem is if you get involved with what the answer is instead of looking at the data objectively,” he said.
Some of the CDC consultants had mixed feelings, even if they switch to risk -based vaccine recommendations.
Such guidelines are useful in countries with universal health insurance, they said. In the United States, however, insurance companies do not have to pay for a vaccination that is not recommended by the CDC
This can leave a vaccine that is too expensive for some that need it and are not explicitly included in a risk -based recommendation. A flat -rate recommendation can be more effective, some experts said.
“Vaccinations for children who have never been vaccinated, people with risk factors are of crucial importance,” said Dr. Denise Jamieson, one of the CDC consultants.
However, it is unclear whether the consultants fluctuate a lot. Recommendations that you made in April for the use of several vaccines that are usually immediately accepted by the CDC have not yet been approved by an agency manager.
The CDC has no constant director. Matthew Buzzelli, which Mr. Kennedy referred to as acting director on Wednesday, is a lawyer. Another civil servant at HHS, Dr. William Archer has sent the CDC several questions about the recommendations of the consultants.
Dr. According to Reuters, Archer has repeatedly discussed the “restrictions” of the Covid vaccine on social media.
In a query considered by the New York Times, he informed the agency employee that he needed “more justification” for a recently carried out recommendation to expand the use of the respiratory syncytial vaccine.
