Larry Saltzman has blood cancer. He is also a retired doctor, so he knows that getting COVID-19 can dangerous for him his underlying disease brings him a high risk of serious complications and death. To prevent him from getting sick, he stays away from large meetings, and he has been comforted to know that healthy people who get boosters protect him by reducing his virus exposure.
So far that is.
Vaccine opponents and skeptics responsible for federal health authorities – starting at the top of health and human service secretary Robert F. Kennedy Jr. – limit access to Covid shots that were a signature of President Donald Trump’s first term and taxpayers over $ 13 billion to developProduce and distribute. The agencies limit vaccination recommendations, urges drug makers to perform expensive clinical studies and to take other steps that will lead to fewer people getting protection against a virus that still kills hundreds Every week in the US
“There are hundreds of thousands of people who trust these vaccines,” said Saltzman, 71, from Sacramento, California. “For people who are immunocromitated, if not enough people have been vaccinated, we lose the ring that protects us. We are completely vulnerable.”
The Trump administration on 20 May rolled out the harder approval requirements for COVID shots, described as a COVID-19 “Vaccination Regulatory Framework”, so that millions of Americans can leave behind that boosters cannot get them.
The FDA will encourage new clinical tests on the commonly used vaccines before they are approved for children and healthy adults. The requirements can cost drug makers tens of millions of dollars and will probably leave boosters largely out of reach this fall for hundreds of millions of Americans.
Under The new guidanceVaccines will be available for people with high risk and seniors. But the FDA will encourage medicine makers to commit to conducting clinical tests after marketing in healthy adults when the Agency Covid vaccines approves those populations.
The shots in the past five years are recommended By the Centers for Disease Control and Prevention for everyone from 6 months and older. They are available every fall after they have been updated to display the circulating tribes of the virus, and the vaccines have proved to be safe and effective in clinical examinations.
Vinay Prasad, who leads the FDA division that supervises vaccines, called “Distrust of the American public” while announcing the new guidelines during a briefing of 20 May.
“We launched this multi -year campaign from Booster na booster after booster,” he said, adding that “we don’t have a gold standard of science to support this for Americans with an average risk, low risk.”
The details were described in an article of 20 May in The New England Journal of MedicineWritten by FDA Commissioner Marty Makary. He and Prasad later followed the briefing, which appeared the same day On YouTube.
The added access limits are not the result of recent data that show that there are new health risks of the COVID vaccines. Instead, they reflect a different regulatory attitude than Kennedy, which has a history of anti-vaccin activism, and Makary, who has interviewed the safety data on COVID-MRNA recordings.
The announcement of a major legal change in a medical journal and YouTube video is a very unusual approach that still leaves many questions about the implementation unanswered. It remains unclear when the changes will come into effect or whether there will be a public commentary period. The changes were announced by the administration before one FDA advisory committee -meeting on May 22 To consider the COVID vaccinus information 2026.
It is a sharp reversal of the first Trump administration, which Launched Operation Warp Speed – The effort that led to the development of Covid’s shots. Trump called the vaccines the ‘gold standard’ and a ‘monumental national performance’.
Concern about higher transmission
The announcement rattles some interest groups for patients, doctors, leaders of nursing homes and researchers who are concerned about the consequences. They say that individuals with a higher risk will become COVID more often if people who do not risk do not get boosters who can help reduce the transmission. And they say that the limitations of the FDA go too far, because they offer no exceptions for healthy people who work in risky institutions, such as hospitals, who may want a COVID booster for protection.
The limits will also make it more difficult to get insurance coverage for the vaccines. And the new position of the FDA could also increase the hesitation of the vaccine by undermining trust in Covid vaccines that have already been Subject to rigorous safety review, said Kate Broderick, Chief Innovation Officer at Maravai Life Sciences, who makes MRNA products for use in vaccine development.
“For the public it raises questions,” she said. “If someone is worried, I would like him to know about all vaccines, those with the most understood safety profile are probably COVID-19 vaccines. An incredible amount of data and more than 10 billion doses have been given.”
Some doctors and epidemiologists say that healthy people can leave particularly vulnerable if more virulent Covid strains come up and they do not have access to Covid recordings.
“It is not based on science,” said Rob Davidson, a first aid in Michigan and executive director of the Committee to protect healthcareHe works to expand health care access. “It is what we were all worried about, it would happen. It risks the lives of people.”
The current federal supervisors say that there is no high -quality evidence that shows that vaccination of healthy people, including health workers who are near or around immunocomromous people, offers an additional advantage.
“It is actually possible that such approvals and strategies offer false reassurance and lead to increased damage,” said Prasad.
The Covid -vaccines underwent clinical examinations to assess safety, and they are subject to Current supervision and monitoring Because they obtained the authorization of emergency use of the FDA in the midst of the pandemic. Heart problems and allergic reactions can occur, but are rare, According to the CDC.
On a separate number, the FDA posted letters sent to makers of The mrna Covid -vaccines Unpleasant Add information About possible heart injury about warning labels, a movement that described a former official of the agency as Overkill. The promotion came after the permanent subcommittee for research, a panel of the Senate Homeland Security and Governmental Affairs Committee, hearing About alleged side effects related to Covid -vaccines.
Limiting boosters to healthy people goes against the guidance of some medical groups.
“The COVID-19 vaccine is safe, effective and the best way to protect children,” said Sean O’Leary, chairman of the Commission for infectious diseases at the American Academy of Pediatrics, in an e-mail. “Young children under the age of 5 remain the highest risk, whereby that risk decreases as they get older.”
No -supported claims about mrna -vaccines
The Covid Booster Clampdown is supported by many supporters of the “Make America Remory Again” movement, which suspects traditional medicine. Some opponents of Covid mrna -vaccines say without proof that the shots cause “turbo” cancer, are genetic Bioweapons and cause more heart damage than the Covid virus.
There is no evidence that the shots lead to fast and aggressive cancers. Cancer rates fell on average 1.7% per year for men and 1.3% for women from 2018 to 2022, according to the National Institutes of Health. The Covid -vaccines debuted in 2021.
Federal supervisors say that narrowing who can get the boosters will tailor the US to the policy of European countries. But other countries have enormous economic structures for healthcare and approaches for preventive care. For example, many European countries do not recommend flu shots for the entire population. The US does partly because of the financial drainage that is attributed to lost productivity when people are sick.
They also want more information. “I think there is a void of data,” Makary told CBS News on April 29. “And I think instead of allowing that emptiness to be filled with opinions, I would like to see some good data.”
A massive five-year study on COVID vaccine safety due to the Global Vaccine Data Network, with millions of people, was underway, with about a year about before completion. The Trump Government Financing finished for the project As part of cuts focused through the efficiency of the President’s Department of Government, and the work on the study has stopped for the time being.
However, there are a large number of studies into the effectiveness of the vaccines in preventing serious illness, hospitalization and death.
Restriction of boosters for healthy people can be risky, some doctors say, because people do not always know when they fall into categories with a higher risk, such as individuals who are prediabetically or have high blood pressure. The limitations of Covid -vaccine can prevent them from stimulating, and they can experience worse complications of the virus. For example about 40% of people with hepatitis C are not aware of their situation, according to a study published in 2023.
The number of people who get COVID vaccins has fallen considerably since the height of the crisis. More than half of the more than 258 million adults in the US had received a Covid vaccination from May 2021, According to the CDC. In each of the last two seasons, less than 25% of Americans received boosters, according to CDC data.
While the deaths from the virus have fallen, Covid remains a risk, especially when cases peak in December and January. Weekly Covid -Sterfaren amounted to 2,580 in January 2024, according to CDC -data.
Some people with a high risk are concerned that the new limitations are only the first Salvo to stop all access to MRNA recordings. “The HHS motivation is really hidden and it is to dismiss all MRNA technology,” said Michael Osterholm, an epidemiologist at the University of Minnesota.
NIH officials have told scientists to remove references to mrna in subsidy applications. HHS also announced plans in May to develop new vaccines without mrna technology, which Messenger -RNA uses to instruct cells to make proteins that cause an immune response.
Rose Keller, 23, is concerned about future access to Covid shots. She would be eligible under the current announcement – she has cystic fibrosis, a progressive genetic disorder that makes the mucus in her lungs thick and sticky, so Covid could land her in the hospital. But she is worried that the Trump government can continue and reduces access to the vaccines as part of a broader opposition against MRNA technology.
“I have every booster that is available for me,” said Keller, a government officer in Augusta, Maine. “It is a real concern if I have no protection of a Covid booster.”
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