Latest news with #HHS
Yahoo
an hour ago
- Business
- Yahoo
HHS slams 'under-tested' mRNA technology as Trump cuts Moderna's vaccine funding
President Donald Trump's Department of Health and Human Services (HHS) is terminating awards totaling more than $750 million dollars that were provided to pharmaceutical manufacturer Moderna to help facilitate its production of mRNA-based bird flu vaccines. During President Joe Biden's final week in office, his administration awarded $590 million to Moderna to help speed up its production of mRNA-based vaccines. The $590 million award followed a separate $176 million award Biden gave to Moderna earlier last year for mRNA vaccine technology. Messenger RNA vaccines are a newer type of vaccine technology, which was utilized by companies like Moderna and Pfizer to develop their COVID-19 vaccines. The vaccine technology was at the center of a lot of criticism amid the coronavirus pandemic for potentially being associated with adverse side effects in some people who took them, such as myocarditis. Military Spouse And Mom Of 5 Fights Back As Vaccine Dispute Blocks Family's Permanent Change Of Station Trump administration officials previously hinted at the potential that this funding could be terminated, citing a lack of oversight during the Biden administration pertaining to vaccine production. "After a rigorous review, we concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable," HHS Communications Director Andrew Nixon said. "This is not simply about efficacy — it's about safety, integrity, and trust. The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public." Read On The Fox News App Trump Fda Overhauls Covid-19 Vaccine Approval To Focus On Older Populations, High-risk Individuals The announcement reflects a larger shift in federal vaccine priorities, after HHS Secretary Robert F. Kennedy Jr. announced earlier this week that COVID-19 vaccines would be removed from the federal government's list of recommended vaccines for children and pregnant women. Meanwhile, a report from Senate Republicans released earlier this month suggested the Biden administration withheld critical safety data and downplayed known risks tied to the mRNA COVID-19 vaccine. In particular, the Senate report focuses on HHS' awareness of, and response to, cases of myocarditis — a type of heart inflammation — following COVID-19 vaccination. "Rather than provide the public and health care providers with immediate and transparent information regarding the risk of myocarditis following mRNA COVID-19 vaccination, the Biden administration waited until late June 2021 to announce changes to the labels for the Moderna and Pfizer COVID-19 vaccines based on the 'suggested increased risks' of myocarditis and pericarditis," the Senate report states. "Even though CDC and FDA officials were well aware of the risk of myocarditis following COVID-19 vaccination, the Biden administration opted to withhold issuing a formal warning to the public for months about the safety concerns, jeopardizing the health of young Americans." In response to the Trump administration's funding termination, Moderna put out a press release acknowledging the move, but also touting the "safety profile" observed amid its work on a new mRNA bird flu vaccine. "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program," said Stéphane Bancel, Chief Executive Officer of Moderna. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats."Original article source: HHS slams 'under-tested' mRNA technology as Trump cuts Moderna's vaccine funding
CNN
an hour ago
- General
- CNN
HHS letter tells health care providers to disregard treatment protocols for trans people, adhere to report by unnamed authors
The US Department of Health and Human Services said Wednesday that Secretary Robert F. Kennedy Jr. sent a letter urging health care providers and medical boards to update treatment protocols for youth with gender dysphoria based on a controversial HHS review of scientific literature that was released earlier this month. The HHS report, released May 1, says it is 'not a clinical practice guideline,' but Kennedy's letter warns providers against relying on science-based professional guidelines and urges them to use the government document to inform their practice instead. The letter also said that HHS is committed to protecting whistleblowers and may soon create new policies and oversight actions to 'hold providers that harm children accountable.' The Centers for Medicare and Medicaid Services - a subagency of HHS - also announced Wednesday that it was launching an oversight initiative into hospitals that performed 'experimental sex trait modification procedures' on children. Administrator Dr. Mehmet Oz said CMS 'will not turn a blind eye to procedures that lack a solid foundation of evidence and may result in lifelong harm.' Oz added that he was concerned about the 'profits related to these harmful procedures.' Research shows that gender-affirming surgery is rarely performed on transgender or gender-diverse children or teens in the US, and professional medical organizations do not recommend surgery for children as part of gender-affirming care. Kennedy's letter, which HHS shared Wednesday on social media, warns providers to avoid relying on guidelines from the World Professional Association for Transgender Health on care for transgender and gender-diverse people. 'These and other guidelines based on the so-called 'gender-affirming' model of care should not be relied upon to harm children any further,' the letter says. Kennedy urges providers to read HHS's review of the scientific literature on care for trans individuals and 'update your treatment protocols and training to ensure that our nation's children are protected from harm.' In the US, care for gender dysphoria – an official diagnosis of a condition in which an individual feels significant distress because of a mismatch between the sex they were assigned at birth and their sense of their gender – is tailored to an individual's needs and is typically offered through a multidisciplinary team of doctors. Not everyone who identifies as transgender or gender-diverse has this diagnosis. Gender-affirming care is guided by several professional association guidelines, based on decades of research that shows that it is safe and that it can have a positive impact on a person's life and mental health. Major medical associations – including the American Medical Association, the American Psychiatric Association, the Endocrine Society, the American Psychological Association, the American Academy of Pediatrics and the American Academy of Child & Adolescent Psychiatry – have affirmed the practice of gender-affirming care and agree that it's clinically appropriate and can provide lifesaving treatment for children and adults. The 400-page review that Kennedy's letter referenced was initiated by an executive order from President Donald Trump that called gender-affirming care 'chemical and surgical mutilation' and stated that the federal government would not 'fund, sponsor, promote, assist or support' any kind of gender-affirming care for people under the age of 19. When the report was released, HHS refused to identify who wrote it. HHS said parts of it were peer-reviewed, but it would not disclose which parts or identify who reviewed it. The report spelled out that 'it is not a clinical practice guideline, and it does not issue legislative or policy recommendations.' Rather, it included sections on evidence, ethical considerations, psychotherapy and 'clinical realities' focused on treatment of gender dysphoria in young people. The review did not examine the treatment of adults. The report said that the science used to inform the practice of gender-affirming care was weak and that the practice was harmful. It also sharply criticized US medical associations for what it said was suppression of dissent among members on the issue. The Endocrine Society, a professional group whose guidelines are also mentioned in Kennedy's new letter, said in an email Wednesday that its guideline development process 'adheres to the highest standards of trustworthiness and transparence.' 'The widely accepted view of the professional medical community is that medical treatment is appropriate for transgender and gender-diverse teenagers who experience persistent feelings of gender dysphoria. Medical studies show that access to this care improves the well-being of transgender and nonbinary people,' the group said. The American Academy of Pediatrics said when the HHS report was issued that it was 'deeply alarmed' and that the report relied on 'select perspectives and a narrow set of data,' the group's president, Dr. Susan Kressly, said at the time. 'This report misrepresents the current medical consensus and fails to reflect the realities of pediatric care,' Kressly said in a statement. Gender-affirming care in the US typically starts with a conversation between the individual and a clinician. If the patient is a child, the conversation will involve the family or caregiver when possible. Once the clinician understands what the individual needs, they will design a plan with a team of providers. The practice can include mental health care, support groups and even legal help. When a person is past the start of puberty, their care may include hormones, but not everyone chooses to use them. When a person is an adult, a patient may also seek out surgery to better align their body with their gender. A 2024 study of medical insurance claims in the US from 2019, the latest year available, found that there were no gender-affirming surgeries performed on transgender youth 12 and younger. For older teens and adults, the rates of gender-affirming surgery with a trans or gender diverse-related diagnosis were 2.1 per 100,000 and 5.3 per 100,000, respectively, the study said. Transgender people have been a major focus of the second Trump administration. Soon after his inauguration, Trump signed executive orders that denied the existence of transgender people and instructed government agencies to acknowledge a strict gender binary and withdraw any support for people who identified otherwise. The administration has cut hundreds of millions of dollars in funding used to study trans issues and removed information about transgender people from government websites. Trump has ordered trans troops out of the military, and on Tuesday, he threatened to withhold federal funding from California over a transgender athlete's participation in an upcoming sporting event. Earlier this year, the administration moved to strip funding from Maine, to include funding that fed children and disabled adults, because the state allows trans students to compete in athletics. Gender-affirming care for youth has also been a growing target for state governments. As of March, 27 states have enacted restrictions on such care, meaning about 40% of trans youth live in a state with limited gender-affirming health care options, according to KFF, a health policy organization.
CNN
an hour ago
- General
- CNN
HHS letter tells health care providers to disregard treatment protocols for trans people, adhere to report by unnamed authors
LGBTQ issues Federal agenciesFacebookTweetLink Follow The US Department of Health and Human Services said Wednesday that Secretary Robert F. Kennedy Jr. sent a letter urging health care providers and medical boards to update treatment protocols for youth with gender dysphoria based on a controversial HHS review of scientific literature that was released earlier this month. The HHS report, released May 1, says it is 'not a clinical practice guideline,' but Kennedy's letter warns providers against relying on science-based professional guidelines and urges them to use the government document to inform their practice instead. The letter also said that HHS is committed to protecting whistleblowers and may soon create new policies and oversight actions to 'hold providers that harm children accountable.' The Centers for Medicare and Medicaid Services - a subagency of HHS - also announced Wednesday that it was launching an oversight initiative into hospitals that performed 'experimental sex trait modification procedures' on children. Administrator Dr. Mehmet Oz said CMS 'will not turn a blind eye to procedures that lack a solid foundation of evidence and may result in lifelong harm.' Oz added that he was concerned about the 'profits related to these harmful procedures.' Research shows that gender-affirming surgery is rarely performed on transgender or gender-diverse children or teens in the US, and professional medical organizations do not recommend surgery for children as part of gender-affirming care. Kennedy's letter, which HHS shared Wednesday on social media, warns providers to avoid relying on guidelines from the World Professional Association for Transgender Health on care for transgender and gender-diverse people. 'These and other guidelines based on the so-called 'gender-affirming' model of care should not be relied upon to harm children any further,' the letter says. Kennedy urges providers to read HHS's review of the scientific literature on care for trans individuals and 'update your treatment protocols and training to ensure that our nation's children are protected from harm.' In the US, care for gender dysphoria – an official diagnosis of a condition in which an individual feels significant distress because of a mismatch between the sex they were assigned at birth and their sense of their gender – is tailored to an individual's needs and is typically offered through a multidisciplinary team of doctors. Not everyone who identifies as transgender or gender-diverse has this diagnosis. Gender-affirming care is guided by several professional association guidelines, based on decades of research that shows that it is safe and that it can have a positive impact on a person's life and mental health. Major medical associations – including the American Medical Association, the American Psychiatric Association, the Endocrine Society, the American Psychological Association, the American Academy of Pediatrics and the American Academy of Child & Adolescent Psychiatry – have affirmed the practice of gender-affirming care and agree that it's clinically appropriate and can provide lifesaving treatment for children and adults. The 400-page review that Kennedy's letter referenced was initiated by an executive order from President Donald Trump that called gender-affirming care 'chemical and surgical mutilation' and stated that the federal government would not 'fund, sponsor, promote, assist or support' any kind of gender-affirming care for people under the age of 19. When the report was released, HHS refused to identify who wrote it. HHS said parts of it were peer-reviewed, but it would not disclose which parts or identify who reviewed it. The report spelled out that 'it is not a clinical practice guideline, and it does not issue legislative or policy recommendations.' Rather, it included sections on evidence, ethical considerations, psychotherapy and 'clinical realities' focused on treatment of gender dysphoria in young people. The review did not examine the treatment of adults. The report said that the science used to inform the practice of gender-affirming care was weak and that the practice was harmful. It also sharply criticized US medical associations for what it said was suppression of dissent among members on the issue. The Endocrine Society, a professional group whose guidelines are also mentioned in Kennedy's new letter, said in an email Wednesday that its guideline development process 'adheres to the highest standards of trustworthiness and transparence.' 'The widely accepted view of the professional medical community is that medical treatment is appropriate for transgender and gender-diverse teenagers who experience persistent feelings of gender dysphoria. Medical studies show that access to this care improves the well-being of transgender and nonbinary people,' the group said. The American Academy of Pediatrics said when the HHS report was issued that it was 'deeply alarmed' and that the report relied on 'select perspectives and a narrow set of data,' the group's president, Dr. Susan Kressly, said at the time. 'This report misrepresents the current medical consensus and fails to reflect the realities of pediatric care,' Kressly said in a statement. Gender-affirming care in the US typically starts with a conversation between the individual and a clinician. If the patient is a child, the conversation will involve the family or caregiver when possible. Once the clinician understands what the individual needs, they will design a plan with a team of providers. The practice can include mental health care, support groups and even legal help. When a person is past the start of puberty, their care may include hormones, but not everyone chooses to use them. When a person is an adult, a patient may also seek out surgery to better align their body with their gender. A 2024 study of medical insurance claims in the US from 2019, the latest year available, found that there were no gender-affirming surgeries performed on transgender youth 12 and younger. For older teens and adults, the rates of gender-affirming surgery with a trans or gender diverse-related diagnosis were 2.1 per 100,000 and 5.3 per 100,000, respectively, the study said. Transgender people have been a major focus of the second Trump administration. Soon after his inauguration, Trump signed executive orders that denied the existence of transgender people and instructed government agencies to acknowledge a strict gender binary and withdraw any support for people who identified otherwise. The administration has cut hundreds of millions of dollars in funding used to study trans issues and removed information about transgender people from government websites. Trump has ordered trans troops out of the military, and on Tuesday, he threatened to withhold federal funding from California over a transgender athlete's participation in an upcoming sporting event. Earlier this year, the administration moved to strip funding from Maine, to include funding that fed children and disabled adults, because the state allows trans students to compete in athletics. Gender-affirming care for youth has also been a growing target for state governments. As of March, 27 states have enacted restrictions on such care, meaning about 40% of trans youth live in a state with limited gender-affirming health care options, according to KFF, a health policy organization.
Time of India
an hour ago
- Health
- Time of India
Trump administration cuts $766 million in funding to Moderna for bird flu, pandemic vaccine projects
(Representative image AP) The Trump administration has slashed $766 million allocated in funding to Moderna Inc., an American biotech and pharmaceutical company responsible for developing vaccines. Moderna was tasked to make vaccines against potential pandemic influenza viruses, as well as the H5N1 bird flu. The Health and Human Services Department had notified the company on Monday about the withdrawal of funds that were awarded through the BARDA (Biomedical Advanced Research and Development Authority) program. HHS is withdrawing funds awarded in January and July this year, intended to finance the development and purchase of the company's investigational vaccine. Moderna had received $590 million in January and $176 million in July in funding meant to help judge the efficacy of the vaccines for bird flu and other pandemic viruses, as said by a company Spokesperson. Health secretary Robert F. Kennedy has expressed his concerns regarding the company's vaccines despite evidence that vaccines developed by Moderna are safe and have saved millions of lives before. 'While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis," said the company in a statement as reported by AP. Using the same technology used to develop and roll out vaccines during the Covid-19 pandemic, Moderna has developed a new vaccine called mRNA-1018. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Ida y vuelta a España desde 589$ Plus Ultra Compra ahora Undo On the other hand, a new, highly contagious variant of Covid-19 has surfaced in the US known as NB. 1.81. Initially detected in late March and early April among international travelers, cases have since been identified in New York, Ohio, California, Rhode Island, Hawaii, Washington State, and Virginia. Last year, the H5N1 bird flu virus spilled from wild birds into cattle and ended up infecting hundreds of animals across several states. 70 people reported sick with the flu, and one person died. Scientists have warned that continued alteration or evolution in the virus can make it more potent and ultimately lead to a pandemic.
Bloomberg
2 hours ago
- Business
- Bloomberg
RFK Jr. Slams Medical Journals, Floats In-House Publishing Plan
US Health and Human Services Secretary Robert F. Kennedy Jr. said he may bar government scientists from publishing in top medical journals, accusing publications like The New England Journal of Medicine of being 'corrupt' and beholden to pharmaceutical companies. 'We're probably going to stop publishing in the Lancet, New England Journal of Medicine, JAMA and those other journals because they're all corrupt,' Kennedy said on ' The Ultimate Human ' podcast with wellness influencer and biohacker Gary Brecka.
