Latest news with #BiomedicalAdvancedResearch
CNN
11 hours ago
- Health
- CNN
HHS slashes funding for mRNA vaccine development
US Health and Human Services is 'winding down' its mRNA vaccine development and will instead fund other vaccine platforms through the Biomedical Advanced Research and Development Authority, the agency said Tuesday. HHS Secretary Robert F. Kennedy Jr. said in a statement that BARDA would terminate 22 mRNA vaccine development investments, suggesting the vaccines 'fail to protect effectively against upper respiratory infections like Covid and flu,' despite evidence they protect against severe disease and death from Covid-19 and show promise against influenza. HHS said some final stage contracts will continue, but 'no new mRNA-based projects will be initiated.' 'We reviewed the science, listened to the experts, and acted,' Kennedy said. 'Going forward, BARDA will focus on platforms with stronger safety records and transparent clinical and manufacturing data practices,' HHS said. 'Technologies that were funded during the emergency phase but failed to meet current scientific standards will be phased out in favor of evidence-based, ethically grounded solutions – like whole-virus vaccines and novel platforms.' Messenger RNA is a single strand of the genetic code that cells can 'read' and use to make a protein. With the Covid vaccine, mRNA instructs cells in the body to make the particular piece of the virus's spike protein. When the immune system sees it, it recognizes it as foreign and is then prepared to attack when there is an actual infection. The vaccines were particularly useful during the Covid-19 pandemic because they can be developed and manufactured quickly. Multiple peer-reviewed studies have shown that mRNA vaccines developed under Operation Warp Speed during the first Trump administration were highly effective at preventing severe disease and were repeatedly demonstrated to be extremely safe. The Trump administration and Kennedy, who has a long history of anti-vaccine claims, had previously said they were evaluating mRNA projects. In May, HHS also terminated a $590 million contract with Modern to develop a vaccine to protect against bird flu. Dr. Peter Hotez, a pediatrician who directs the Center for Vaccine Development at Texas Children's Hospital, said Tuesday's HHS announcement will 'promote their pseudoscience agenda and weaken our nation's biosecurity.' 'The mRNA technology, like all biotechnologies, has strengths and weaknesses, but for a pandemic situation with a new and previously unknown pathogen, or for cancer vaccines and immunotherapeutics it has distinct advantages,' Hotez said. 'HHS under Mr. Kennedy is telling us that we should no longer look to the federal government for innovation in biomedicine. The states are on their own.' HHS said it is canceling BARDA's award to Moderna/UTMB for an mRNA vaccine for H5N1, known as avian flu. It is also terminating contracts with Emory University and Tiba Biotech. Emory has been working on a dry powder mRNA antiviral platform that could be inhaled and Tiba is working on a platform that uses a nanoparticle carrier technology, according to the BARDA website. HHS also said it is 'de-scoping' mRNA-related work in contracts it has with Luminary Labs, ModeX, and Sequirus. HHS said it was also rejecting or canceling multiple pre-award solicitations with proposals from Pfizer, Sanofi Pasteur, CSL Sequirus, Gritstone and others. And it was also restructuring collaborations with the US Department of Defense that would impact nucleic acid-based vaccine projects with AAHI, AstraZeneca and HDT Bio. HHS said the impacted projects were worth about $500 million. 'Other uses of mRNA technology within the department are not impacted by this announcement,' it said. In a statement, Moderna spokesman Kelly Cunningham said, 'We are not aware of any new contract cancellations by BARDA involving Moderna. As previously announced in May, our pandemic flu contract was canceled, and we do not currently have any active collaboration with BARDA.' A spokesperson for Gritstone said the company ceased operations 'as a company some time ago.' AstraZeneca declined to comment. CNN reached out to Tiba Biotech, Emory, Pfizer, ModeX, Luminary Labs, CSL Seqirus and Sanofi for a response. Dr. Paul Offit, a vaccine scientist at Children's Hospital of Philadelphia and an outside vaccine adviser to the FDA criticized Kennedy for making 'a policy decision again that contradicts the scientific data.' 'He has said things like the mRNA vaccines are unnecessarily dangerous,' Offit said. 'It's just wrong. I mean it's actually remarkably safe and it's effective.' 'A decision based on cutting back all this funding based on false statements is just hard to watch,' Offit added. If another pandemic comes 'we'll just be behind the eight ball again,' without additional research into mRNA vaccines. 'All it does is put us at unnecessary risk for no good reason and just a few bad reasons too,' Offit said. Dr. Jake Scott, an infectious diseases doctor in California who worked many long days treating patients during the Covid-19 pandemic, said he lost several patients early in the pandemic, but the mRNA vaccines brought major changes by safely protecting billions of people from severe disease and death. 'I cannot really convey accurately what a profound difference there was in the hospital pre vaccine and post vaccine and that was thanks to the mRNA technology,' said Scott, a clinical associate professor, medicine - infectious disease with Stanford Medicine. To hear that HHS was going to eliminate investment in mRNA vaccines, Scott said, is 'really depressing.' 'This just hits differently. It makes me sad. It's kind of heartbreaking,' said Scott.
Yahoo
2 days ago
- Health
- Yahoo
RFK Jr. is canceling mRNA vaccine development. Can I still get a COVID vaccine?
Health and Human Services Secretary Robert F. Kennedy Jr. revealed his agency will be cutting funding to mRNA development, calling the vaccine technology "ineffective" and claiming it poses more risks than benefits. In a video posted on X Aug. 5, Kennedy said the decision will impact 22 projects worth nearly $500 million at the Biomedical Advanced Research and Development Authority, which helps companies develop medical supplies to address public health threats. Messenger RNA, or mRNA, is used in the two most common COVID-19 vaccines licensed in the U.S. Kennedy's announcement has raised questions about these vaccines, how mRNA works and what this decision means for future research. "This technology played a vital role in our pandemic response and continues to show promise for treating serious diseases," said Jeff Coller, Bloomberg Distinguished Professor of RNA biology and therapeutics at Johns Hopkins University. "As other countries advance these proven, safe and effective therapies, American patients may increasingly depend on foreign innovation for breakthrough treatments." How do mRNA vaccines work? The COVID-19 vaccine works by instructing the body's immune system to recognize the virus and creating fighting antibodies to attack it. Messenger RNA, or mRNA, is a code that tells the body's cells to produce just a piece of the virus, the protein on the surface. The code is protected by a lipid coating, like a fat bubble. mRNA vaccines: RFK Jr. to wind down $500M vaccine development Once injected into the body, the vaccine releases the mRNA to program the cell to produce the spike proteins like those on the surface of SARS-CoV-2, the COVID-19 virus. Our immune system recognizes those vaccine-created spike proteins as invaders and creates antibodies to block future attacks from the virus. Messenger RNA vaccines contain only a fraction of the virus, so unlike some vaccines, they can't give people the disease they're trying to prevent or trigger allergies to eggs or other traditional vaccine ingredients. Should I expect a COVID vaccine this fall? It's unclear whether patients should be expecting COVID-19 vaccines this fall, said Dr. Beth Oller, a family physician in Stockton, Kansas, and clinical instructor at the University of Kansas School of Medicine-Wichita. In June, Kennedy fired all members of the Advisory Committee on Immunization Practices, a key vaccine panel that makes recommendations for COVID-19 and other vaccines, and appointed eight new members. During its first meeting, the committee did not make any recommendations for the fall and isn't expected to reconvene until "September/October," according to the Centers for Disease Control and Prevention website. Kennedy said on May 27 that the COVID-19 vaccine would no longer be included in the CDC's recommended immunization schedule for healthy children and pregnant women, a move that broke with previous expert guidance and bypassed the normal scientific review process. Under the changes, the only people who will be recommended for COVID-19 vaccines are those over 65 and people with existing health problems. This could make it harder for others who want the COVID-19 vaccine to get it, including health care workers and healthy people under 65 with a vulnerable family member or those who want to reduce their short-term risk of infection. The American College of Obstetricians and Gynecologists (ACOG) and American Academy of Pediatrics (AAP), among other organizations, issued statements condemning the change, with the ACOG saying it was "...concerned about and extremely disappointed by the announcement that HHS will no longer recommend COVID-19 vaccination during pregnancy." Will insurance cover my COVID shot? Many consumers are worried about possible cuts to health insurers' coverage of vaccines, a recent poll said. A KFF poll published Aug. 1 found 40% of adults said they will "definitely" or "probably" get a COVID-19 vaccine shot. Of those who intend to get vaccinated, 62% said they are worried insurance won't cover the cost of the vaccine. Groups representing commercial health insurance companies said they still plan to cover vaccines recommended by the CDC and ACIP, the vaccine advisory panel. "Health plans continue to follow federal requirements related to coverage of ACIP-recommended vaccines and will continue to support broad access to critical preventive services, including immunizations," said Tina Stow, spokesperson for AHIP, which represents health insurance companies. COVID: As new variant spreads, what's the latest vaccine guidance? The CDC currently recommends shared decision-making between parents and doctors for immunizing children with the COVID-19 vaccine. It also recommends vaccines for people who are moderately or severely immune compromised. Large employers that provide health insurance benefits for workers and their families will likely continue to cover Food and Drug Administration-approved vaccines, said James Gelfand, president and CEO of the ERISA Industry Committee. In some cases, employer vaccine coverage might follow FDA approvals rather than narrower ACIP Mary Walrath-Holdridge Adrianna Rodriguez can be reached at adrodriguez@ This article originally appeared on USA TODAY: RFK Jr. defunds COVID shot technology. What is mRNA vaccine? Solve the daily Crossword
CNN
3 days ago
- Health
- CNN
HHS slashes funding for mRNA vaccine development
US Health and Human Services is 'winding down' its mRNA vaccine development and will instead fund other vaccine platforms through the Biomedical Advanced Research and Development Authority, the agency said Tuesday. HHS Secretary Robert F. Kennedy Jr. said in a statement that BARDA would terminate 22 mRNA vaccine development investments, suggesting the vaccines 'fail to protect effectively against upper respiratory infections like Covid and flu,' despite evidence they protect against severe disease and death from Covid-19 and show promise against influenza. HHS said some final stage contracts will continue, but 'no new mRNA-based projects will be initiated.' 'We reviewed the science, listened to the experts, and acted,' Kennedy said. 'Going forward, BARDA will focus on platforms with stronger safety records and transparent clinical and manufacturing data practices,' HHS said. 'Technologies that were funded during the emergency phase but failed to meet current scientific standards will be phased out in favor of evidence-based, ethically grounded solutions – like whole-virus vaccines and novel platforms.' Messenger RNA is a single strand of the genetic code that cells can 'read' and use to make a protein. With the Covid vaccine, mRNA instructs cells in the body to make the particular piece of the virus's spike protein. When the immune system sees it, it recognizes it as foreign and is then prepared to attack when there is an actual infection. The vaccines were particularly useful during the Covid-19 pandemic because they can be developed and manufactured quickly. Multiple peer-reviewed studies have shown that mRNA vaccines developed under Operation Warp Speed during the first Trump administration were highly effective at preventing severe disease and were repeatedly demonstrated to be extremely safe. The Trump administration and Kennedy, who has a long history of anti-vaccine claims, had previously said they were evaluating mRNA projects. In May, HHS also terminated a $590 million contract with Modern to develop a vaccine to protect against bird flu. Dr. Peter Hotez, a pediatrician who directs the Center for Vaccine Development at Texas Children's Hospital, said Tuesday's HHS announcement will 'promote their pseudoscience agenda and weaken our nation's biosecurity.' 'The mRNA technology, like all biotechnologies, has strengths and weaknesses, but for a pandemic situation with a new and previously unknown pathogen, or for cancer vaccines and immunotherapeutics it has distinct advantages,' Hotez said. 'HHS under Mr. Kennedy is telling us that we should no longer look to the federal government for innovation in biomedicine. The states are on their own.' HHS said it is canceling BARDA's award to Moderna/UTMB for an mRNA vaccine for H5N1, known as avian flu. It is also terminating contracts with Emory University and Tiba Biotech. Emory has been working on a dry powder mRNA antiviral platform that could be inhaled and Tiba is working on a platform that uses a nanoparticle carrier technology, according to the BARDA website. HHS also said it is 'de-scoping' mRNA-related work in contracts it has with Luminary Labs, ModeX, and Sequirus. HHS said it was also rejecting or canceling multiple pre-award solicitations with proposals from Pfizer, Sanofi Pasteur, CSL Sequirus, Gritstone and others. And it was also restructuring collaborations with the US Department of Defense that would impact nucleic acid-based vaccine projects with AAHI, AstraZeneca and HDT Bio. HHS said the impacted projects were worth about $500 million. 'Other uses of mRNA technology within the department are not impacted by this announcement,' it said. In a statement, Moderna spokesman Kelly Cunningham said, 'We are not aware of any new contract cancellations by BARDA involving Moderna. As previously announced in May, our pandemic flu contract was canceled, and we do not currently have any active collaboration with BARDA.' A spokesperson for Gritstone said the company ceased operations 'as a company some time ago.' AstraZeneca declined to comment. CNN reached out to Tiba Biotech, Emory, Pfizer, ModeX, Luminary Labs, CSL Seqirus and Sanofi for a response. Dr. Paul Offit, a vaccine scientist at Children's Hospital of Philadelphia and an outside vaccine adviser to the FDA criticized Kennedy for making 'a policy decision again that contradicts the scientific data.' 'He has said things like the mRNA vaccines are unnecessarily dangerous,' Offit said. 'It's just wrong. I mean it's actually remarkably safe and it's effective.' 'A decision based on cutting back all this funding based on false statements is just hard to watch,' Offit added. If another pandemic comes 'we'll just be behind the eight ball again,' without additional research into mRNA vaccines. 'All it does is put us at unnecessary risk for no good reason and just a few bad reasons too,' Offit said. Dr. Jake Scott, an infectious diseases doctor in California who worked many long days treating patients during the Covid-19 pandemic, said he lost several patients early in the pandemic, but the mRNA vaccines brought major changes by safely protecting billions of people from severe disease and death. 'I cannot really convey accurately what a profound difference there was in the hospital pre vaccine and post vaccine and that was thanks to the mRNA technology,' said Scott, a clinical associate professor, medicine - infectious disease with Stanford Medicine. To hear that HHS was going to eliminate investment in mRNA vaccines, Scott said, is 'really depressing.' 'This just hits differently. It makes me sad. It's kind of heartbreaking,' said Scott.
CNN
3 days ago
- Health
- CNN
HHS slashes funding for mRNA vaccine development
US Health and Human Services is 'winding down' its mRNA vaccine development and will instead fund other vaccine platforms through the Biomedical Advanced Research and Development Authority, the agency said Tuesday. HHS Secretary Robert F. Kennedy Jr. said in a statement that BARDA would terminate 22 mRNA vaccine development investments, suggesting the vaccines 'fail to protect effectively against upper respiratory infections like Covid and flu,' despite evidence they protect against severe disease and death from Covid-19 and show promise against influenza. HHS said some final stage contracts will continue, but 'no new mRNA-based projects will be initiated.' 'We reviewed the science, listened to the experts, and acted,' Kennedy said. 'Going forward, BARDA will focus on platforms with stronger safety records and transparent clinical and manufacturing data practices,' HHS said. 'Technologies that were funded during the emergency phase but failed to meet current scientific standards will be phased out in favor of evidence-based, ethically grounded solutions – like whole-virus vaccines and novel platforms.' Messenger RNA is a single strand of the genetic code that cells can 'read' and use to make a protein. With the Covid vaccine, mRNA instructs cells in the body to make the particular piece of the virus's spike protein. When the immune system sees it, it recognizes it as foreign and is then prepared to attack when there is an actual infection. The vaccines were particularly useful during the Covid-19 pandemic because they can be developed and manufactured quickly. Multiple peer-reviewed studies have shown that mRNA vaccines developed under Operation Warp Speed during the first Trump administration were highly effective at preventing severe disease and were repeatedly demonstrated to be extremely safe. The Trump administration and Kennedy, who has a long history of anti-vaccine claims, had previously said they were evaluating mRNA projects. In May, HHS also terminated a $590 million contract with Modern to develop a vaccine to protect against bird flu. Dr. Peter Hotez, a pediatrician who directs the Center for Vaccine Development at Texas Children's Hospital, said Tuesday's HHS announcement will 'promote their pseudoscience agenda and weaken our nation's biosecurity.' 'The mRNA technology, like all biotechnologies, has strengths and weaknesses, but for a pandemic situation with a new and previously unknown pathogen, or for cancer vaccines and immunotherapeutics it has distinct advantages,' Hotez said. 'HHS under Mr. Kennedy is telling us that we should no longer look to the federal government for innovation in biomedicine. The states are on their own.' HHS said it is canceling BARDA's award to Moderna/UTMB for an mRNA vaccine for H5N1, known as avian flu. It is also terminating contracts with Emory University and Tiba Biotech. Emory has been working on a dry powder mRNA antiviral platform that could be inhaled and Tiba is working on a platform that uses a nanoparticle carrier technology, according to the BARDA website. HHS also said it is 'de-scoping' mRNA-related work in contracts it has with Luminary Labs, ModeX, and Sequirus. HHS said it was also rejecting or canceling multiple pre-award solicitations with proposals from Pfizer, Sanofi Pasteur, CSL Sequirus, Gritstone and others. And it was also restructuring collaborations with the US Department of Defense that would impact nucleic acid-based vaccine projects with AAHI, AstraZeneca and HDT Bio. HHS said the impacted projects were worth about $500 million. 'Other uses of mRNA technology within the department are not impacted by this announcement,' it said. In a statement, Moderna spokesman Kelly Cunningham said, 'We are not aware of any new contract cancellations by BARDA involving Moderna. As previously announced in May, our pandemic flu contract was canceled, and we do not currently have any active collaboration with BARDA.' A spokesperson for Gritstone said the company ceased operations 'as a company some time ago.' AstraZeneca declined to comment. CNN reached out to Tiba Biotech, Emory, Pfizer, ModeX, Luminary Labs, CSL Seqirus and Sanofi for a response. Dr. Paul Offit, a vaccine scientist at Children's Hospital of Philadelphia and an outside vaccine adviser to the FDA criticized Kennedy for making 'a policy decision again that contradicts the scientific data.' 'He has said things like the mRNA vaccines are unnecessarily dangerous,' Offit said. 'It's just wrong. I mean it's actually remarkably safe and it's effective.' 'A decision based on cutting back all this funding based on false statements is just hard to watch,' Offit added. If another pandemic comes 'we'll just be behind the eight ball again,' without additional research into mRNA vaccines. 'All it does is put us at unnecessary risk for no good reason and just a few bad reasons too,' Offit said. Dr. Jake Scott, an infectious diseases doctor in California who worked many long days treating patients during the Covid-19 pandemic, said he lost several patients early in the pandemic, but the mRNA vaccines brought major changes by safely protecting billions of people from severe disease and death. 'I cannot really convey accurately what a profound difference there was in the hospital pre vaccine and post vaccine and that was thanks to the mRNA technology,' said Scott, a clinical associate professor, medicine - infectious disease with Stanford Medicine. To hear that HHS was going to eliminate investment in mRNA vaccines, Scott said, is 'really depressing.' 'This just hits differently. It makes me sad. It's kind of heartbreaking,' said Scott.
