Latest news with #vaccine
CBS News
2 hours ago
- Health
- CBS News
Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose - a fifth of the dose of its current COVID-19 vaccine, Spikevax - by refining its immune target. The approval "adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective - and more by some measures - than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. It also comes as the Centers for Disease Control and Prevention changes its recommendation to children for COVID-19 vaccine under Kennedy's directive. The agency on Thursday dropped its recommendation for all children to get the vaccinated but still broadly recommends COVID-19 vaccines for moderately or severely immunocompromised children, in addition to most adults for now. Kennedy's directive cited "a review of the recommendations" of the Food and Drug Administration and National Institutes of Health, saying that the risks of the COVID-19 vaccine for healthy children "do not outweigh the purported benefits of the vaccine." The directive also cited "the lack of high-quality data demonstrating safety of the mRNA vaccines during pregnancy combined with the uncertainty of the benefits" for pregnant moms and their baby. "Truly the death of expertise. This would be like the secretary of transportation directing that all planes must fly 5,000 feet higher than current. It's vibe-based decision making," one federal health official said of the directive.
Daily Mail
4 hours ago
- Health
- Daily Mail
Devastating blow in race for vaccine against deadly disease that affects millions
A major US research program to develop a vaccine against HIV has been abruptly canceled by the Trump administration, sparking outrage as infections rise and global prevention efforts stall. The administration's termination of the promising $258million research program stunned scientists, whose years-long project had also benefited the development of treatments for COVID-19, autoimmune conditions, and even snakebite antivenom. Researchers at Duke University and the Scripps Research Institute were informed on Friday that their funding would be cut. 'The consortia for HIV/AIDS vaccine development and immunology was reviewed by NIH leadership, which does not support it moving forward,' a senior official, who asked not to be named, told the New York Times. 'NIH expects to be shifting its focus toward using currently available approaches to eliminate HIV/AIDS.' 'I find it very disappointing that, at this critical juncture, the funding for highly successful HIV vaccine research programs should be pulled,' Dennis Burton, an immunologist who led the program at Scripps, told the New York Times. For decades, the United States has led the world in HIV research, pouring billions into cutting-edge science that turned a once-fatal virus into a manageable condition for millions. American labs were the first to crack the genetic code of HIV, to develop life-saving antiretroviral drugs, and to pioneer global initiatives like PEPFAR that saved more than 25 million lives worldwide. The now-axed vaccine program was another shining example of US scientific leadership, bringing together top researchers from coast to coast and pushing the boundaries of immunology. The cancellation is part of a broader rollback of federal HIV efforts. The NIH has also paused funding for a separate clinical trial of an HIV vaccine developed by Moderna. HIV rates remain high. In 2023 alone, the World Health Organization reported 1.3 million new infections, including 120,000 children. More than 32,000 people in the US contracted the virus last year and there was another 4,000 new cases in the UK. 'This is just inconceivable,' Mitchell Warren, executive director of the HIV prevention organization AVAC, told the New York Times. In some parts of the US, the effects are already being felt. In Texas, the state's Department of Health Services told grantees to pause HIV prevention activities 'until further notice.' In Mecklenburg County, North Carolina, 10 health department staffers have been laid off. Across Africa, several countries are reporting major disruptions in prevention work after delays in US aid. 'The HIV pandemic will never be ended without a vaccine, so killing research on one will end up killing people,' John Moore, an HIV researcher at Weill Cornell Medical College, said. 'The NIH's multiyear investment in advanced vaccine technologies shouldn't be abandoned on a whim like this.' Trial after trial has failed to produce a traditional HIV vaccine, but the Duke and Scripps teams had been taking a new approach: studying broadly neutralizing antibodies shown in animals to protect against multiple strains of the virus. That promising pipeline may now run dry. 'Almost everything in the field is hinged on work that those two programs are doing,' said Warren. 'The pipeline just got clogged.' During his first term, President Trump had supported efforts to curb the HIV epidemic. But in his second term, his administration has slashed prevention efforts, terminated several PrEP-related grants, and shut down the HIV prevention division at the CDC. While officials say the work may be transferred to a yet-to-be-formed federal agency, no details have been shared.
Yahoo
5 hours ago
- Health
- Yahoo
FDA approves Moderna's new lower-dose COVID-19 vaccine
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target. The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. The Associated Press Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Independent
5 hours ago
- Health
- The Independent
FDA approves Moderna's new lower-dose COVID-19 vaccine
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target. The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
5 hours ago
- Health
- Associated Press
FDA approves Moderna's new lower-dose COVID-19 vaccine
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target. The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
