Latest news with #StéphaneBancel
Yahoo
13-06-2025
- Health
- Yahoo
FDA approves expanded use of Moderna's RSV shot, but uncertainty remains
The Food and Drug Administration (FDA) expanded the approval of Moderna's RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from respiratory syncytial virus, the company said. The vaccine was previously only licensed for adults 60 years and older. 'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' said Stéphane Bancel, Moderna's CEO, in a statement. The expanded approval was a much-needed win for the company, which has experienced setbacks due to Trump health officials' distrust of messenger RNA-based (mRNA) vaccines. The Department of Health and Human Services (HHS) recently canceled more than $750 million in contracts for Moderna to develop and test mRNA vaccines to protect against pandemic flu. Moderna's RSV shot was the first non-COVID-19 mRNA vaccine to be approved in the United States. The Centers for Disease Control and Prevention's (CDC) independent vaccine panel, the Advisory Committee on Immunization Practices (ACIP), previously voted to recommend an RSV vaccine for adults aged 50 to 59 who have medical conditions that increase their risk of severe illness from the virus. But the recommendation needs to be endorsed by the CDC director for it to take effect; there currently is no CDC director. Susan Monarez, who was acting director, is awaiting Senate confirmation and isn't allowed to serve as acting director at the same time. HHS Secretary Robert F. Kennedy Jr. has the power to endorse the recommendation in the absence of a CDC director, but he has not signed off on it since the committee voted more than two months ago. He has also not acted on the other recommendations from the same meeting, including the use of a meningitis vaccine. He endorsed the panel's recommendations for chikungunya vaccines in May. Without an officially accepted ACIP recommendation, insurers don't have to cover the vaccine for the expanded population. Kennedy fired all 17 members of ACIP earlier this week, arguing a 'clean sweep' was needed to purge conflicts of interest and help restore trust in vaccinations and public health. On Wednesday, he named eight handpicked replacements, including some vocal vaccine critics. A scheduled late June meeting is still expected to occur. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Boston Globe
13-06-2025
- Health
- Boston Globe
FDA clears Moderna's RSV vaccine for use in people aged 18 to 59
'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' Moderna CEO Stéphane Bancel, said in a statement. Advertisement The approval was a welcome win for the Cambridge-based company, which has faced several setbacks of late due to deep distrust of its messenger RNA vaccine platform among supporters of health secretary Robert F. Kennedy Jr. A number The next step in the vaccine's path to expanded use has already been cleared. At a meeting in April, the Center for Disease Control and Prevention's expert vaccines panel, the Advisory Committee on Immunization Practices, voted to recommend use of RSV vaccine Advertisement At the time of the vote, only two of the three licensed RSV vaccines — Pfizer's Abryso and GSK's Arexvy — were licensed for use in adults under the age of 60. The committee's recommendation was worded in such a way as to include any RSV with a license for use in this age group, so should, in theory, apply as well to the Moderna vaccine now that the age extension has been endorsed by the FDA. But that ACIP recommendation is currently in limbo. A recommendation from the advisory body must be approved by the CDC director or the secretary of the Health and Human Services Department in order to come into force. There is currently no CDC director and in the nearly two months since ACIP endorsed the recommendation, Kennedy has chosen not to sign off on it. He did, however, approve three other recommendations the committee made related to use of chikungunya vaccines. Without a recommendation from the ACIP that has been accepted by the CDC director or the health secretary, the vaccine can be administered to an individual in the new age group, but health insurers do not have to cover its cost. Kennedy Advertisement Late last month Moderna The company said it will have mRESVIA available in the U.S. for both younger adults at increased risk — the ages 18 to 59 cohort — and adults aged 60 and older for the 2025-2026 respiratory virus season.
The Hill
13-06-2025
- Health
- The Hill
FDA approves expanded use of Moderna's RSV shot, but uncertainty remains
The Food and Drug Administration (FDA) expanded the approval of Moderna's RSV vaccine late Thursday to include individuals 18-59 years of age who are at increased risk for severe illness from respiratory syncytial virus, the company said. The vaccine was previously only licensed for adults aged 60 years and older. 'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' Stéphane Bancel, Moderna's CEO, said in a statement. The expanded approval was a much-needed win for the company, which has experienced setbacks due to Trump health officials' distrust of messenger RNA-based (mRNA) vaccines. The Department of Health and Human Services (HHS) recently canceled more than $750 million in contracts for Moderna to develop and test mRNA vaccines to protect against pandemic flu. Moderna's RSV shot was the first non-COVID-19 mRNA vaccine to be approved in the United States. The Centers for Disease Control and Prevention's (CDC) independent vaccine panel, the Advisory Committee on Immunization Practices (ACIP), previously voted to recommend an RSV vaccine for adults aged 50 to 59 who have medical conditions that increase their risk of severe illness from the virus. But the recommendation needs to be endorsed by the CDC director for it to take effect; there currently is no CDC director. Susan Monarez, who had previously been acting director, is awaiting Senate confirmation and isn't allowed to serve as acting director at the same time. HHS Secretary Robert F. Kennedy Jr. has the power to endorse the recommendation in the absence of a CDC director, but he has not signed off on it since the committee voted more than two months ago. He has also not acted on the other recommendations from the same meeting, including the use of a meningitis vaccine. He endorsed the panel's recommendations for chikungunya vaccines in May. Without an officially accepted ACIP recommendation, insurers don't have to cover the vaccine for the expanded population. Kennedy fired all 17 members of ACIP earlier this week, arguing a 'clean sweep' was needed to purge conflicts of interest and help restore trust in vaccinations and public health. On Wednesday, he named eight handpicked replacements, including some vocal vaccine critics. A scheduled late June meeting is still expected to occur.
13-06-2025
- Health
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease. Previously, the vaccine, known as mRESVIA, had been licensed for use for those aged 60 and older. Approval for mRESVIA came after Moderna conducted a late-stage clinical trial showing the vaccine helped boost immune responses in younger adults. More than one-third of adults between ages 18 and 59 have at least one underlying condition that puts them at increased risk of RSV, according to Moderna. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Stéphane Bancel, CEO of Moderna, said in a press release. "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV." Although the FDA approves vaccines and may expand approvals for certain age groups, the Centers for Disease Control and Prevention sets recommendations regarding who should get vaccines and when. Currently, the CDC recommends RSV vaccination only for those aged 75 and older and for those aged 60 and over at increased risk. The CDC's independent vaccine advisory committee will need to vote to recommend that the new age group be eligible for the shot, followed by a final recommendation from the director of the CDC. Earlier this week, Kennedy removed all 17 sitting members of the committee and replaced them with eight new members. It remains unclear how the new members of the panel will decide to approach recommendations for the RSV vaccine. As of Friday, the CDC director role remains vacant and Health and Human Services Secretary Robert F. Kennedy Jr. has been making final recommendations. In an April meeting, the prior advisory committee voted to recommend RSV vaccination for those aged 50 to 59 with increased risk of disease, but Kennedy did not adopt the recommendations. meeting scheduled to be held between June 25 and June 27 Moderna's RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines. Despite availability, RSV vaccination has been lagging. As of April 26, the latest date for which CDC data is available, an estimated 47.5% of adults aged 75 and older and 38.1% of adults aged 60 to 74 with a high-risk condition reported ever having received an RSV vaccine.
Yahoo
13-06-2025
- Health
- Yahoo
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease. Previously, the vaccine, known as mRESVIA, had been licensed for use for those aged 60 and older. Approval for mRESVIA came after Moderna conducted a late-stage clinical trial showing the vaccine helped boost immune responses in younger adults. MORE: Despite 'game-changing' new RSV shots, uptake lagged among infants, adults: Experts More than one-third of adults between ages 18 and 59 have at least one underlying condition that puts them at increased risk of RSV, according to Moderna. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Stéphane Bancel, CEO of Moderna, said in a press release. "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV." Although the FDA approves vaccines and may expand approvals for certain age groups, the Centers for Disease Control and Prevention sets recommendations regarding who should get vaccines and when. Currently, the CDC recommends RSV vaccination only for those aged 75 and older and for those aged 60 and over at increased risk. The CDC's independent vaccine advisory committee will need to vote to recommend that the new age group be eligible for the shot, followed by a final recommendation from the director of the CDC. Earlier this week, Kennedy removed all 17 sitting members of the committee and replaced them with eight new members. It remains unclear how the new members of the panel will decide to approach recommendations for the RSV vaccine. MORE: Respiratory virus activity remains 'high' in US and will 'continue for several more weeks': CDC As of Friday, the CDC director role remains vacant and Health and Human Services Secretary Robert F. Kennedy Jr. has been making final recommendations. In an April meeting, the prior advisory committee voted to recommend RSV vaccination for those aged 50 to 59 with increased risk of disease, but Kennedy did not adopt the recommendations. Instead, it appears Kennedy plans to have the new committee re-discuss the recommendations for RSV vaccination as well as discuss HPV and COVID vaccinations in their meeting scheduled to be held between June 25 and June 27 Moderna's RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines. Despite availability, RSV vaccination has been lagging. As of April 26, the latest date for which CDC data is available, an estimated 47.5% of adults aged 75 and older and 38.1% of adults aged 60 to 74 with a high-risk condition reported ever having received an RSV vaccine. FDA expands approval of Moderna's RSV vaccine to some adults under age 60 originally appeared on
