Latest news with #Abrysvo
Yahoo
09-05-2025
- Health
- Yahoo
Infant hospitalizations from RSV dropped after shots became available, US data shows
(Reuters) -Infant hospitalizations due to respiratory syncytial virus (RSV) infections in the United States dropped as much as 43% last year compared to previous years, following the widespread availability of preventative shots, federal data showed. The U.S. Centers for Disease Control and Prevention in a report on Thursday said that hospitalizations related to RSV decreased by 28% and 43% across two large national databases, compared to pooled rates from 2018-2020. Years from 2020 to 2023 were excluded from the study because the COVID-19 pandemic led to unusual RSV seasonality and circulation, the study authors said. WHY IT'S IMPORTANT The 2024-2025 season marked the first period of widespread availability of preventive shots against RSV, a virus that often results in cold-like symptoms but is a major cause of severe infection and death in infants and older adults. Separately, CDC data showed a drop in the infant mortality rate in 2024, compared to the previous year. Pfizer's maternal vaccine, sold as Abrysvo, and Sanofi and AstraZeneca's antibody shot, Beyfortus, are available in the United States to prevent RSV infection in infants. BY THE NUMBERS The largest estimated reductions in hospitalization rates occurred among infants aged up to 2 months, the CDC said. The infant mortality rate in the United States, defined as the number of deaths of children under one year of age per 1,000 live births, dropped to 5.49 in 2024, down from 5.63 a year earlier, CDC data showed. CONTEXT The data suggest that the most severe RSV disease among infants up to seven months old is preventable, the CDC said, adding that it is important to protect infants, ideally within their first week of life, especially those born during the RSV season.
Straits Times
06-05-2025
- Health
- Straits Times
Kennedy aide and vaccine critic questions recent expert recommendations
FILE PHOTO: U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. discusses the findings of the Centers for Disease Control and Prevention's (CDC) latest Autism and Developmental Disabilities Monitoring (ADDM) Network survey, during a press conference at the Department of Health and Human Services in Washington, D.C., U.S., April 16, 2025. REUTERS/Elizabeth Frantz/File Photo FILE PHOTO: Employees work in the manufacturing of Pfizer's new respiratory syncytial virus (RSV) vaccine Abrysvo, in this undated handout picture. Pfizer/Handout via REUTERS/ File Photo An aide to U.S. Health Secretary Robert F. Kennedy Jr. is seeking more information about three vaccines recommended by a panel of outside experts last month, according to documents reviewed by Reuters and two sources familiar with the situation. The advisory panel to the Centers for Disease Control and Prevention had made recommendations regarding the use of separate shots approved to help protect against RSV, meningitis and chikungunya. The CDC is not required to adopt their recommendations, but when it does, they become guidelines for medical practitioners to follow. Dr. William 'Reyn' Archer III joined the Health and Human Services Department, which oversees CDC, as a counselor in the secretary's office after Kennedy took over in February, HHS records show. A critic of vaccines on social media for the past several years, Archer served as Texas state health commissioner in the late 1990s. Archer's hiring and activity at HHS have not previously been reported. His role reviewing the Advisory Committee on Immunization Practices' recommendations is the latest indication of how Kennedy, who has spent decades raising doubts about the safety and efficacy of vaccines, is reshaping U.S. policy. HHS spokesman Andrew Nixon said the agency "will ensure that all recommendations adhere to the Gold Standard of Science." As part of his HHS role, Archer has in recent days posed questions to the CDC about the advisory committee recommendations, according to the documents and the two sources. One recommendation would expand eligibility for RSV vaccines made by Pfizer and GSK to high-risk adults aged 50-59 from a current threshold age of at least 60 years. In response, Archer asked for more justification of the expansion given what he described as a 'possible decline in efficacy with a second dose,' according to the documents and two sources. It is unclear what decline in efficacy data Archer is referring to. At the ACIP meeting, a GSK representative presented clinical trial results the company described as showing 'robust' immune responses following re-vaccination at 24 and 36 months. A GSK spokesperson said the data showed waning efficacy of a single dose over time, but not enough to justify revaccination yet. A Pfizer spokesperson did not immediately respond to requests for comment. ACIP also voted to recommend expanded use of GSK's vaccine for meningitis, and Archer questioned how providers administer it. In addition, ACIP recommended the use of a new chikungunya vaccine from Bavarian Nordic, which Archer has not disputed. However, Kennedy's aide asked for more information about a recommendation to expand the use of a vaccine for the mosquito-borne virus made by Valneva, the documents show. Archer also asked to know what adjuvants and platforms are being used for all the vaccines discussed at the ACIP meeting, and their length of immunity. FROM TEXAS TO WASHINGTON Kennedy is currently reviewing the latest ACIP recommendations in the absence of a CDC director, and it is unclear whether the HHS secretary will ultimately sign off on them. The decision will impact public health and major drug companies. Pfizer and GSK last month touted ACIP's vote to lower the age at which adults can be eligible for their respective RSV vaccines, decisions that affect whether insurers will likely pay for them. The FDA previously approved the age expansion. Kennedy says he is not opposed to vaccination, but described them as a personal choice in the midst of a large U.S. measles outbreak mostly among the unvaccinated. Kennedy argues that the nation's health bureaucracy should focus on chronic illness. Archer is a trained obstetrician who served in the early 1990s as a deputy assistant secretary of HHS under the administration of George H.W. Bush. At HHS, he helped implement a so-called gag rule restricting medical providers at federally-funded clinics from advising patients on abortion, according to court documents and media reports. He was appointed by then-Texas Governor George W. Bush to serve as commissioner of the state's Department of Health. He resigned in 2000 after a Black administrator in the department secretly recorded him making comments about her race, according to an Associated Press report at the time. Archer later served as chief of staff for Congressman Jeff Fortenberry of Nebraska from 2016 to 2022, according to his LinkedIn profile. Fortenberry, who opposed COVID-19 vaccine mandates during his tenure, was subsequently charged with lying to federal authorities about a campaign donation. The Justice Department dropped those charges after President Donald Trump took office in January. On his personal Facebook page, Archer posted repeatedly from 2020 to 2022 about the "limitations" of the COVID vaccine, Reuters found. In a deleted post on X, accessed with the Internet Archive, Archer said as Texas health commissioner he felt pressure to support vaccine mandates without "scientific counterfactual.' "My own son developed autism in early years then took his life at 16," he said in the post, which linked to a Trump campaign ad critical of the measles vaccine. Kennedy had long promoted a debunked link between vaccines and autism, contrary to scientific evidence, and last month promised a study to determine the cause of the condition. REUTERS Join ST's Telegram channel and get the latest breaking news delivered to you.
Yahoo
18-04-2025
- Health
- Yahoo
US CDC advisers recommend lowering the age for RSV shots to 50-59 years
By Sneha S K and Mariam Sunny (Reuters) -The U.S. Centers for Disease Control and Prevention's panel of outside experts on Wednesday recommended the use of respiratory syncytial virus vaccines in younger adults who are at increased risk of severe illness from the virus. The 15-member panel voted 14-to-0 to recommend that at-risk adults ages 50 to 59 receive a single dose of RSV vaccine. One of the panel members abstained from voting. The CDC currently recommends the vaccine for adults age 75 and older and at-risk adults ages 60 to 74. "What's swaying me is there clearly are people in that 50 to 59 years age group, for example lung transplant patients, ...that would clearly benefit from having access to this vaccine," Jane Zucker, one of the voting members of the panel, said ahead of the vote. If the recommendation is adopted by the CDC, it would make about 30% of U.S. adults in that age group eligible for the RSV vaccine, according to panelist Michael Melgar. The outside vaccine experts also asked for more data on durability of the shot's benefits as well as the timing for re-vaccination. "I'm a huge proponent of lowering the age as well as making it as simple as possible... and the fact that they kept the risk base as broad as it was," said Jason Goldman, a non-voting panel member. RSV typically causes cold-like symptoms, but is also a leading cause of pneumonia in toddlers and older adults. An estimated 15,000–20,000 annual RSV-associated hospitalizations occur in the U.S. in adults aged 50 to 59, according to the CDC. The CDC director typically signs off on the panel's recommendations before they are implemented, but the agency does not currently have one. President Donald Trump's nomination for the post, Susan Monarez, has yet to be confirmed by the U.S. Senate. The U.S. Food and Drug Administration has approved three vaccines for RSV — GSK's Arexvy, Moderna's mRESVIA and Pfizer's Abrysvo. Arexvy and Abrysvo are approved to prevent RSV-associated lower respiratory tract disease in adults aged 50 to 59 and 18 to 59, respectively, who are at an increased risk from the disease. Moderna's application for at-risk adults aged 18 to 59 is under FDA review. The panel is expected to consider the use of RSV vaccines in adults younger than 50 at its June meeting. The panel also voted to recommend use of GSK's pentavalent meningococcal vaccine and separate vaccines from Bavarian Nordic and Valneva against chikungunya, a mosquito-borne virus. On Tuesday, the panel discussed narrowing recommendations on the use of COVID-19 booster shots for the upcoming immunization campaign.
Yahoo
17-04-2025
- Health
- Yahoo
GSK & PFE's RSV Vaccines Recommended for Use in Adults Aged 50-59
GSK GSK and Pfizer PFE announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the expanded use of their respiratory syncytial virus (RSV) vaccines. The ACIP has now recommended the use of GSK's RSV vaccine, Arexvy, and PFE's RSV vaccine, Abrysvo, in adults aged 50-59 who are at high risk of severe RSV disease. Individuals with underlying medical conditions like obesity, cardiovascular disease, diabetes, chronic obstructive pulmonary disorder (COPD), asthma and other chronic illnesses are at increased risk of RSV disease. The updated ACIP recommendation expands the committee's previous vote issued last June, which recommended the use of RSV vaccines for all adults aged 75 years. However, for those aged between 60 and 74, the ACIP recommended the vaccines for individuals at a higher risk of severe RSV disease due to underlying medical conditions. The updated ACIP recommendation lowers the recommended age for RSV vaccination from 60 to 50 for high-risk adults. The ACIP's recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. Year to date, shares of GSK have increased 4.6% against the industry's decline of 6.6%. Image Source: Zacks Investment Research Year to date, shares of Pfizer have decreased 16.9% compared with the industry's decline of 5.4%. Image Source: Zacks Investment Research Arexvy and Abrysvo are approved by the FDA for use in all individuals aged 60 and above. Arexvy is also approved for high-risk individuals aged 50-59, while Abrysvo is approved for high-risk adults aged 18-59 in the United States. GSK is currently conducting clinical studies on Arexvy for expanded use in adults aged 18 to 49 years. Arexvy generated sales worth £590 million in 2024, while Abrysvo generated sales worth $755 million. Sales of both Arexvy and Abrysvo were impacted last year, mainly due to the revised recommendations for RSV vaccinations issued by the ACIP in June 2024. Another vaccine maker, Moderna's MRNA RSV vaccine – mResvia – was approved last year by the FDA and the European Commission to prevent RSV-LRTD in older adults aged 60 years and above. An FDA filing is currently under review, seeking the expanded use of Moderna's vaccine in high-risk adults aged 18-59 years. A final decision is expected by June 12, 2025. MRNA is also working on expanding the vaccine's use in pediatric populations. Both GSK and Pfizer currently carry a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
17-04-2025
- Health
- Yahoo
CDC panel backs broader use of RSV shots
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. A panel of advisers to the Centers for Disease Control and Prevention on Wednesday recommended lowering the age at which some people can receive a vaccine for respiratory syncytial virus, but stopped short of advocating for booster shots. Committee members voted nearly unanimously endorse vaccination in adults who are 50 to 59 years of age and at a higher risk of severe RSV-related disease. If adopted by the CDC, that recommendation would expand on the agency's current guidance, which suggests use in all people 75 or older and high-risk adults between 60 and 74 years of age. The CDC isn't bound to follow the advice of its committees, though it typically does. The policy would immediately benefit GSK and Pfizer, both of which have RSV shots approved for people under 60. It could also soon help Moderna, whose vaccine the Food and Drug Administration could clear for use in that age group later this year. However, the recommendation comes at a time of uncertainty for the CDC, whose acting director Susan Monarez hasn't yet been confirmed by Congress. The decision to adopt it, then, could fall on Health and Human Services Secretary and prominent vaccine skeptic Robert F. Kennedy Jr. Additionally, while recommending broader use than before, committee members still didn't endorse vaccinating younger adults or booster shots. In a slide presentation, CDC panelists noted how clinical testing hasn't clearly shown an additional dose can improve protection against disease. Levels of protective antibodies appear to surge higher after revaccination, but not as high as they do after an initial dose. It's unclear how people with weakened immune systems will respond, too, the presentation said. 'There remains important uncertainty in whether revaccination can restore protection to levels seen after the first dose, and this may be more important when developing a recommendation for younger adults who have longer remaining life expectancy,' said Michael Melgar, co-lead of the work group for RSV in adults for the CDC's Advisory Committee on Immunization Practices, or ACIP. Committee members also highlighted the risk of Guillain-Barré syndrome, a rare neurological side effect that was added to the prescribing information for Pfizer's Abrysvo and GSK's Arexvy last year. Advisers will discuss revaccination at a meeting in June. In the meantime, the lack of an endorsement for boosters 'remains a major overhang to the market potential' of RSV shots, wrote William Blair analyst Myles Minter in a note to clients Thursday. Shares of Pfizer, GSK and Moderna all dipped slightly on Wednesday.
