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New NFID survey shows fewer than 1 in 5 US adults are concerned about flu, COVID-19, RSV, or pneumococcal disease, and many do not plan to get vaccinated this fall and winter CDC Director Mandy K. Cohen, MD, MPH, to present final 2023-2024 US season data showing low flu vaccination rates among US children and adults, as flu-related pediatric deaths hit record high of 199 Cohen and health experts get flu vaccinations at press conference in Washington, DC BETHESDA, Md., Sept. 25, 2024 /PRNewswire/ -- Following a summer wave of COVID-19 activity and a record number of reported influenza (flu) deaths among US children during the 2023-2024 respiratory season, new survey results released today by the National Foundation for Infectious Diseases (NFID) show that few US adults intend to get vaccinated against flu, COVID-19, respiratory syncytial virus (RSV), or pneumococcal disease this fall and winter, citing concerns about vaccine side effects and a general distrust of vaccines. Continue Reading Only 38% of US adults say they will definitely get a flu vaccine, despite 2 out of 3 (67%) agreeing that annual flu vaccination is the most effective way to prevent flu-related hospitalizations and deaths. Even fewer, only about 1 in 4 (26%), say they will definitely get an updated COVID-19 vaccine, and among those for whom it is recommended, only 21% definitely plan to get vaccinated against RSV and 24% against pneumococcal disease. Overall, few US adults are concerned about themselves or a family member getting infected with flu (17%), COVID-19 (20%), RSV (16%), or pneumococcal disease (17%). Few US adults are concerned about flu, COVID-19, RSV, or pneumococcal disease, and many do not plan to get vaccinated Post this At a news conference today in Washington, DC, health officials from NFID and the Centers for Disease Control and Prevention (CDC) emphasized that everyone age 6 months and older, including pregnant women, should get an annual flu vaccine and an updated 2024-2025 COVID-19 vaccine to help protect against severe disease, hospitalization, and death. Officials also urged persons at higher risk, including older adults and those with certain chronic health conditions, to talk to a healthcare professional about vaccines to help protect against RSV and pneumococcal disease. "Last flu season, an estimated 25,000 people in the US died from flu or related complications and 75,000 from COVID-19 in 2023, demonstrating how dangerous these diseases can be," said CDC Director Mandy K. Cohen, MD, MPH. "We can protect ourselves and those we care about by getting updated vaccines to reduce the risk of serious illness from flu and COVID-19 and do more of the things we enjoy. I encourage everyone 6 months and older to get an annual flu vaccine and the updated COVID-19 vaccine in the coming weeks." Cohen was joined at today's press conference by Demetre C. Daskalakis, MD, MPH, director of the National Center for Immunization and Respiratory Diseases at CDC; NFID Medical Director Robert H. Hopkins, Jr., MD; Flor M. Muñoz, MD, MSc, associate professor of pediatrics and infectious diseases at Baylor College of Medicine and NFID director; and Reed V. Tuckson, MD, co-founder of the Black Coalition Against COVID and chair of the board of the Coalition For Trust In Health & Science. The panelists got vaccinated at an onsite flu vaccine clinic following the news conference as part of the NFID Leading By Example initiative to raise awareness about the importance of disease prevention through vaccination. "The good news is that there are safe and effective vaccines that can help protect against certain respiratory diseases, preventing severe cases, hospitalizations, and deaths," said Hopkins. "Vaccines are not just a shield against illness—they are an important tool in our public health efforts." According to new CDC data released today, the 2023-2024 flu season in the US was moderately severe with an estimated 41 million illnesses, 490,000 hospitalizations, and 25,000 flu-related deaths. Less than half (45%) of US adults received a flu vaccine during the 2023-2024 season, 2 percentage points lower than in 2022-2023 (47%), and 4 percentage points lower than in 2021-2022 (49%). In 2023-2024, slightly more than half (55%) of children age 6 months to 17 years received a flu vaccine, and 199 children died due to flu-related illness, matching the previous high reported during the 2019-2020 season. Historically, about 80% of reported pediatric deaths have been in children who were not fully vaccinated, and this is consistent last season as well. Despite the fact that 95% of US adults who were hospitalized with flu-related complications last season had at least 1 underlying chronic health condition, only 46% of those age 18-64 years with at least 1 chronic health condition received a flu vaccine last season, 3 percentage points lower than in 2022-2023 (49%), and 4 percentage points lower than in 2021-2022 (50%). "The low vaccination rates among persons with chronic health conditions are of particular concern because they are more likely to develop serious and even life-threatening complications from respiratory infections," said Hopkins. "We encourage everyone at increased risk to talk to a healthcare professional about which vaccines are right for them. Vaccines save lives, and we all play an important role in helping protect ourselves, our loved ones, and our communities from preventable infectious diseases." NFID survey data also show that among US adults who were diagnosed with flu in the last 2 years, nearly 72% say they will likely get vaccinated against flu, suggesting that firsthand experience with flu may significantly impact the decision to get vaccinated. The NFID survey data show that vaccine confidence plays a major role in vaccination intent for flu, COVID-19, RSV, and pneumococcal disease. Many who do not plan to get vaccinated are worried about potential side effects from the vaccines or have a general distrust of vaccines, demonstrating the urgent need for greater awareness and education about vaccines. "We must build trust by enhancing our support for people in using science and evidence to make personally appropriate decisions regarding vaccines and other health choices," said Tuckson. "The pandemic taught us that it is possible to close some of the gaps in immunization rates among communities of color, but we still have a long way to go. In addition to evidence-based messaging, we know that guidance from familiar, trusted healthcare professionals working with minority communities is essential to building vaccine confidence." According to new CDC data, COVID-19 vaccination rates are significantly lower than flu vaccination rates­—only 23% of US adults age 18 years and older got an updated COVID-19 vaccine during the 2023-2024 respiratory season versus 45% who got a flu vaccine. And while individuals can safely get both flu and COVID-19 vaccines administered in the same visit, according to the NFID survey, most US adults (61%) say they would not or are unsure about getting both vaccines at the same time. "Now is the time to act! As we approach the fall and winter virus season, it is important that we communicate to healthcare professionals and the public the risks of respiratory illnesses such as flu, COVID-19, and RSV and the life-saving benefits of immunization," said Daskalakis. According to CDC estimates, flu vaccination prevented approximately 131,000 hospitalizations and 7,000 deaths, and COVID-19 vaccination likely prevented an additional 40,000-100,000 hospitalizations. "Flu and COVID-19 can be serious diseases with potentially life-threatening consequences and long-term risks," he said. "Flu and COVID-19 vaccines are now available and are the best protection we have, and it's safe to get both vaccines at the same time." RSV vaccination rates for US adults age 60 years and older and pregnant women (32-36 weeks) were only 24% and 33%, respectively during the 2023-2024 respiratory season. Since then, RSV vaccine recommendations have been updated, and among US adults for whom an RSV vaccine is now recommended—adults age 75 years and older, adults age 60-74 years who have certain risk factors, and pregnant women to help protect their infants—NFID survey data show that only 21% say they will definitely get vaccinated. "RSV is a common respiratory disease that can be severe and even life-threatening for older adults and young children," said Muñoz. "Each year in the US, we see about 2 million outpatient visits and up to 80,000 hospitalizations among children age 5 years and younger due to RSV. If you are pregnant, talk with a healthcare professional about how best to protect your baby from RSV." The NFID survey also asked respondents about knowledge and attitudes around pneumococcal disease. Pneumococcal disease vaccines are recommended for children age 2 years and younger, adults age 65 years and older, and individuals age 2-64 years with chronic health conditions or other risk factors. NFID survey data show that among adults for whom vaccination is recommended, 25% say they have already received a pneumococcal vaccine and 44% plan to do so. Survey results also show that healthcare professionals remain the most trusted source of information about vaccines—75% of US adults trust doctors, nurses, and pharmacists, followed by the CDC (55%) and state and local health departments (51%). NFID and CDC health officials emphasized that vaccines are safe and effective. Potential side effects are rare and much less severe than the diseases they prevent. Vaccination is especially critical for individuals at higher risk, including infants, older adults, and those with chronic health conditions. For more information about the 2024 NFID survey and news conference, and to access resources for use throughout the fall and winter, visit . About the National Foundation for Infectious Diseases Founded in 1973, the National Foundation for Infectious Diseases (NFID) is a non-profit 501(c)(3) organization dedicated to educating and engaging the public, communities, and healthcare professionals about infectious diseases across the lifespan. For more information, visit . NFID promotes the CDC Take 3 approach to help prevent respiratory illnesses this fall and winter: Get vaccinated Practice healthy habits to help stop the spread of infectious diseases (stay home when sick, cover coughs and sneezes, wash hands often, and consider wearing a mask if you or a household member are at increased risk of severe illness) Treat with prescription medication if recommended by a healthcare professional 2024 National Survey: Attitudes and Behaviors about Influenza, COVID-19, Respiratory Syncytial Virus, and Pneumococcal Disease The NFID survey was conducted by NORC at the University of Chicago. Data were collected using the AmeriSpeak Omnibus®, NORC's probability-based panel designed to be representative of the US household population. Interviews for the survey were conducted between August 8-12, 2024, with adults age 18 years and older representing the 50 states and the District of Columbia. Randomly selected US households were sampled with a known, non-zero probability of selection from the NORC National Sample Frame and 1,160 completed the survey—1,130 online and 30 by telephone. Interviews were conducted in English. This news conference is sponsored by NFID in collaboration with CDC, with support from professional societies and patient advocacy partners, in-kind support from Walmart and Sanofi Vaccines, and unrestricted educational grants from GSK, Merck & Co., Inc., Moderna, Sanofi, and Seqirus. NFID policies prohibit funders from controlling program content. Contact: Ned Berkowitz, 914-740-8255, [email protected] SOURCE National Foundation for Infectious Diseases WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Amgen released data from two pivotal trials on Tuesday that showed its experimental drug rocatinlimab succeeded in a Phase 3 test in atopic dermatitis, while its approved drug Uplizna also yielded positive results in myasthenia gravis. The data are a boost to Amgen’s immunology hopes, and the success with rocatinlimab — an anti-OX40 monoclonal antibody — will solidify its advantage over Sanofi’s asset amlitelimab, which goes after a related target. The rocatinlimab results are the first of eight different Phase 3 trials Amgen is running for the drug. In Tuesday’s trial, called ROCKET-Horizon, rocatinlimab met its primary endpoint and all secondary endpoints by a statistically significant margin, Amgen said. The drug induced at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) in 32.8% of patients, compared with 13.7% on placebo after 24 weeks. Amgen said that the study’s other co-primary endpoints, also measuring skin clearance, were successful as well. Sanofi has positioned amlitelimab, which binds to OX40-Ligand, as one of its key growth drivers in its pivot to immunology. But its first Phase 3 readout won’t take place until the end of 2026. In the meantime, Amgen has at least four other Phase 3 trials for rocatinlimab expected to report data before next July, including studies looking at different doses, the drug’s use as a combination or maintenance therapy, and a trial in adolescents. Amgen will likely have a significant market advantage by filing for rocatinlimab approval much earlier, although on a conference call Tuesday, CSO Jay Bradner didn’t say when it might file with the FDA. Amgen licensed rocatinlimab from Kyowa Kirin in 2021, a few months after it reported Phase 2 results, paying $400 million upfront and promising another $850 million in milestones. Sanofi acquired amlitelimab in its $1.1 billion buyout of Kymab in 2021. Sanofi is still hoping for big things from amlitelimab. Earlier this year, an early look at Phase 2b data prompted the company to amend its Phase 3 trial protocol to allow for increased time off-drug. Amgen also said Tuesday that its rare disease drug Uplizna hit its primary endpoint in a Phase 3 trial for the autoimmune disease myasthenia gravis. In a measurement scale called the Myasthenia Gravis Activities of Daily Living, or MG-ADL, two doses of Uplizna produced an improvement of -4.2 points after 26 weeks, compared with -1.9 points on placebo (p<0.0001). Four of the study’s five secondary endpoints were also statistically significant, Bradner said. The win comes a few months after Uplizna recorded a successful Phase 3 study in IgG4-related disease back in June. Uplizna was first approved in 2020 for an autoimmune disease that affects the eyes called neuromyelitis optica spectrum disorder, or NMOSD.

Sanofi released new Phase 3 data for its BTK inhibitor tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS), showing a 31% improvement in delaying onset of disease progression compared to placebo. But safety issues that have dogged the drug class could complicate the readout. Tolebrutinib is a BTK inhibitor, and it and other related drugs have faced issues with elevated liver enzymes. In the Phase 3 readout, those signals showed up again — 4.1% of patients on tolebrutinib had their liver enzymes jump to three times the normal limit, compared with 1.6% in the placebo group. A smaller group in the trial, called HERCULES, showed even sharper liver enzyme increases: 0.5% of patients saw their liver enzymes spike to 20 times the normal limit, and one of those patients died after needing a liver transplant and suffered post-surgery complications. Every other case resolved without medical intervention, but Sanofi had to implement more rigorous monitoring of patients. Robert Fox, a clinician at the Cleveland Clinic and chair of the HERCULES global steering committee, said that if tolebrutinib is approved, he wouldn’t be surprised if it came with a boxed warning. “Would I be surprised if it’s in a black box? No,” Fox said. “But predicting whether it is or not, that’s not something I can do.” More intensive safety monitoring has lessened the amount of patients whose liver enzymes exceed the 20-fold threshold, but hasn’t eliminated cases entirely, a Sanofi spokesperson told Endpoints News . The spokesperson also said the company is still working through unblinding its safety data and can’t give an exact number of cases after the new protocols were instituted (the patient who died after a liver transplant received the drug beforehand). Sanofi presented the data at the 2024 ECTRIMS conference in Copenhagen. It plans to file with the FDA by the end of 2024. Despite the safety concerns, Fox said the data represented an impressive milestone in MS treatment — the efficacy results were statistically significant, with a p-value of p=0.0026. Fox noted that there isn’t anything on the market to slow secondary progressive MS’ disease progression, and that approved drugs only reduce the frequency of relapse episodes. Tolebrutinib “actually does something where none of the other therapies do anything. So that’s where we are, and so that is the decision that a clinician will have to consider,” Fox said. “If this were to be available for clinical use, how much anti-inflammation does my patient need, and how much slowing [of] that insidious progression does my patient need?” Sanofi acquired tolebrutinib as part of its $3.7 billion acquisition of Principia Biopharma in 2020 and has made it a central part of its new pipeline focus around immunology in addition to amlitelimab (bought from Kymab), lunsekimig (developed from Ablynx’s platform) and rilzabrutinib (also from Principia), among others. But the FDA placed a partial clinical hold on the drug in June 2022 in both MS and myasthenia gravis, an autoimmune disease, after reports of liver injury. While the partial hold remains in effect for other Phase 3 MS studies (it was “modified” to account for the new monitoring protocols, the spokesperson said), Sanofi discontinued development in myasthenia gravis in early 2023. Sanofi released data from two other Phase 3 relapsing MS trials earlier this month comparing tolebrutinib to standard of care, which showed mixed efficacy results. While neither study hit their primary endpoints, a pooled analysis showed they successfully delayed the time to disability. Safety data also presented at ECTRIMS across these two trials were more numerically balanced between the active and standard-of-care arms, but there were still cases of liver enzymes rising 20 times above the normal limit and patient deaths, though the latter were deemed unrelated to treatment. Another Phase 3 in patients with primary progressive MS is expected to read out in 2025. Editor’s note: This story has been updated to correct the p-value from 0.026 to 0.0026, that previously released mixed data came in RMS studies, not nrSPMS, and that patient deaths in these studies were not linked to treatment.