Savara announces new data in two poster presentations at ATS Conference 2025
Savara (SVRA) announced new data in two poster presentations at the ATS International Conference 2025. Data presented were from the Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP and demonstrated that molgramostim reduces surfactant burden and improves health-related quality of life outcomes in patients with aPAP. ATS 2025 Posters: Poster Title: Molgramostim Reduces Surfactant Burden and Number of Whole Lung Lavage Procedures in Patients with Autoimmune Pulmonary Alveolar Proteinosis: Results From the IMPALA-2 Phase 3 Clinical Trial. Summary: Molgramostim reduced surfactant burden as measured by ground-glass opacification scores, a radiological measure of surfactant burden. The mean reduction in GGO score from baseline to Week 24 was greater in the molgramostim group than in the placebo group; Fewer patients in the molgramostim group required rescue whole lung lavages compared with placebo. During the 48-week double-blind treatment period, 6 patients in the molgramostim group underwent a total of 15 WLLs and 11 patients in the placebo group underwent a total of 24 WLLs. Poster Title: The Effects of Molgramostim on Respiratory Health-related Quality of Life and Patient-reported Outcomes in Patients with Autoimmune Pulmonary Alveolar Proteinosis. Summary: Molgramostim showed benefit on measures of health-related quality of life and patients' assessment of breathing problems and physical activity, including changes from baseline in St. George's Respiratory Questionnaire Impact and Symptom scores, the EuroQol 5 Dimensions, 5 Levels, Patient Global Impression of Severity, and Patient Global Impression of Change at Weeks 24 and 48, which were included as exploratory endpoints in the trial; Molgramostim improved respiratory HRQoL as measured by changes from baseline to Week 24 in SGRQ Impact and Symptom scores compared with placebo, and the EQ-5D-5L, a generic HRQoL instrument comprised of a short descriptive system questionnaire that allows patients to rate their health across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Odds ratios of responses on the EQ-5D-5L numerically favored the molgramostim group on 3 of the 5 dimensions at Weeks 24 and 48; Molgramostim reduced the severity of breathing problems, as assessed by PGIS, at both Weeks 24 and 48. Additionally, more molgramostim patients reported improvements in overall change in daily physical activity level, as measured by more patients assessing themselves as 'Much better' or 'A little better' compared with placebo at Week 24 and Week 48
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The Hill
8 hours ago
- The Hill
Trump administration vs. mRNA vaccines
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Yahoo
14 hours ago
- Yahoo
HHS justifies decision to stop recommending Covid shots during pregnancy with studies supporting the shots' safety
The Department of Health and Human Services is circulating a document on Capitol Hill to explain its decision to remove the Covid-19 vaccine recommendation for pregnant women — citing studies that largely found the shot is safe. The document, which HHS sent to lawmakers days before Secretary Robert F. Kennedy Jr. announced his plan to fire the panel that advises the CDC on immunizations, says that studies have shown that women who got the vaccine during pregnancy had higher rates of various complications. And it claims that "a number of studies in pregnant women showed higher rates of fetal loss if vaccination was received before 20 weeks of pregnancy,' footnoting a research paper on vaccination during pregnancy. But Dr. Maria P. Velez of McGill University, the lead author of one of the studies, told POLITICO in an email that 'the results of our manuscript were misinterpreted.' The 2023 study shows a slightly higher rate of miscarriages among women who were immunized against Covid-19 during their pregnancies. But, Velez said, that after adjusting for 'variables that can confound a crude association,' like 'age, rurality, neighbourhood income quintile, immigration status, comorbidity' and other factors that could affect the outcome, Canadian researchers found 'no association between SARS-CoV-2 vaccination and an increased risk of miscarriage.' Raw numbers don't account for significant differences among the groups being compared — such as underlying conditions and when during pregnancy the people were vaccinated, said Katelyn Jetelina, an epidemiologist who's consulted for the Centers for Disease Control and Prevention. Scientists, including the Canadian researchers, use statistical methods to adjust for those factors, she said, which is how they determined the vaccine wasn't associated with miscarriage. In a statement, HHS spokesperson Andrew Nixon pointed to the raw study data, which showed a slightly higher rate of miscarriage in the first half of pregnancy for women who were vaccinated against Covid compared with those who weren't. "The underlying data speaks for itself — and it raises legitimate safety concerns," he said. "HHS will not ignore that evidence or downplay early pregnancy loss." Nixon added that HHS and the CDC encourage people to talk to their providers "about any personal medical decision." Vaccine researchers and obstetricians criticized the decision to remove the recommendation for pregnant women, and researchers cited in the HHS document largely dismissed any connection between Covid vaccination and miscarriages. 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'Our findings contribute to the growing body of evidence regarding the safety of COVID-19 vaccination in women who are trying to conceive.' The HHS document also includes an incorrect link for that study, instead leading to a different study — also cited in HHS' document — by Israeli researchers that found the vaccine 'appears to be safe during pregnancy,' with no increase in preterm labor or in newborns with low birth weight. That February 2022 study did note a possible increase in preterm birth rates for women vaccinated during the second trimester, and the authors suggested future investigations of outcomes based on the timing of immunization. HHS' assertion about significant risks to pregnant women 'contradicts the bulk of published studies,' said Dr. Paul Offit, an expert who has served as an outside adviser on vaccines to the FDA and the CDC. HHS deviated from past practice when it changed the Covid vaccine guidance last month, announcing the decision without the endorsement of an existing outside panel of expert advisers. Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, told POLITICO at the time that he was disappointed by HHS' decision, and pointed to data showing that newborns can benefit from maternal antibodies from the vaccine for protection from Covid. 'In fact, growing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalized infants less than 6 months of age — those who are not yet eligible for vaccination — born to unvaccinated mothers,' Fleischman said.
Scientific American
15 hours ago
- Scientific American
Can You Still Get a COVID Vaccine This Fall? Here's What to Know
For the first time since the COVID vaccines became available in pharmacies in 2021, the average person in the U.S. can't count on getting a free annual shot against a disease that has been the main or a contributing cause of death for more than 1.2 million people around the country, including nearly 12,000 to date this year. 'COVID's not done with us,' says Jennifer Nuzzo, an epidemiologist at Brown University. 'We have to keep using the tools that we have. It's not like we get to forget about COVID.' In recent weeks, the Department of Health and Human Services, led by prominent antivaccine activist Robert F. Kennedy, Jr., has announced a barrage of measures that are likely to reduce COVID vaccine access, leading to a swirl of confusion about what will be available for the 2025–2026 season. HHS officials did not respond to a request for comment for this article. On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today. Government officials appear to be limiting COVID shots to people who are aged 65 and older and to those who have certain preexisting health conditions—groups that have long been known to face a higher risk of developing severe COVID. Pregnant people and some children, meanwhile, appear to be explicitly excluded from access, despite plentiful evidence that vaccines are very safe and effective for them and that COVID infections can cause them significant harm. Scientific American spoke with clinicians and public health experts about the latest COVID vaccine recommendations, what access may look like this fall and how these policies might influence people's vaccination choices and health. What COVID vaccines will be manufactured this year? Public health experts are monitoring a strain of the COVID-causing virus SARS-CoV-2 called NB.1.8.1, which was first detected early this year and last month became responsible for one in 10 COVID cases globally. So far, the new variant has mostly been reported in Asia and Europe. But it has also been picked up in airport surveillance in multiple U.S. states, says Peter Chin-Hong, an infectious disease physician and a professor of medicine at the University of California, San Francisco. The emergence of a new variant isn't surprising, particularly at this time of year, Chin-Hong says. 'It's kind of acting like clockwork—maybe this might be the variant of the summer,' he adds. Still, NB.1.8.1 has led to concerns about a potential surge in cases—although Chin-Hong and other scientists don't have any evidence so far that it causes more serious disease than other currently circulating strains. 'All of these new variants, they might be more transmissible, they might be more immune evasive, but I've seen no data whatsoever that suggests that they're more pathogenic,' says Angela Rasmussen, a virologist at the University of Saskatchewan. Within the U.S., a strain called LP.8.1 has been the most common one detected since March. Both NB.1.8.1 and LP.8.1 are among the alphabet soup of strains that descended from a key ancestor lineage called Omicron JN.1, which dominated U.S. cases by early 2024. Current vaccines target this category of strains. And in May a Food and Drug Administration panel determined that, this year, vaccine producers should again tailor their shots to a single strain within the JN.1 lineage—preferably LP.8.1. What's going on with COVID vaccine policy? Strain selection aside, the recent messaging and decision-making on vaccine policy for COVID and beyond have been chaotic, with various governmental groups and officials announcing different access guidelines and restrictions. 'The situation we're in right now is nuts,' says Nuzzo, referring to the fact that agency leaders have sidestepped the formal science committees that traditionally make vaccine-related decisions. 'We don't change vaccine policy on a willy-nilly basis. There's an incredible amount of nuance, and all of the data need to be considered.' But on June 9 Kennedy took a major step against this evidence-driven decision-making process by firing the entire CDC Advisory Committee on Immunization Practices (ACIP). Kennedy announced the committee rehaul in a Wall Street Journal op-ed, in which he alleged there were 'persistent conflicts of interest' among committee members. According to a recent HHS statement, new committee members are under consideration, and the group will still meet as scheduled from June 25 to 27. ACIP has traditionally been particularly important because any vaccine it recommends must be fully paid for by health insurance companies—a condition that greatly determines real-world access. It's unclear what the committee's overhaul will mean for COVID vaccine access in particular. Another concern is that Kennedy announced in late April that HHS would implement a policy requiring all 'new' vaccines—including updated versions of existing ones, such as COVID shots—to be tested against a placebo. The original COVID vaccines were tested in just this manner. But conducting similar tests when an effective and very safe vaccine already exists would be not only unethical for researchers but also expensive and time-consuming for manufacturers. It remains unclear when the new policy will take effect. What does this mean for COVID vaccine access this fall? If you are 65 years old or older, you should be able to get a COVID shot as you have in recent years. If you have an underlying condition such as cancer, diabetes, or heart or lung problems, you may also be able to get a COVID shot as usual. These issues and several others are on the CDC's list of conditions that leave people more vulnerable to severe disease, and this list is included in the description of the new regulatory framework. One 2021 study looked at many (but not all) of the conditions on the list and estimated that three in four U.S. adults has at least one. People are allowed to self-disclose a preexisting condition at pharmacies without a prescription or doctor's note. That list could also be expanded later if new research finds other risk factors that increase people's risk of severe COVID, says Jacinda Abdul-Mutakabbir, a clinical pharmacist and an assistant professor at the University of California, San Diego. But there's also a chance that qualifying conditions may be reduced instead. For example, current or recent pregnancy is included in the CDC's existing list, but HHS officials announced in late May that the COVID vaccine would no longer be recommended for pregnant people. Data have shown that COVID may cause various complications during pregnancy —increasing the risk that the pregnant person may require emergency care, be put on a ventilator or die. The newborn child of an infected person is also more likely to be born preterm or to have low birth weight. And babies younger than six months old—who are ineligible for vaccination because of their immature immune system—have the highest rates COVID hospitalization after adults aged 75 and older. In contrast, evidence from people vaccinated during pregnancy show that newborns receive protective immunity through antibodies that cross the placenta and are found in breast milk, Chin-Hong explains. Healthy children also face new restrictions to COVID vaccine access: The shot is now only recommended to them based on 'shared clinical decision-making,' according to the vaccine schedules released by the CDC last month. This means parents must consult with a health practitioner about whether to vaccinate such children. Experts worry about the consequences of restricting access for kids. Children under age 18 make up a smaller percentage of COVID hospitalizations and deaths. But that doesn't mean zero risk, Chin-Hong says. 'We know that COVID still kills kids,' he says. 'No death of a child is a good death—and these are all preventable.' 'Because children and pregnant people are considered vulnerable populations, they were not included in the original studies that were done for the COVID vaccines,' Abdul-Mutakabbir says. But five years' worth of real-world vaccine data from these groups show the health benefits. 'We do see effectiveness and safety in these vaccines,' she says. It's still possible that the late June ACIP meeting will shift the landscape again. But if you want a COVID vaccine this fall and don't meet current guidelines, you may still be able to request a shot. Your insurance may not pay for it, however, leaving you to risk a price tag of around $200. 'Insurance companies or providers are only required to pay for vaccines that are listed as recommended by the CDC,' Abdul-Mutakabbir says. Full, partial or no-cost coverage for nonrecommended vaccines is at the insurance provider's discretion. Any changes to coverage—and the times at which those changes are announced—will vary among programs, including private and governmental ones, such as the federal-state program Medicaid and the federal program Medicare. Until then, Chin-Hong and Abdul-Mutakabbir say, the COVID vaccines released in the fall of 2024 are still recommended and available to people who haven't already had one. And as of April 26, only 23 percent of adults and 13 percent of children in the U.S. had received the shot. 'If you are nervous about the surge or planning summer travel, I would recommend' getting the vaccine, Abdul-Mutakabbir says. The larger fight over vaccines For Rasmussen, the confusion over COVID shots signals the beginning of a longer tug-of-war—with Kennedy's HHS on one end. 'I think I know what their plan is, and it's to reduce access to vaccines in general,' she says. 'In my view, this is an incremental step in a larger attack on vaccination in general.' She encourages people worried about vaccine restrictions—and about the role of science in making these decisions—to call their congressional legislators. 'A lot of people speaking out is what is needed right now to make a big difference here,' she says. Abdul-Mutakabbir also hopes people continue to seek vaccines for COVID and other diseases—especially while they are still easily available. 'It's important that we consider the things that we can protect ourselves against,' Abdul-Mutakabbir says. 'Should you have a barrier with getting a COVID vaccine, guess what? There's no change to the flu vaccine; there's no changes to the pneumococcal recommendations; there's no change to measles, mumps, rubella vaccine. Get the vaccines that we can get.'
