Latest news with #covid19
Gizmodo
4 days ago
- General
- Gizmodo
Worrying Covid-19 Variant Hits the U.S. Just in Time for Summer
A new variant of covid-19, NB.1.8.1, is stirring up trouble. The variant, already linked to recent surges in parts of Asia, has now been spotted in the U.S. as well. The World Health Organization singled out the growing emergence of NB.1.8.1 in its latest status report on covid-19 Wednesday. Scientists have also recently detected NB.1.8.1 in California and other states. Though NB.1.8.1 isn't dramatically different from existing variants, the WHO warns that covid-19 remains a high public health risk. So far, fewer than 20 NB.1.8.1 cases in the U.S. have been reported, the CDC told NBC News this past Wednesday. But the variant is linked to a spike in cases and hospitalizations in other countries like China. And compared to other current variants, NB.1.8.1 may possess some mutations that could increase its transmissibility. The WHO first recognized NB.1.8.1 as a variant under monitoring last week, though it was first detected in late January. More recently, it's become an increasing threat. As of mid-May, just about 10% of all cases reported worldwide to the WHO have come from NB.1.8.1 (up from 2% just four weeks earlier). Covid-19 activity in general has been on the upswing, with a worldwide test positivity rate of 11% as of May 11—a level not seen since July 2024. That said, NB.1.8.1 is genetically still within the same broad lineage of covid-19 viruses that first began with Omicron in late 2021. That means it's very unlikely to spark the sort of massive outbreaks that Omicron initially did when it arrived. The WHO also hasn't found any evidence yet that NB.1.8.1 is causing any more severe illness than current variants. 'Evaluation of…the most recently designated VUM, NB.1.8.1, suggests no increased public health risk posed by these variants compared to other circulating variants,' the WHO stated in its report. But covid-19 itself still poses a very real public health problem, even if its overall danger has significantly declined since 2022. From October 2024 through May 2025, covid-19 is estimated to have killed between 30,000 and 50,000 Americans and hospitalized up to 430,000 people, a burden on par with the average flu season. And the recent emergence of NB.1.8.1 could certainly fuel a new peak of cases in the U.S. and elsewhere, just in time for summer. Adding to the danger is rock-bottom vaccination rates as of late, even among older adults who are most vulnerable to severe illness. According to the WHO, just 1.68% of older adults across 75 countries received a booster covid-19 shot in 2024. While the original covid-19 vaccines continue to ensure a lower risk of death and severe illness from covid-19, booster doses further reduce this risk. And the situation in the U.S. isn't looking to get better anytime soon. Under the reign of HHS chief Robert F. Kennedy Jr., who has long spread misinformation about vaccine safety, the Centers for Disease Control and Prevention has removed its recommendation that pregnant women and young children receive covid-19 vaccines, for instance. Trump-era health officials have also signaled their plans to only recommend covid-19 vaccines for older Americans in general, and the new regime has already impeded the development of newer, possibly more effective vaccines for both flu and covid-19. While covid-19 is no longer the world-shaking threat it once was, it isn't gone, and variants like NB.1.8.1 could soon painfully teach us that lesson again. 'As per the latest WHO global risk assessment, covering the period July-December 2024, the global public health risk associated with COVID-19 remains high,' the WHO said in its report.
Gizmodo
22-05-2025
- Health
- Gizmodo
Moderna Pulls Promising Covid-Flu Combo Shot as RFK Continues Antivax Campaign
Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the drugmaker said it would withdraw its application seeking approval from the U.S. Food and Drug Administration for the time being, according to a report from Reuters—the latest indication that Department of Health and Human Services Secretary Robert F. Kennedy Jr.'s vaccine skepticism has fully infected the federal government. Moderna isn't giving up on the combo shot entirely—it plans to resubmit later this year after it collects more data from its Phase III trials, which test how well a new treatment works compared to existing options. But the early indicators out of its trials have been positive, with recipients of the dual vaccine generating the same or greater immune response compared to those given separate vaccines. But for the time being, the company is pulling back and doesn't anticipate approval being granted until at least 2026. The company's decision to pump the brakes comes just one day after the FDA announced that it will require new clinical trials to be conducted before any of the annual covid-19 boosters receive approval for healthy Americans under the age of 65. The agency will require boosters to go through a randomized, controlled trial before getting approval—a process that vaccine makers warned would likely delay the availability of the shots well beyond the point in which they would be useful to address the currently circulating strain of covid-19 that they were designed to address. This new restriction has already had an impact. Novavax's covid-19 vaccine shot received approval last week, more than a month later than the initial deadline for approval, but the FDA limited access to people over the age of 65 and people between the ages of 12 and 64 who have at least one underlying condition that puts them at risk of severe illness from a covid-19 infection. The agency is also requiring existing covid-19 vaccines to carry an expanded warning label about the risk of myocarditis, or inflammation of the heart. This is a potential side effect of the vaccines, but multiple studies have found that experiencing a covid-19 infection puts young people at substantially higher risk of experiencing myocarditis than getting the vaccine.
Gizmodo
11-05-2025
- Health
- Gizmodo
Moderna's Super-Vaccine for Flu and Covid Works—Now Politics Could Sink It
A new trial suggests a combination vaccine may offer equal or better protection against both flu and covid-19 compared to current vaccines. Moderna's mRNA-based flu and covid-19 vaccine could provide the best of both worlds—if it's actually ever approved by the Food and Drug Administration. This week, scientists at Moderna published data from a Phase III trial testing the company's combination vaccine, codenamed mRNA-1083. Individuals given mRNA-1083 appeared to generate the same or even greater immune response compared to those given separate vaccines, the researchers found. But the FDA's recent policy change on vaccine approvals, orchestrated by Health Secretary Robert F. Kennedy Jr, could imperil the development of this and other future vaccines. The trial involved 8,000 people split into two age groups: those between the ages of 50 and 64, and those over 65. People were randomly given mRNA-1083 (plus a placebo) or two already approved flu and covid-19 vaccines. The vaccine seemed effective across both age groups, with mRNA-1083 participants showing at least the same level of humoral immune response (antibody-based) to circulating flu and covid-19 strains as participants who were given the separate vaccines. On average, this response was actually higher to the flu strains in particular among those given mRNA-1083. The experimental vaccine also appeared to be safe and well-tolerated, as the authors explained in their paper, published Wednesday in JAMA. The study results are certainly encouraging, and typically they would pave the way toward a surefire FDA approval. But the political situation has changed for the worse. The Department of Health and Human Services recently mandated an overhaul of the vaccine approval process, one that will require all new vaccines to undergo placebo-controlled trials to receive approval. While many experimental vaccines today are placebo-tested (including the original covid-19 vaccines), it's unclear whether this order will also apply to vaccines that can be compared to existing vaccines, like the combination mRNA-1083 vaccine, or to vaccines that have to be regularly updated to match fast-evolving viruses like the flu and covid-19. Some vaccine experts have said that these changes are unnecessary and potentially unethical, since it could leave some people vulnerable to an infection that already has a vaccine. The new rule also might delay the availability of upcoming seasonal vaccines, particularly the current covid-19 shots. A potentially important wrinkle for the mRNA-1083 vaccine is that no mRNA-based vaccine for the flu is currently approved. That reality could very well be all that the FDA needs to demand further placebo-controlled trials. RFK Jr. and other recent Trump appointees have also been highly skeptical of mRNA-based vaccines in general, despite no strong evidence that these vaccines are significantly less safe than other types. Kennedy, who has a long history of supporting the anti-vaccination movement, has even wrongly declared that the mRNA covid-19 vaccine was the 'deadliest vaccine ever made.' Moderna stated last week it doesn't expect its mRNA-1083 vaccine to be approved before 2026, following the FDA's request for late-stage data showing the vaccine's effectiveness against flu specifically. But it's worth wondering if even that timeline is now in jeopardy under the current public health regime.
