• chevron_right

      Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

      news.movim.eu / ArsTechnica · Wednesday, 14 February - 23:37 · 1 minute

    Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

    Enlarge (credit: Nozin.com )

    More than four years after SARS-CoV-2 made its global debut, the US Food and Drug Administration is still working to clear out the bogus and unproven products that flooded the market, claiming to prevent, treat, and cure COVID-19.

    The latest example is an alcohol-based sanitizer meant to be smeared inside the nostrils. According to its maker, the rub can protect you from becoming infected with SARS-CoV-2 and other nasty germs, like MRSA, and that protection lasts up to 12 hours after each swabbing. That all sounds great, but according to the FDA, none of it is proven. In a warning letter released Tuesday, the agency determined the sanitizer, called Nozin, is an unapproved new drug and misbranded.

    While ethyl alcohol is used in common topical antiseptics, like hand sanitizers, the FDA does not generally consider it safe for inside the nostrils—and the agency is unaware of any high-quality clinical data showing the Nozin is safe, let alone effective. The FDA also noted that, for general over-the-counter topical antiseptics, calling out specific pathogens it can fight off—like SARS-CoV-2 and MRSA—is not allowed under agency rules without further FDA review. Making claims about protection duration is also not allowed.

    Read 4 remaining paragraphs | Comments

    • chevron_right

      Contact-tracing software could accurately gauge COVID-19 risk

      news.movim.eu / ArsTechnica · Wednesday, 20 December - 19:29 · 1 minute

    A woman wearing a face mask and checking her phone.

    Enlarge (credit: Maridav )

    It’s summer 2021. You rent a house in the countryside with a bunch of friends for someone’s birthday. The weather’s gorgeous that weekend, so mostly you’re all outside—pool, firepit, hammock, etc.—but you do all sleep in the same house. And then on Tuesday, you get an alert on your phone that you’ve been exposed to SARS-CoV-2, the virus that causes COVID-19. How likely are you to now have it?

    To answer that question, a group of statisticians, data scientists, computer scientists, and epidemiologists in the UK analyzed 7 million people who were notified that they were exposed to COVID-19 by the NHS COVID-19 app in England and Wales between April 2021 and February 2022. They wanted to know if—and how—these app notifications correlated to actual disease transmission. Analyses like this can help ensure that an app designed for the next pathogen could retain efficacy while minimizing social and economic burdens. And it can tell us more about the dynamics of SARS-CoV-2 transmission.

    Over 20 million quarantine requests

    The NHS COVID-19 app was active on 13 to 18 million smartphones per day over 2021. It used Bluetooth signals to estimate the proximity between those smartphones while maintaining privacy and then alerted people who spent 15 minutes or more at a distance of 2 meters or less from a confirmed case. This led to over 20 million such alerts, each of which came with a request to quarantine—quite a burden.

    Read 6 remaining paragraphs | Comments

    • chevron_right

      Anti-viral drug backfires: COVID drug linked to viral mutations that spread

      news.movim.eu / ArsTechnica · Tuesday, 26 September - 21:41

    A worker handles a bottle of Merck & Co. and Ridgeback Biotherapeutics LPs molnupiravir antiviral medication in a warehouse in Shoham, Israel, on January 18, 2022.

    Enlarge / A worker handles a bottle of Merck & Co. and Ridgeback Biotherapeutics LPs molnupiravir antiviral medication in a warehouse in Shoham, Israel, on January 18, 2022. (credit: Getty | Kobi Wolf )

    With every new infection, the pandemic coronavirus gets new chances to mutate and adapt, creating opportunities for the virus to evolve new variants that are better at dodging our immune systems and making us sicker.

    Anti-viral drugs, such as Paxlovid and remdesivir, aim to halt this incessant evolution in individual patients—shortening illnesses, snuffing out opportunities for mutation, and reducing transmission. But one antiviral appears to be backfiring—allowing SARS-CoV-2 more opportunities to mutate.

    According to a new peer-reviewed study in the journal Nature , the anti-viral drug dubbed molnupiravir is linked to specific SARS-CoV-2 mutation signatures that happened to spring up in 2022 when the drug was introduced.

    Read 12 remaining paragraphs | Comments

    • chevron_right

      US to again offer free COVID tests ahead of respiratory virus season

      news.movim.eu / ArsTechnica · Thursday, 21 September - 20:54

    US to again offer free COVID tests ahead of respiratory virus season

    Enlarge (credit: Getty | picture alliance )

    Americans will again have an opportunity to receive free at-home COVID-19 rapid tests from the US government, with orders beginning next Monday, September 25, the Biden administration announced Wednesday.

    Households will be eligible to receive four free rapid tests that will "detect the currently circulating COVID-19 variant," the Department of Health and Human Services said in an announcement. The tests, available next week via COVIDTests.gov and expected to start shipping on October 2, are meant to help Americans detect COVID-19 and keep from spreading it for the rest of the year—especially during holiday gatherings.

    "At this point, our focus is getting through the holidays and making sure folks can take a test if they’re going to see Grandma for Thanksgiving ,” Dawn O’Connell, assistant secretary for preparedness and response at the HHS, told the Associated Press.

    Read 7 remaining paragraphs | Comments

    • chevron_right

      Updated COVID boosters get green light from FDA ahead of CDC review

      news.movim.eu / ArsTechnica · Monday, 11 September - 21:38

    Words and symbols adorn a large outdoor sign.

    Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly )

    The Food and Drug Administration greenlit two updated COVID-19 vaccine booster shots Monday—a day before advisors for the Centers for Disease Control and Prevention are scheduled to meet and vote on recommendations for use of the updated vaccines.

    The two shots are the 2023-2024 formulations of mRNA vaccines from Moderna and Pfizer-BioNTech, both of which target the recent omicron subvariant XBB.1.5 . The FDA granted full approval of both Pfizer-BioNTech's updated vaccine (Comirnaty) and Moderna's updated vaccine (Spikevax) for use in those ages 12 years and up. The agency issued emergency use authorizations for both updated vaccines for use in children ages 6 months to 11 years.

    If CDC and its advisors sign off on use of the vaccines Tuesday—which is likely—the shots could become fully available at local pharmacies and doctor's offices in the coming days. While the FDA timed today's actions to boost the population ahead of an anticipated winter wave of infection, the regulatory clearance come amid a mild increase of COVID-19 transmission that began in late summer.

    Read 12 remaining paragraphs | Comments

    • chevron_right

      BA.2.86 fears fizzle as other variants drive up hospitalizations, deaths

      news.movim.eu / ArsTechnica · Wednesday, 6 September - 23:11

    BA.2.86 fears fizzle as other variants drive up hospitalizations, deaths

    Enlarge (credit: Getty | Justin Sullivan )

    Concern over the highly evolved omicron subvariant BA.2.86 is easing as the first batch of preliminary studies on the virus suggests it may not be as immune evasive or dangerous as its numerous mutations suggest.

    But the good news is tempered by the latest COVID-19 data, which shows increasing rates of hospitalizations, emergency department visits, and deaths—all driven by the current gang of circulating omicron subvariants, led in the US by EG.5, FL.1.5.1 and XBB.1.16.6 . No single variant is dominant globally, though EG.5 is on the rise.

    In the US, hospitalizations are up nearly 16 percent since last week, and deaths have risen almost 18 percent in that time. Test positivity is also on a steep incline, according to the latest Centers for Disease Control and Prevention data .

    Read 11 remaining paragraphs | Comments

    • chevron_right

      Global COVID monitoring is crashing as BA.2.86 variant raises alarm

      news.movim.eu / ArsTechnica · Friday, 25 August, 2023 - 21:36 · 1 minute

    WHO's COVID-19 technical lead, Maria Van Kerkhove, looks on during a press conference at the World Health Organization's headquarters in Geneva, on December 14, 2022.

    Enlarge / WHO's COVID-19 technical lead, Maria Van Kerkhove, looks on during a press conference at the World Health Organization's headquarters in Geneva, on December 14, 2022. (credit: Getty | FABRICE COFFRINI )

    With global attention and anxiety locked onto the latest coronavirus omicron subvariant BA.2.86, health officials and experts are still mostly in the dark about how the highly mutated virus will play out.

    At the start of the week, amid a flurry of headlines, researchers had only six genetic sequences of the virus in the public repository GISAID, even though the virus had already spread to at least four countries (Denmark, Israel, UK, and the US). As of the time of publication of this article on Friday, there are still only 10 sequences from five countries (Denmark, Israel, UK, US, and South Africa). According to the World Health Organization, the variant has also appeared in wastewater sampling from Thailand and Switzerland.

    As Ars reported Monday , BA.2.86 gained attention for having a large number of mutations compared with BA.2, the omicron subvariant from which it descended. The number of mutations in BA.2.86's critical spike protein is over 30, rivaling the number seen in the original omicron subvariant, BA.1, which went on to cause a tidal wave of cases and hospitalizations. BA.2.86's spike mutations appear geared toward evading neutralizing antibody protections built up from past infections and vaccinations. But with such scant and spotty detection, it's impossible to say whether this variant can outspread its many omicron-subvariant cousins to cause a wave of infection. It's also still not possible to determine if it can cause more severe disease than other variants. So far, severe disease symptoms have not been reported from the 10 cases—but that is not enough data to draw any conclusions. As the Centers for Disease Control and Prevention reported in a risk assessment Wednesday, it's " too soon to know " the impact of BA.2.86 on transmission and disease severity.

    Read 10 remaining paragraphs | Comments

    • chevron_right

      BA.2.86 shows just how risky slacking off on COVID monitoring is

      news.movim.eu / ArsTechnica · Monday, 21 August, 2023 - 20:17

    Transmission electron micrograph of a SARS-CoV-2 virus particle isolated from a patient sample and cultivated in cell culture.

    Enlarge / Transmission electron micrograph of a SARS-CoV-2 virus particle isolated from a patient sample and cultivated in cell culture. (credit: Getty | BSIP )

    A remarkably mutated coronavirus variant classified as BA.2.86 seized scientists' attention last week as it popped up in four countries, including the US.

    So far, the overall risk posed by the new subvariant is unclear. It's possible it could lead to a new wave of infection; it's also possible (perhaps most likely) it could fizzle out completely. Scientists simply don't have enough information to know. But, what is very clear is that the current precipitous decline in coronavirus variant monitoring is extremely risky.

    In a single week, BA.2.86 was detected in four different countries, but there are only six genetic sequences of the variant overall —three from Denmark, and one each from Israel, the UK, and the US (Michigan). The six detections suggest established international distribution and swift spread. It's likely that more cases will be identified. But, with such scant data, little else can be said of the variant's transmission or possible distribution.

    Read 13 remaining paragraphs | Comments

    • chevron_right

      Fall COVID shots will boost protection against latest subvariants, Moderna says

      news.movim.eu / ArsTechnica · Friday, 18 August, 2023 - 16:39

    A vial containing Moderna COVID-19 booster vaccine at a vaccination center.

    Enlarge / A vial containing Moderna COVID-19 booster vaccine at a vaccination center. (credit: Getty | SOPA Images )

    Moderna's updated COVID-19 vaccine provided a "significant boost" in people's neutralizing antibody levels against the latest omicron SARS-CoV-2 subvariants circulating in the US, that is, EG.5 and FL.1.5.1, according to a press release from the company .

    The updated booster shot is expected to be authorized and rolled out in the coming weeks.

    Moderna, which was reporting its takeaway from preliminary clinical trial data, did not release additional details of the study, including the number of trial participants or the relative increase of neutralizing antibody levels. But the announcement aimed to ease concerns about whether the fall booster will adequately match this season's variants.

    Read 5 remaining paragraphs | Comments