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FDA granted an emergency use authorization for the first machine learning–based COVID-19 nondiagnostic screening device. The Tiger Tech COVID Plus Monitor identifies certain biomarkers that may be indicative of SARS-CoV-2 infection. It can also detect hypercoagulable conditions, such as sepsis or cancer, or hyper-inflammatory states in asymptomatic individuals over the age of 5 years...FDA said the device, which is an armband embedded with light sensors and a small computer processor, is intended for use by trained personnel to help prevent exposure to and the spread of COVID-19...READ MORE

An FDA inspector-turned-whistleblower claims the agency soft-pedaled violations at a range of pharma manufacturing plants, including a Merck & Co. vaccine facility in Durham, North Carolina, where staff allegedly destroyed evidence of unsanitary practices. Those allegations have now been passed along to the White House… The whistleblower alleged that employees at Merck's plant were moving between cleanrooms and uncontrolled areas without properly ungowning, and that a biohazard bin contained employee uniforms soiled with blood, urine and feces. Employees were soiling their uniforms rather than taking restroom breaks, the whistleblower claimed, citing a confidential informant, because staffers would have otherwise needed to remove sterile gowning and leave manufacturing areas…READ MORE

Forged vaccination certificates and fake negative tests are also reportedly available for purchase on the black market...The World Health Organization...issued a warning about counterfeit and stolen COVID-19 vaccines being sold on the dark web...Fake vaccination certificates are also being sold, as well as fake negative tests, aimed at those traveling abroad...The WHO is "aware of vaccines being diverted and reintroduced into the supply chain, with no guarantee that [the] cold chain has been maintained...READ MORE

In an unusual move... officials with the National Institute of Allergy and Infectious Diseases urged AstraZeneca to ensure it is providing the most recent efficacy data on its coronavirus vaccine. The statement came 1 day after the manufacturer released interim data from its U.S. trials...NIAID...said an independent monitoring board informed it that AstraZeneca's disclosures of the study results may have been based on outdated evidence. The agency's response to the company...READ MORE

Vaccine passports being developed to verify COVID-19 immunization status and allow inoculated people to more freely travel, shop and dine have become the latest flash point in America’s perpetual political wars, with Republicans portraying them as a heavy-handed intrusion into personal freedom and private health choices...They currently exist in only one state — a limited government partnership in New York with a private company — but that hasn’t stopped GOP lawmakers in a handful of states from rushing out legislative proposals to ban their use...READ MORE

Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine ingredients weeks ago and ruined a large batch of the vaccine containing up to 15 million doses...The FDA is investigating the mistake, but the episode has led to a temporary halt of future J&J shot deliveries from the site...In a statement, J&J said it's working with federal authorities to deliver 24 million doses of the vaccine in April...The mistake happened early in the production process, so none of the doses made it out to distribution...READ MORE

In their clinical trials, the Pfizer and Moderna vaccines did okay, well enough for the FDA to grant emergency use authorization. But in a real-world study, where participants were all on the front lines fighting Covid, the vaccines proved 90% effective against the virus – not just the symptomatic disease. In the clinical studies, Pfizer and Moderna were testing against disease...According to the CDC-sponsored study released today, it didn’t matter which vaccine the participants received. What mattered was that both vaccines were designed using messenger RNA to repel the coronavirus. The results showed that the vaccines were even effective against asymptomatic virus...READ MORE

Throughout the frantic response to the pandemic last year, drugmakers worldwide tested hundreds of potential treatments. Gilead’s antiviral remdesivir quickly rose to the top of treatment guidelines, and with the pandemic spiraling out of control, advocacy groups called on the U.S. government to step in and enforce patents against the company...But it turns out the government has no intellectual property covering remdesivir, the Government Accountability Office concluded in a new report...READ MORE

Here's a look at how it was created, what it offers – and how it grew to reach more than 38 million visits in seven months...Amid the COVID-19 pandemic, Johns Hopkins Medicine needed to provide accurate content very quickly in an information environment that was changing by the hour...In a pre-pandemic world, the organization's content team would look to search engine optimization strategies to see what questions people are asking and determine what information would be most useful. However, that data was just not yet available for COVID-19 when the pandemic hit...READ MORE

AstraZeneca created a COVID-19 vaccine data controversy this week by reportedly selecting the most favorable data to tout on its program, a move independent data monitors publicly flagged in a middle-of-the-night missive. Now, with a speedy data update and analysis, AstraZeneca says it can “confirm” the vaccine’s phase 3 success...In a newly released primary analysis, AstraZeneca says its vaccine was 76% effective against symptomatic COVID-19 and 85% effective against symptomatic disease in people 65 and over. The shot was also 100% effective against severe disease and hospitalization in the phase 3 trial...READ MORE