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FDA Rejects Antidepressant Seen as Possible COVID Treatment
The Food and Drug Administration declined Monday to authorize a 30-year-old generic antidepressant as a treatment for COVID-19, dealing a major blow to a small group of doctors who have organized around the pill for months, arguing that it could provide a cheap and accessible way to prevent hospitalizations and deaths both in the U.S. and around the world.
In an unusual two-page summary — the FDA does not generally disclose the reasoning behind rejections — regulators said that the doctors failed to provide adequate evidence of the effectiveness of the drug, called fluvoxamine.
In a detailed rebuttal submitted last week and shared with STAT, David Boulware, the University of Minnesota infectious disease physician who has led the push to get fluvoxamine authorized as a COVID-19 treatment, said the FDA’s logic was “inconsistent.”
FDA Clears COVID Booster Shot for Healthy Kids Ages 5 to 11
U.S. regulators on Tuesday authorized a COVID-19 booster shot for healthy 5- to 11-year-olds, hoping an extra vaccine dose will enhance their protection as infections once again creep upward.
The Food and Drug Administration’s authorization now opens a third shot to elementary-age kids, too — at least five months after their last dose.
There is one more hurdle: The Centers for Disease Control and Prevention must decide whether to formally recommend the booster for this age group. The CDC’s scientific advisers are scheduled to meet on Thursday.
Pfizer’s shot is the only COVID-19 vaccine available for children of any age in the U.S. Those ages 5 to 11 receive one-third of the dose given to everyone 12 and older.
Coronavirus May Be Linked to Cases of Severe Hepatitis in Children
The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.
SARS-CoV-2 could be at the root of mysterious hepatitis in kids. A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis reported in hundreds of young children around the world, researchers suggest.
Children with COVID-19 are at significantly increased risk for liver dysfunction afterward, according to a report posted on Saturday on medRxiv ahead of peer review. But most of the children with acute hepatitis — which is generally rare in that age group — do not report a previous SARS-CoV-2 infection.
It is possible that the affected children, many of whom are too young to be vaccinated, may have had mild or asymptomatic COVID infections that went unnoticed, a separate team of researchers suggest in The Lancet Gastroenterology & Hepatology.
NYC Elevates to ‘High’ COVID Alert Level, Indoor Masks Urged
New York City entered the “high” COVID-19 alert level Tuesday, and health officials are strongly recommending wearing masks in public indoor settings.
Health officials say there is high community spread, and pressure on the healthcare system is increasing.
Despite the steady increase in COVID-19 infections across the state, New York City Mayor Eric Adams insisted on Monday that the city is not yet ready to reinstate its indoor mask mandate.
How Fast Omicron’s BA.2 Variant Is Spreading Around the World
In a pattern the world has seen twice over the past year, a new version of the coronavirus is sweeping across the globe. Omicron’s BA.2 subvariant is already by far the world’s dominant form of the coronavirus, as recorded in the GISAID international repository of coronavirus genetic sequences analyzed by The Washington Post.
The impact of the BA.2 subvariant is unclear. An uptick in coronavirus cases in the United Kingdom and parts of Europe is attributed to the new version of the virus. Some experts say a new wave could hit the United States amid relaxed safety protocols in the same way that Delta hit last summer when many thought the coronavirus was finished.
COVID Remains a Public Health Emergency in U.S., Administration Says
The Biden administration is continuing the COVID-19 public health emergency declaration beyond July 15, two administration officials told CNN, as coronavirus cases are rising again across the U.S.
The declaration is now expected to be renewed for up to another 90 days.
The public health emergency declaration allows many Americans to obtain free COVID-19 testing, therapeutic treatment and vaccines.
FDA Authorizes First Non-Prescription Test for COVID, Flu, RSV
The Food and Drug Administration authorized the first non-prescription COVID-19 test that can also detect the flu and RSV, the agency announced on Monday.
In addition to COVID-19, the test can detect other respiratory viruses, including influenza A and B, commonly known as the flu, and respiratory syncytial virus, also known as RSV.
With the newly authorized test from Labcorp, individuals can collect their own nasal swabs at home and send the sample to Labcorp for testing. They can then access their results through an online portal, with a healthcare provider following up about positive or invalid results.
Third Round of Free COVID Tests Now Available
The federal government started taking orders Monday for a third round of COVID-19 test kits to be mailed to any U.S. household.
A Department of Health and Human Services website said Monday that all U.S. households were eligible to order a third round of tests. Each order now contains eight rapid antigen tests, the U.S. Postal Service website says. Previously, four tests were sent out at a time.
Dogs Accurately Sniff out COVID at Airports
U.S. News & World Report reported:
Dogs’ ultra-sensitive noses can detect illegal drugs and even cancer, and a new study suggests they may also be able to sniff out COVID-19 in airline passengers.
Not only that, these trained canines can do so with an accuracy comparable to a PCR nose and throat swab test, the researchers noted.
In this study, four dogs previously trained to detect illicit drugs, dangerous goods or cancers were trained over a few weeks to sniff out SARS-CoV-2.
Overall, the dogs were 92% successful at detecting infected people and 91% successful at detecting uninfected people. Of the samples from the 28 infected people without symptoms, the dogs were just over 89% successful at identifying them as positive, the investigators found.
