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Covid News Watch

May 20, 2022

CDC Says COVID Vaccine-Related Myocarditis Much Lower for Children Than Teens + More

U.S. CDC Says COVID Vaccine-Related Myocarditis Much Lower for Children Than Teens

Reuters reported:

The U.S. Centers for Diseases Control and Prevention (CDC) on Thursday said reports of heart inflammation linked to the Pfizer (PFE.N)/BioNTech (22UAy.DE) COVID-19 vaccine have been much lower in 5- to 11-year-old boys than in adolescents and young men, representing only a slightly elevated rate than normal.

The agency, in a presentation to an advisory committee discussing the need for booster vaccine doses for children, cited data from the Vaccine Adverse Event Reporting System (VAERS).

CDC Recommends COVID Booster Shot for Children Ages 5 to 11

The Washington Post reported:

The Centers for Disease Control and Prevention recommended Thursday that children ages 5 to 11 get a third dose of the Pfizer-BioNTech coronavirus vaccine to boost their immunity as cases and hospitalizations tick upward in many pockets of the United States.

CDC director Rochelle Walensky greenlit the recommendation Thursday evening, and she also encouraged parents of children in that age group who have not yet been vaccinated to get their first shot soon.

Walensky also announced that the CDC was strengthening its recommendation that people 50 and older should get a second booster dose — a fourth shot in most cases — to be considered up to date on their coronavirus vaccinations.

Previously, the agency said that older adults may get a booster. Immunocompromised people 12 and older should also get a second booster, she added.

Bay Area Clinics Start Delivering COVID Booster Shots for Kids 5-11

NBC Bay Area reported:

Children ages 5-11 on Friday became eligible to receive a COVID-19 booster shot, and several clinics across the Bay Area were ready to deliver them. The Centers for Disease Control and Prevention on Thursday recommended the booster for young children four months after they receive their initial vaccine.

In Santa Clara County, the fairgrounds expo center was just one of the locations preparing for and accepting the 5-11 age group for smaller doses of the vaccine booster. Pediatric practices also were taking appointments.

But parents of elementary school-aged children aren’t exactly clamoring for the protection. Only a third of California children in the age group are fully vaccinated.

Biden Seeks New Unilateral Powers for WHO Chief to Declare Public Health Emergencies

The Epoch Times reported:

President Joe Biden’s administration is pushing amendments to the World Health Organization’s (WHO) governing regulations to give Director-General Tedros Adhanom Ghebreyesus unilateral authority to declare a public health emergency in any nation based on whatever evidence he chooses.

The proposed U.S. amendments were forwarded to the WHO in January for consideration next week by the UN’s 75th World Health Assembly in Geneva, Switzerland.

In a Jan. 26 letter to a virtual meeting of WHO’s executive board, Loyce Pace, Assistant Secretary for Global Affairs of the U.S. Department of Health and Human Services (HHS) described “the importance of equity and equitable access to medical countermeasures and the negative impacts of misinformation and disinformation related to the pandemic. We agree that we must all do better.”

Nowhere do the amendments or accompanying documents explain how or why U.S. public health officials believe the equity issue in healthcare would be addressed by giving Tedros the authority to declare a public health emergency on the basis of information provided by a source other than the affected nation.

Alcohol-Related Deaths Have Soared During the COVID Pandemic

Time reported:

The pandemic and its attendant anxiety, boredom and loneliness have not been good for people who struggle with alcohol use. According to a new study published in JAMA Network Open, alcohol-related deaths among U.S adults ages 25 and up increased by 25% in 2020, and 22% in 2021, compared to average annual deaths from 2012 to 2019.

Led by Dr. Yee Hui Yeo, an internal medicine physician at Cedars-Sinai Medical Center in Los Angeles, the study relied on a massive database maintained by the U.S. Centers for Disease Control and Prevention (CDC) that registers nearly all deaths in the U.S. and their causes.

Not all groups were affected equally. Men and women were similar in alcohol-related mortality, with both showing a 25% increase in 2020. Age was a much more significant factor. Far and away, the hardest-hit age group was the youngest measured — 25 to 44-year-olds — among whom deaths rose by 40% in 2020 and 33% in 2021.

Family’s Legal Bid as Blood Clots Killed Man After COVID Jab

Leicestershire Live reported:

A man’s life was tragically cut short after he died from blood clots following an AstraZeneca COVID-19 jab. His devastated family is now wanting to take legal action after he died two weeks after receiving his vaccine.

Jack Hurn, from Redditch, received his first dose of the vaccine at a Dudley center on May 29 last year, reports our neighboring county site Coventry Live. He died from blood clots on his brain.

They had allegedly asked staff about alternative vaccines as they were “aware of concerns around the use of AstraZeneca” for younger people. Lawyers say medical advice at the time recommended that under-30s should get an alternative to the AstraZeneca vaccine after it was revealed that younger people were at greater risk of blood clots.

However, the staff reassured the family that it was safe and they went ahead with the vaccination. Jack started suffering headaches within days and died 11 days later at Birmingham’s Queen Elizabeth Hospital where doctors allegedly described him as having “catastrophic” blood clots on his brain.

America’s COVID Apathy Stress Test

Axios reported:

A third of Americans say the pandemic is over, and the spike in cases hasn’t prompted much noticeable policy or behavioral change. But vaccines and therapeutics are now widely available, making the virus much less dangerous — at least for people who have access to and choose to use them.

Biden administration officials yesterday said that a third of Americans live in areas where the risk of COVID infection is high enough that they should consider wearing a mask indoors, the NYT reports.

But there’s no sign that mask mandates are coming back, even in the bluest parts of the country. New York City Mayor Eric Adams said yesterday that, although the city is considered to be in the high alert level, he’s not bringing back mask mandates now.

Hopelessness Around Youth Mental Health Is Creating a ‘Nihilistic Contagion’

STAT News reported:

I have been a child psychiatrist for more than 20 years. I’ve worked in the city, in the suburbs and in rural settings. I’ve seen patients in teaching hospitals and I’ve run a busy private practice.

In all that time, I have never seen psychiatric suffering as pervasive and intractable as I have over the last 18 months. The lack of real change in our nation’s child and adolescent mental health infrastructure has fostered pernicious and pervasive defeatism among patients and clinicians alike.

This hopelessness is a major feature of the current emergency. It might even be the major feature. Things will not get better unless the approach to it can effectively remedy this deeply ingrained pessimism. Mental health stigma has been impressively diminished. Now it’s time to overcome the ugly defeatism that fosters the ongoing inertia in mental healthcare.

The Quest for Longer-Lasting COVID Vaccines

CNN Health reported:

To maintain durable protection against the virus that causes COVID-19, scientists are working around the clock to develop next-generation vaccines. But some of the nuances around why and how immunity against COVID-19 fades remains a mystery.

The steepest drops in immunity — which come about four to five months after vaccination and up to eight months after infection, but can vary — are against COVID-19 symptoms, getting infected and getting sick.

But there’s another piece of the immunity puzzle that scientists are urgently trying to solve, and that is whether some of this drop off in our protection may be a result of the mRNA technology used to build some COVID-19 vaccines, such as those developed by Moderna and Pfizer/BioNTech, which were the first in the world to use this platform.

New Clue About Why COVID Is Deadlier for Men: Estrogen May Play a Protective Role

NBC News reported:

It’s one of the pandemic’s prolonged mysteries: Why have men died of COVID at higher rates than women?

COVID’s fatality rate for men was 1.7 times higher, on average than the rate for women across 38 countries, a 2020 study found. More recent research from Harvard University scientists found that although men represented 49% of COVID cases in the U.S., they accounted for 55% of COVID deaths from April 2020 through May 2021.

This week, a study lent further support to a leading theory about the discrepancy: Estrogen may offer some protection against severe COVID.

COVID: Sexually Transmitted Diseases Surged in U.S. During Pandemic

The BMJ reported:

U.S. cases of gonorrhea, syphilis and congenital syphilis declined at the beginning of the COVID-19 pandemic in 2020, but then rose markedly for the rest of the year, the U.S. Centers for Disease Control and Prevention (CDC) has reported. Chlamydia declined slightly. The CDC cautioned that the data may be an undercount because of the pandemic.

The CDC’s report said the decline in chlamydia, the most common STD, was most likely because of changes in screening rather than a drop in new infections. Cases were highest among young adults aged 15-24. Since chlamydia is usually asymptomatic, diagnosis depends on screening or routine preventive care.

During the pandemic many health departments redirected employees to help control COVID-19, thus reducing screening and emphasizing of the diagnosis and treatment of syphilis and gonorrhea.

Suicidal Thoughts Among Canadians Significantly Higher During COVID: StatCan

Global News reported:

When COVID-19 hit in 2020, 16-year-old Lexi Daken’s routine changed. Her father, Chris Daken, told Global News Wednesday, “Once COVID-19 hit, she was home, isolated and didn’t really get that social interaction as much.”

Lexi, who was a Grade 10 student, spent eight hours at Dr. Everett Chalmers Regional Hospital in Fredericton, N.B., in February 2021 being assessed by a mental health professional after a guidance counselor noticed mental health issues.

She eventually left the hospital without receiving any immediate help, according to her family. Less than a week later, she died by suicide. Daken said the mental impact of lockdown due to COVID-19 was “definitely a part of the outcome.”

Researchers with the Public Health Agency of Canada (PHAC) found that the prevalence of suicidal thoughts among adults was significantly higher in 2021 than in 2019 before COVID-19 hit.

May 19, 2022

More of the Vaccinated and Boosted Landing in Hospital With COVID + More

More of the Vaccinated and Boosted Landing in Hospital With COVID

The Atlanta Journal-Constitution reported:

As summer once again brings signs of a coming COVID-19 wave, an unusual trend has emerged: The Georgians who are fully vaccinated and boosted are increasingly winding up in the hospital with serious COVID-19 symptoms.

The phenomenon points to two changes in the unpredictable pandemic battleground more than two years in. The circulating Omicron variant has become better at evading the vaccine, which was designed on the first version of coronavirus to appear in China. And the people most likely to get boosted are those who were most vulnerable, to begin with: the elderly, or patients with pre-existing conditions. Despite the extra vaccine protection, those people remain the most vulnerable.

Even in light of the unexpected hospitalizations of those vaccinated and boosted, doctors say it’s still true that boosted groups are the least likely to die.

The rate of hospitalizations for boosted Georgians fell again this week but still remains higher than the rate of hospitalizations for those with only the primary vaccine series (2 shots).

CDC’s Independent Vaccine Advisers Will Meet to Discuss COVID Boosters for Kids

CNN Health reported:

The U.S. Centers for Disease Control and Prevention’s Independent Advisory Committee on Immunization Practices (ACIP) will meet Thursday to discuss updates on COVID-19 vaccine safety and effectiveness for children ages 5-11 years, CDC guidance on boosters for that age group and the framework for that booster dose.

The committee will vote in the afternoon on whether or not this age group should be eligible for a booster.

On Tuesday, the U.S. Food and Drug Administration expanded the eligibility for the Pfizer/BioNTech COVID-19 vaccine to children 5 to 11 years of age. The children would be able to get the booster at least five months after they have completed their primary series of shots.

AstraZeneca’s Ambitious Vaccine Dreams Are Finally, Officially Dead

STAT News reported:

AstraZeneca was once the world’s best bet to develop a speedy COVID-19 vaccine, and the company got a bigger initial contract from Operation Warp Speed than any other drugmaker. But AstraZeneca’s unfortunate vaccine saga came to an end in December, when the White House quietly canceled its contract, documents published by STAT show.

AstraZeneca told us that its contract for 300 million doses was structured so payments would be sent upon delivery. The government only ended up paying for 70 million doses, the documents show, which means the cancellation did save some money.

Depending on when it’s released, that extra cash could be helpful to the White House while it scrounges for more COVID-19 relief funds. (Actually canceling the contract wasn’t a huge surprise, since AstraZeneca decided not to file for emergency use authorization in the United States.)

According to a recent report released by the House Oversight Committee, at least 105 million AstraZeneca doses were destroyed following manufacturing issues at an Emergent Biosolutions plant. The White House still hasn’t publicly announced the cancellation and didn’t respond to a request for comment.

WHO: COVID Deaths Dropped by 21% Last Week but Cases Rising

Associated Press reported:

The number of coronavirus deaths globally dropped by about 21% in the past week while cases rose in most parts of the world, according to the World Health Organization.

In its weekly report on the pandemic released Thursday, the U.N. health agency said the number of new COVID-19 cases appears to have stabilized after weeks of decline since late March, with about 3.5 million new cases last week, or a 1% rise. WHO said cases increased in the Americas, Middle East, Africa and the Western Pacific, while falling in Europe and Southeast Asia. Some 9,000 deaths were recorded.

Pfizer’s Grip on Paxlovid Thwarts Research on COVID Treatment

Bloomberg reported:

Pfizer Inc. is resisting requests for study supplies of its COVID-19 pill, Paxlovid, disappointing researchers who say combining the $22 billion therapy with other drugs might stave off resistance.

Pfizer hasn’t started any combination trials in people, and a review of the clinicaltrials.gov database shows no outpatient studies combining Paxlovid, the mainstay U.S. COVID therapy, with other antiviral drugs or antibodies. Some academic researchers and advocacy groups say they can’t get Paxlovid for human studies that could maintain or improve its effectiveness and expand use.

Pfizer’s apparent reluctance to share its antiviral with collaborators has been “disturbing,” said Reshma Ramachandran, a postdoctoral fellow in Yale University’s National Clinician Scholars Program who studies transparency in drug company trials. “It’s all very puzzling,” she said. “It really makes me wonder what’s going on.”

COVID: Second Boosters May Benefit at-Risk Groups but Have ‘Minimal’ Impact for Others, Says WHO

The BMJ reported:

Short-term benefits are seen after a second COVID-19 vaccine booster — normally a fourth vaccine dose — in health workers, over 60s and people with immunocompromising conditions, the World Health Organization has said.

But early data show that the benefit may be “minimal” in healthy younger populations, it added. WHO said that evidence on the usefulness of these doses in all groups was sparse, with studies available only for mRNA vaccines such as the Pfizer-BioNTech and Moderna vaccines.

WHO’s evidence review included seven studies, six of which were conducted in Israel and one in Canada. Six of the studies evaluated the relative effectiveness of a fourth dose four months after a third dose of mRNA vaccine, compared with people who received three doses.

The other study provided data on absolute vaccine effectiveness, comparing the fourth dose schedule with unvaccinated people. The maximum follow-up in the available studies was short, ranging from two to 10 weeks after the fourth dose.

Woman Pleads Guilty in $1.2M COVID Fraud Scheme

Associated Press reported:

A woman pleaded guilty Tuesday in federal court in Virginia to a $1.2 million scheme that defrauded COVID-19 pandemic relief programs using victims’ personal information that she obtained through her state government employment, a prosecutor said.

U.S. Attorney Jessica Aber said court documents show that in one scheme, from May 2020 to August 2021, Sadie Mitchell, 30, of Midlothian, with help from a co-conspirator, defrauded the Virginia Employment Commission by filing at least 20 fraudulent unemployment applications using inmates’ personal information.

As an employee of the Virginia Motor Vehicle Dealer Board, Mitchell had access to a government database, officials said. The conspirators filed at least 30 fake applications in the names of other people whose personal information was obtained, in part, through Mitchell’s database queries, officials said.

Through this scheme, the conspirators collected approximately $1 million in Pandemic Unemployment Assistance and unemployment insurance benefits.

White House Warns the U.S. Can’t Buy Updated COVID Vaccines ‘for Every American Who Wants One’ Without More Funding

CNN Politics reported:

White House COVID-19 coordinator Dr. Ashish Jha warned Wednesday that without more funding from Congress the U.S. will not be able to buy enough COVID-19 vaccines for every American who wants an updated shot later this year.

Scientists are working to develop new vaccines that would offer additional protection from infection and severe illness from new variants, including the possibility of a bivalent vaccine, a vaccine that would combine a currently approved vaccine with an Omicron-specific vaccine, for example.

The U.S. Food and Drug Administration could make a decision as soon as next month based on data from manufacturers Moderna and Pfizer for distribution in the fall.

1 in 3 Americans Now Live in Areas Where Indoor Masks Advised, CDC Says

U.S. News & World Report reported:

Masks may not be required, but Americans should consider wearing one anyway if they live in an area where COVID-19 case numbers are high, federal health officials said Wednesday.

That advice currently applies to about one-third of Americans, all of whom now live in areas with high levels of community transmission, according to the U.S. Centers for Disease Control and Prevention. Most of those areas are in the Northeast.

In those regions, “we urge local leaders to encourage the use of prevention strategies like masking in public indoor settings, and increasing access to testing and treatment for individuals,” said CDC director Dr. Rochelle Walensky, The New York Times reported. She spoke at the first pandemic-focused White House COVID briefing in six weeks.

U.S. Pedestrians Dying at Highest Rate in 40 Years

U.S. News & World Report reported:

U.S. pedestrian deaths in 2021 were the highest in four decades, with an average of 20 deaths every day, according to the Governors Highway Safety Association.

An estimated 7,485 pedestrians were killed in 2021, which was 12% more than in 2020, preliminary data show. The findings are “heartbreaking and unacceptable,” said Jonathan Adkins, executive director of the highway safety association.

“The pandemic has caused so much death and damage, it’s frustrating to see even more lives needlessly taken due to dangerous driving,” he said in an association news release.

The reasons are clear: There has been an increase in speeding, impaired, distracted driving and other dangerous driving behaviors in recent years, according to the association’s report.

WHO Clears China’s CanSino COVID Vaccine for Emergency Use

Associated Press reported:

The World Health Organization said Thursday that it has granted an emergency use authorization for the coronavirus vaccine made by China’s CanSino Biologics, the 11th such shot to receive the green light.

The U.N. health agency said the single-dose CanSino vaccine was found to be about 92% effective against severe COVID-19 and 64% effective in preventing people from getting symptoms of the disease. WHO’s expert vaccine group recommended the vaccine for everyone age 18 and over.

The CanSino vaccine uses a harmless virus called an adenovirus to deliver the spike protein of the coronavirus into the body, which then prompts an immune response. The technology is similar to vaccines made by Johnson & Johnson and AstraZeneca, which use different adenoviruses.

May 18, 2022

As COVID Cases Rise, U.S. Health Officials Mull Widening Additional Booster Eligibility + More

As COVID Cases Rise, U.S. Health Officials Mull Widening Additional Booster Eligibility

Reuters reported:

Health officials are considering extending the eligibility for a second COVID-19 vaccine booster dose to people under 50 amid a steady rise in cases, with the United States seeing a threefold increase over the past month.

The U.S. Food and Drug Administration had in late March authorized a second booster dose of the Moderna (MRNA.O) and Pfizer (PFE.N)/BioNTech SE (22UAy.DE) vaccines for people aged 50 and older, citing data showing waning immunity and the risks posed by Omicron variants of the virus.

“With regard to a fourth dose for those under the age of 50, that is going to require action from the FDA, and we’re in conversations there,” U.S. Centers for Disease Control and Prevention Director Rochelle Walenksy said on Wednesday.

PM Dismisses Need for More Measures to Limit COVID Deaths, Suggesting Australians Are Dying With, Not of, the Virus

The Guardian reported:

Scott Morrison brushed off the need for further measures to curtail Australia’s ongoing high rates of COVID-19 transmission and deaths and suggested many Australians are dying with, not of, COVID.

Morrison told reporters on Wednesday that medical advice does not currently support a fourth COVID vaccine for the general population and asserted, without evidence, that Labor under Anthony Albanese may return to lockdowns to combat COVID.

Morrison has leaned heavily on Australia’s record combating COVID in his campaign for re-election by citing low deaths in the first two years of the pandemic when the country’s borders were shut to the world.

“What you see when you have case numbers of that level is that people, when they pass away from many other causes, they will die with COVID, and their deaths are recorded as COVID deaths — but that doesn’t necessarily mean … that they passed away because of COVID, that’s a very different proposition,” said Morrison, who added that the premiers, chief medical officer and health authorities also recognized that distinction.

Does Paxlovid Help People Who Have Been Vaccinated Against COVID? Show Us the Data!

STAT News reported:

As a primary care doctor in New York City, I am grateful to drug companies for providing effective COVID-19 therapies for my patients. But I am also frustrated that these companies appear to be completely running the show, and believe that Americans could get more from Big Pharma if only our regulators dared to ask for it.

This dynamic is on display with Paxlovid, which was approved based on a study that seems designed to exaggerate the benefit most Americans can expect from this drug rather than provide us with relevant information about it.

Among antiviral agents for COVID-19, Pfizer’s Paxlovid has emerged as the clear winner for two reasons: First, as a pill, Paxlovid is easy to administer, compared to the infusions required for monoclonal antibodies and remdesivir. Second, Paxlovid appears to be highly effective, with a clinical trial showing an 89% relative reduction in hospitalizations or death among high-risk patients who receive it.

I say “appears to be” because there’s a problem: The single trial supporting the FDA’s emergency use authorization of Paxlovid included only unvaccinated people who had never previously had COVID-19. Since 76% of U.S. adults are now vaccinated, and an estimated 58% of Americans have already had COVID, the trial supporting Paxlovid is not directly applicable to a majority of Americans.

Convicted Killer Charged With Heading COVID Fraud Scam

Associated Press reported:

A woman who is serving a life sentence for murder in California is charged with masterminding a $2 million fraud scheme involving COVID-19 unemployment money from behind bars, federal prosecutors said Tuesday.

Natalie Le Demola, 37, is among 13 people charged with using stolen identities to apply online for — and receive — benefits from the California Employment Development Department, the U.S. Department of Justice said in a statement.

Most of the money had been earmarked for relief for people suffering from business lockdowns and restrictions aimed at reducing the deadly spread of COVID-19 and most of the fraud occurred in the second half of 2020 when infections were rising rapidly.

Some of the personal identifying information used — such as names, birth dates and Social Security numbers — was provided by a state prison official who wasn’t named, the indictment alleged.

As U.S. COVID Cases Rise, so Does Demand for Antivirals

Reuters reported:

Rising COVID-19 cases are driving up the use of therapeutics, with Pfizer Inc’s (PFE.N) oral antiviral treatment Paxlovid seeing a 315% jump over the past four weeks, U.S. health officials said on Tuesday.

The increase in U.S. cases and hospitalizations is starting to affect recommendations on behavior, with New York City, the nation’s most populous city, advising stricter mask usage but stopping short of new mandates. Apple (AAPL.O) has scrapped return to office plans.

Nearly 43,000 Traffic Deaths Last Year, Most in 16 Years, U.S. Agency Says

New York Daily News reported:

The U.S. saw almost 43,000 traffic deaths in 2021, according to the National Highway Traffic Safety Administration.

The estimated 42,915 fatalities represent a 10.5% increase over the year prior when 38,824 deaths were reported and was the biggest percentage jump since the agency began tracking the data in 1975.

The NHTSA said 44 states, Puerto Rico and Washington, DC, are projected to have increased traffic deaths in 2022, with Texas, California and Florida making up the top three.

“An increase in dangerous driving — speeding, distracted driving, drug- and alcohol-impaired driving, not buckling up — during the pandemic, combined with roads designed for speed instead of safety, has wiped out a decade and a half of progress in reducing traffic crashes, injuries and deaths,” Russ Martin, senior director of policy and government relations for the Governors Highway Safety Association, said.

When Africans Asked for COVID Shots, They Didn’t Get Them. Now They Don’t Want Them.

Reuters reported:

It’s noisy inside the Mamprobi clinic in Accra as kids clamber over their mothers while they wait to get their measles vaccines. Outside, an area reserved for COVID-19 shots is empty. A health worker leans back in his chair and scrolls on a tablet.

One woman, waiting to get her daughter inoculated, is fully aware of the dangers of measles: the high fever, the rash, the risk to eyesight. But COVID-19? She has never heard of a single case.

The perception that COVID-19 doesn’t pose a significant threat is common in Ghana’s capital and elsewhere in Africa, whose youthful populace has suffered a fraction of the casualties that have driven vaccine uptake in places like Europe and America, where the disease tore through elderly populations.

Germany OKs More COVID Vaccine Spending for This Fall

Associated Press reported:

Germany plans to spend another 830 million euros ($872 million) to buy new coronavirus vaccines that will allow the country to deal with a series of possible variants this fall, the health minister said Wednesday.

Health Minister Karl Lauterbach said that the government, via the European Union, already has ordered enough of the existing vaccines and of one that has been developed by Germany’s BioNTech to counter the Omicron variant. He said the new funding is earmarked for a vaccine being developed by Moderna to tackle both Omicron and other variants.

May 17, 2022

FDA Rejects Antidepressant Seen as Possible COVID Treatment + More

FDA Rejects Antidepressant Seen as Possible COVID Treatment

STAT News reported:

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

Associated Press reported:

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

Reuters reported:

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

ABC 7 NY reported:

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

The Washington Post reported:

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

CNN Politics reported:

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

Axios reported:

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

NBC News reported:

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.