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U.S. FDA Flags Risk of Heart Inflammation After Novavax COVID Vaccine

Reuters reported:

U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc’s (NVAX.O) vaccine, even as the company’s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.

“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines,” the FDA staff wrote in briefing documents released on Friday.

The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an “important identified risk” in its materials. The company had not yet agreed to do so.

Doctors Accuse FDA of Unlawfully Blocking Their Ability to Treat COVID Patients With Ivermectin

The Daily Wire reported:

A group of doctors has filed a lawsuit against the Biden administration claiming it unlawfully attempted to block the use of ivermectin in treating COVID-19.

It names the Department of Health and Human Services, HHS Secretary Xavier Becerra, the Food and Drug Administration (FDA), and FDA Commissioner Robert M. Califf as defendants.

In the filing, plaintiffs Mary Talley Bowden, Paul E. Marik, and Robert L. Apter argued that by publicly ordering health professionals and patients to avoid ivermectin, the FDA both acted outside of its authority and inhibited the doctors’ ability to practice medicine.

The filing emphasizes that the case is not about the efficacy of ivermectin in treating COVID-19: rather, it said, “it’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.”

A Growing Number of Young People Are Attempting Suicide by Self-Poisoning

Time reported:

A new study published in the journal Clinical Toxicology has looked more closely at a particular method of attempted suicide — self-poisoning — and turned up some disturbing results: From 2015 to 2020, suicide attempts by ingesting toxic substances or overdosing on medications soared by 26% among people ages 6 to 19.

The research, led by Dr. Jennifer Ross, a medical toxicologist at the University of Virginia School of Medicine, relied on figures from the National Poison Data System, which aggregates information from the country’s 55 state and territorial poison control centers.

From 2015-2020, there were 514,350 calls to poison control centers involving children ages 6-19 who, according to the control centers’ guidelines for suspected suicide attempts, had “an exposure resulting from the inappropriate use of a substance for self-harm or self-destructive” reasons.

Not every segment of the 6 to 19 age group was hit equally hard. The greatest increase in self-poisonings occurred among 10 to 12 year olds, with numbers leaping 109% in the five-year study period.

White House: 1st Shots for Kids Under 5 Possible by June 21

Associated Press reported:

The Biden administration said Thursday that children under 5 may be able to get their first COVID-19 vaccination doses as soon as June 21, if federal regulators authorize shots for the age group, as expected.

​​White House COVID-19 coordinator Ashish Jha outlined the administration’s planning for the last remaining ineligible age group to get shots. He said the Food and Drug Administration’s outside panel of advisers will meet on June 14-15 to evaluate the Pfizer and Moderna shots for younger kids. Shipments to doctors’ offices and pediatric care facilities would begin soon after FDA authorization, with the first shots possible the following week.

Jha said states can begin placing orders for pediatric vaccines on Friday, and said the administration has an initial supply of 10 million doses available. He said it may take a few days for the vaccines to arrive across the country and vaccine appointments to be widespread.

Gun Suicide Soars as Cause of Death Among Youth: Report

ABC News reported:

The rate of young people taking their own lives with firearms in the U.S. has increased faster than for any other age group, and the youth suicide rate is at its highest point in more than 20 years, according to a new gun violence prevention report by Everytown For Gun Safety and first obtained by ABC News.

While firearm suicide overall increased about 2% during the pandemic, the rate among young people increased 15% and nearly half of all suicide attempts by young people involve a gun, researchers with Everytown For Gun Safety found.

Experts have not pinned down exactly what is causing more young people to turn to suicide with guns, the report notes. But increased anxiety and depression, likely exacerbated by the pandemic, along with the impacts of social media and cyberbullying are among the theorized drivers.

Pfizer and Moderna Rapidly Falling out of Favor as Americans’ Favorite Brands: Report

Fierce Pharma reported:

What a difference a year makes: Pfizer and Moderna were riding high in Americans’ minds last year, but a new report from The Harris Poll shows how both have fallen from grace.

In 2021, Moderna ranked third and Pfizer came in at No. 7 in the annual Axios survey, undertaken by The Harris Poll, that focuses on Americans’ favorite brands in what it calls the 100 “most visible companies.”

But in 2022, the two are on a downward spiral. Pfizer has dropped 37 places to 44th on the list, while Moderna has fallen out of the top 100 completely. In 2020, Moderna didn’t place at all, while Pfizer was 61st.

Why Boosted Americans Seem to Be Getting More COVID Infections

CBS News reported:

As COVID-19 cases began to accelerate again this spring, federal data suggests the rate of breakthrough COVID infections in April was worse in boosted Americans compared to unboosted Americans — though rates of deaths and hospitalizations remained the lowest among the boosted.

It serves to illustrate a tricky reality facing health authorities amid the latest COVID-19 wave: even many boosted Americans are vulnerable to catching and spreading the virus, at a time when officials are wary of reimposing pandemic measures like mask requirements.

Melatonin Poisoning Reports Are up in Kids, Study Says

Associated Press reported:

Researchers are drawing attention to a rise in poisonings in children involving the sleep aid melatonin — including a big jump during the pandemic.

Last year, U.S. poison control centers received more than 52,000 calls about children consuming worrisome amounts of the dietary supplement — a six-fold increase from about a decade earlier. Most such calls are about young children who accidentally got into bottles of melatonin, some of which come in the form of gummies for kids.

Reported melatonin poisonings have been increasing for at least a decade, but the largest increases happened after the COVID-19 pandemic hit the United States in 2020. Between 2019 and 2020, the count shot up 38%.

CDC Has Recommended Booster Shots for Those 50 and Over. But Only 17.5% of Those Eligible in Mass. Have Gone Ahead and Done It.

The Boston Globe via MSN reported:

The U.S. Centers for Disease Control and Prevention has recommended that people 50 and older get a second COVID-19 booster shot, but so far Massachusetts residents have not jumped at the opportunity.

Only about 471,000 people 50 and older in Massachusetts have gotten a second booster shot, or about 17.5 percent of the 2.7 million people in that age group, according to data from the state’s Department of Public Health.

The data come from the state’s weekly vaccination report, which is updated every Thursday.

Pfizer’s Paxlovid Reduces COVID Risk in Seniors Regardless of Vaccine Status — Study

Reuters reported:

Pfizer Inc.’s (PFE.N) antiviral treatment Paxlovid reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, according to a new study in Israel conducted during the rise of the Omicron variant of the coronavirus.

The treatment, however, was not found to prevent severe illness among younger adults, according to research from Clalit Health Services, Israel’s largest healthcare provider.

Senior citizens who had no prior immunity — meaning they were neither vaccinated nor recovered from a previous COVID case — saw an 86% drop in hospitalizations with Paxlovid. Those who had prior immunity also benefited, but at a lower rate of 60%.

COVID Deaths in Africa May Fall 94% in 2022, WHO Model Shows

Bloomberg reported:

The number of deaths from the coronavirus in Africa may fall 94% to 22,563 this year if current variants and transmission rates remain the same, according to a World Health Organization model.

The fall in deaths, from an estimated 350,000 in 2021, comes even though as many as 73% of people will be infected. This reflects the less lethal nature of the Omicron variant in relation to the delta strain and the protection people have from prior infections and vaccination, the WHO said in a statement on Thursday. The modeling exercise used data from the 47 nations included under WHO’s Africa region.

Africa has the lowest vaccine coverage against the virus of any continent, with just 17.1% of the population having had a full course of inoculations, according to the Africa Centres for Disease Control and Prevention.