Day: August 18, 2022

A group of World Health Organization experts is recommending COVID-19 booster shots for people at the highest risk of severe illness and death. The Strategic Advisory Group of Experts on Immunization or SAGE, which met in extraordinary session August 11, issued its updated guidance Thursday.

SAGE recommends continued use of the two-dose mRNA COVID-19 vaccines. Since the vaccines’ efficacy wanes after several months, however, the group of experts advises a booster shot for everyone, beginning with those at highest risk.

This is the first time SAGE has updated its guidance on the administration of a second booster shot. Its recommendations are based on increasing evidence on the benefits of a second booster dose of COVID-19 vaccines for select groups of people.

SAGE chairman Alejandro Cravioto said the group recommends a second booster shot for people older than 55 who are considered at highest risk of developing severe disease and in need of hospitalization. He said SAGE does not advocate a second booster for the general public, for adults who are generally healthy and do not suffer from severe immunodeficiency.

“We also include persons with moderate and severe immuno-compromising conditions from, say, 6 months and above,” Cravioto said. “And that includes the children and adults with co-morbidities at higher risk of severe disease. We also include pregnant women and health workers.”

SAGE recommends a second booster be given four to six months after the administration of the first. It says healthy children and adolescents remain at low risk of severe disease from COVID-19, so there currently is no recommendation for youth groups to be vaccinated.

Cravioto, however, said SAGE has made interim recommendations for the use of Pfizer and Moderna vaccines in relation to their use in children.

“In the case of both vaccines, children from 6 months to 17 years with co-morbidities should be vaccinated to avoid a higher risk in these groups of severe disease. … This includes, of course, children with Down syndrome, who we know are at the highest risk of dying of COVID if they get infected.”

The group of experts notes the recommendations are based on the current available data. They say it is not a projection into the future but relates specifically to the omicron variant of the coronavirus. It says the guidance is likely to change depending on how the pandemic evolves and new variants circulate.
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The White House announced Thursday it will make an additional 1.8 million doses of monkeypox vaccine available for distribution beginning next week.

At a news conference, White House national monkeypox response coordinator Bob Fenton said the additional doses will be available for U.S. jurisdictions to order starting Monday, through the Department of Health and Human Services (HHS).

U.S. Centers for Disease Control and Prevention Director Rochelle Walensky and HHS Secretary Xavier Becerra also took part in the news briefing.

Fenton said in the less than 10 days since the U.S. Food and Drug Administration and the CDC authorized the Jynneos vaccine for emergency use against monkeypox in individuals 18 years of age and older, HHS has delivered nearly 1 million doses to U.S. states and cities, making it the largest program of its kind for monkeypox vaccine in the world.

Fenton said the additional doses are part of the National Monkeypox Response Team’s plan to address the viral disease’s outbreak in the United States and mitigate its spread.

He said HHS has been working on launching a pilot program that will provide up to 50,000 doses from the national stockpile to be made available for events that will have high attendance of gay and bisexual men.

While monkeypox is not classified as a sexually transmitted infection, or STI, it has been found to be disproportionally affecting men who have sex with men. The disease can spread through close or intimate physical contact such as hugging, kissing and sex. It can also be transmitted by touching infected items such as clothing, bedding or towels.

Fenton said the Biden administration has also significantly increased availability and convenience of monkeypox tests, expanding capacity from 6,000 tests per week to 80,000 tests per week.

Some information for this report was provided by The Associated Press and Reuters.
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Today’s sharks have nothing on their ancient cousins. A giant shark that roamed the oceans millions of years ago could have devoured a creature the size of a killer whale in just five bites, new research suggests.

For their study published Wednesday, researchers used fossil evidence to create a 3D model of the megalodon — one of the biggest predatory fish of all time — and find clues about its life.

At around 16 meters from nose to tail, the megalodon was bigger than a school bus, according to the study in the journal Science Advances. That’s about two to three times the size of today’s great white shark. The megalodon’s gaping jaw allowed it to feed on other big creatures. Once it filled its massive stomach, it could roam the oceans for months at a time, the researchers suggest.

The megalodon was a strong swimmer, too: Its average cruising speed was faster than sharks today and it could have migrated across multiple oceans with ease, they calculated.

“It would be a superpredator just dominating its ecosystem,” said co-author John Hutchinson, who studies the evolution of animal movement at England’s Royal Veterinary College. “There is nothing really matching it.

It’s been tough for scientists to get a clear picture of the megalodon, said study author Catalina Pimiento, a paleobiologist with the University of Zurich and Swansea University in Wales.

The skeleton is made of soft cartilage that doesn’t fossilize well, Pimiento said. So the scientists used what few fossils are available, including a rare collection of vertebrae that’s been at a Belgium museum since the 1860s.

Researchers also brought in a jaw’s worth of megalodon teeth, each as big as a human fist, Hutchinson said. Scans of modern great white sharks helped flesh out the rest.

Based on their digital creation, researchers calculated that the megalodon would have weighed around 70 tons, or as much as 10 elephants.

Even other high-level predators may have been lunch meat for the megalodon, which could open its jaw to almost 2 meters wide, Pimiento said.

Megalodons lived an estimated 23 million to 2.6 million years ago.

Since megalodon fossils are rare, these kinds of models require a “leap of imagination,” said Michael Gottfried, a paleontologist at Michigan State University who was not involved in the study. But he said the study’s findings are reasonable based on what is known about the giant shark. 
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A federal judge in Cleveland awarded $650 million in damages Wednesday to two Ohio counties that won a landmark lawsuit against national pharmacy chains CVS, Walgreens and Walmart, claiming the way they distributed opioids to customers caused severe harm to communities and created a public nuisance.

U.S. District Judge Dan Polster said in the ruling that the money will be used to abate a continuing opioid crisis in Lake and Trumbull counties, outside Cleveland. Attorneys for the counties put the total price tag at $3.3 billion for the damage done to the counties.

Lake County is to receive $306 million over 15 years. Trumbull County is to receive $344 million over the same period. Polster ordered the companies to immediately pay nearly $87 million to cover the first two years of the abatement plan.

In his ruling, Polster admonished the three companies, saying they “squandered the opportunity to present a meaningful plan to abate the nuisance” after a trial that considered what damages they might owe.

CVS, Walmart and Walgreens said they will appeal the ruling. It is unclear whether the companies will have to immediately pay the nearly $87 million during their appeals.

Trumbull County Commissioner Frank Fuda praised the award in a statement, saying “the harms caused by this devastating epidemic” can now be addressed.

Lake County Commissioner John Hamercheck said in a statement: “Today marks the start of a new day in our fight to end the opioid epidemic.”

A jury returned a verdict in November in favor of the counties after a six-week trial. It was then left to Polster to decide how much the counties should receive from the three pharmacy companies. He heard testimony in May to determine damages.

The counties convinced the jury that the pharmacies played an outsized role in creating a public nuisance in the way they dispensed pain medication into their communities.

It was the first time pharmacy companies completed a trial to defend themselves in a drug crisis that has killed a half-million Americans since 1999.

Attorneys for the pharmacy chains maintained they had policies to stem the flow of pills when their pharmacists had concerns and would notify authorities about suspicious orders from doctors. They also said it was doctors who controlled how many pills were prescribed for legitimate medical needs, not their pharmacies.

Walmart issued a statement Wednesday saying the counties’ attorneys “sued Walmart in search of deep pockets, and this judgment follows a trial that was engineered to favor the plaintiffs’ attorneys and was riddled with remarkable legal and factual mistakes.”

Walgreens spokesperson Fraser Engerman said, “The facts and the law did not support the jury verdict last fall, and they do not support the court’s decision now.

“The court committed significant legal errors in allowing the case to go before a jury on a flawed legal theory that is inconsistent with Ohio law and compounded those errors in reaching its ruling regarding damages.”

CVS spokesperson Michael DeAngelis said, “We strongly disagree with the court’s decision regarding the counties’ abatement plan, as well as last fall’s underlying verdict.”

CVS is based in Rhode Island, Walgreens in Illinois and Walmart in Arkansas.

Two chains — Rite Aid and Giant Eagle — settled lawsuits with the counties before trial. The amounts they paid have not been disclosed publicly.

Mark Lanier, an attorney for the counties, said during the trial that the pharmacies were attempting to blame everyone but themselves.

The opioid crisis has overwhelmed courts, social services agencies and law enforcement in Ohio’s blue-collar corner east of Cleveland, leaving behind heartbroken families and babies born to addicted mothers, Lanier told jurors.

Roughly 80 million prescription painkillers were dispensed in Trumbull County alone between 2012 and 2016 — equivalent to 400 for every resident. In Lake County, 61 million pills were distributed during that period.

The rise in physicians prescribing pain medications such as oxycodone and hydrocodone came as medical groups began recognizing that patients have the right to be treated for pain, Kaspar Stoffelmayr, an attorney for Walgreens, said at the opening of the trial.

The problem, he said, was “pharmaceutical manufacturers tricked doctors into writing way too many pills.”

The counties said pharmacies should be the last line of defense to prevent the pills from getting into the wrong hands.

The trial before Polster was part of a broader constellation of about 3,000 federal opioid lawsuits consolidated under his supervision. Other cases are moving ahead in state courts.

Kevin Roy, chief public policy officer at Shatterproof, an organization that advocates for solutions to addiction, said in November that the verdict could lead pharmacies to follow the path of major distribution companies and some drugmakers that have reached nationwide settlements of opioid cases worth billions. So far, no pharmacy has reached a nationwide settlement.

Also on Wednesday, attorneys general from numerous states announced they had reached an agreement with Endo International to pay as much as $450 million over 10 years to settle allegations the company used deceptive marketing practices “that downplayed the risk of addiction and overstated the benefits” of opioids it produced.

Based in Ireland, Endo’s U.S. headquarters are in Malvern, Pennsylvania. The company did not respond Wednesday to telephone and email requests for comment.

The agreement calls for the $450 million to be divided among participating states and communities. It also calls for Endo to put opioid-related documents online for public viewing and pay $2.75 million in expenses to publicly archive those documents.

Endo can never again market opioids, according to the agreement.

The company filed for Chapter 11 bankruptcy protection Tuesday night.

Endo produces generic opioids and name brands such as Percocet and Endocet. The company’s Opana ER opioid was withdrawn from the market in 2017. The attorneys general say Endo “falsely promoted the benefits” of Opana ER’s “so-called abuse deterrent formulation.” The attorneys general said the formulation did not deter abuse of the drug and led to deadly outbreaks of hepatitis and HIV resulting from people injecting the drug.
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