Senators press Moderna CEO on COVID-19 vaccine price hike

Senators press Moderna CEO on COVID-19 vaccine price hike

WKMG News 6 & ClickOrlando

Moderna’s CEO on Wednesday defended a plan to more than quadruple the company’s COVID-19 vaccine price, but he also said the drugmaker will work to ensure patients continue paying nothing at drugstores or clinics.

Stephane Bancel told the Senate Committee on Health, Education, Labor and Pensions that the drugmaker will charge a list price of around $130 per dose for the vaccine in the U.S.

That price is expected to go into effect later this year. Until now, the federal government had been Moderna’s lone U.S. customer, buying doses in bulk to make sure that people weren’t charged anything.

The government paid around $15 per dose in 2020 and more than $26 last summer for Moderna’s bivalent booster, according to an analysis by the non-profit Kaiser Family Foundation.

More than 270 million doses of Moderna’s original COVID-19 vaccine and booster shots have been administered in the U.S., according to the U.S. Centers for Disease Control and Prevention. That makes it the second most popular coronavirus vaccine, trailing the shot made by Pfizer, which is also raising prices.

Sen. Bernie Sanders, I-Vt., noted that Moderna has made more than $20 billion in profits over the past two years, and the federal government contributed billions of dollars toward the vaccine’s development.

The hike will hit government payers like Medicaid and cost taxpayers, Sanders said as he pressed Bancel to reconsider the price.

The CEO said Moderna gave the government a discount with its initial prices. Now, the company must assume more costs and risk, he said.

He said, for instance, that the drugmaker will switch to single-dose vials from ones that held 10 doses.

He also that Moderna will have to make more doses than it anticipates using to ensure enough is available. The company will then have to eat the cost of unused doses, something the government has done.

“The volume we had during the pandemic gave us economies of scale we won’t have anymore,” he said.

Sanders later asked Bancel if Moderna was prepared to negotiate the price with Medicare, Medicaid and other agencies. Bancel replied that Moderna was “having discussions with all the different customers.”

While Moderna’s list price for its Spikevax vaccine will soar, company leaders have emphasized that people with insurance will continue to pay nothing out of pocket for the shots. Moderna also has a patient assistance program that will cover shots for people without coverage or who are underinsured.

Senators noted during Wednesday’s hearing that these programs can involve complex paperwork and be difficult to use.

“We want that (patient assistance program) to be something that works for patients and is not just something that’s like, ’Oh yeah, we have it, but no one can use it,’” said Sen. Bill Cassidy, R-La., a doctor.

Bancel said Moderna will announce more details this fall on plans to help the uninsured, and the company was working to make the program as “easy as possible to access.”

Pfizer also has said it will charge $110 to $130 for a dose of its COVID-19 vaccine. It also cited the cost of switching to single-dose vials and commercial distribution in explaining the new prices. Pfizer used no government funding to develop its vaccine.

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Follow Tom Murphy on Twitter: https://twitter.com/thpmurphy

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Superbug fungus cases rose dramatically during pandemic

Superbug fungus cases rose dramatically during pandemic

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U.S. cases of a dangerous fungus tripled over just three years, and more than half of states have now reported it, according to a new study.

The COVID-19 pandemic likely drove part of the increase, researchers at the Centers for Disease Control and Prevention wrote in the paper published Monday by Annals of Internal Medicine. Hospital workers were strained by coronavirus patients, and that likely shifted their focus away from disinfecting some other kinds of germs, they said.

The fungus, Candida auris, is a form of yeast that is usually not harmful to healthy people but can be a deadly risk to fragile hospital and nursing home patients. It spreads easily and can infect wounds, ears and the bloodstream. Some strains are so-called superbugs that are resistant to all three classes of antibiotic drugs used to treat fungal infections.

It was first identified in Japan in 2009 and has been seen in more and more countries. The first U.S. case occurred in 2013, but it was not reported until 2016. That year, U.S. health officials reported 53 cases.

The new study founds cases have continued to shoot up, rising to 476 in 2019, to 756 in 2020, and then to 1,471 in 2021. Doctors have also detected the fungus on the skin of thousands of other patients, making them a transmission risk to others.

Many of the first U.S. cases were infections that had been imported from abroad, but now most infections are spread within the U.S., the authors noted.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Biden signs bill on COVID origins declassification

Biden signs bill on COVID origins declassification

WKMG News 6 & ClickOrlando

President Joe Biden signed a bipartisan bill Monday that directs the federal government to declassify as much intelligence as possible about the origins of COVID-19 more than three years after the start of the pandemic.

The legislation, which passed both the House and Senate without dissent, directs the Office of the Director of National Intelligence to declassify intelligence related to China’s Wuhan Institute of Virology. It cites “potential links” between the research that was done there and the outbreak of COVID-19, which the World Health Organization declared a pandemic on March 11, 2020. The law allows for redactions to protect sensitive sources and methods.

U.S. intelligence agencies are divided over whether a lab leak or a spillover from animals is the likely source of the deadly virus. Experts say the true origin of the coronavirus pandemic, which has killed more than 1.1 million in the U.S. and millions more around the globe, may not be known for many years — if ever.

Biden, in a statement, said he was pleased to sign the legislation.

“My Administration will continue to review all classified information relating to COVID–19’s origins, including potential links to the Wuhan Institute of Virology,” he said. “In implementing this legislation, my Administration will declassify and share as much of that information as possible, consistent with my constitutional authority to protect against the disclosure of information that would harm national security.”

Florida may ban girls’ period talk in elementary grades

Florida may ban girls’ period talk in elementary grades

WKMG News 6 & ClickOrlando

Legislation moving in the Florida House would ban discussion of menstrual cycles and other human sexuality topics in elementary grades.

The bill sponsored by Republican Rep. Stan McClain would restrict public school instruction on human sexuality, sexually transmitted diseases and related topics to grades 6 through 12. McClain confirmed at a recent committee meeting that discussions about menstrual cycles would also be restricted to those grades.

“So if little girls experience their menstrual cycle in 5th grade or 4th grade, will that prohibit conversations from them since they are in the grade lower than sixth grade?” asked state Rep. Ashley Gantt, a Democrat who taught in public schools and noted that girls as young as 10 can begin having periods.

“It would,” McClain responded.

The GOP-backed legislation cleared the House Education Quality Subcommittee on Wednesday by a 13-5 vote mainly along party lines. It would also allow parents to object to books and other materials their children are exposed to, require schools to teach that a person’s sexual identity is determined biologically at birth and set up more scrutiny of certain educational materials by the state Department of Education.

McClain said the bill’s intent is to bring uniformity to sex education across all of Florida’s 67 school districts and provide more pathways for parents to object to books or other materials they find inappropriate for younger children.

At the committee meeting, Gantt asked whether teachers could face punishment if they discuss menstruation with younger students.

“My concern is they won’t feel safe to have those conversations with these little girls,” she said.

McClain said “that would not be the intent” of the bill and that he is “amenable” to some changes to its language. The measure must be approved by another committee before it can reach the House floor; a similar bill is pending in the Senate.

An email seeking comment was sent Saturday to the office of Republican Gov. Ron DeSantis, who is widely seen as a potential 2024 presidential candidate.

New COVID origins data point to raccoon dogs in China market

New COVID origins data point to raccoon dogs in China market

WKMG News 6 & ClickOrlando

Genetic material collected at a Chinese market near where the first human cases of COVID-19 were identified show raccoon dog DNA comingled with the virus, suggesting the pandemic may have originated from animals, not a lab, international experts say.

Other experts have not yet verified their analysis, which has yet to appear in a peer-reviewed journal. How the coronavirus began sickening people remains uncertain. The sequences will have to be matched to the genetic record of how the virus evolved to see which came first.

“These data do not provide a definitive answer to how the pandemic began, but every piece of data is important to moving us closer to that answer,” World Health Organization Director-General Tedros Adhanom Ghebreyesus said Friday.

He criticized China for not sharing the genetic information earlier, telling a press briefing that “this data could have and should have been shared three years ago.”

The samples were collected from surfaces at the Huanan seafood market in early 2020 in Wuhan, where the first human cases of COVID-19 were found in late 2019.

Tedros said the genetic sequences were recently uploaded to the world’s biggest public virus database by scientists at the Chinese Center for Disease Control and Prevention.

They were then removed, but not before a French biologist spotted the information by chance and shared it with a group of scientists based outside China that’s looking into the origins of the coronavirus.

The data show that some of the COVID-positive samples collected from a stall known to be involved in the wildlife trade also contained raccoon dog genes, indicating the animals may have been infected by the virus, according to the scientists. Their analysis was first reported in The Atlantic.

“There’s a good chance that the animals that deposited that DNA also deposited the virus,” said Stephen Goldstein, a virologist at the University of Utah who was involved in analyzing the data. “If you were to go and do environmental sampling in the aftermath of a zoonotic spillover event … this is basically exactly what you would expect to find.”

Ray Yip, an epidemiologist and founding member of the U.S. Centers for Disease Control office in China, said the findings are significant, even though they aren’t definitive.

“The market environmental sampling data published by China CDC is by far the strongest evidence to support animal origins,” Yip told the AP in an email. He was not connected to the new analysis.

WHO’s COVID-19 technical lead, Maria Van Kerkhove, cautioned that the analysis did not find the virus within any animal, nor did it find any hard evidence that any animals infected humans.

“What this does provide is clues to help us understand what may have happened,” she said. The international group also told WHO they found DNA from other animals as well as raccoon dogs in the samples from the seafood market, she added.

“There’s molecular evidence that animals were sold at Huanan market and that is new information,” Van Kerkhove said.

Efforts to determine the origins of the COVID-19 pandemic have been complicated by factors including the massive surge of human infections in the pandemic’s first two years and an increasingly bitter political dispute.

It took virus experts more than a dozen years to pinpoint the animal origin of SARS, a related virus.

Goldstein and his colleagues say their analysis is the first solid indication that there may have been wildlife infected with the coronavirus at the market. But it is also possible that humans brought the virus to the market and infected the raccoon dogs, or that infected humans simply happened to leave traces of the virus near the animals.

After scientists in the group contacted the China CDC, they say, the sequences were removed from the global virus database. Researchers are puzzled as to why data on the samples collected over three years ago wasn’t made public sooner. Tedros has pleaded with China to share more of its COVID-19 research data.

Gao Fu, the former head of the Chinese CDC and lead author of the Chinese paper, didn’t immediately respond to an Associated Press email requesting comment. But he told Science magazine the sequences are “nothing new. It had been known there was illegal animal dealing and this is why the market was immediately shut down.”

Goldstein said his group presented its findings this week to an advisory panel the WHO has tasked with investigating COVID-19’s origins.

Mark Woolhouse, an infectious diseases expert at the University of Edinburgh, said it will be crucial to see how the raccoon dogs’ genetic sequences match up to what’s known about the historic evolution of the COVID-19 virus. If the dogs are shown to have COVID and those viruses prove to have earlier origins than the ones that infected people, “that’s probably as good evidence as we can expect to get that this was a spillover event in the market.”

After a weeks-long visit to China to study the pandemic’s origins, WHO released a report in 2021 concluding that COVID-19 most probably jumped into humans from animals, dismissing the possibility of a lab origin as “extremely unlikely.”

But the U.N. health agency backtracked the following year, saying “key pieces of data” were still missing. And Tedros has said all hypotheses remain on the table.

The China CDC scientists who previously analyzed the Huanan market samples published a paper as a preprint in February suggesting that humans brought the virus to the market, not animals, implying that the virus originated elsewhere. Their paper didn’t mention that animal genes were found in the samples that tested positive.

Wuhan, the Chinese city where COVID-19 was first detected, is home to several labs involved in collecting and studying coronaviruses, fueling theories that the virus may have leaked from one.

In February, the Wall Street Journal reported that the U.S. Department of Energy had assessed “with low confidence” that the virus had leaked from a lab. But others in the U.S. intelligence community disagree, believing it more likely it first came from animals. Experts say the true origin of the pandemic may not be known for many years — if ever.

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Cheng reported from London.