(Reuters) – Potentially deadly fungal infections with Candida auris are spreading rapidly in U.S. healthcare facilities, with cases nearly doubling between 2020 and 2021, the Centers for Disease Control and Prevention said.

The number of cases rose by 44% to 476 in 2019, up from 330 in 2018, and subsequently 59% to 756 in 2020 and by an additional 95% to 1,471 in 2021, the agency’s researchers reported on Monday in Annals of Internal Medicine.

Also concerning was a tripling in 2021 of the number of cases that were resistant to echinocandins, the class of drugs most often recommended for treatment of the disease.

A high fever with chills that does not get better after taking antibiotics may be a sign of Candida auris infection.

People who are very sick, have invasive medical devices such as mechanical ventilators, or have long or frequent hospital stays are at particular risk for the infections, the report said.

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” study leader Dr. Meghan Lyman said in a statement.

The CDC noted that spread of the infections in 2021 may have been exacerbated as the healthcare system was hit by pandemic-related stressors, such as staff and equipment shortages.

The report did not include data from 2022, but the CDC’s website shows 2,377 cases of confirmed Candida auris infections in the U.S. last year, a sharp increase from 53 in 2016, the year in which cases were first reported in the country.

Although it was initially limited primarily to the New York City and Chicago metropolitan areas, Candida auris has now been detected in more than half of U.S. states, with recent cases mostly reflecting local transmission of the disease, according to the report.

Other countries have also reported increased spread of the fungus, the researchers said.

(Reporting by Leroy Leo in Bengaluru; editing by Caroline Humer, Nancy Lapid and Jonathan Oatis)

By Patrick Wingrove

(Reuters) -Moderna Inc expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday.

“There are different customers negotiating different prices right now, which is why it’s a little bit complicated,” Hoge said ahead of a Congressional hearing run by Democratic U.S. Senator Bernie Sanders on Moderna’s pricing plans.

Moderna previously said it was considering pricing its COVID vaccine in a range of $110 to $130 per dose in the United States, similar to the range Pfizer Inc said in October it was considering for its rival COVID shots sold in partnership with BioNTech.

Hoge said the government’s Medicare health plan for seniors pays $70 per dose for the seasonal influenza vaccine. That there were two to three times more hospitalizations and deaths from COVID in the past three months alone than from the flu went into the company’s pricing reasoning, Hoge said.

The Biden Administration has said the pandemic public health emergency will end in May, shifting price negotiations to insurers and other purchasers instead of just the federal government.

Sanders, chair of the Senate’s powerful Health, Education, Labor and Pensions Committee, has said Moderna should not raise the price of its vaccine because of the government funding it received. He plans to question Moderna Chief Executive Stephane Bancel on the price increase at the hearing on Wednesday.

Hoge said the company had more than paid back that federal support by selling a similar number of mRNA COVID vaccines as Pfizer to the government for around $3 billion less, and that Moderna had paid to ramp up its vaccine manufacturing itself.

Moderna in February forecast significantly declining 2023 COVID-19 vaccine sales, which reached $18.4 billion in 2022.

Demand for the shots has declined sharply this year due to built up product inventories around the world and increased population immunity from high rates of vaccination and previous infections.

(Reporting by Patrick WingroveEditing by Caroline Humer and Bill Berkrot)

By Patricia Zengerle

WASHINGTON (Reuters) -U.S. President Joe Biden on Monday signed a bill that requires declassification of information related to the origins of the coronavirus that causes COVID-19, the White House said.

Biden said he shared Congress’ goal of releasing as much information as possible about the origin of COVID-19.

“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,” Biden said in a statement. 

The bill sailed through the Senate and House of Representatives without opposition before being sent to the White House.

Washington has been conducting a highly politicized debate about the origins of the coronavirus pandemic almost since the first human cases were reported in the Chinese city of Wuhan in late 2019, amid calls from both Biden’s fellow Democrats and Republicans to push back harder against a rising China.

The debate was refueled last month, when the Wall Street Journal reported that the U.S. Energy Department had assessed with that the pandemic likely arose from a Chinese laboratory leak, an assessment Beijing denies.

The department made its judgment with “low confidence” in a classified intelligence report. The FBI has also assessed that the pandemic likely originated from a lab leak. Four other U.S. agencies still judge that COVID-19 was likely the result of natural transmission, while two are undecided.

Many U.S. officials have said the pandemic’s origins may never be known. China said claims that a laboratory leak likely caused the pandemic have no credibility.

Biden noted that he had directed intelligence agencies to investigate COVID-19’s origins in 2021, that work is ongoing and his administration would continue to review all classified information, including potential links to the Wuhan Institute of Virology.

“We need to get to the bottom of COVID-19’s origins to help ensure we can better prevent future pandemics,” he said.

(Reporting by Patricia Zengerle; additional reporting by Kanishka Singh and Costas Pitas; Editing by Tim Ahmann and Bill Berkrot)

By Bhanvi Satija

(Reuters) -The U.S. health regulator’s staff said on Monday safety issues with Biogen Inc’s drug to treat an ultra-rare form of amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease, should not prevent its accelerated approval.

A panel of outside advisers to the U.S. Food and Drug Administration on Wednesday will closely scrutinize mixed efficacy data from the drug’s late-stage trial and vote on the drug’s effectiveness, and if reduction of a key protein related to the disease is enough to conclude that it may benefit ALS patients.

The drug, tofersen, failed to meet its main goal of reducing symptoms but reduced protein neurofilament levels during a late-stage study.

“Our regulations allow for regulatory flexibility to expedite the … marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses,” the FDA’s staff said in briefing documents.

The risks related to Biogen’s drug, such as spinal cord inflammation and optic nerve swelling, observed in trial patients “are acceptable to the patient population”, the staff said.

They added that a majority of these risks may be related to the way in which the drug is administered, rather than the drug itself.

Biogen has also submitted data from an extension study to support the drug’s approval.

If approved under the FDA’s accelerated approval pathway, the drug will have to show that it provides a clinical benefit in a confirmatory trial.

The company is seeking approval for the drug in ALS patients with mutation in a gene known as superoxide dismutase 1.

(Reporting by Raghav Mahobe and Bhanvi Satija in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini Ganguli)

By David Shepardson

WASHINGTON (Reuters) -The U.S. Commerce Department on Tuesday released proposed rules to prevent $52 billion in semiconductor manufacturing and research funding from being used by China and other countries deemed of concern.

The proposal limits recipients of U.S. funding from investing in the expansion of semiconductor manufacturing in foreign countries of concern such as China and Russia, and limits recipients of incentive funds from engaging in joint research or technology licensing efforts with a foreign entity of concern.

It also classifies some semiconductors as critical to national security – defining these chips as not considered to be a legacy chip and therefore subject to tighter restrictions. This measure covers chips “including current-generation and mature-node chips used for quantum computing, in radiation-intensive environments, and for other specialized military capabilities.”

Commerce Secretary Gina Raimondo said “these guardrails will help ensure we stay ahead of adversaries for decades to come.”

The Commerce Department plans to begin accepting applications in late June for a $39-billion semiconductor manufacturing subsidy program. The law also creates a 25% investment tax credit for building chip plants, estimated to be worth $24 billion.

In October, the department issued new export controls to cut China off from certain semiconductor chips made anywhere in the world with U.S. equipment, vastly expanding its reach in its bid to slow Beijing’s technological and military advances.

The rules built on restrictions sent in letters last year to top toolmakers KLA Corp, Lam Research Corp and Applied Materials Inc, effectively requiring them to halt shipments of equipment to wholly Chinese-owned factories producing advanced logic chips.

The Commerce Department on Tuesday said it would reinforce those controls by aligning prohibited technology thresholds for memory chips between export controls and CHIPS national security guardrails and include “a more restrictive threshold for logic chips than is used for export controls.”

(Reporting by David Shepardson; Editing by Chizu Nomiyama and Mark Potter)