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U.S. FDA to Soon Decide on Second Round of Omicron-Tailored Boosters — WSJ

Reuters reported:

The U.S. Food and Drug Administration is close to making a decision on the authorization of a second dose of updated COVID-19 vaccine boosters for high-risk people, the Wall Street Journal reported on Tuesday, citing sources.

FDA officials could make the decision within a few weeks, the WSJ said, adding the regulator is considering authorizing second jabs of Omicron-targeted shots for people who are 65 years and older or those who have weakened immune systems, although officials are yet to reach a final decision.

The Centers for Disease Control and Prevention would have to recommend the shots after the FDA authorizes the second Omicron-tailored boosters from Pfizer-BioNTech (PFE.N)/(22UAy.DE) and Moderna (MRNA.O) for them to become widely available.

The decision comes at a time when the FDA plans to shift to an annual COVID booster campaign with an updated strain, similar to the way Americans receive their flu shots.

Biden Will Release COVID Origin Intelligence

Politico reported:

President Joe Biden signed into law Monday a bill to declassify intelligence on the origins of COVID-19, offering the public a chance to review the information that government agencies say is inconclusive.

The legislation called the COVID-19 Origin Act of 2023, which passed the Senate and House with unanimous support earlier this month, orders the Director of National Intelligence to declassify within 90 days of enactment all information relating to potential links between China’s Wuhan Institute of Virology and COVID-19. The director is then to submit the information in a report to Congress. Sen. Josh Hawley (R-Mo.) sponsored the bill.

Why it matters: Biden’s signature is a step further in providing transparency about what the U.S. knows about how the pandemic started. Some scientists and government agencies have theorized that researchers at the Wuhan Institute of Virology inadvertently spread COVID-19 to people in the city where the virus first emerged, while others have insisted that an animal more likely transmitted it to people.

The Wall Street Journal has reported that U.S. intelligence agencies believe three workers at the Wuhan lab were hospitalized in the month before the virus emerged. A determination that the virus leaked from the Chinese lab would further strain the U.S.-China relationship, and also erode trust in leading scientists who argued for the natural origin hypothesis.

‘I Suspected a China Lab Leak Early on — but My Research Was Rejected’

Newsweek reported:

I became aware of SARS-CoV-2 in late December 2019. I happened to hear a news report about a new unknown virus coming out of China and the next day saw an unusual clinical case report about a family in Wuhan Central Hospital.

When I initially saw the viral genome, in January 2020, I noticed a pretty esoteric thing. The virus we would later call SARS-CoV-2 has something called a furin cleavage site (FCS). The FCS, which had never before been seen in a SARS-CoV-2-related coronavirus, is a genetic feature that makes it easier for a virus to infect human cells. So, when I saw this FCS on SARS-CoV-2, I knew it was going to make it easier to infect cells and easier to evade the immune system by tunneling into neighboring cells.

Knowing FCSs were not found in nature in these SARS-related viruses I also knew that for years scientists have been artificially putting new FCSs into viruses to see what they do, and in every case I have seen, in which they published their results, it has increased infectivity, transmissibility, pathogenicity, or a combination of them.

I found that when you looked at this virus, it had none of the properties of natural infection and it still doesn’t to this day. I have not found a single shred of actual evidence that supports the idea that SARS-CoV-2 is a type of spillover infection that we have ever seen in the past.

Why ‘Lab Leak’ Proponents Are Unconvinced by Raccoon Dog Evidence for Coronavirus Origins

Yahoo!News reported:

A new report suggesting that the coronavirus may have originated in raccoon dogs has energized scientists who have long argued that the pandemic began at a wildlife market in Wuhan, where the pathogen jumped from animals to humans.

But to the smaller faction of researchers who maintain that the coronavirus was the result of a laboratory accident, the raccoon dog findings — described in an Atlantic article published on Thursday — failed to produce convincing evidence of a natural origin that rules out human involvement.

“It speaks volumes that this weak and missing data is considered the strongest evidence for a market origin,” molecular biologist Alina Chan of the Broad Institute of MIT and Harvard told Yahoo News. A leading proponent of the lab origin hypothesis, Chan noted that “even the natural origin proponents analyzing this data have said it is not definitive and not direct evidence of infected raccoon dogs at the market.”

Moderna Expects to Price Its COVID Vaccine at About $130 in the U.S.

Reuters reported:

Moderna Inc (MRNA.O) 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. (PFE.N) said in October it was considering for its rival COVID shots sold in partnership with BioNTech (22UAy.DE).

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.

8 Burning Questions Bernie Sanders and Other Senators Should Ask Moderna’s Stéphane Bancel

STAT News reported:

Moderna CEO Stéphane Bancel has some explaining to do. Bancel will appear alone before Sen. Bernie Sanders’ health committee on Wednesday, where he’ll have to defend his company’s suggestion it will likely quadruple the price of its COVID vaccines once sales transition from bulk federal purchases to the open market.

The Senate hearing will be a watershed moment for Bancel, a biotech superstar forged during the pandemic. While COVID vaccine rival manufacturer Pfizer is an established pharmaceutical behemoth with a massive lobbying influence in Washington, in contrast, Moderna registered its first lobbyist in Washington in 2019 and its COVID-19 vaccine is its only product on the market.

Sanders, a Vermont Independent, has in the past accused Bancel and Moderna’s other co-founders of profiteering off of taxpayer-funded research since facets of the company’s approach to making its messenger RNA-based vaccine were developed at the National Institute of Health’s Vaccine Research Center.

On the same day the hearing was announced, Moderna revealed plans to create a patient assistance program to provide vaccines at no cost to people who are uninsured or underinsured. Those with insurance won’t face out-of-pocket fees at the time they are vaccinated, but the higher price could well be reflected in insurance premiums.

Deadly Drug-Resistant Yeast Gained Ground, More Drug Resistance Amid COVID

Ars Technica reported:

A deadly, drug-resistant fungus emerging in the US gained ground faster and picked up yet more drug resistance amid the COVID-19 pandemic, researchers at the Centers for Disease Control and Prevention reported Monday.

The yeast Candida auris has been considered an “urgent threat” — the CDC’s highest level of concern — since it was first reported in the U.S. in 2016. The yeast lurks in healthcare settings and preys upon vulnerable patients, causing invasive infections with a fatality rate of between 30 to 60%.

In 2019, before the pandemic began, 17 states and Washington, DC, reported a total of 476 clinical cases. But in 2020, eight additional states reported cases for the first time, with the national clinical case count jumping 59% to 756. In 2021, 28 states were affected, with the clinical case count nearly doubling to 1,471. Asymptomatic cases detected through patient screening also jumped amid the pandemic, tripling from 1,310 cases in 2020 to 4,041 cases in 2021. The data appeared Monday in the Annals of Internal Medicine.

But its spread wasn’t the only alarming aspect of the yeast’s pandemic activities. It also became more drug-resistant. Before the pandemic, six patients developed infections resistant to first-line antifungal drugs, echinocandins. But, in 2021 alone, there were 19 such cases. Similarly, before the pandemic, there were only four reports of pan-resistant infections; that is, the fungus was resistant to all available drugs. In 2021, there were seven patients with pan-resistant infections.

Anthony Fauci Documentary on PBS Covers a Career of Crises

Associated Press reported:

There’s a moment in the new PBS documentary about Dr. Anthony Fauci when a protester holds up a handmade sign reading, “Dr. Fauci, You Are Killing Us.” It says something about Fauci that it’s not initially clear when that sign was waved in anger — in the 1980s as AIDS made its deadly rise or in the 2020s with COVID-19 vaccine opponents.

American Masters: Dr. Tony Fauci,” offers a portrait of an unlikely lightning rod: A government infectious disease scientist who advised seven presidents. Fauci hopes it can inspire more public servants like him.

Director Mark Mannucci offers an intimate look at his subject, with images of Fauci running from meeting to meeting and wolfing down Wheat Thins between Zooms. His wife attests to the stress by pointing out their security detail due to threats.

COVID-19 may have introduced Fauci to millions of Americans, but his long career at the National Institute of Allergy and Infectious Diseases was marked by numerous previous health scares, among them HIV, SARS, MERS, Ebola and even the nation’s 2001 anthrax attacks.

The Lab Leak Conversation Shows It’s Time to Rethink Our Biosecurity Infrastructure, Not Just Policies

STAT News reported:

The COVID pandemic exacerbated fear and panic regarding the potential for a future bioterrorism agent. As the lab leak theory continues to cause debate, politicians want to be able to tell their constituents that they are solving the problem by adding more oversight to biological research. But if all they are doing is adding more burden, bureaucracy, and box-checking, is it really making anyone more secure?

For half a century, efforts to build a governance system around the security of biology have largely focused on the development and use of biological weapons, starting with the Biological Weapons Convention, which opened for signatories in 1972 and went into force in 1975. It wasn’t until the early 2000s that the research side of biology started getting more attention from the security community, with experts creating methods to determine what security issues we need to worry about, and what we should do about them.

After 9/11 and the anthrax mailings, the federal government placed heavy restrictions on research with agents that were deemed to be biological weapons of mass destruction — referred to as select agents. Then, from 2007, there was new attention paid to dual-use research or experiments that could both benefit and harm society, agriculture, or the environment.

Scientific advances such as CRISPR, gene drives, synthetic viruses and increased pathogen capabilities, are rapidly proceeding while innovation in our collective ability to govern their security concerns is not.

‘COVID-Somnia’ and the Impact of Long COVID on Sleep

CBS News reported:

When Priya Mathew recovered from a mild case of COVID-19 in November, she thought she was out of the woods. Then came long COVID.

“At one point I counted 23 symptoms,” Mathew told CBS News. “The most alarming ones were shortness of breath, labored breathing, heart palpitations.”

One of the most crippling symptoms? Insomnia. Mathew isn’t alone. Dr. Emmanuel During, a psychiatrist and neurologist, has been seeing this in sleep patients at Mount Sinai Hospital. For those with long COVID, he says insomnia is often related to pain and is resistant to treatment.

Even for those without long COVID, the pandemic has robbed many of a restful night’s sleep. Nearly a third of Americans said they’ve experienced sleep disturbances since COVID began, according to a 2022 survey from the American Academy of Sleep Medicine. That’s down from 56% the year before. The phenomenon is described as “COVID-somnia.”