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Tuesday, November 30, 2021

Overnight Health Care — Presented by March of Dimes — FDA advisers back first at-home COVID-19 pill

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OVERNIGHT POLICY:
Health Care

 

FDA advisers back first at-home COVID-19 pill

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Welcome to Tuesday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.

Tomorrow, Roe v. Wade will hang in the balance as the Supreme Court hears arguments on Mississippi’s 15-week abortion ban.  Read our colleague John Kruzel’s preview here

On the COVID-19 front, FDA advisers backed a treatment from Merck, but only narrowly. The vote came as experts work to determine how effective existing vaccines are against the new omicron variant of the virus.

For The Hill, we’re Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let’s get started.

 

FDA advisers endorse Merck COVID-19 pill

© Merck's Media for Press

An advisory group for the Food and Drug Administration (FDA) narrowly voted to recommend Merck’s COVID-19 antiviral pill for infected adults at high risk for severe coronavirus illness, hospitalization or death.

The panel endorsed Merck’s five-day oral treatment in a 13-10 vote on Tuesday.

The advisers recommended the FDA authorize the pill, developed with Ridgeback Biotherapeutics, for adult patients enduring mild-to-moderate COVID-19 who face a higher risk of serious illness, including due to underlying health conditions. 

Split vote: The close vote came as experts considered concerns about updated data showing the pill linked to a 30 percent reduction in hospitalizations, a decrease in effectiveness from previous research. 

Advisers also discussed the potential risks the drug could present for pregnant people and worries that the treatment could spark the virus to mutate into a more dangerous strain. 

But several who backed the pill for high-risk infected adults pointed to the ongoing state of emergency amid COVID-19 and the limited treatments for the virus. 

Significance: Antiviral COVID-19 drugs have been considered a potential game changer in the pandemic, since all current drugs require an injection or IV. 

Approval of these pills could expand accessibility with at-home COVID-19 treatments, pending FDA authorization and Centers for Disease Control and Prevention (CDC) approval.

Read more here

 

A MESSAGE FROM MARCH OF DIMES

The U.S. remains among the most dangerous developed nations for childbirth. Help prioritize the health of our nation’s moms and babies by joining the #BlanketChange movement today at BlanketChange.org.

 

REGENERON SAYS ITS ANTIBODY TREATMENT ‘MAY BE’ LESS EFFECTIVE AGAINST OMICRON

Regeneron said Tuesday that its COVID-19 antibody treatment “may be” less effective against the new omicron variant, though tests are ongoing. 

Big picture: The statement shows how the new variant is shaking up the response to COVID-19, though there is still much that is unknown. Experts worry that the current vaccines could also be less effective against the omicron variant, though that has not been confirmed and it is likely some effectiveness will still be maintained. 

Regeneron said in a statement that preliminary analyses “indicate that there may be reduced neutralization activity” from its antibody treatment.

“Further analyses are ongoing to confirm and quantify this potential impact using the actual Omicron variant sequence,” the company added. 

The company added that research is ongoing on other antibody formulations that could maintain effectiveness against the new variant. 

On the other hand, Pfizer’s pill could still work well: On a separate treatment front, Pfizer CEO Albert Bourla said Monday that he has a “high level of confidence” that the company’s antiviral treatment will still be effective against the omicron variant. 

Pfizer’s treatment is in pill form, which could make it easier to administer, while the Regeneron treatment requires infusion. 

Read more here

 

BioNTech co-founder: Vaccinated unlikely to become seriously ill from omicron

© Andreas Gora - Pool/Getty Images

BioNTech co-founder Ugur Sahin said in an interview published Tuesday that while the omicron variant may result in more breakthrough cases of COVID-19, most vaccinated individuals who contract the strain will likely experience mild illness.

Speaking to The Wall Street Journal, Sahin said, "Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot."

Although no studies on the new variant have been released yet, Sahin said he believed vaccinated people will still be protected from severe illness based on how the vaccine he helped develop has protected against past variants that are more contagious.

As an example, Sahin pointed to the delta variant. It has been shown to infect vaccinated individuals at a higher rate than previous strains, but immunized people have still been shown to be protected against severe cases of the coronavirus.

BioNTech's vaccine, which was produced alongside Pfizer, works by creating antibodies that prevent infection from occurring in the first place as well as T lymphocytes, white blood cells that attack cells in the body that have already been infected. According to Sahin, even if the virus evades antibodies, it should still be vulnerable to T lymphocytes.

Read more here

 

A MESSAGE FROM MARCH OF DIMES

The U.S. remains among the most dangerous developed nations for childbirth. Help prioritize the health of our nation’s moms and babies by joining the #BlanketChange movement today at BlanketChange.org.

 

VIRTUAL EVENT ANNOUNCEMENT

Investing in Maternal & Infant Health--Thursday, December 2 at 1:00 PM ET

According to the CDC, over 700 women die of pregnancy complications annually and nearly two-thirds of these deaths are preventable. U.S. maternal mortality rates are moving in the wrong direction, and disparities run rampant, with Black women being up to three times more likely to die from pregnancy-related causes than White women. On Thursday, December 2, Rep. Alma Adams (D-N.C.), Rep. Jaime Herrera Beutler (R-Wash), CDC Division of Reproductive Health Director Dr. Wanda Barfield, and more join The Hill for a discussion on improving access to quality maternal and infant health care throughout the country.  RSVP today.

 

BIDEN GLOBAL COVID-19 RESPONSE COORDINATOR STEPS DOWN

The head of the Biden administration's global COVID-19 pandemic response is stepping down from her role after eight months, Secretary of State Antony Blinken announced Tuesday.

Gayle Smith will return to her position as leader of the ONE Campaign, an organization focused on ending extreme poverty and preventable disease, with a focus on Africa. Smith's departure comes as the omicron variant of COVID-19 is spreading, triggering new fears about a surge in cases worldwide.

"As Gayle heads back to the ONE Campaign, she leaves behind a phenomenal set of accomplishments, a robust team and network who are prepared to carry our important work forward, and a comprehensive set of next steps to build on our progress," Blinken said in a statement. "As Gayle has said many times, our work to defeat this pandemic and prevent future health threats is not over."

Mary Beth Goodman, a senior member of the State Department's pandemic response team who previously served as the department's senior director for global development and humanitarian response, will serve as the acting coordinator in Smith's absence, Blinken said.

Blinken touted that the U.S. has donated more than 260 million COVID-19 vaccine doses since April. That figure is far shy of the Biden administration's commitment of 1.2 billion doses, but still puts the U.S. as the top giver of shots to both the global COVAX effort and to individual countries.

Read more here

 

Pfizer requests authorization for booster shot in teens 16 and 17

© Associated Press — Nam Y. Huh

 

Pfizer on Tuesday said the company and its partner BioNTech submitted a request to expand authorization of its coronavirus booster shot for teens aged 16 and 17 

The move to expand eligibility comes as the Biden administration is exhorting everyone currently eligible to get vaccinations and booster shots to protect against the delta and omicron variant.

Currently, only adults over the age of 18 are eligible to receive a booster dose of either the Pfizer-BioNTech, Moderna or Johnson & Johnson vaccine. They can receive the Johnson & Johnson booster two months after getting the single-shot vaccine, and receive a booster of Moderna or Pfizer's shot six months after the second dose.

"It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant," Pfizer CEO Albert Bourla tweeted Tuesday in announcing the move. 

The White House is grappling with how to respond to omicron, which has garnered much attention and anxiety, but without much information about it. Still, administration officials are continuing to urge vaccinations as the first line of defense, and then boosters. 

Read more here.

 

WHAT WE'RE READING

    • Doctors hope Omicron causes milder cases of Covid — but it’s still too early to say (Stat
    • The inside story of the Pfizer vaccine: ‘a once-in-an-epoch windfall’ (Financial Times)
    • With federal Covid sick leave gone, workers feel pressure to show up at work (Kaiser Health News)
 

STATE BY STATE

    • A growing number of Texas Republicans want a fourth special session to pass COVID-19 vaccine mandate ban (Texas Tribune)
    • New Hampshire becomes first state to provide free at-home rapid COVID test kits to residents statewide (Mass Live)
    • Federal COVID Task Force Team Providing Backup For Burned-Out Hospital Workers In St. Cloud (CBS Minnesota
 

OP-EDS IN THE HILL

 

That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Wednesday.

 
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Hillicon Valley — Amazon draws COVID scrutiny

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OVERNIGHT POLICY:
Hillicon Valley

 

Amazon draws COVID scrutiny

© getty

Today is Tuesday. Welcome to Hillicon Valley, detailing all you need to know about tech and cyber news from Capitol Hill to Silicon Valley. Subscribe here: thehill.com/newsletter-signup.

Follow The Hill’s cyber reporter, Maggie Miller (@magmill95), and tech team, Chris Mills Rodrigo (@millsrodrigo) and Rebecca Klar (@rebeccaklar_), for more coverage.

A new analysis of Amazon injury reporting to OSHA found a massive discrepancy between publicly announced and officially recorded COVID-19 case numbers, leading labor groups to call for a federal investigation.

Meanwhile, the sixth and final individual involved in a multimillion cryptocurrency scheme was sentenced to prison and given a hefty fine, while Twitter announced a new policy that will ban users from sharing images or videos of private individuals without their consent. 

Let’s jump into the news.

 

Amazon accused of underreporting cases

© Getty

A coalition of labor groups released a report calling on federal officials to investigate Amazon over allegedly underreporting cases of COVID-19 at its warehouses.

Despite admitting that almost 20,000 workers contracted the coronavirus in 2020, the report claims the e-commerce giant only reported 27 cases of “respiratory conditions” to federal regulators.

Calling for investigation: The Strategic Organizing Center, along with the International Brotherhood of Teamsters, Warehouse Workers Resource Center and the Awood Center, are also calling on the Occupational Safety and Health Administration to investigate that discrepancy.

“Amazon has failed to explain why it believes that out of the tens of thousands of its employees infected with COVID-19, virtually none of them were infected at work,” the organizations write in their complaint. 

“This persistent pattern of apparent non-compliance would be alarming on its own at any employer — not to mention the second-largest private employer in the entire country,” the complaint continues. “However, these evident failures have also happened with little or no federal oversight.”

Pushback: Amazon spokesperson Kelly Nantel countered that the SOC’s analysis is “intentionally misleading to try and paint a false picture.”

Read more here.

 

Hackers face the music

The Department of Justice logo is seen at their headquarters in Washington, D.C., on Thursday, August 5, 2021 prior to a press conference regarding a civil rights matter.

© Greg Nash

The Justice Department on Tuesday announced the sentencing of the last member of an international hacking group indicted for allegedly stealing millions in cryptocurrency as part of a “SIM hijacking” effort.

Missouri-based Garrett Endicott, the sixth and final member of a hacking group known as “The Community,” was sentenced Monday to 10 months in prison and ordered to pay a fine of more than $120,000 for his part in the cryptocurrency scheme.

Huge payout: The scheme, which members of The Community were indicted in connection with in 2019, involved the hackers using “SIM hijacking” to take control of the victim’s phone number and rerouting calls and texts to their own devices. This then enabled the group members to individually steal between $50,000 and $9 million total from victims across the United States through gaining access to email and cryptocurrency accounts on the victims' phones. 

Individual victims of the hijacking effort lost between $2,000 and $5 million. 

“The actions of these defendants resulted in the loss of millions of dollars to the victims, some of whom lost their entire retirement savings,” Acting U.S. Attorney Saima Mohsin for the Eastern District of Michigan said in a statement Tuesday. “This case should serve as a reminder to all of us to protect our personal and financial information from those who seek to steal it.”

Endicott was given a lighter sentence than other members of The Community who had already stood trial, with Endicott and three others being sentenced in the Eastern District of Michigan.

Read more here.

 

NO PICTURES, PLEASE

Twitter will no longer ​​allow users to share images or videos of private individuals without that person's consent, the company announced Tuesday.  

The policy expands on the social media company’s existing policy banning users from sharing a person’s private information such as a phone number or address. 

The ban won't pertain to sharing videos or images of public figures.

Twitter said that it also acknowledges that videos or images of private individuals may be shared “as part of a newsworthy event or to further public discourse on issues or events of public interest.” 

In those cases, Twitter said “we may allow the media to remain on the platform,” but the company did not detail in Tuesday’s blog post how those decisions will be made.

Read more about the update.

 

KEEP CALM AND SELL

The United Kingdom's Competition and Markets Authority advised Facebook's parent company on Tuesday to sell Giphy, a platform that allows users to share GIFs.

The antitrust watchdog reportedly argued that the acquisition deal between Meta and Giphy could harm social media users and U.K. advertisers by suppressing competition for animated images on the Facebook platform.

“By requiring Facebook to sell Giphy, we are protecting millions of social media users and promoting competition and innovation in digital advertising,” Stuart McIntosh, chair of the group that carried out the investigation, told The Associated Press.

According to CNBC, the group also found that if Facebook were able to limit other social platforms' use of Giphy's images, it would “increase its already significant market power.”

A Meta spokesperson told The Hill that the company disagrees with the watchdog's decision.

Read more here.

 

MOVING ON

A Meta executive who co-founded Diem digital currency is set to leave the company at the end of this year to embark on new projects. 

David Marcus said in a blog post Tuesday he will be leaving the parent company of Facebook after seven years.

Marcus started at the company in 2014 and worked for the Messenger platform for years. A trusted lieutenant to CEO Mark Zuckerberg, he moved on to the company’s digital wallet service, Novi, and then co-founded Diem digital currency, Bloomberg reported.

“While there’s still so much to do right on the heels of hitting an important milestone with Novi launching — and I remain as passionate as ever about the need for change in our payments and financial systems — my entrepreneurial DNA has been nudging me for too many mornings in a row to continue ignoring it,” Marcus said. 

Read more here.

 

BITS AND PIECES

An op-ed to chew on: Can the ‘Summit for Democracy’ deliver for independent media?

Lighter click: Your daily dose of cute

Notable links from around the web:

Investors Snap Up Metaverse Real Estate in a Virtual Land Boom (The New York Times / Debra Kamin)

Judge orders Google to disclose secret anti-union documents (Vice Motherboard / Lauren Kaori Gurley)

UK calls on government agencies to reveal details of AI use (Protocol / Kate Kaye)

 

One last thing: Legislation in the pipeline

© Greg Nash

Rep. Bobby Rush (D-Ill.) is pushing for the creation of an organization that would seek to set both physical and cybersecurity reliability standards for pipelines. 

According to a draft of forthcoming legislation that was first shared with The Hill, Rush wants to create a reliability organization that’s run through the Federal Energy Regulatory Commission (FERC). 

This reliability organization would be stakeholder-driven, according to Rush’s office, meaning it would be largely made up of industry. 

But the standards would have to be approved by FERC — an independent agency that regulates interstate energy transmission. Currently, the commission is comprised of three Democratic commissioners and two Republicans. 

The reliability organization would also consult with the Energy Department and Transportation Security Administration. 

It comes after high-profile incidents this year involving energy reliability. For instance, a May cyberattack on Colonial Pipeline, which provides fuel to many East Coast states, led to consumer panic buying that in turn caused fuel shortages. 

Read more here.

 

That’s it for today, thanks for reading. Check out The Hill’s technology and cybersecurity pages for the latest news and coverage. We’ll see you Wednesday.

 
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