What we know so far about Omicron

From: POLITICO Pulse - Monday Nov 29,2021 03:04 pm
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Quick Fix

Health officials worldwide are seeking answers on a new Covid variant but that could take weeks.

The Supreme Court takes up two Medicare cases this week, each dealing with payments and reimbursements in the program.

Countries push to end deadlock on a pandemic treaty with a three-day Geneva meeting kicking off today.

WELCOME TO MONDAY PULSEWe hope you had a restful holiday, Omicron news aside. Tell us what we’ve missed and send tips to sowermohle@politico.com and acancryn@politico.com.

 

A message from PhRMA:

At a time when the science has never been more promising, the Democrats’ latest drug pricing scheme puts patients in harm’s way by threatening future treatments and cures. Learn more.

 
Driving the Day

WHAT WE KNOW ABOUT OMICRONNews just before Thanksgiving that a new coronavirus variant, Omicron, had emerged sparked a storm of questions and meetings between top health officials around the world.

Scientists in South Africa, where the variant was first identified and sequenced, say Omicron is to blame for the recent surge in South Africa’s most populous province, Gauteng, and that it’s spread to almost the entire country, POLITICO’s Erin Banco reported. Individuals who’ve traveled between South Africa and Belgium, Hong Kong, Israel and Botswana have all contracted the variant. The World Health Organization Friday classified the new strain as a “variant of concern.”

The WHO first received a report about the new variant, which appears to pose an increased risk of reinfection, on Nov. 24.

Biden health officials held a series of meetings over the holidays and through the weekend to plan for U.S. cases of the variant and possible surges around the country. Officials also debated how long to shut down travel from southern Africa, whether to allow U.S. citizens to return and whether to change domestic public health guidelines to safeguard Americans from potential infection, three senior Biden officials told Erin. The administration is set to impose restrictions on Monday but isn't applying them to U.S. citizens.

The White House said Biden is slated to provide an update on the variant today.

What we know so far:

It’ll be in the U.S. soon (if not already.) “There’s no evidence that it is here but I would be surprised if it doesn’t ultimately land here,” Anthony Fauci, the president’s chief medical officer, told POLITICO.

Fauci reaffirmed the message Sunday, telling ABC’s “This Week” with George Stephanopoulos that Omicron will “inevitably” get to the country and travel bans could delay landfall, which would provide time for research.

But it will take two to three weeks to get key details. There still are many unknowns including how contagious the new variant is, the chances for severe illness and the efficacy of existing coronavirus treatments against it, National Institutes of Health Director Francis Collins said Sunday.

“We do know this is a variant that has a lot of mutations, like 50 of them,” Collins told “Fox News Sunday” host Trace Gallagher. Those mutations could mean it evades vaccines better than predecessors, but it’s too early to say.

It may be less severe than old variants. Infections in South Africa appear to be “very mild” so far but include extreme fatigue, according to Angelique Coetzee, a physician and chair of the South African Medical Association. Coetzee told Reuters that in her experience, most patients were under 40 years old and roughly half were vaccinated.

Yet the small patient pool so far could be skewing our picture of the variant’s threats. “Initial cases are mostly young people, who tend to have mild infections anyway,“ Collins said on Fox. “We need more data there before we can say confidently that this is not a severe version of the virus.”

It’s already posing equity concerns. Africa remains the most undervaccinated region of the world, with some 7 percent of its 1.3 billion people fully immunized.

After waiting on supplies for months, South Africa, at the epicenter of the new outbreak, now has enough doses of Pfizer and Johnson & Johnson vaccines, but the number of people getting shots is about 120,000 a day, less than half of the government’s target of 300,000 a day. Immunizations among 20- to 40-year-olds are lagging, making the young adult cohort particularly vulnerable to the fast-spreading variant.

“We will only prevent variants from emerging if we are able to protect all of the world’s population, not just the wealthy parts,” said Seth Berkley, CEO of Gavi, the organization co-leading the COVAX vaccine equity initiative, in a statement emailed to Carmen Paun.

 

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SCOTUS KICKS OFF MEDICARE CASESThe Supreme Court will hear arguments today and tomorrow on two separate cases concerning Medicare reimbursement rates and the 340B program, Alice Miranda Ollstein reports.

The first, Becerra v. Empire Health Foundation, concerns how the HHS Secretary calculates add-on payments for hospitals that serve a disproportionate number of low-income people.

The 9th Circuit Court of Appeals previously vacated part of a Centers for Medicare and Medicaid Services rule directing HHS to count all the days hospitals cared for people eligible for Medicare Part A benefits, regardless of whether Medicare actually paid the hospital for those days, when calculating payments.

The second, American Hospital Association v. Becerra, concerns a challenge to President Trump’s cuts to the 340B program, which cut drug reimbursement rates by nearly 30 percent starting in 2018. The cuts were upheld by the D.C. Circuit Court of Appeals last summer.

The fairly wonky arguments will focus on whether the so-called Chevron defense gives HHS the authority to set those kinds of reimbursement rates and what information they have to take into account when they do so. Depending on how the justices lean, the decision could ripple beyond just 340B rates and impact HHS’ authority on other fronts.

Decisions in both cases are expected next summer.

Reminder: During the pandemic, audio from the court’s oral arguments is streamed live on supremecourt.gov, so you can follow along in real time.

 

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COUNTRIES AGREE TO START NEGOTIATING A PANDEMIC TREATYAs yet another virus variant scares the world, the 194 member countries of the World Health Organization are starting a three-day meeting today in Geneva to discuss an international accord to have a better preparation and response when a pandemic strikes.

The meeting, which has been planned for months, will be the starting gun for negotiations toward an international treaty, POLITICO Europe’s Ashleigh Furlong reports.

An international negotiating body made of WHO member countries will be tasked with identifying the agreement’s elements and submitting a draft treaty proposal in May 2023, according to a text to be adopted at the meeting this week . Equitable access to vaccines, medicines and tests developed in response to a health emergency is expected to be a top issue of a future agreement.

LAB TEST EXEC TALKS DATA, TESTING NEEDS — The U.S. government must put more funding towards public health efforts such as bolstered data reporting, Julie Khani, the departing head of the American Clinical Laboratory Association, said in an interview with David Lim.

Khani, who is headed to diagnostics company Hologic as its vice president of government affairs, sat down with David to discuss the Covid-19 pandemic’s impact on commercial laboratories and her tenure atop the trade association that represents players like LabCorp and Quest Diagnostics. Read the full Q&A here.

“I hope that one of the lessons learned from this pandemic is that we will robustly support a comprehensive data reporting system and the ability of agencies to really look at and review all of this data, because there have been gaps, and that's hampered our ability to respond,” she said.

The former ACLA president predicted that as long as the nation can use multiple types of Covid-19 tests — including lab-based, point-of-care and at-home antigen tests — it will be able to meet demand driven by the Biden administration’s vaccinate-or-test mandate next year if the regulation survives court challenges.

“We do have the advantage that many clinical laboratories have maintained their testing capacity,” Khani said. “I think collectively we do have the capacity to meet need.”

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 
What We're Reading

Moderna President Stephen Hoge says the Omicron variant “is the highest level of alert we’ve ever been on,” because the virus has pulled its “greatest hits” into a new mutation, The Washington Post’s Dan Diamond, Joel Achenbach, Chico Harlan and Lesley Wroughton report in a look at the weekend scramble.

Omicron poses new challenges but the world is also in a new reality of vaccines, treatments and lessons learned from nearly two years of the pandemic, Zeynep Tufekci writes in a New York Times op-ed.

In The Los Angeles Times, Doug Smith takes a harrowing look at the cycle of mental illness and homelessness through one family whose loved one had countless brief hospital stays as he struggled.

 

A message from PhRMA:

The Democrats’ hyper-partisan drug pricing plan is a detriment to patients and the future of medical research.

The plan guts the very incentives necessary to encourage investment in further research and development after medicines are approved, giving the government the power to pick winners and losers for lifesaving medicines.

While some would have you believe this is “negotiation,” it isn’t. It’s government price setting that does little to address patient affordability and will decimate the competitive ecosystem in the United States that has brought hope to so many Americans in the form of new medical advances where before there were none. No matter what they call it, this plan will result in the same outcome: negative consequences for the patients with the most need. Read more.

 
 

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