The coronavirus vaccines have shattered expectations

https://www.axios.com/coronavirus-vaccines-safe-effective-science-immunity-aaa8b39e-1840-482a-a099-050c31529d1c.html

No matter how hard you squint, or what angle you look at it from, the coronavirus vaccines are a triumph. They are saving lives today; they will help end this pandemic eventually; and they will pay scientific dividends for generations.

The big picture: The pandemic isn’t over. There are still big threats ahead of us and big problems to solve. But for all the things that have gone wrong over the past year, the vaccines themselves have shattered even the most ambitious expectations.

The vaccines represent a “stunning scientific achievement for the world … unprecedented in the history of vaccinology,” said Dan Barouch, an expert on virology and vaccines at Harvard, who worked on the Johnson & Johnson vaccine.

Details: Developing a vaccine takes an average of 10 years — if it works at all. Despite years of well-funded research, there are still no vaccines for HIV or malaria, for example.

  • We now have multiple COVID-19 vaccines, all developed in less than a year.
  • The Pfizer and Moderna vaccines are the world’s first successful mRNA vaccines — which, to oversimplify it, teach our bodies to generate an immune response without relying on weakened or inactivated viruses. It’s a milestone that scientists have been working toward for 30 years.
  • Moderna’s vaccine is the company’s first licensed product of any kind.

Most importantlyall the leading vaccines work extremely well.

  • All four vaccines or vaccine candidates in the U.S. — from Pfizer, Moderna, AstraZeneca and Johnson & Johnson — appear to prevent coronavirus deaths, and to offer total or near-total protection against serious illness.
  • Some of the vaccines are more effective than others at preventing mild or asymptomatic infections, but all of them significantly exceed the FDA’s threshold to be considered effective.

The catch: South Africa on Sunday halted distribution of the AstraZeneca vaccine because it appeared not to work against the dangerous variant discovered there — which is spreading across the world.

  • The other vaccine makers have also said their products aren’t as effective against the South African variant.

But that’s a reason for the rest of the world to lean into the existing vaccines, not to be wary of them.

  • Viruses can mutate when they spread widely. The best defense against widespread variants is to vaccinate as many people as possible and step up social distancing to contain the virus.
  • Drugmakers may need to develop booster shots or new recipes to deal with variants, but waiting for a vaccine that addresses every variant will only leave the door open for more variants.

Our biggest problems are not with the vaccines, but rather the processes that surround them.

  • Supplies need to increase; distribution needs to become far more efficient; we need to ensure that people get their second shots, when applicable; and people need to be willing to get vaccinated once they’re eligible.
  • That’s a long and difficult to-do list, and getting those things wrong could drag the pandemic out for years. But if we can get the process right, the vaccines themselves are powerful enough to do the job.

Once the history of this is written, they are going to be referred to as some of the greatest achievements of science,” Zeynep Tufekci, a University of North Carolina sociologist with a track record of prescience on the coronavirus, told The New York Times’ Ezra Klein.

  • “It’s the kind of thing you would have national celebration and fireworks and church bells ringing and all of that,” she said.

This wasn’t a miracle, and it didn’t happen overnight. “What we’ve seen over the last year is the result and culmination of decades of scientific advances,” Barouch said.

  • Researchers have been building toward mRNA-based vaccines for roughly 30 years, fueled by broader advances in genetic science.
  • Those same advances have also greatly accelerated genetic sequencing — which is why researchers were able to map out COVID-19’s structure within weeks of discovering the virus, and to then begin working on potential vaccines.

What’s next: The vaccine race is one of the few areas of this entire pandemic where the U.S. and the world will be able to learn from our successes, rather than our failures.

  • The breakthrough of successful mRNA vaccines will, scientists hope, pave the way for a new generation of products that are more effective and easier to develop than previous vaccines.
  • Shoveling money at vaccine developers and establishing early, step-by-step communication with regulatory agencies also helped accelerate this process, and can help again in future pandemics.

The bottom line: “Good funding, great science and great collaboration with the regulatory agencies — that’s how they were able to do something that I didn’t think could be done in a year,” said Mark Slifka, an immunology professor at Oregon Health & Science University.

America’s nightmarish year is finally ending

America's nightmare year of COVID is finally ending

One year after the World Health Organization declared COVID-19 a pandemic, the end of that pandemic is within reach.

The big picture: The death and suffering caused by the coronavirus have been much worse than many people expected a year ago — but the vaccines have been much better.

Flashback“Bottom line, it’s going to get worse,” Anthony Fauci told a congressional panel on March 11, 2020, the day the WHO formally declared COVID-19 to be a global pandemic.

  • A year ago today, the U.S. had confirmed 1,000 coronavirus infections. Now we’re approaching 30 million.
  • In the earliest days of the pandemic, Americans were terrified by the White House’s projections — informed by well-respected modeling — that 100,000 to 240,000 Americans could die from the virus. That actual number now sits at just under 530,000.
  • Many models at the time thought the virus would peak last May. It was nowhere close to its height by then. The deadliest month of the pandemic was January.

Yes, but: Last March, even the sunniest optimists didn’t expect the U.S. to have a vaccine by now.

  • They certainly didn’t anticipate that over 300 million shots would already be in arms worldwide, and they didn’t think the eventual vaccines, whenever they arrived, would be anywhere near as effective as these shots turned out to be.

Where it stands: President Biden has said every American adult who wants a vaccine will be able to get one by the end of May, and the country is on track to meet that target.

  • The U.S. is administering over 2 million shots per day, on average. Roughly 25% of the adult population has gotten at least one shot.
  • The federal government has purchased more doses than this country will be able to use: 300 million from Pfizer, 300 million from Moderna and 200 million from Johnson & Johnson.
  • The Pfizer and Moderna orders alone would be more than enough to fully vaccinate every American adult. (The vaccines aren’t yet authorized for use in children.)

Yes, millions of Americans are still anxiously awaiting their first shot — and navigating signup websites that are often frustrating and awful.

  • But the supply of available vaccines is expected to surge this month, and the companies say the bulk of those doses should be available by the end of May.
  • Cases, hospitalizations and deaths are all falling sharply at the same time vaccinations are ramping up.

The bottom line: Measured in death, loss, isolation and financial ruin, one year has felt like an eternity. Measured as the time between the declaration of a pandemic and vaccinating 60 million Americans, one year is an instant.

  • The virus hasn’t been defeated, and may never fully go away. Getting back to “normal” will be a moving target. Nothing’s over yet. But the end of the worst of it — the long, brutal nightmare of death and suffering — is getting close.

Rural MA Enrollees Have Substantial Rates Of Switching To Traditional Medicare

Brent Langellier (@blangellier) | Twitter

In their recent Health Affairs paper, Sungchul Park and coauthors examine rates of switching from Medicare Advantage (MA) to traditional Medicare by patient characteristics. MA plans are the private insurance alternative to traditional fee-for-service Medicare overseen by the Centers for Medicare and Medicaid Services. While enrollment in MA has doubled over the past decade, Park and coauthors find that the needs of certain enrollees are not being met by MA plans.

Park and coauthors report that rural enrollees switch from MA to traditional Medicare at an adjusted annual rate of 10.5 percent, significantly higher than metropolitan residents, who switch at a rate of 5.0 percent

This phenomenon was more pronounced among those who required the use of costly services such as facility stays or hospitalizations, those who had poor self-reported health, and individuals who reported lower satisfaction with their access to care.

THE BIG DEAL—House passes $1.9T coronavirus relief bill

https://thehill.com/policy/finance/542448-heres-whats-in-the-19t-covid-19-relief-package

Will there be a third stimulus check? Biden's Deputy Press Secretary on American  Rescue Plan: 'The time for bold action is now' - ABC11 Raleigh-Durham

The House on Wednesday passed the mammoth $1.9 trillion COVID-19 relief package, which President Biden is expected to sign Friday.

The House approved the relief package in a starkly partisan 220-211 vote, sending the legislation to the White House and clinching Democrats’ first big legislative victory in the Biden era. No Republicans voted for the package and all but one House Democrat—Rep. Jared Golden of Maine—supported it. The Hill’s Cristina Marcos has more here.

The political split: Unlike the previous relief measures enacted last year, Democrats barely bothered to negotiate with Republicans and pushed the relief package through Congress along party lines using the budget reconciliation process. That allowed them to go as big as they wanted to go without running into a Senate GOP filibuster.

  • Republicans argue the use of a process dodging the filibuster shows Biden wasn’t serious about bringing unity, and House GOP lawmakers on Wednesday warned of the bill’s total cost.
  • But Democrats think Republicans will pay for their opposition to the popular bill and argued that they would oppose anything Biden proposed.

What’s in the $1.9T COVID-19 relief packageAlong with $1,400 direct payments to households, an extension of expanded unemployment benefits, and aid for state and local governments, the package is loaded with other provisions intended to speed up the recovery from the recession and help struggling families fight the impact of COVID-19.

  • Tax credits: The bill increases the child tax credit for households below certain income thresholds for 2021 and makes it fully refundable, and also expands the earned income tax credit for the year.
  • Child care: $15 billion for grants to help low-income families afford child care and increases the child and dependent care tax credit for one year.
  • Pensions: $86 billion to bailout struggling union pension funds.
  • Transportation: $30 billion to bolster local subway and bus systems, $8 billion for airports, $1.5 billion for furloughed Amtrak workers, and $3 billion for wages at aerospace companies.
  • Housing: $27.4 billion in emergency rental assistance, another $10 billion to help homeowners avoid foreclosure, $5 billion in vouchers for public housing, $5 billion to tackle homelessness and $5 billion more to help households cover utility bills.
  • Small businesses: The American Rescue Plan broadens eligibility guidelines for the Paycheck Protection Program, allowing more nonprofit entities to be eligible, adds $15 billion in emergency grants and also sets aside more than $28 billion in funding for restaurants.
  • ObamaCare subsidies and Medicaid expansion: The bill increases ObamaCare subsidies through 2022 to make them more generous, a longtime goal for Democrats, and opens up more fully subsidized plans to individuals. It also would provide extra Medicaid funding to states that expand the program and have yet to do so.

Sutter’s $575M antitrust settlement gains preliminary approval

Sutter Health, CA Reach $575M Settlement Over Anti-Trust Concerns

Dive Brief:

  • A San Francisco Superior Court judge has granted preliminary approval of the $575 million settlement agreement Sutter Health reached in the antitrust case that alleges it drove up healthcare prices in Northern California through anticompetitive practices.
  • A hearing for final approval of the settlement has been set for July 19, according to the judge’s order issued Tuesday.
  • Now, class members, or certain self-funded payers in California, will be notified of the preliminary approval and may object to part or all of the settlement agreement.

Dive Insight:

This preliminary approval comes more than a year after Sutter Health first agreed to settle the case with the plaintiffs, including California Attorney General Xavier Becerra, now nominee for HHS secretary, and a grocer’s union.

To put the settlement and all its elements in motion, it must first be approved by a judge. Tuesday’s order moves the case one step closer to final approval.

That 2019 settlement came on the eve of a court case that was supposed to lay out in open court how the regional powerhouse’s practices led to higher healthcare costs.

Even though the settlement averted a trial, it was designed to force Sutter to change some of these practices. As part of the settlement, Sutter agreed to stop “all-or-nothing” contracting and instead allow insurers and other payers to contract with some, but not all, of Sutter’s facilities.

The settlement is also designed to limit what patients pay out-of-network in an effort to shield them from exorbitant, surprise medical bills.

Sutter Health has tried to delay the $575 million antitrust settlement, citing the fallout from the novel coronavirus that has squeezed providers, including Sutter.

The health system, though battered by the pandemic’s fallout, was still able to post net income of $134 million for 2020, in part thanks to investment income. However, it did report an operating loss of $321 million as expenses outpaced revenue. Sutter said it was launching a sweeping review of its finances and operations as a result.

The litigation was first initiated in 2014 when the grocer’s union, joined by other plaintiff’s, filed suit against Sutter’s practices. It ultimately drew the attention of Becerra’s office.

‘Ticking time bomb’ could invalidate thousands of health regulations, lawsuit says

Why Your DIY Social Selling Program Is A Ticking Time Bomb

A coalition of health groups and others sued HHS March 9 over a Trump administration rule that was finalized the day before President Joe Biden’s inauguration. 

The lawsuit, pending in U.S. District Court of the Northern District of California, alleges that thousands of HHS regulations could disappear because of the Securing Updated and Necessary Statutory Evaluations Timely, or SUNSET, rule. The rule requires HHS to review its existing 18,000 regulations within several years. If the review isn’t completed, the rule automatically expires, according to NPR

“The rule does not even specify which of the department’s 18,000 existing regulations are exempted under the limited exceptions. In other words, the outgoing administration planted a ticking time bomb set to go off in five years unless HHS, beginning right now, devotes an enormous amount of resources to an unprecedented and infeasible task,” the complaint states. 

The complaint further alleges that the rule exceeds the authority of HHS and creates uncertainty and instability in the U.S. healthcare system at a time when the public needs clear guidelines because of the pandemic. 

The plaintiffs are asking the court to declare that the rule is arbitrary and capricious and to vacate it. 

The plaintiffs are Santa Clara County, Calif., the National Association of Pediatric Nurse Practitioners, the American Lung Association, the Center for Science in the Public Interest, the California Tribal Families Coalition and the Natural Resources Defense Council.