Some good pandemic news to end a bad pandemic year

From: POLITICO Pulse - Thursday Dec 23,2021 03:02 pm

Dec 23, 2021

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Quick Fix

— The Food and Drug Administration authorized the first antiviral Covid-19 pill, giving the Biden administration a new tool in fighting the virus.

— A pair of studies out of Europe indicate Omicron infections could cause less severe disease than previous variants.

— A year full of high-profile health care developments resulted in plenty of great journalism, some of the best of which PULSE curated in a year-end list.

WELCOME TO END-OF-YEAR PULSE — and wishing you a very safe and happy holiday. We’ll be back in the New Year and, in the meantime, thanks as always for reading and don’t forget to send your tips to acancryn@politico.com and sowermohle@politico.com.

Driving the Day

Pfizer's Covid-19 pills are shown.

Pfizer's Covid-19 pills are shown. | Pfizer via AP, File

A NEW COVID TREATMENT ENTERS THE CHAT — The Biden administration will begin 2022 with a new Covid-19 treatment in its arsenal after the FDA delivered its long-awaited authorization of Pfizer’s antiviral pill.

The drug can be used to combat Covid-19 in patients 12 years and older who are at high risk of severe illness, POLITICO’s Katherine Ellen Foley and Erin Banco report. That marks a significant development in the pandemic response by opening up an at-home treatment designed to avert hospitalization and death.

The authorization is well-timed, with Omicron expected to drive a steep rise in cases this winter that officials worry could strain the health system.

Pfizer’s antiviral pill slashed the risk of ending up in the hospital or dying by 89 percent in clinical trials when taken three days after the start of symptoms.

But access will be limited to start. Though the federal government pre-purchased 10 million doses, only a fraction of that will be immediately available — with the rest being manufactured and delivered over the next several months. The FDA is preventing pharmacists from writing prescriptions for the pill, according to groups representing the industry.

The agency has also held off so far on authorizing a separate antiviral pill from Merck and Ridgeback Biotherapeutics that’s less effective but more readily available in the near term — further reducing the government’s anticipated stockpile.

MORE PROMISING SIGNS ON OMICRON’S SEVERITY — Two new studies suggest Omicron infections may result in less severe disease than previous variants, POLITICO Europe’s Helen Collis reports.

The data out of Scotland and England showed significant declines in the hospitalization rate for vaccinated Omicron patients compared with those who contracted the Delta variant. The two studies looked at different metrics — but each offered early signs that while Omicron is far more transmissible, it’s not as deadly as its predecessors.

Still, there’s reason for caution. The results are far from conclusive, health experts said, and haven’t accounted for variations in how long it takes for people to be hospitalized or vaccine immunity to wane. Also unclear is how Omicron will hit older people, who are among the highest risk for severe illness.

During a White House Covid-19 briefing Wednesday, Anthony Fauci warned that even if the studies are right about Omicron being less severe, the sheer number of infections means many more people could end up in the hospital overall.

“You don’t want to count on anything when you’re dealing with a virus that has fooled us so many times before,” he said.

BIDEN: TESTING PREP FELL SHORT — President Joe Biden on Wednesday acknowledged his administration could have better prepared for the spike in demand for Covid-19 tests, telling ABC News’ David Muir that “nothing’s been good enough.”

Biden earlier this week announced plans to purchase 500 million at-home tests that the government would make available free on demand. But he said he “wished” he would have thought about ordering them two months ago, before Omicron emerged.

The remarks represent a shift from the White House’s prior defensiveness on testing, including Biden’s insistence earlier that “it didn’t take long at all” to ramp up supplies. The administration in early December rejected the idea of sending people rapid tests for free, before reversing course this week.

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Vaccines

SCOTUS TO HEAR VAX MANDATE CASE — The Supreme Court will hear arguments on Jan. 7 over the administration’s vaccine-or-test requirement for large employers and its vaccine requirement for health workers.

The announcement comes after an appellate panel ruled that the new rules for companies could take effect and sets up a final decision on policies central to Biden’s pandemic response.

Several GOP-led states and other groups have challenged the rules, arguing the government doesn’t have the authority to impose such requirements.

DC PLANS WIDESPREAD VAX MANDATE — The district will require proof of vaccination to enter many businesses, including restaurants, bars and gyms beginning in mid-January, making it the latest major city to take a hard line on Covid-19 vaccinations.

The new requirement — which comes as Washington sees record Covid-19 case counts — will take effect Jan. 15 and require those 12 years and older to be partially vaccinated to access a range of businesses in the city. A month later, the baseline will bump up to full vaccination.

Grocery stores, pharmacies, religious congregations and other retail shops will be exempt from the mandate. And even in the places where customers must be vaccinated, staff won’t be held to the same standard.

Even so, the rules represent the latest escalation of public health measures in Washington since it broke with the White House in November and eliminated its indoor mask mandate. That masking requirement has since been reinstated, along with plans to require that government workers be vaccinated.

Coronavirus

NYC TO BIDEN: HELP IS NEEDED — New York City Mayor Bill de Blasio is appealing to the White House for more aid in fighting Omicron as cases skyrocket across the city’s five boroughs, POLITICO’s Deanna Garcia reports.

De Blasio on Wednesday called for the administration to accelerate manufacturing of at-home tests and monoclonal antibody treatments through the use of the Defense Production Act, saying there’s a “need to act urgently.”

New York City is also running its own $10 million campaign to encourage vaccination, and plans to open new testing sites to alleviate the demand crunch that’s hit as thousands of new Covid-19 cases crop up each day.

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What We're Reading

THE STORIES THAT STUCK WITH US IN 2021 — For the last PULSE edition of this unpredictable and newsy year, we’ve compiled a selection of the most memorable, scoop-filled or just downright prescient health care journalism we read at POLITICO and elsewhere. Happy reading, happy holidays and we’ll see you in January.

Amid last winter’s Covid-19 surge, ProPublica’s David Armstrong and Marshall Allen zoomed in on Los Angeles County to detail the life-or-death decisions overwhelmed frontline doctors were forced to make every day.

‘We want to be educated, not indoctrinated’ : Trump voters in a March focus group discussed their hesitation about Covid-19 shots in the early days of the vaccination drive, The Washington Post’s Dan Diamond reported months before the Delta and Omicron surges threw vaccine holdouts into sharper relief.

Covid-19 defied the “droplet rule,” spreading through aerosol despite decades of science saying it shouldn’t have been able to. The Wired’s Megan Molteni wrote about how mistaken notions guided early Covid rules.

Stat News’ Adam Feuerstein, Matthew Herper and Damian Garde in June delved into Biogen’s “Project Onyx,” an effort to backchannel with the FDA on the now-approved, pricey Alzheimer’s drug Aduhelm — the cost of which Biogen halved this week.

In a Nov. 1 dispatch prophetic for our current moment of widespread but generally mild cases, The Atlantic’s Sarah Zhang questions our long-term view on Covid-19 success: “[Case rates], the metric that has guided much of our pandemic thinking … are becoming less and less useful.”

This year’s ivermectin-as-Covid-treatment boom was as weird as it was damaging to the nation’s vaccine rollout. Willamette Week’s Anthony Effinger introduced us to a chief figure responsible for fueling it.

Robert F. Kennedy Jr.’s longtime and unproven anti-vaccine theories gained steam this year as he courted vaccine holdouts on the right and revenue for his charity, Children’s Health Defense, blossomed, AP News’ Michelle R. Smith reports.

From our newsroom:

POLITICO’s Alice Miranda Ollstein and Darius Tahir in March laid out the battle lines and power players in the fight over abortion pills. This month, the FDA loosened restrictions for prescribing those pills.

‘Alex Azar Anonymous’: a small group of top Trump officials came together earlier this year to ward off fears they would become scapegoats in the telling of Trump and then-HHS Secretary Alex Azar’s coronavirus response, Adam reported.

Biden officials back in March fretted that Johnson & Johnson wouldn’t deliver on its goal of 20 million coronavirus vaccines that month, Erin Banco, Sarah and Rachel Roubein reported. The problems only compounded from there: The administration all but wrote J&J off in April amid delivery issues and safety concerns. The CDC this month recommended getting messenger RNA shots over J&J, sealing its fate as a second-string vaccine option.

Drugmakers this March were bracing for the unthinkable — a loss in Congress and the prospect of government negotiations on drug prices, Susannah Luthi and Sarah wrote. But subsequent months saw Democrats lose momentum and splinter on drug policy, as Alice, Heather Caygle and Sarah Ferris reported — leaving price negotiation for a 2022 battle or two.

HHS Secretary Xavier Becerra took a backseat on the coronavirus response this year, making his influence in the internal policy debates over key issues unclear, Adam wrote.

The booster conversation — when to authorize them, who gets them — dominated this fall and winter. It divided Biden officials as early as September, Erin, Sarah and Adam reported. The discussion continues to evolve as we face down a bad winter.

The pandemic dealt a devastating blow to veterans care facilities, where at least 1,400 people died of coronavirus in 110 state veterans homes — a number only expected to rise as data is assessed, Joanne Kenen, Allan James Vestal and Darius Tahir reported.

Despite bold promises of a game-changing coronavirus vaccine, Novavax was beset with manufacturing issues and unclear timelines as recently as this summer, Sarah, Erin and Adam reported. The company has filed for European use and earned World Health Organization endorsement this week, but hasn’t filed with U.S. regulators yet.

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