with Alexandra Ellerbeck

By the time President-elect Joe Biden takes the oath of office on Wednesday, more than 400,000 Americans will have died of covid-19 — a dismal milestone in the deadly pandemic.

Yet the crucial task he faces rapidly distributing coronavirus vaccines to the American public is one that most experts one year ago didn't think would even be an option by this point. Few expected multiple vaccines to be approved within a year — a record for vaccine development, by any measure. And although the rollout has been criticized, Israel and Great Britain are the only major nations the United States lags in vaccinations per capita and its daily rate of immunizations has more than doubled in the past two weeks.

“You have my word: We will manage the hell out of this operation,” Biden said in a speech on Friday, announcing his own vaccination plan. 

Regardless of whether one views the vaccine effort up to this point as a failure or success, this much is true: Biden and his new administration will face an enormous task, not only in getting the vaccines distributed but also in ramping up testing, convincing Americans to follow public health recommendations and responding to the economic fallout from the pandemic. 

Here are six key promises Biden is making about his pandemic response:

1. Administer 100 million doses of coronavirus vaccine during the first 100 days of his administration.

Biden previously cited this as a goal. He reiterated it Friday while rolling out a broader plan for coronavirus vaccinations

The plan would require a rate of 1 million immunizations per day — and the United States isn’t too far away from that goal right now. Nearly 800,000 Americans are getting shots every day on average. That’s a considerable improvement from two weeks ago, when the daily rate was closer to 350,000.

The 100-shot goal is “absolutely a doable thing,” Anthony S. Fauci, direct of the National Institute for Allergy and Infectious Disease, told NBC’s Chuck Todd yesterday.

“The feasibility of his goal is absolutely clear; there’s no doubt about it,” Fauci said. “That can be done.”

But top Biden advisers are also cautioning ramping up immunizations will be gradual and will require lots of coordination.

“The first days of that 100 days may be substantially slower than it will be towards the end,” Michael Osterholm, a member of Biden’s covid-19 task force, told Stat News. “It’s not going to occur quickly … you’re going to see the ramp-up occurring only when the resources really begin to flow.”

2. Set up mass vaccination clinics.

By the end of his first month in office, Biden has promised to open 100 federally managed clinics to administer shots. According to his vaccination plan, these sites would be set up by the Federal Emergency Management Agency. The federal government would reimburse states for sending National Guard members to help run them.

Biden says he also wants to deploy mobile units to rural and underserved areas, along with boosting the role already being played by pharmacies in distributing shots. 

This approach would diverge significantly from how things are being done now, with the Trump administration leaving it up to hospitals, doctors, pharmacies and state public health departments to administer the shots. Some cities and states have set up large vaccination sites, but many haven't.

Overall, the president-elect’s plan lays out a more muscular federal role than the Trump administration’s approach, which has relied heavily on each state to administer vaccines once the federal government ships them out,” Anne Gearan, Amy Goldstein and Laurie McGinley report.

“Many of the elements — such as seeking to expand the number of vaccination sites and setting up mobile vaccination clinics — were foreshadowed in a radio interview Biden gave last week and in an economic and health ‘relief plan’ he issued Thursday, which contains a $20 billion request of Congress to pay for a stepped-up campaign of mass vaccination,” our colleagues add.

3. Allow federally qualified health centers to directly access vaccines.

These community health centers — which receive higher government reimbursements but are required to accept all patients regardless of their ability to pay — are a core part of the nation’s safety net for low-income Americans.

Biden’s plan proposes a new program “to ensure [federally qualified health centers] can directly access vaccine supply where needed,” although here, too, it’s unclear exactly how that might work.

Under the Trump administration’s plan, these centers have been asked to enroll with state health departments as vaccine providers. States were then supposed to communicate to the federal government how many doses were needed and where they should go.

How well this is actually working is “all over the map,” said Amy Simmons Farber of the National Association of Community Health Centers. She said supplies vary from county to county and many health centers have received their supplies with little notice, making it challenging to prioritize and plan.

Farber declined to comment on the Biden plan, saying she doesn’t have a lot of details about it. But she’s “very encouraged by the recognition of the important role health centers have played in fighting the pandemic and the need to adequately resource them.”

4. Use the Defense Production Act to ensure plenty of vaccine supplies.

Several times over the course of the pandemic, President Trump has invoked the Defense Production Act, which allows the president to require companies to prioritize contracts deemed essential for national security.

He has used the DPA to speed the production of coronavirus tests and ventilators, and to keep meatpacking plants open. But he hasn’t invoked the authority to compel faster production of the supplies needed for packaging and administering the vaccine.

Biden says he will invoke DPA to ensure a steady stream of these supplies, which include glass vials, stoppers, syringes, needles and the capacity for companies to rapidly fill vaccine vials and finish packaging them.

5. Sign executive actions to combat the virus.

Biden has promised a raft of executive actions in his first ten days as president, laid out over the weekend in a memo from incoming White House Chief of Staff Ron Klain. They’ll include a number of pandemic-related orders.

On Inauguration Day, Biden intends to issue a mask mandate on federal property and for interstate travel, while encouraging all Americans to wear masks for what he’s calling a “100 Day Masking Challenge.”

The following day, Thursday, he’ll sign executive orders aimed at helping schools and businesses reopen safely, expanding testing, protecting workers and establishing clearer public health standards. And on Friday, Biden will direct his Cabinet secretaries to take immediate action to deliver economic relief to families.

“President-elect Biden will take action — not just to reverse the gravest damages of the Trump administration — but also to start moving our country forward,” Klain wrote.

6. Launch a vaccine education campaign.

The memo says Biden will run a “federally-run, locally-focused public education campaign.”

“The campaign will work to elevate trusted local voices and outline the historic efforts to deliver a safe and effective vaccine as part of a national strategy for beating covid-19,” it says.

But the transition team hasn’t detailed how the education campaign might differ from one launched by the Trump administration last month. 

The Department of Health and Human Services said it plans to spend $250 million on efforts to promote vaccine awareness. It kicked off the effort with a $150,000 buy on YouTube for ads that feature Fauci and Food and Drug Administration Commissioner Stephen Hahn. 

Ahh, oof and ouch

AHH: Biden has tapped former FDA commissioner David Kessler as chief science adviser for the federal vaccine effort.

“His appointment comes at a pivotal moment — as the president-elect has begun spelling out plans to speed up the Trump administration’s sluggish effort on vaccinations to protect against covid-19,” The Post’s Laurie McGinley and Amy Goldstein report

A transition official told The Post that Kessler, who served as a close Biden adviser on the coronavirus crisis, will essentially take over the role played by Moncef Slaoui, the  outgoing scientific adviser to Operation Warp Speed. But although the focus of Operation Warp Speed under the Trump administration was centered on developing a vaccine, Kessler will concentrate on leading the federal government’s efforts to accelerate vaccine manufacturing, distribution and administration.

The transition official said that Kessler will serve as an adviser based at the Department of Health and Human Services under secretary-designate Xavier Becerra. Kessler was head of the FDA from 1990 to 1997, when he worked to accelerate the first AIDS drugs, implemented standardized food nutrition labels, and unsuccessfully tried to regulate cigarettes as “drug delivery devices.”

“Within the Food and Drug Administration and outside groups that work closely with the agency, Kessler provokes strong reactions. He gets praise for his extensive work on public health, especially on tobacco and nutrition issues, and criticism for his penchant for stirring controversy,” Laurie and Amy write. 

Kessler’s appointment was announced alongside seven other additions to Biden’s covid-19 response team. They include Andy Slavitt, who will become a senior adviser to Jeff Zients, the Biden White House’s coronavirus response coordinator; Vidur Sharma, who is becoming a policy adviser for coronavirus testing on the Biden White House’s Domestic Policy Council; and Ben Wakana, who will have a communications role.

Biden also announced he will make the White House Office of Science and Technology a Cabinet-level agency.

The president-elect will nominate Eric Lander, a mathematician, biology professor and geneticist, to head the agency, The Post's Sarah Kaplan writes. The appointment of a scientist with a background in the life scientists suggests a renewed attention to biological expertise amid the coronavirus pandemic. The job usually has gone to physicists who can advise the president about nuclear weapons and other technologies. 

Lander helped map the human genome and founded the Broad Institute, a Boston-based biomedical research center famous for work on the gene-editing technology CRISPR-Cas9. He has been a vocal proponent of increasing public funding for research.

OOF: The United States could hit half a million covid-19 deaths by mid-February.

“It took 12 weeks for the death toll to rise from 200,000 to 300,000. The death toll has leaped from 300,000 to almost 400,000 in less than five weeks,” The Post’s  Marc Fisher, Lori Rozsa, Mark Kreidler and Annie Gowen report. 

Yet despite the massive death toll and the changes to daily life caused by the pandemic, the individual deaths are largely invisible.  

“Coronavirus victims who die in the hospital often spend their final days cut off from family and friends, their only human contact coming from medical personnel hidden behind layers of protective gear. Even those who die at home often decline in quarantine, keeping a lonely vigil over their body’s fight,” my colleagues write.

The numbers are expected to quickly rise. Rochelle Walensky, the incoming director of the Centers for Disease Control and Prevention, told “Face The Nation” on Sunday that she anticipated half a million deaths by mid-February.

“That doesn’t speak to the tens of thousands of people who are living with a yet- uncharacterized syndrome after they’ve recovered. We still yet haven’t yet seen the ramifications from holiday travel, holiday gathering in terms of high rates of hospitalizations," Walensky added.

OUCH: Operation Warp Speed achieved most of its goals before stumbling at the finish line.

When top health and defense officials in March and April came up with the idea of a massive federal push to develop a coronavirus vaccine in under a year, they nicknamed the plan the Manhattan Project 2, or MP2, after the race to create nuclear weapons in World War II, Politico’s Dan Diamond reports.

“Now, in the final days of the Trump administration, their ‘MP2’ — later redubbed ‘Operation Warp Speed’ — occupies a peculiar place in the annals of the administration’s ill-fated response to Covid-19: In many ways, it was successful, living up to the highest expectations of its architects. The Trump administration did help deliver a pair of working vaccines in 2020, with more shots on the way. But the officials who expected to be taking a victory lap on distributing tens of millions of vaccine doses are instead being pressed to explain why the initiative appears to be limping to the finish,” Dan reports.

Governors complained that vaccine shipments from the federal government have fallen short of promises, and logistical challenges have meant that only one-third of available vaccines have been administered. 

“Meanwhile, officials involved in Operation Warp Speed from its early days concede that they're dismayed by perceptions that the vaccine project is a failure,” Dan writes. “For much of 2020, they had safeguarded the effort from the political pressures that had warped the White House task force and led Azar to be shunted aside. They had gotten a nearly blank check from Trump — and convinced him, for the most part, to back off public pressure.”

The project, meant to be HHS Secretary Azar’s flagship initiative, leaned on the business and military expertise of many of the participants and operated with a tight chain of command. And with two vaccines approved by the FDA, the project largely set out what it meant to achieve — a promise that was seen as so ambitious that it was dismissed by some fact-checkers as unrealistic last spring. 

Coronavirus latest

  • CDC warned that a new, more contagious coronavirus variant first seen in the United Kingdom is likely to become the dominant strain in the United States within about two months, The Post’s Joel Achenbach reports.
Some experts fear vaccines may be less effective against strains of the coronavirus that were first found in the United Kingdom, South Africa and Brazil. (The Washington Post)
  • A new airflow study suggests that opening certain windows could reduce coronavirus transmission risks within cars, the New York Times’s Emily Anthes reports. Researchers found that opening all of the windows is the best strategy. But since opening all the windows may not be practical in the dead of winter, the researchers also modeled other options. They found that, for a car with one driver and a passenger in the back, it was better for the riders to open the windows opposite than roll down their own — although both strategies were better than leaving the windows shut.
  • HHS has signed a contract enlisting a private consulting firm to review the accuracy of some coronavirus tests in the latest effort by officials to bypass the Food and Drug Administration, Politico’s David Lim reports. The contract is relatively small — worth around $1.5 million — and the move may be largely symbolic, since the incoming Biden administration can return responsibility for the reviews to the FDA.
  • West Virginia Gov. Jim Justice (R) called his state a “diamond in the rough” for successful coronavirus response during an interview with CBS News’s “Face The Nation.” The state has vaccinated more residents per capita than anywhere else in the country, in part the result of a decision to partner with mom-and-pop pharmacies. The state was also the first in the nation to complete vaccinations in all of its nursing homes.

Elsewhere in health care

The Trump administration is making it easier for doctors to prescribe treatments for opioid addiction.

“The Department of Health and Human Services is eliminating the requirement that physicians obtain a special federal waiver in order to prescribe buprenorphine, a medication to treat opioid use disorder. Previously, doctors had to take an eight-hour course to receive the license, called the ‘X-waiver,’ ” NPR’s Jaclyn Diaz and Brian Mann write.

Advocates have long argued that the regulatory requirements have discouraged doctors from prescribing one of the most effective medications to treat opioid addition.

“The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” Adm. Brett P. Giroir, assistant secretary for HHS, said in a statement. “Removing some of the certification requirements for an X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment.”

The American College of Emergency Physicians and the American Medical Association praised the move, saying that it will lead to improved treatment at a time when the United States is facing an acceleration of the opioid epidemic amid the coronavirus pandemic.

Doctors will still be limited to the number of patients to whom they can prescribe buprenorphine, however, and nurse practitioners and physician assistants still will need to apply for separate waivers to prescribe the drug.

Drug prices have been rising this month.

“With most Americans focused on COVID-19 vaccines, pharmaceutical companies are quietly raising the list prices of name-brand prescription drugs at a torrid pace,” the Columbus Dispatch’s Darrel Rowland reports. “January is typically when increases hit the U.S. market. Already, more price hikes by drugmakers have been recorded in less than half a month (813) this year than for all of January 2020 (737), according to research by Ohio nonprofit 46brooklyn.”

“It is clear from the data that January 2021 is bucking the recent downward trends in brand drugmaker list price increases,” one of the founders of 46brooklyn, former Ohio Pharmacists Association lobbyist Antonio Ciaccia, told the Columbus Dispatch. “And it is also clear that aside from price increases, the launch prices for new drugs has been going up over time.”

Ciaccia noted several possible reasons for the price increases, including the possibility that drugmakers are raising their prices to compensate for increased Medicaid enrollment or for a growing number of discounts and rebates offered to governments and pharmacy middlemen. Alternatively, they may simply be trying to make more money.

Almost no one pays the list price for drugs. The actual cost is the result of negotiations with health insurers or the government, as well as a series of discounts or rebates. In fact, the overall net cost of brand-name drugs actually fell in 2019, according to an analysis published last year by Drug Channels.

Sugar rush