Mon, November 29, 2021

in-focus

10 days of struggle in Biden's vaccine push


WASHINGTON - For the first five days of President Joe Biden's administration, he and his aides promised 100 million coronavirus shots in 100 days.

But then on the sixth day, Biden surprised everyone, including many of his own aides, by upping the ante - to 150 million.

"I think, with the grace of God, and the goodwill of the neighbor, and the creek not rising, as the old saying goes, I think we may be able to get that to 1.5 million a day, rather than 1 million a day," Biden said. "But we have to meet that goal of a million a day."

The number Biden floated was not a figure that was planned in advance, but rather a hypothetical possibility based on private briefings with his covid-19 task force, senior administration officials said. Biden's comments prompted his team to reiterate that their official goal was still 100 million but also to stress that vaccinating more Americans would be preferable.

Andy Slavitt, Biden's senior adviser for covid-19 response, said during a briefing that the 100 million vaccines in 100 days was "a floor, not a ceiling."

"What we have tasked our team with is as many vaccines as possible into as many arms as possible," he said.

The lack of clarity on vaccine targets underscores that the new administration is still reckoning with the complexity of conducting a mass vaccination campaign - while trying to control the messaging about its timing and scope. Biden's advisers are scrambling to manage an ever-changing pandemic that has infected more than 25 million Americans, decimated the economy and strained the country's social fabric - a challenge exacerbated by the patchwork approach they inherited from the previous administration and their early inability to immediately deliver on the full range of their promises.

 

The new administration has sought to provide better forecasting of vaccine allocation to the states and to outline a more robust federal role in the administering of the shots, enlisting the Federal Emergency Management Agency and taking steps to augment the public health workforce that is able to act as vaccinators.

But in expanding supply - among the most critical hurdles to a return to normalcy - Biden has relied on strides made under the previous administration, hoping that he and his team can help further expedite production and keep the country ahead of dangerous virus variants spreading in the population. Biden's advisers have maintained that the Trump administration's strategy was too reliant on existing infrastructure for vaccine delivery, failing to anticipate that state and local authorities would require not just expanded federal funding but also would need more direct coordination and assistance in carrying out immunizations.

The stakes for both the Biden team and the nation could not be higher: The deadly contagion has killed more than 436,000 Americans and continues to course through the country. One of Biden's central promises on the campaign trail was that he would "shut down the virus" if elected president, and his administration's handling of the crisis is likely to be critical to the success of his presidency.

Los Angeles Mayor Eric Garcetti, an ally of the president's, said that in his earliest conversations with Biden, he stressed that progress on coronavirus would be the key to all other aims of his presidency.

"I tried to underscore with him the only thing that's going to matter to America is covid and the economy coming back," Garcetti said. "This will make or break our country, and certainly how people see this administration."

 

So far, Biden has signed more than a dozen executive orders aimed at combating the pandemic, some of them symbolic statements of aspiration and others tangible directives already being implemented. The executive actions include creating a task force aimed at ensuring racial equity in the administration's response; reversing the decision by former president Donald Trump to withdraw the United States from the World Health Organization; and reimbursing states up to 100% for using their National Guards to help fight covid-19.

On Tuesday, the administration told governors that because of increased manufacturing, they will get 16% more vaccine doses for the next three weeks. The announcement that Biden's advisers also were seeking an additional 200 million doses of the two vaccines already authorized for emergency use in the United States will bring the nation's total to at least 600 million doses, officials said, meaning enough for 300 million people to be fully vaccinated with the two-dose regimens.

Whether those additional doses can really be delivered by summer will be a test of the new administration's capacity to augment supply beyond forecasts made last year. Biden and his advisers, for instance, have assured the public that they are making greater use of the Defense Production Act - a Korean War-era law that can be used to prioritize certain contracts and compel production of specific goods - but the behind-the-scenes reality is more complicated.

White House Chief of Staff Ron Klain recently said the administration had "used the Defense Production Act authority to order the production" of specialized syringes needed to extract a sixth dose from vaccine vials produced by Pfizer, as well as to speed production of N95 masks. The administration has not taken new steps under the Defense Production Act in either case but is relying on existing ratings and could soon take further action, according to Tim Manning, the supply coordinator for the White House's coronavirus response.

One of the main syringe suppliers, Retractable Technologies, already had a priority rating, and the government has been able to secure enough of the equipment through other contracts to avoid ordering the company to take over more of the market. When it comes to masks, the administration is still assessing why there are shortages in some areas and surpluses in others, Manning said.

Where the administration has taken new steps, he said, is largely in engaging the private sector about the possibility of using loans and purchase agreements to pursue long-term expansion of the industrial base, which could mean additional production lines for a range of products including vaccine ingredients and specialized needles.

In a statement, White House spokesman Kevin Munoz said, "With regards to the Defense Production Act, we recognize the need to educate the American public around this process - and next week, you will see us do just that."

 

Senior members of the new president's team continue to accuse the Trump administration of inadequate planning, saying, in the words of one official, that the system they inherited was "so disorganized and unclear" that they're still trying to locate all the vaccine. Yet the federal government tracks vaccine to the more than 100,000 enrolled providers across the country. What happens next, in terms of vaccine administration and reporting, is managed by provider agreements handled by the Centers for Disease Control and Prevention.

Rochelle P. Walensky, the new CDC director, has faulted Tiberius, a software for vaccine allocation developed by Palantir, according to people with knowledge of her views, while career officials have recoiled at her criticism of ongoing efforts. The CDC did not respond to a request for comment.

On Wednesday, just hours after the new administration's first White House covid-19 briefing, the Dow Jones industrial average fell more than 600 points - its worst drop in almost three months - amid concerns about coronavirus vaccine distribution.

Former Chicago mayor Rahm Emanuel, who also served as chief of staff under President Barack Obama, said the growing pains of the Biden administration were of a different magnitude from what he characterized as the dangerous disregard of the crisis by the Trump administration.

"Look, we're having a different qualitative argument," Emanuel said. "We're discussing 100 million or 150 million vaccines, and whether 100 million was a low bar, and also having a president who is leading by example with best practices, versus a White House that became a superspreader event and was hawking Lysol as a medical treatment. It's literally night and day."

Administration officials say Biden is regularly briefed about the pandemic and often asks about top-line issues as well as about how different communities are being affected, while largely leaving the technical specifics to public health officials and other government experts.

"The way that the president comes across is, 'Don't PowerPoint me. Don't talk in fancy terms. What is really going on, and what is really going on at the ground level?' " Slavitt said in a phone interview. " 'And by the way, I don't want to just know what's going on with the average American. I want to know what's going on with Black and Brown Americans. I want to know what's going on with rural Americans. If this is hard, then there's some people this is even harder for.' "

Yet as the administration works to get up to speed, the challenges it faces are mounting, experts say.

Christopher Murray, the director of the University of Washington's Institute for Health Metrics and Evaluation, said the three major hurdles facing the Biden team are increasing the rate of vaccinations, working to track and halt the new virus variants, and making sure that Americans who have been vaccinated do not overreact and engage in risky behavior.

After several months, Murray said, the administration should be able to begin vaccinating people at a rate of 3 million a day - roughly the rate of seasonal flu vaccinations.

"The current official ambition of one million a day is extremely conservative because we're already doing one million a day," Murray said. "We are a long way to go, and there's obviously lots of logistical challenges, et cetera, but we should be able to get to three million quickly and then get beyond that."

Biden's transition team, signaling an aggressive approach to speeding distribution of the vaccine, announced this month, before Biden was inaugurated, that the new president would release all available vaccine supply. It was an apparent departure from a policy - introduced in December at the program's outset - of keeping a reserve of second doses necessary for the two-dose regimens that have gained emergency use authorization in the United States.

Four days later, Trump's health secretary, Alex Azar, said the federal government had gained enough confidence in the supply chain to make the reserve of second doses available to states. At the same time, he urged state and local officials to expand eligibility for the shots, leading health officers and medical providers to expect a windfall of vaccine.

But what Azar did not say was that the reserve of second doses had already been liquidated. The administration had shifted to a strategy of taking second doses directly off the manufacturing line, rather than holding them in reserve but had not announced the new approach.

 

Meanwhile, Azar's instruction that states expand eligibility to adults 65 and older - not just those 75 and up - preempted one of the changes that Biden's team was planning to pursue, according to two people familiar with the planning who spoke on the condition of anonymity because they were not authorized to discuss the matter.

Biden's advisers objected to an additional instruction by the Trump administration that states also include those under 65 with a high-risk medical condition - a category they believed would open the floodgates and overwhelm health authorities. An administration official said they felt that individual states could expand their vaccine eligibility guidelines but worried that a blanket directive would cause unnecessary confusion.

Production is hardly seamless. A case study is the single-shot Johnson & Johnson vaccine that soon could gain federal clearance. The effectiveness and availability of the product could determine whether coronavirus vaccine is widely available by the summer or not until the fall. Because of production setbacks, only about 6 million or 7 million doses would initially be available, with significantly higher production not possible until March or April, according to two federal officials with knowledge of the estimates.

Better supply forecasting for states has been among the central objectives for Jeff Zients, Biden's coronavirus coordinator, who has applied an "overarching strategy" to the effort that was lacking under Trump, in the words of one of the officials involved in the effort.

Zients has expedited the setting up of a system enabling increased reliance on pharmacies to receive and administer vaccine. And he was intent on rushing ramped-up supply from Moderna, which has overtaken Pfizer in manufacturing, out to the states in the coming week.

He announced the increase - from about 8.6 million doses to 10 million, distributed across the country - on a call Tuesday with governors. State leaders appreciated the estimates but remained frustrated by the lack of detail about when significant scale-up would occur, thus enabling access for members of the general public, according to two people who participated in the call.

 

Top Biden advisers say they are eager to assist the vaccine manufacturers with equipment and other needs, possibly using the Defense Production Act, but federal officials and outside experts see few opportunities to wield the law to speed up production in the short term.

"You can invoke the Defense Production Act for some things, perhaps some of the raw materials or other consumables that go into producing vaccines or administering vaccines," said Céline Gounder, an infectious-disease specialist who was a member of Biden's coronavirus advisory team during the transition. "But there are limits to that."

The Trump administration already instructed suppliers to prioritize the needs of the six vaccine candidates in its portfolio. Pfizer, which sought the same status despite not taking research and development money from the government, gained priority under the law at the end of last year. The problem is the shortage - in the United States and globally - of biologic manufacturing capacity, which can take months, if not longer, to surge in the best of scenarios. Facility space is limited, as is the workforce with the expertise to manufacture the vaccines.

The act was used 18 times in relation to vaccine production under Trump, according to current and former federal officials, and retrofitting a plant or ordering a manufacturer to make a new product can take months to yield results.

On Tuesday, when pressed by reporters on the vaccine supply, White House press secretary Jen Psaki said the administration did have a handle on what quantities of doses were available in which states but declined to provide more details.

"We've been here for now six days," Psaki said. "I'll - at a certain point - stop saying that. But less than a week is not that long a period of time."

Published : January 31, 2021

By : The Washington Post · Ashley Parker, Isaac Stanley-Becker, Annie Linskey