What went wrong with distribution, what’s being changed

In late December, the idea that safe, effective vaccines against COVID-19 had been created in less than a year seemed miraculous. A triumph of science and American ingenuity.

It only took six weeks to tarnish that image.

Pride in the remarkable feat has been replaced by confusion, accusations of unfairness, frustrating waits and the nightmare of vaccine vials gathering dust while tens of thousands of people continue to die of what is now a preventable disease.

Even people leading the effort are at a loss to explain how and why things took such a bad turn so fast.

“I would love to understand it,” said Moncef Slaoui, head of the vaccine development effort under the Trump administration and now an advisor to the Biden administration.

“What makes me sad,” he said, is “the thousands of people that have worked day and night over the last many, many months really feel terrible, feel depressed, because the whole thing is now positioned as a disaster.”

So, what happened?

A clearer picture of the challenges is emerging from interviews and news conferences with more than two dozen government officials and vaccine experts. A laundry list of issues slowed the vaccine rollout, USA TODAY found, ranging from unrealistic public expectations and a lack of communication, to overwhelmed software and competing visions for the role of government. All taking place amid a seismic shift in White House leadership.

The Trump administration focused on delivering millions of vaccine doses to loading docks. States and localities were expected to take over from therewith little support, guidance or money.

The Biden administration, by contrast, sees a broader mandate for the federal government. It already has begun helping states organize their vaccination efforts and get doses the “last mile,” into the hands of vaccinators and the shoulders of eager Americans.

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“There are times when we are 50 states and there are times when we’re one nation. This is a time where we have to be one nation,” incoming Surgeon General Dr. Vivek Murthy recently told podcaster Ezra Klein. “And if we don’t do that, then we are not going to turn this pandemic around.”

The Biden administration already has begun a public relations campaign to better understand the problems and promote solutions, and has requested huge sums from Congress to ramp up vaccination programs nationwide.

“Even so,” said Andy Slavitt, an advisor to the White House’s COVID-19 effort, “it will be months before everyone who wants a vaccine will be able to get one.”

A few things have gone right: 28 million Americans have received at least one shot in less than six weeks. The Trump administration accurately predicted how much vaccine would be available this month and the number of doses distributed meets that prediction.

“The physical shipment of vaccine from manufacturing sites to distribution sites has been done very well, with 99% accuracy,” Slaoui said.

But multiple issues have marred the rollout so far:

• The amount of vaccine states receive weekly fluctuates wildly and there’s no clear explanation why;
• States were not immediately prepared to distribute at the scale the public demanded, even when they did get expected amounts of vaccine;
• The federal government was not forceful enough in explaining it would take months to vaccinate everyone and early rationing would be necessary;
• Appointment scheduling programs crashed under overwhelming demand, leading to chaos as people tried to get in line. Digital scheduling systems advantaged people who are internet savvy and had hours to spend waiting for their turn;
• Full-scale manufacturing didn’t start until late in the year; while 100million doses initially were promised by the end of the year, only 20 million were available in December and another 30 million this month.

Expectation and supply problems

The Trump administration’s vaccine effort did not include a public information campaign to drive home the fact that demand for vaccines would vastly exceed supply for months. While mentioned, it was not emphasized in federal briefings. A long-promised federal education campaign scheduled to launch in Januarydid not materialize.

Hospitals were thought to be a good place to start administering vaccinations because of their expertise. But just as vaccine became available in late December, the holidays arrived, reducing staffing.

At the same time, hospitals were overwhelmed by the highest rate of COVID-19 infections since the start of the pandemic, filling beds, taxing workers and stretching finances in an already desperate year.

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States also struggled to ramp up their vaccination efforts. Health department workers and budgets already were spread thin over the course of the pandemic. Many didn’t have the resources to plan a large-scale vaccination effort. Money intended to help support their work wasn’t approved by Congress until the last days of 2020, and only began to trickle in recent weeks.

“We’ve seen states do this valiant effort without much government support,” said Glen Nowak, director of the Center for Health and Risk Communication at the University of Georgia.

In addition, states have struggled with constantly fluctuating amounts of vaccine, making planning extremely difficult.

During the week of Jan. 5, for example, the San Francisco Department of Public Health received 3,900 doses of vaccine from the federal government. The next week it got 11,825, the week after 1,775. Last week it got approximately 11,100.

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Officials say they request the same amount of vaccine each time and have no idea why there’s so much variation, and no one else seems to be able to explain the discrepancy. 

“It drives me crazy that nobody seems to know the truth about supply,” said Dr. Bruce Gellin, president for Global Immunization at the Sabin Vaccine Institute. “If the companies could stand up and talk about what their numbers are, then there’d be a lot less finger-pointing.”

Computer systems also have been a huge challenge for states, with each left to develop programs on its own for tracking vaccine distribution and signing people up for shots.

Some states have custom-built programs, others are tweaking existing scheduling systems and many are simply using products like Eventbrite or SignUpGenius that might also be used to organize a child’s birthday party.

Stories abound of people spending hours online or on hold, trying to make appointments only for systems to crash or phone lines cut.

Vaccine production confusion

Operation Warp Speed staff have been saying since springthat the various vaccine candidates were being manufactured “at risk.”

Most people assumed that meant vaccine vials would roll off assembly lines and be stockpiled in freezers until the day regulators determined the product was effective and safe to deliver to millions of Americans.

In normal vaccine development, companies wait until after clinical trials are completed to begin building manufacturing lines and buying equipment. That process, which often takes years, was accelerated but it still didn’t lead to actual production in the United States until fall. So there was no enormous vaccine stockpile available on Dec. 11 when the Pfizer vaccine became the first in the U.S. to be authorized for use against COVID-19.

“Keep in mind that these manufacturing lines are made up of one-of-a kind equipment, custom made for each particular vaccine,” Health and Human Services said in statement to USA TODAY. “All manufacturing capacity in the U.S. that can be used for COVID-19 vaccine manufacturing is being used.”

Pfizer and Moderna have not provided much insight into their timeline, other than to say that they started work in the spring.

Emergent BioSolutions, the primary North American manufacturer for the AstraZeneca and Johnson & Johnson vaccine candidates, was more forthcoming. It signed manufacturing contracts in May and June, and just began producing the vaccines in the fall

“One might say, ‘Why so late?’ said Sean Kirk, the company’s executive vice president for manufacturing and technical operations. “Well, it’s not late, it’s extraordinarily soon in the grand scheme of things.”

It was never going to be “a flip of a switch,” he said.

Improvements promised to come

Barring disaster, vaccination efforts will continue to ramp up over the coming weeks and months.

Three additional vaccines are nearing the finish line, with more on the horizon.

Biden has invoked the Defense Production Act to make raw materials needed for manufacturing COVID-19 vaccines more available, and has changed rules to allow retired doctors and nurses to deliver shots.

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Administration officials also have provided more detailed data about how many doses are available, and they’ve been meeting regularly with media to increase the flow of information to the public.

To do much more, the administration will need help from Congress, including passage of Biden’s $1.9 trillion “American Rescue Plan,” both Slavitt and CDC director Dr. Rochelle Walensky said last week at White House COVID news briefings.

Among other things, the extra funds would support local public health systems and enable the administration to launch mass vaccination clinics across the country.

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Amid the efforts, the flow of vaccinations is improving.

Two weeks ago, about 700,000 shots on average were delivered every day. Last week, the figure reached 1.2 million.

To get past the pandemic, those daily totals must keep climbing.

“Every day, when the number comes out,” said Slavitt, “all of us are breathlessly awaiting the number and looking for as high a number as possible.”

Contact Karen Weintraub at kweintraub@usatoday.com and Elizabeth Weise at eweise@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.