Sydney Lupkin

Sydney Lupkin is the pharmaceuticals correspondent for NPR.

She was most recently a correspondent at Kaiser Health News, where she covered drug prices and specialized in data reporting for its enterprise team. She's reported on how tainted drugs can reach consumers, how companies take advantage of rare disease drug rules and how FDA-approved generics often don't make it to market. She's also tracked pharmaceutical dollars to patient advocacy groups and members of Congress. Her work has won the National Press Club's Joan M. Friedenberg Online Journalism Award, the National Institute for Health Care Management's Digital Media Award and a health reporting award from the Society for Advancing Business Editing and Writing.

Lupkin graduated from Boston University. She's also worked for ABC News, VICE News, MedPage Today and The Bay Citizen. Her internship and part-time work includes stints at ProPublica, The Boston Globe, The Boston Herald, The New England Center for Investigative Reporting and WCVB.

ARI SHAPIRO, HOST:

Neera Tanden has withdrawn her name as President Biden's nominee to head the Office of Management and Budget. Her nomination has been controversial, mostly because of disparaging comments she's made in the past about Republican lawmakers. White House correspondent Franco Ordoñez is with us now for more.

Hi, Franco.

FRANCO ORDOÑEZ, BYLINE: Hi, Ari.

SHAPIRO: What did the White House and Tanden say this evening?

With two COVID-19 vaccines available in the United States and more on the way, things are starting to look up. But virus mutations being detected around the world mean the vaccines may one day need updates to ensure they stay effective.

The Food and Drug Administration is already working on a playbook for how it could greenlight vaccine changes.

President Biden said last Tuesday that his administration is already working on ordering more COVID-19 vaccine doses to increase the U.S. supply through this summer. But before that can happen, Pfizer and Moderna have to fulfill their commitments under their original federal supply contracts.

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With a spotlight on COVID-19 vaccine distribution shortcomings, there's another bottleneck that could prevent inoculations from significantly speeding up in the near future: Pfizer's and Moderna's ability to scale up manufacturing and deliver doses to the U.S. government.

The companies promised to deliver 100 million doses apiece to the United States by the end of March. But they'll need to make huge leaps in a short time to meet that goal.

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Families banding together in shifts to try and get appointments, clogged phone lines and glitchy Web portals - the vaccine rollout in America has been a mess so far. All that as we're seeing a staggering rise in infections and after almost 400,000 Americans have died of COVID-19. And now we're learning that a federal deal to increase vaccine manufacturing has an unusual clause that could allow certain people to cut the line. NPR pharmaceuticals correspondent Sydney Lupkin is here to tell us about it. Good morning.

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Moderna's COVID-19 vaccine is expected to become the second to get the Food and Drug Administration's green light. A decision could come within days.

But compared with pharmaceutical giant Pfizer, which was granted emergency use authorization last week, upstart Moderna doesn't have a track record when it comes to mass production.

With Pfizer's COVID-19 vaccine poised for Food and Drug Administration authorization for emergency use, there's speculation about when the United States will buy another batch of doses — and whether the Trump administration already missed its chance.

When the Department of Health and Human Services released Pfizer's $1.95 billion coronavirus vaccine contract with Operation Warp Speed last Wednesday, the agreement revealed that the Trump administration didn't include government rights to intellectual property typically found in federal contracts.

While the country was focused on the outcome of the election Saturday, the Department of Health and Human Services released a trove of new Operation Warp Speed documents.

The newly released contracts include the crash program's $1 billion agreement with Johnson & Johnson, which was issued through a third-party firm and lacks some customary protections against potential future price-gouging.

The Department of Health and Human Services has released the contract of pharmaceutical industry veteran Moncef Slaoui, a key adviser to Operation Warp Speed, after questions from the press, members of Congress and advocacy groups.

Operation Warp Speed is the Trump administration's multibillion-dollar push to develop and manufacture hundreds of millions of doses of coronavirus vaccine. Slaoui has been instrumental in guiding the effort, but the terms of his employment raised concerns about potential conflicts of interest.

Even as the companies enlisted by the government's Operation Warp Speed project to develop COVID-19 vaccines say they're making quick progress, details of their lucrative federal contracts have been slow to emerge.

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Members of Congress, advocacy groups and a former administration official say Operation Warp Speed should release its vaccine contracts with pharmaceutical companies, following an NPR report that the Trump administration awarded billions of dollars through a third party, bypassing the usual contracting process.

The Food and Drug Administration published guidance Tuesday detailing what's required for the emergency authorization of a coronavirus vaccine after the advice to pharmaceutical companies was delayed by White House review.

The Trump administration has compared Operation Warp Speed's crash program to develop a COVID-19 vaccine to the Manhattan Project. And like the notoriously secretive government project to make the first atomic bomb, the details of Operation Warp Speed's work may take a long time to unravel.

President Trump promised this week to send cards worth $200 to seniors to help them pay for their prescription drugs, but it's unclear how he will be able to pull it off — or how legal it is.

If he can, that's $6.6 billion to a key voting bloc weeks before Election Day.

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By the second week in July, COVID-19 cases in North Carolina were climbing fast.

With nearly 19,000 diagnoses over the previous two weeks, only five states recorded more new coronavirus cases than North Carolina did.

"Today is our highest day of hospitalizations and our second-highest day of cases," Gov. Roy Cooper, a Democrat, announced on July 9, standing behind a podium in the state's Emergency Operations Center. "Please continue to treat the virus like the deadly threat that it is."

How much will vaccines against the coronavirus cost? Even though none has finished clinical testing, some clues about pricing are starting to emerge.

Cambridge, Mass.-based Moderna, one of the leading horses in the vaccine race, has already made deals at between $32 and $37 per dose of its experimental coronavirus vaccine in agreements with some foreign countries, rattling consumer advocates, who fear an unfair deal for U.S. taxpayers.

The Trump administration has announced four executive orders to lower drug prices, but health policy experts say they will likely offer patients only minimal relief and may take months to implement, if they're implemented at all.

The orders signed Friday afternoon included allowing certain drugs to be imported from Canada and making changes to the way discounts negotiated by middlemen called pharmacy benefit managers are passed on to Medicare patients.

The federal government has reached a $1.95 billion deal with Pfizer to acquire 100 million doses of its vaccine candidate against the coronavirus if the Food and Drug Administration OKs it. The vaccine would be free to Americans, according to the deal, though health care providers could charge to administer it.

When the order of 100,000 masks arrived at an unnamed factory for use in protecting workers against COVID-19, they were covered in dirt, dust and mysterious stains. In short, they were "not fit to be used," according to a complaint filed with the Food and Drug Administration in late March.

The drugmaker behind the experimental COVID-19 treatment remdesivir has announced how much it will charge for the drug, after months of speculation as the company tried to figure out how to balance profit and public health needs in the middle of a pandemic.

More than 100 coronavirus vaccines are being studied around the world, but less than a dozen have begun testing in humans.

The federal government's goal is to have a COVID-19 vaccine ready by January 2021. To achieve that objective, the White House formed Operation Warp Speed, a public-private partnership, to push the development, testing and manufacture of a vaccine at a breakneck pace.

States are beginning to receive cases of an experimental COVID-19 drug that the Food and Drug Administration authorized for emergency use on May 1.

But the distribution process so far has puzzled some hospitals and states about why they've been left empty-handed.

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