Sydney Lupkin

Some Americans are already lining up for COVID-19 booster shots, but the Centers for Disease Control and Prevention is warning that administering doses of the vaccine in ways that aren't OK'd by the federal government could put health care providers at risk of lawsuits and leave patients with unexpected bills.

These so-called "off-label" uses include giving the vaccine out as a booster shot to people who are not immunocompromised, or using it to vaccinate children under the age of 12 for whom the shot is not yet authorized.

It was 17 days before Pfizer's first delivery deadline under its federal COVID-19 vaccine contract, and the company wasn't going to meet it, according to federal records and several people familiar with the matter.

Officials with Operation Warp Speed, the Trump administration's multibillion-dollar push to make a COVID-19 vaccine available in record time, didn't know there was a problem.

Health officials are preparing to roll out COVID-19 booster shots in the United States this September. According to a plan announced Wednesday, all U.S. adults who received a two-dose vaccine would be eligible for an additional jab of the Pfizer or Moderna vaccine eight months from when they got their second one.

As Emergent BioSolution's Baltimore factory was throwing away unfinished COVID-19 vaccine doses and struggling to pass muster with the Food and Drug Administration, the company awarded at least $3 million in bonuses to a handful of executives, according to documents released by a congressional subcommittee Wednesday.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

STEVE INSKEEP, HOST:

There will be 86% fewer Johnson & Johnson vaccine doses allocated to states next week, new data from the Centers for Disease Control and Prevention show, highlighting the company's yo-yoing vaccine supply from week to week.

But next week's dip in supply isn't exactly the setback it appears to be.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

AUDIE CORNISH, HOST:

Copyright 2021 NPR. To see more, visit https://www.npr.org.

NOEL KING, HOST:

Updated March 24, 2021 at 5:57 PM ET

Moncef Slaoui, who led the Trump administration's COVID-19 vaccine development efforts under Operation Warp Speed, has lost his job as chairman of the board at a medical device startup.

In the run-up to President Biden's promise on March 2 that there would be enough COVID-19 vaccines for every adult in the United States by the end of May, he talked up a Korean War era law called the Defense Production Act.

President Biden's promise that there will be enough vaccines for every U.S. adult by the end of May has some Americans wondering if it's too good to be true.

Time will tell.

But before the pharmaceutical companies can hit their May goal, they'll need to reach an earlier target: Pfizer and Moderna agreed to supply 100 million doses a piece to the U.S. by the end of March. With just under three weeks left, both companies have their work cut out for them.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

ARI SHAPIRO, HOST:

Copyright 2021 NPR. To see more, visit https://www.npr.org.

ARI SHAPIRO, HOST:

Pharmaceutical giants Merck and Johnson & Johnson are normally competitors, but the Biden administration announced today that Merck will help make Johnson & Johnson's COVID-19 vaccine, which was authorized by the FDA over the weekend.

Pharmaceutical giant Merck will help manufacture Johnson & Johnson's COVID-19 vaccine, White House Press Secretary Jen Psaki announced, calling it "an unprecedented historic step," considering that the two companies are normally competitors.

Merck will produce the drug substance at the heart of Johnson & Johnson's vaccine as well as work on filling vaccine vials and getting them ready for distribution.

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.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

MARY LOUISE KELLY, HOST:

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.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

MARY LOUISE KELLY, HOST:

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.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

STEVE INSKEEP, HOST:

LULU GARCIA-NAVARRO, HOST:

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.

As the nation grapples with a slower-than-promised coronavirus vaccine rollout, one federal deal to increase factory capacity includes an unusual condition: the manufacturer would be allowed to earmark doses to vaccinate employees and their families, giving them an opportunity to skip the line that public health policymakers have been crafting for months.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

ARI SHAPIRO, HOST:

Copyright 2021 NPR. To see more, visit https://www.npr.org.

DAVID GREENE, HOST:

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.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

AILSA CHANG, HOST:

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.

A day after Pfizer's announcement that its COVID-19 vaccine is more than 90% effective, rival Novavax shared its $1.6 billion Operation Warp Speed contract on Tuesday.

Operation Warp Speed is the Trump administration's crash program to make a vaccine available in record time. While there's been rapid progress on vaccines, the government has been slow to release details of its billions of dollars' worth of deals with manufacturers.

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.

Pages