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.

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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.

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.

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.

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.

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.

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.

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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.

A committee of advisers to the Food and Drug Administration generally supported the agency's approach to reviewing COVID-19 vaccines for emergency use during a public meeting Thursday.

But the expert panel raised concerns about the expedited regulatory path, including details of the clinical studies the agency will rely on to determine if the potential benefits of the vaccines outweigh the risks.

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.

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.

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