Sydney Lupkin

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.

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.

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.

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.

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.

Now that the Food and Drug Administration has authorized remdesivir for emergency use in seriously ill COVID-19 patients, the experimental drug is another step closer to full approval. That's when most drugs get price tags.

Gilead Sciences, which makes remdesivir, is donating its initial supply of 1.5 million doses, but the company has signaled it will need to start charging for the drug to make production sustainable. It's unclear when that decision might be made.

Gilead Sciences, the drugmaker behind the experimental COVID-19 treatment remdesivir, spent more on lobbying Congress and the administration in the first quarter of 2020 than it ever has before, according to federal filings.

The pharmaceutical company spent $2.45 million on lobbying in the first three months of the year, a 32% increase over the $1.86 million it spent in the first quarter of 2019.

The coronavirus pandemic has renewed concerns about the dependence of the United States on other countries for supplies of prescription drugs and ingredients.

The U.S. ignored the decline of domestic medical manufacturing and waited too long to seriously invest in the federal office designed to prepare for pandemics, Sen. Chris Coons, D-Del., said in an interview.

"We are now paying both in needless exposure by our front-line health workers and needless deaths for having not been better prepared for this," he says.

Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify.

Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been.

"That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md.