Out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated in diabetes prevention classes since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018.

This article was published on Wednesday, July 21, 2021 in Kaiser Health News.

By Harris Meyer

Damon Diessner tried for years to slim down from his weight of more than 400 pounds, partly because his size embarrassed his wife but even more because his doctors told him he was at risk of developing Type 2 diabetes. His hemoglobin A1c level, a blood sugar marker, was 6.3%, just below the diabetes range of 6.5%.

Then, two years ago, one of his doctors helped get him into a YMCA-run Diabetes Prevention Program not far from his home in Redmond, Washington. The group classes, at first held in person and then via Zoom during the covid-19 pandemic, were led by a lifestyle coach. He learned how to eat better, exercise more and maintain a healthier lifestyle overall. He now weighs 205 pounds, with an A1c level of 4.8%, which is in the normal range.

“This has been a life-changing program,” said Diessner, 68, an environmental consultant. “My cardiologist said you have clearly beaten diabetes. I tell everyone who has blood sugar issues or just wants to lose weight that this is the thing to do.”

Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers and other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).

Researchers and people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, and usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs and requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.

Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population and potentially cut federal spending to treat diabetes-related conditions.

On July 13, the agency proposed shortening the program to one year, starting in 2022, because providers complain that too few beneficiaries complete the second year. That and other changes proposed by Medicare would modestly enhance reimbursement to providers. The government is also planning to waive a one-time $599 fee that groups offering the classes must pay Medicare to be part of its program. CMS said the rule changes would make it easier and more attractive for MDPP providers, including YMCAs and other local community organizations, to participate.

While providers have welcomed the proposed revisions as marginally helpful, they criticized CMS for not letting them provide classes and counseling to Medicare beneficiaries through online methods including apps, videoconferencing and texting. Many health insurers covering people under age 65 offer similar diabetes classes online, and they claim success rates comparable to in-person classes.

“The proposed rule changes should have the intended effect on increasing access for Medicare members,” said Dr. Liz Joy, senior medical director for wellness and nutrition at Intermountain Healthcare in Salt Lake City. It offered in-person classes at many of its hospitals but switched to online classes during the pandemic. “Virtual access would improve access and reduce disparities for people who have barriers such as transportation and distance,” Joy said.

A bipartisan bill in the House and Senate, the Prevent Diabetes Act, would let virtual providers certified by the Centers for Disease Control and Prevention participate in the Medicare Diabetes Prevention Program. The bill’s sponsors say virtual programs are needed to better serve lower-income, minority and rural Americans.

The diabetes prevention initiative is just one of several programs that have been found effective in reducing or treating chronic medical conditions but have been underused due to the U.S. health care system’s lack of focus on disease prevention. For instance, Medicare’s coverage of personal nutrition counseling for people with diabetes or kidney disease is used by fewer than 1% of the 15 million beneficiaries with those conditions. Insurers, hospitals, and doctors lack adequate financial incentives to offer preventive services.

“Patients might change providers next year, so why would a company invest in prevention if they don’t know that they’ll reap the benefits?” said Maria Alva, an assistant research professor at Georgetown University who has studied the MDPP. “And doctors are paid more for prescribing diabetes drugs than taking the time to recommend the diabetes prevention program.”

CMS started paying for the diabetes prevention program in 2018, following studies showing its effectiveness in helping overweight, prediabetic beneficiaries lose nearly 5% of their body weight, which can cut the risk of developing diabetes by 71%. The agency had estimated that the program would save Medicare $182 million over 10 years by reducing diabetes. CMS had projected that 110,000 beneficiaries would enroll.

An evaluation of the program by the research group RTI International published in March found there aren’t enough enrollees to determine whether participation improves health outcomes or lowers Medicare costs. With about 200 organizations providing MDPP classes at 762 sites around the country, CMS needs to prioritize signing up more providers, RTI said. Nationwide, about 1,900 organizations are certified by the CDC to offer diabetes prevention classes, but only a small percentage choose to participate in Medicare.

A key factor limiting providers’ participation up to now is that CMS has tied a bonus payment to beneficiaries’ losing at least 5% of their body weight, which only a minority of participants achieve. But studies show that weight loss of just 2% to 3% can significantly reduce A1c levels and the associated risk of developing diabetes.

In contrast, the CDC recently updated its certification standards for Diabetes Prevention Programs to include two alternative measures for successful completion of the program — a 0.2% decrease in hemoglobin A1c levels, or a 4% weight loss combined with at least 150 minutes a week of physical activity.

But under Medicare’s new proposed rule, MDPP providers would receive up to $635 if a participant hit the 5% weight loss target and attended 13 sessions over one year, or $661 if the person lost 9% of body weight. Providers’ payments would be capped at $338 if a participant fell short of the 5% weight loss goal.

Researchers and providers say that payment model hurts organizations that serve low-income and minority groups, whose members are less likely for a variety of reasons to attend all the sessions and achieve 5% weight loss but who still can benefit from the program. Even without the penalty for not hitting the 5% target, Medicare’s payment rate doesn’t come close to covering the cost of running in-person classes, experts say.

“Five percent is a stretch goal, and 9% is laughable,” said Dr. Amanda Parsons, who previously headed the MDPP program at Montefiore Health System in New York City, which serves mostly low-income Black and Hispanic beneficiaries. “I want to know how many folks are coming anywhere close to achieving that.”

Asked to comment, CMS said CDC standards require providers to meet performance targets but did not explain why it didn’t adopt the CDC’s alternative success measures. On the issue of online classes, CMS said MDPP was originally intended to provide primarily in-person services.

Diessner, who far exceeded the 5% weight loss goal, said he was inspired to get into MDPP by watching his young grandson’s brave efforts to cope with Type 1 diabetes. Despite Diessner’s determination, his doctor had to lobby YMCA staff members over several months to get him a slot, because the few available classes were full. He was shocked when told the low number of participants nationally.

“I see lots of people out in the street who could use help with this,” he said. “The idea that so few people are taking advantage of it is a travesty.”

A provision in California's newly approved state budget will eliminate the asset test for the 2 million Californians enrolled in both Medi-Cal and Medicare.

This article was published on Tuesday, July 20, 2021 in Kaiser Health News.

By Rachel Bluth

SACRAMENTO, Calif. — Getting clean drinking water cost Ignacio Padilla his health insurance.

The World War II veteran needed to repay the loan for the water pump installed on his 1-acre property in rural Tulare County, the only source of water to his mobile home. He carefully socked away a few thousand dollars so he could make the payoff — only to find that those savings put him over the asset threshold to remain on Medi-Cal, California's Medicaid program for low-income people. He was booted from the health insurance program in 2019.

It wasn't an emergency at the time. Padilla still had coverage from Medicare and the Department of Veterans Affairs, and he could live an independent, if remote, life.

But now Padilla is 95 and has congestive heart failure. His children are trying to get him back on Medi-Cal so it can eventually cover the costs for nursing home care.

His older daughter, Emily Ysais, worries that Padilla's finances — limited though they are — will again disqualify him. He gets $1,100 a month from his pension and Social Security. If Veterans Affairs approves the monthly caregiving stipend she helped her dad apply for, it could tip him over the limit of Medi-Cal's "asset test."

"Our hands are tied," said Ysais, 67. "It's hard to keep figuring out a way to take care of him."

Change is coming, though perhaps not soon enough for Padilla. A provision in California's newly approved state budget will eliminate the asset test for the 2 million Californians enrolled in both Medi-Cal and Medicare, the federal health insurance program for people 65 and older and people under 65 with certain disabilities. Instead, their financial eligibility will be based solely on income, as it is for the millions of other people in Medi-Cal.

The elimination of the test will be a game changer for aging or impaired Californians who need long-term care but are caught in a common conundrum: They don't earn enough to cover the high costs of ongoing nursing home care and can't rely on Medicare, which does not cover extended nursing home stays. They can get that care through Medi-Cal, but they would have to wipe out their savings first.

The 2021-22 state budget deal includes several provisions that will make it easier to get on and stay on Medi-Cal, including the elimination of the asset test. Everyone 50 and over will be eligible, regardless of immigration status. And new mothers will be allowed to remain on Medi-Cal for one year after giving birth, up from 60 days.

The budget also includes $15 million over the next three years, starting this year, to develop online enrollment forms and translate them into multiple languages, and $8 million for counties to help some people who get in-home care stay enrolled.

California has a strong Medi-Cal takeup rate, with 95% of eligible people enrolled, said Laurel Lucia, director of the healthcare program at the Center for Labor Research and Education at the University of California-Berkeley. But of the remaining uninsured people, about 610,000 qualify for Medi-Cal, she said.

"We are doing well, but so many people are eligible and not enrolled," Lucia said. "The barriers to Medi-Cal enrollment and retention are really multifaceted, so the solutions have to be as well."

This is an especially volatile moment for the program, which covers 13.6 million Californians. The state is trying to improve the quality of care by renegotiating its contracts with managed-care insurance companies. At the same time, Gov. Gavin Newsom and the state Department of Healthcare Services are proposing a massive overhaul that would provide more services to homeless people and incarcerated people and boost mental healthcare. 

Meanwhile, Medi-Cal enrollment continues to grow: State officials estimate enrollment will balloon to 14.5 million this fiscal year, which began July 1.

The changes to Medi-Cal that were approved in the budget include an expansion that Democratic lawmakers have been seeking for years: California already allows eligible unauthorized immigrants up to age 26 to receive full Medi-Cal benefits. Starting next spring, that will expand to people 50 and up.

State officials estimate about 175,000 people will enroll in the first year, with an additional 3,600 people signing up every year thereafter, eventually costing the state $1.3 billion annually.

And, starting next July, new mothers will be able to stay on Medi-Cal for up to one year after giving birth. By 2027, the additional coverage is expected to cost the state about $200 million a year.

Assembly Republican Leader Marie Waldron (R-Escondido), who said she supports expanding eligibility for the program in limited circumstances, was the author of a bill to allow incarcerated people to enroll before they're released that was ultimately folded into the budget and will take effect in 2023.

But she said the changes in this year's budget go too far.

"Expensive government-run healthcare doesn't really work, and most voters don't want to pay for it," Waldron said. "But California Democrats seem to think everyone will love it once they are on it, which is not true. It's creeping socialism."

The elimination of the Medi-Cal asset test for older Californians and those with certain disabilities, which takes effect July 1, 2022, marks a dramatic change to the program. Officials estimate it will cost the state roughly $200 million a year once fully implemented because of the increased enrollment.

Right now, these people can't qualify for Medi-Cal if they have saved more than $2,000. For couples, it's $3,000. Complicated rules dictate what counts as an "asset" and what doesn't: A house doesn't count and neither does one car, but a second car does. Engagement rings and heirlooms are fine, but other jewelry counts toward the limit.

Ultimately, the test favors individuals and families who can navigate the rules and find ways to hide money in exempt accounts, said Claire Ramsey, a senior attorney with Justice in Aging.

"You create administrative hurdles, which keeps people artificially off the program," Ramsey said. "If it's hard for the lawyers to understand all the rules, what does that mean for the average person who's just trying to have health insurance?"

The federal Affordable Care Act eliminated the asset test for most Medicaid enrollees, basing financial eligibility exclusively on income, but left out people who qualify for both Medicaid and Medicare.

This is especially important when it comes to expensive long-term care, like nursing homes, which can cost $10,000 a month, said Patricia McGinnis, executive director of California Advocates for Nursing Home Reform.

Medicare covers nursing home care only in limited circumstances and for up to 100 days. After that, patients must find another way to pay, either out-of-pocket or through Medi-Cal. Because many people don't qualify for Medi-Cal if they have too much money or other assets, they have to spend through their savings and shed their belongings before they can get on the program.

"Thousands and thousands of people have become impoverished to afford nursing home care," McGinnis said. "You want free medical care? You're going to have to spend every penny you have to get it."

A state Assembly analysis estimated that 17,802 additional Californians would have become eligible in 2018 if the asset test hadn't been required. Of those, 435 were in long-term care, and over the course of the year, 263 spent their money or gave away their assets to qualify for Medi-Cal.

Assembly member Wendy Carrillo (D-Los Angeles), the author of the asset test bill that was folded into the budget, sees eliminating the requirement as part of a larger movement toward universal coverage, in line with efforts to expand Medi-Cal to older unauthorized immigrants or establish a single-payer system.

"We need to aggressively and proactively work on legislation that gives more people coverage," Carrillo said. "And until we have universal healthcare, these are the steps necessary to ensure that."

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

Rachel Bluth: rbluth@kff.org, @RachelHBluth

Novavax's quest to scale up operations underscores how difficult it can be to launch a vaccine ― even with the formula and technology in hand.

This article was published on Monday, July 19, 2021 in Kaiser Health News.

By Sarah Jane Tribble and Rachana Pradhan

On a sweltering June morning, Novavax CEO and COVID vaccine maker Stanley Erck stood on a stage unmasked and did something that would have been unthinkable six months ago: He shook hands with Maryland's governor.

Erck was with Gov. Larry Hogan to announce Novavax's global vaccine headquarters ― a campus expected to house laboratories and more than 800 employees. Hogan called Novavax's future "bright" and marveled that more than 71% of the state's adults had received at least one shot.

None of those was a Novavax vaccine, which is still unavailable for the American public due to delayed clinical trial results and other difficulties. Hogan, for his part, received his first vaccine dose ― made by fellow biotech upstart Moderna ― in January.

"As you can imagine, we're eager to receive our own," said John Trizzino, Novavax's chief commercial officer and interim chief financial officer. Its two-dose COVID vaccine, which showed overall 90.4% efficacy in key U.S. and Mexico trials, has yet to be authorized. "In the meantime," Trizzino said, "we've had to use one of the existing licensed vaccines and we look forward to the booster" made by Novavax.

Looking forward has kept Novavax afloat for decades ― along with its deep ties to grant makers and federal agencies. With its focus on developing vaccines, including for the SARS and MERS pandemics, Erck argues Novavax is "built for this moment." Still, the 34-year-old startup has never brought one to market.

Novavax's quest to scale up operations underscores how difficult it can be to launch a vaccine ― even with the formula and technology in hand. So what happened? It has had the financial backing of the U.S. government and full faith of international agencies. Everything took longer than expected: hiring necessary researchers and scientists, getting supplies and transferring its vaccine technology. It didn't move at warp speed.

America is awash with vaccine options, and Novavax does not plan to file for regulatory authorizations until late July at the earliest. The delay could have dire consequences for people across the globe awaiting a vaccine.

"We're not making aspirin," Trizzino said. "We're making a very complicated biological."

A Moonshot Goal

A year before the COVID pandemic hit, Novavax had a failed late-stage trial on a potential respiratory virus vaccine, after which it cut its workforce and sold off all its manufacturing capabilities. So, when more than $2 billion in federal and international funding landed at its doorstep, Novavax found itself developing both "a vaccine and a company" in 12 months, said Dr. Gregory Glenn, president of research and development.

Novavax's proprietary secret ingredient is Matrix-M, an immune booster. Executives say the additive ― derived from Chilean soapbark trees ― works so well that less of an antibody-producing antigen would be needed with it in a vaccine. One financial filing said Matrix-M "has the potential to be of immense value."

Equipped with its recombinant nanoparticle vaccine mixed with Matrix-M, Novavax deployed a core team of employees, dubbed "SuperNOVAs," to crisscross the globe. They assembled a manufacturing network and shared vaccine technology in India, South Korea, Spain, Japan and the Czech Republic as well as in the United States ― about 20 contract manufacturing and test sites in all.

"This takes time and expertise," Trizzino said. "You just simply can't hand over the recipe and then walk away from it and expect you're going to have a high-quality product."

Novavax is contracted to form the backbone of the COVAX initiative, having promised 1.1 billion doses starting this year for developing countries. And while President Joe Biden announced the U.S. would donate 500 million doses of the Pfizer-BioNTech vaccine abroad, Novavax is still seen as vital to urgent efforts worldwide to battle the virus and its variants.

Novavax's moonshot goal of producing 2 billion shots a year increasingly looks like a pipe dream for 2021. "It is very hard to accept that they will make 2 billion doses as they had originally committed. I'm very skeptical," said Prashant Yadav, a healthcare supply chain expert and senior fellow at Harvard's Center for Global Development.

One of Novavax's biggest challenges, Yadav said, is relying on "so many sites" that aren't fully under its control, while other manufacturers own their plants. The more places Novavax produces the vaccine, the more challenging it is to make sure the vaccine and its elements are comparable in every place.

When Novavax executives announced another delay in May, the company's stock plummeted to $121 a share ― down 62% from a high of about $319 in February. As the company's fortunes rose last year, Novavax executives cashed out tens of millions of dollars in common stock, according to securities filings. Last year, after the company benefited from grants and government contracts, CEO Erck sold $9.3 million in company shares, Glenn sold $14 million, and Trizzino sold $11.3 million.

Those top executives continued selling in 2021. Erck sold more than $22.5 million worth of common stock in early July.

Novavax executives use trading plans, and the sales often appear at the same time each month. In June, after Novavax announced its long-awaited U.S. and Mexico clinical trial results, Glenn sold more than 8,000 shares for $1.5 million. As a measure of the company's spectacular rise in the pandemic, Glenn purchased 1,000 shares of stock in December 2016 for the price tag of just $1,446.

Novavax spokesperson Amy Speak said the company has programs in place to ensure best practices on stock sales. "Most people, including our executives, sell stock for a wide variety of reasons," she said, adding that Novavax's executives have "generally sold a fraction of their overall holdings in the company."

Charles Duncan, a biotechnology research analyst at Cantor Fitzgerald, called Novavax a "show me" investment in May. "It's one thing to have a place to make it," he said. "It's another thing to be able to make it there and get it certified."

'Hadn't Heard of COVID-19'

John Kutney, Novavax's senior director of manufacturing, joined a BioBuzz video in December, in an effort to recruit urgently needed talent. Kutney described the technology transfer as taking a recipe and teaching it to others. With that mission, he has traveled to the Czech Republic, Spain and the United Kingdom as well as Texas, North Carolina and New England.

When Novavax began work on its vaccine in January 2020, "most of us hadn't heard of COVID-19 and we were only beginning to become aware of what was happening in China," Kutney said. Novavax adapted its established vaccine platform to the new virus and then had to scale and transfer it to larger manufacturing sites, build a global supply chain and develop a regulatory strategy for emergency use.

"These steps would normally take years," he said.

The key step of transferring Novavax's vaccine technology can take three to six months, depending on the quality of the partner's team. Once equipment and raw materials are secured, the teams start with small batches ― first with a 50-liter bioreactor, then a 200-liter and eventually a 2,000-liter bioreactor, checking to make sure the partner operators know the process every step of the way.

"What we're trying to do here is not easy," said Fred Shemer, Novavax's vice president of quality systems and compliance, in the video: "It's a challenging situation."

In March 2020, Novavax received the first $4 million of nearly $400 million pledged by the Coalition for Epidemic Preparedness Innovations. CEPI is a global alliance backed by the Bill and Melinda Gates Foundation, which previously supported Novavax with $89 million for a vaccine for a common respiratory virus.

CEPI's investment jump-started Novavax's technology transfer to plants across Europe and Asia. It helped Novavax partner with SK bioscience in South Korea and paid for ramping up production at Praha Vaccines, which Novavax eventually bought, in the Czech Republic. It also supported scaling up production of Matrix-M at facilities in Sweden and Denmark.

Operation Warp Speed awarded $1.6 billion in July 2020 to Novavax so it would produce 100 million doses ― one of the largest awards from the Trump administration's vaccine incubator. It was "kind of a stunning number for us," Trizzino said. In December, officials bumped the total to $1.74 billion with no changes to the previous contract. Novavax also has a $60 million contract with the Department of Defense for 10 million doses.

Paul Mango, a former senior official at the Department of Health and Human Services, said it wasn't a "big concern" for the Trump administration that Novavax had no successful vaccine. After all, that was also true for Moderna, which went on to launch its wildly successful mRNA vaccine.

Operation Warp Speed's personnel resources and financial support would help carry the day. "We thought we could do it," Mango said.

At the time, Trump officials invested in several vaccine platforms to hedge bets because it wasn't known what would work, if any. "We didn't want to put all our eggs in mRNA," he said. "We didn't want to put all our eggs in viral vector," the platform used by Johnson & Johnson and AstraZeneca. Novavax's technology uses a more established process with a baculovirus grown inside insect cells in a bioreactor.

"It was very important to have that array of technologies," Mango said. "We had to pick the ones that had the best early results and the ones we thought could go through clinical trials before the spring of 2021."

Novavax scientists have spent years collaborating with officials at federal agencies such as the National Institutes of Health, National Institute of Standards and Technology, and Walter Reed National Military Center ― sometimes hiring from their ranks. In 2011, Novavax signed a $179 million contract to develop a seasonal and pandemic influenza vaccine with BARDA, the Biomedical Advanced Research and Development Authority.

As concerns about COVID-19 rose, Novavax and BARDA began another negotiation, but Operation Warp Speed officials "stepped over the top," Trizzino said. They asked Novavax what it would take to ramp up large-scale manufacturing, run a 30,000-subject clinical trial and the follow-on trials, and produce millions of doses.

"They said, 'Do all these things in parallel paths. You don't worry about the funding risk. You do the work and we'll pay for those activities,'" Trizzino recalled.

Troubles in Texas

It was a tall order. Novavax had worked with Emergent BioSolutions and signed a contract for manufacturing in early 2020, but BARDA pushed Novavax to partner instead with Fujifilm Diosynth Biotechnologies and its plants in North Carolina, Texas and the U.K.

In retrospect, Trizzino said, Novavax "dodged a bullet." Production problems at Emergent's Baltimore plant led to contamination or suspected contamination of millions of Johnson & Johnson and AstraZeneca doses, and in June federal regulators declared 60 million J&J doses unusable, The New York Times first reported.

Fujifilm's Texas site, like Emergent's plant in Baltimore, was set up in the aftermath of the 2009 H1N1 pandemic to better prepare federal officials for the next one. It received $265 million last July to quickly boost manufacturing capacity, according to a federal contract.

The site began production in January but had to slow the cadence of its manufacturing lines for "troubleshooting" during Novavax's technology transfer process, Fujifilm spokesperson Christine Jackman said. The plant is producing the Novavax vaccine and another undisclosed COVID vaccine.

Trizzino said Fujifilm's site in North Carolina was up and running quickly, but Texas didn't have as much experience so "it's taken us a bit longer to ramp that up." A March inspection by the Food and Drug Administration found overcrowded and unorganized storage areas, a failure to consistently follow cleaning procedures and questions about why there was a backlog of batches, according to documents obtained by KHN in response to a public records request. The backup formed because bulk drug substance was being made faster than the facility could review produced batches, Fujifilm's Jackman said.

FDA inspectors called Fujifilm's operations "sub optimal quality," according to an April response memo written by Gerry Farrell, Fujifilm's chief operating officer for the facility. He said the criticism resonated and promised a thorough review with fixes completed in April and May.

Novavax and Fujifilm work closely to ensure all batches are reviewed and inspected by both companies' quality control teams, said Speak, the Novavax spokesperson. The number of doses produced in Texas to date have not met projections. However, responding to federal inspections in Texas has not delayed Novavax's vaccine development because Fujifilm's North Carolina plant is the primary supplier of vaccine doses for the initial federal approval, Speak said.

Novavax's manufacturing process is complicated because the vaccine is made in steps in different places. One plant makes the protein antigen, and another makes the adjuvant. Then the two components go to a final fill-and-finish facility where they are combined into 10-dose vials.

Its Matrix-M relies on quillaja extract from soapbark trees. The extract is also an additive in root beer and Slurpees. Novavax warned investors in its December 2020 financial filings that an inability to secure enough of the extract could delay production and prevent it from meeting "obligations under our various collaborations and supply agreements." Still, Trizzino said that supply is "not an obstacle to total number of doses."

Supply shortages have plagued the industry. For Novavax, those supplies included 2,000-liter bioreactor bags, used to culture cells; depth filters for the purification process; and the growth media, which is used to feed the cells.

Not having raw materials forced Novavax to trim the number of test batches that manufacturing lines could run. It has also taken longer to create quality control tests, known as assays, to ensure that vaccines are consistent and establish a standard quality for all subsequent batches. Those delays slowed the company's ability to properly train operators, Trizzino said.

Novavax is working to reach "a level of comfort that we're able to produce these batches and then go to full capacity," Trizzino said. Novavax is working to complete the final phases of validating those tests.

Too Late?

At the headquarters event, Glenn acknowledged that Novavax is late to the game. But the global demand is still enormous, he stressed.

"We know that 2 billion people worldwide have received at least one shot," he said, "but there are 6 billion people that need to be inoculated."

The company is working to prove its vaccine will be useful even after the pandemic is contained. With its Matrix-M adjuvant, Novavax is testing a combined flu and COVID vaccine, which is showing strong results in ferrets and hamsters. Novavax is also focused on booster shots.

Novavax joined mix-and-match trials this spring in the U.K. to test whether its vaccine works when paired with Moderna, Pfizer or AstraZeneca's vaccines. Glenn said the results, so far, have been promising that "we're going to be able to use our vaccine after other licensed vaccines."

First, though, "the world has to collectively, as one, really stymie this global pandemic," said Dr. Dawd Siraj, a University of Wisconsin professor specializing in infectious diseases.

Siraj said Novavax's delays shouldn't cast doubt on the quality of the vaccine itself, given the positive trial results it has reported globally.

The shot is a "very good vaccine," he said, that could help turn the tide in developing countries unable to support their own vaccine development.

"Let us never miss the most important point here," Siraj added. "Anyone who is getting a vaccine that is approved, the chances of dying, the chances of requiring ICU care, the chances of requiring a ventilator and high-flow oxygen, they almost disappear."

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

Rachana Pradhan: rpradhan@kff.org, @rachanadixit