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Race for vaccine faces daunting distribution challenges

Race for vaccine faces daunting distribution challenges
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Even as the country eagerly awaits a coronavirus vaccine, the development of a vaccine itself is only half the battle.

There are daunting challenges in making sure the U.S. has the millions of vials, needles and syringes needed to administer a vaccine nationwide, and some experts warn the Trump administration is not doing enough to lay the logistical groundwork.

If production is not ramped up sufficiently, the country risks a repeat of the supply shortages that have plagued widespread COVID-19 testing, meaning more people would be waiting longer to get a vaccine even after it’s proven to work.

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The left-leaning Center for American Progress (CAP) released a report this week on the myriad needs for manufacturing and distributing a coronavirus vaccine, highlighting everything from the need for enough equipment to make the vaccines to the complex prioritization of which groups should get the first doses.

“A massive coordinated effort is needed and there is little evidence that the Trump administration is adequately preparing now,” the report stated.

Trump officials have started preparing by entering into contracts with a range of companies for vials, needles and syringes. But there are questions about whether the orders will be enough to meet demand, in addition to concerns about the reliability of some of the technologies and businesses securing government contracts.

Timing and capacity will also play key roles.

Prashant Yadav, a health care supply chain expert at the Center for Global Development, said some vaccine supply production can be ramped up by getting more out of existing production lines, but major manufacturing capacity increases will take eight to 12 months.

If a vaccine is ready by the end of the year, “then we would not have sufficient vials, we would not have sufficient syringes, essentially all of the things for meeting a significant cohort of the U.S. demand,” he said.

Yadav noted that it also takes time to manufacture the vaccine doses and administer it at sites across the country, “so it’s a question of which will be a bigger bottleneck.”

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The U.S. could need roughly 700 million needles and syringes, given the likelihood that people will each need two doses of the vaccine.

The Trump administration has put in $110 million for orders for 320 million needles and syringes from two companies, Retractable Technologies and Marathon Medical.

There is an additional government order for 190 million needles and syringes before the end of the year, from Becton Dickinson (BD), the company said.

On top of that, the government has placed an order with a company called ApiJect to produce 100 million devices that combine a needle, vial and syringe all in one. The goal is to fill that order by the end of the year, followed by 500 million more in 2021.

But there are questions about the reliability of some of these companies. The Associated Press reported earlier this month that Retractable Technologies is doing about 80 percent of its manufacturing in China, and the Center for American Progress report found that its current capacity is only about 40 million needles and syringes per year.

The AP also reported that Marathon Medical, a medical supply distributor, has no experience with manufacturing.

The ApiJect technology, meanwhile, is a new product that has never been used on a large scale for a vaccine before. 

BD is a more established company.

“We are very concerned that the government engaged with BD pretty late in the game and it’s unclear even now that enough capacity has been lined up,” said Topher Spiro, one of the authors of the CAP report, which called for additional funding and using the powers of the Defense Production Act to expand manufacturing capacity for vaccine supplies.

Elizabeth Woody, vice president of public affairs at BD, said in an interview that the company has the ability to produce more needles and syringes than have been ordered already, and remains in “ongoing conversations” with the Trump administration.

“We have signaled to them that we can do more than what we’ve committed to so far, and like I said, we're continuing the conversations with them to make sure we're prepared to support any additional volumes they would need from us,” Woody said.

“They definitely signaled to us that additional orders could come well into 2021,” she added.

Asked about the preparations for vaccine supplies, a Department of Health and Human Services spokesperson listed the range of orders the department has placed, and said, “Awarding these contracts now helps ensure adequate [amounts of] these supplies are available when vaccine doses become available.”

“It’s important to keep in mind that when a safe, effective vaccine becomes available, doses will be manufactured over a period of time, so ancillary supplies will be needed over time rather than all on day one, which aids ancillary supply manufacturers in meeting the need,” the spokesperson added.

The spokesperson did not respond when asked if the department is confident there will be enough supplies by the end of the year and if it is confident in the track records of the companies that were awarded contracts.

Aside from needles and syringes, there is widespread concern about a shortage of glass vials.

Rick Bright, the former Trump administration vaccine official who filed a whistleblower complaint in part saying his warnings about supply shortages went unheeded, stated in his complaint that there is a “critical shortage” of glass vials, and that “it could take up to two years to produce enough vials for U.S. vaccine needs.”

The Trump administration has tried to get around this shortage by pursuing new technologies, such as the plastic pre-filled syringes from ApiJect and plastic containers with a glass coating from a company called SiO2.

The CAP report, though, warned that these alternative technologies are “unproven.”

“More oversight over progress in developing these new technologies is urgently needed,” the report stated.

Lawrence Ganti, president of customer operations for SiO2, said the company is “working like crazy” to scale up production of its vaccine containers. Each of the company’s vials holds 10 doses of vaccine, and Ganti said the company hit its target of manufacturing 4 million vials in June, enough for 40 million doses. By December, the company plans to be making 13 million vials per month, he said.

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“If they gave us more money, yes we could make more,” Ganti said of the Trump administration, but added: “I think they’re doing a pretty good job of hedging their bets” by awarding money to multiple companies.

Corning, which makes more traditional glass vials, said it is looking to increase its capacity by three to four times by the end of the year, and 10 times over the next three years, with the help of government funding, though it declined to reveal its current capacity.

A spokeswoman for West Pharmaceutical Services, which makes the stoppers for vials, said it is ramping up capacity, but declined to say how many stoppers it’s capable of making now.

Increased government spending, experts say, could guard against slow distribution down the line.

“You really need to over-invest in this situation,” Awi Federgruen, a supply chain expert at Columbia Business School, said of planning for vaccine supplies. “The extra investment costs in this area pale against the cost of having to delay the distribution of vaccines for another three, four months.”