How the US hopes to avoid bottlenecks in much-needed vaccine supplies

The first shipments of Covid-19 vaccines could be just days away, as the Pfizer/BioNTech and Moderna shots await regulatory approval. Within 24 hours of the Food and Drug Administration’s go-ahead, either of these vaccines could begin shipping throughout the US in weeks, if not days.

The vaccines’ successful journey from the pharmaceutical companies’ manufacturers to Americans’ immune systems will require more than just the vaccine itself. The inoculation of more than 300 million people in the United States will require everything from glass vials to syringes to sophisticated cooling systems. But since this summer, there has been fear that the production of these supplies won’t have ramped up enough by the time a viable vaccine is ready for distribution.

These worries aren’t unfounded. The early months of the pandemic saw strained supply chains and a slew of shortages. There was a massive manufacturing effort to boost the number of ventilators, and a logistical gridlock over personal protective equipment like N-95 masks. Testing has been delayed in recent months because there aren’t enough chemical reagents.

Now, the imminent arrival of Covid-19 vaccines brings with it a whole new round of supply chain worries. The groups that represent the links in the supply chain for vaccine production — drug companies, pharmaceutical supplies manufacturers, government agencies — have had months to prepare. Their overall attitude seems to be one of cautious confidence. Many of these companies say they’ve produced enough of the materials needed for the beginning of a mass vaccination campaign.

But that doesn’t mean they’ll have enough in the future. Some initial projects for vaccine production are already being reduced due to delays in securing enough raw material: Pfizer announced it will ship only half the vaccine supply it planned to distribute this year, though it expects to still make a billion doses available next year.

Meanwhile, the hardware components are coming together. Production of freezer systems to distribute vaccines is ramping up, and companies that produce pharmaceutical glass for vials have spent the summer preparing their production lines. The US government has also brought on the medical supply company McKesson to assemble handy vaccination kits filled with materials like syringes and needles.

Suppliers and experts told Recode that while distributing Covid-19 vaccines will take a significant amount of coordination, we shouldn’t expect widespread shortages of any needed materials — if everything goes as planned. The vaccines from both Pfizer/BioNTech and Moderna require two shots given weeks apart, which is certain to make the logistics even more complicated. And underlying the whole effort is a fear of waste and the idea that precious vaccine doses could go bad due to logistical failures.

“The most important question that countries have to ask themselves is where will this go wrong?” said Glyn Hughes, the global head of cargo at the International Air Transport Association. “If it goes wrong, and a vaccine is effectively no longer usable, that’s potentially a life that’s at stake.”

Then there’s the question of how willing to take a vaccine Americans will be. A November Gallup poll found that 58 percent of Americans would get a Covid-19 vaccine, up from 50 percent in September. If enough people are willing to get inoculated and health care facilities have enough supplies and coordination to inoculate them, the effective end of the pandemic in the US could be months away, not years.

A leading vaccine must be kept very, very cold

The Pfizer/BioNTech vaccine will likely be the first to receive emergency use authorization from the Food and Drug Administration, and Moderna is expected to be next. While Moderna’s vaccine can be kept in a regular refrigerator for up to a month, the Pfizer vaccine has to be stored at around minus 70 degrees Celsius, a fact that creates some major challenges for distribution.

For shipping and short-term storage, Pfizer has built packaging equipped with a cooling system that can keep the vaccine cold for up to 30 days if it’s refilled with dry ice every five days. This system also includes a GPS-enabled thermal sensor to track the location and temperature of the shipment. The Pfizer vaccine can also be stored in ultra-low-temperature freezers for up to six months.

Companies that supply such freezers have been working hard to meet the surge in demand. While many hospitals already have ultra-cold freezers, they’re typically used for other medical purposes, which means that hospitals need more. “Right now, we are out of everything,” an executive of So-Low Environmental Equipment, one of the makers of these freezers, told CNBC in November.

Alex Esmon of Thermo Fisher Scientific, which also makes ultra-low-temperature freezers, told Recode that the company started preparing for a surge in demand earlier this year and that orders have grown at least two-fold since then. He points out that thousands of doses can be stored in a relatively small freezer, which means that health care facilities can calibrate what cooling supplies they need based on how many people they expect to inoculate in a given time period.

“It doesn’t necessarily require a huge build-out,” Esmon explained. “It requires the right build-out based on what each clinic and hospital system determines is going to be their need.”

And then there’s the need for dry ice, both for Pfizer’s custom vaccine packaging and for other types of freezers that rely on the material. Dry ice companies have expressed some caution about the supply of carbon dioxide that they rely on, as there was a shortage of the compound earlier this year. While some of these providers say they’re fine for now, they don’t know what will happen once a vaccine receives authorization, but they anticipate a surge in demand.

“Right now we have a great supply chain of CO2, which is beautiful for us because we haven’t let down any of our customers in the last six months,” Marc Savenor, the CEO of the company Acme Dry Ice, told Recode. He added that his company is already hearing from transportation and pharmaceutics companies for advance orders.

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Still, the unique temperature needs of the Pfizer vaccine necessitates some thinking ahead from facilities that will distribute it. The cooling requirements could make it harder to distribute in rural areas, and even some hospitals don’t yet have enough infrastructure to keep it cold.

Those planning to distribute the Pfizer vaccine have to decide between investing in ultra-low-temperature freezers, or buying lots and lots of dry ice, according to Jessica Daley, a supply chain expert at the health care supplier Premier. And as health care facilities consider the requirements of the first vaccine available, there are likely others down the line that will have different needs.

A Covid-19 vaccine means glass vials — and new alternatives

Anticipation of a vaccine has also boosted demand for pharmaceutical glass to make vials that will hold and protect doses while they’re being transported and stored. Vials are important because they allow for the shipment of multiple shots of a vaccine in the same container. These vials can’t be too big, because once they’re opened, the vaccine inside can spoil quickly. So we need a lot of vials.

Over the summer, there was enough concern about a shortage of vials that the German company Schott, the world’s largest producer of pharmaceutical glass, denied requests from drugmakers to reserve its borosilicate glass in advance. (Borosilicate is a type of glass that can protect the vaccine from contamination — like tiny glass particles — and high temperatures.) Schott says it made three out of every four glass vials used in all three stages of vaccine trials, and in preparation for a vaccine, the company aims to produce enough vials for 2 billion vaccinations. The Italian firm Stevanato Group, which also aims to produce enough glass for 2 billion doses, and the German company Gerrescheimer, have also committed to supplying pharmaceutical glass for vaccine containers.

US companies are also producing alternatives as protection against bottlenecks. For several years, the New York-based glass manufacturer Corning has been working on a novel type of pharmaceutical glass, but the pandemic has given the novel material new promise. Valor Glass is supposed to be stronger than borosilicate glass, and less likely to produce cracks that can affect the sterility of a vaccine dose. (Corning also produces borosilicate glass tubing as well as Gorilla Glass, which is used for smartphone screens.)

In June, Corning received a $200 million contract from the US government to expand production of Valor Glass. The company now plans to produce an extra 164 million vials annually by the end of 2021, which would be 10 times what it produced before the pandemic, according to Brendan Mosher, the vice president and general manager of Corning’s pharmaceutical glass business.

Another alternative is from SiO2 Materials Science, which makes medical-grade containers out of plastic that have a very thin coating of pure silica, the primary ingredient in most glass. The material can withstand incredibly cold temperatures, is lighter than traditional glass, and is less likely to break, SiO2’s chief business officer Lawrence Ganti told Recode. These high-tech vials are already being used by Moderna and other companies that make Covid-19 treatments. A $143 million contract with the federal government helped SiO2 Materials Science add more than 100 additional employees, and Ganti says the company will be producing vials for about 200 million doses every month by 2021.

Vaccines require lots of syringes and needles

When vials full of doses are delivered to and unpackaged at their facilities, health care workers will use needles and syringes to remove the dose from the container and inject the vaccine into patients. Across the US and the world, this will require an incredible number of syringes and needles.

Over the summer, Trump administration trade and manufacturing policy director Peter Navarro warned that it could take up to two years to manufacture enough syringes and needles to distribute a coronavirus vaccine nationwide. In a whistleblower complaint, vaccine expert Rick Bright also warned that the Strategic National Stockpile only had 15 million syringes and later urged members of Congress to boost the government’s supply. The country, the experts said, would need hundreds of millions of needles.

The government has ramped up the production of syringes and needles in the intervening months. The Department of Defense has spent $100 million to secure more syringes and safety needles in a deal meant to provide over 500 million safety syringes within a year to the Strategic National Stockpile. The federal government also loaned nearly $600 million to a Connecticut-based company called ApiJect, which produces pre-filled syringes that serve as an alternative to the standard methods of injection. This particular device hasn’t been used before — a fact that has prompted some confusion and concern, especially since the device has yet to be approved by the FDA.

Meanwhile, health care supplier McKesson has been charged by the federal government with assembling vaccine kits, which include needles and syringes, for both the Pfizer and Moderna vaccines on behalf of the Strategic National Stockpile. The government is also working with Becton, Dickinson, and Company, also known as BD, which is one of the world’s largest producers of syringes and needles. BD aims to supply the government with 286 million syringes by early spring, many of which will be sent to McKesson to be included in the US supply of vaccine kits.

“This is a wonderful solution for providers because all of those little things that, like you said, you don’t often think about — the alcohol wipes, the Band-Aids, the syringes, the needles — those things will be provided in those kits,” Daley, the supply chain expert at Premier, told Recode, adding that they don’t anticipate a shortage of syringes.

Still, BD has also warned buyers not to stockpile or buy more than they need, and that health care providers planning to distribute the Covid-19 vaccine should not order injection devices on their own. But the company’s senior vice president for public affairs, Elizabeth Woody, expressed confidence in the plans, saying that the company felt prepared for the pandemic in part because of its experience with the H1N1 outbreak.

“We got a flavor of what might be required at a time like this,” Woody told Recode. “Since the start of the Covid pandemic, we’ve been working around the clock, discussing our needs with governments across the globe, and really running our needle and syringe production lines 24/7.”

The task of distributing vaccines to hundreds of millions of people is daunting

Taking all of the needed materials into account — freezers, glass vials, syringes, needles — there’s still a lot of anxiety around making sure that the vaccine ends up in the right place at the right time. No one wants vaccine doses to go to waste.

While Pfizer will distribute its own vaccine, McKesson will handle the distribution of the vaccine from Moderna once it’s approved. But there are other key players that are preparing for their role in vaccine distribution. Airlines are bracing to start moving the vaccine, even turning to passenger planes that have been grounded by low demand during the pandemic. Shippers like FedEx, UPS, and DHL are all preparing for deliveries, and some are boosting freezer storage while also balancing the demands of holiday season online shopping.

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Once the vaccine arrives, there’s another hurdle before injection. Depending on their area and resources, local health facilities could vary widely in their ability to get vaccines to patients.

“My concern is there may not be enough storage capacity or staff to be able to vaccinate at the desired rate,” Northwestern professor Hani Mahmassani told Recode. “There’s a myriad of little things that can go wrong at that level, and you may not have the health care infrastructure to deliver.”

The second dose also presents unique challenges: Vaccine distributors injecting patients with the Pfizer or Moderna vaccine need to be meticulous about which patients receive which vaccine, and keep track of who needs a booster shot just a few weeks later. Meditech, one prominent provider of electronic health records in the US, is working on providing a certificate to patients as they receive the first and second dose, for instance. US health officials have also said that people who get vaccinated will receive “vaccine cards,” harking back to the idea of immunity passports discussed earlier this year.

But that means that even if all the supply chains for delivering vaccines and supplies hold up, the greatest challenge will still be logistical: getting the right people to show up and receive the vaccine — and a necessary booster — at the right time. For health care facilities, that will mean a high level of coordination and meticulous tracking. There’s understandable fear that that might be a far-fetched goal, too. Nearly a year into the pandemic, Covid-19 testing is still crippled by long lines, delays, and confusion.

Even if the supply chain holds and the distribution of the vaccine goes off without a hitch, the public has to be willing to take the vaccine and get their booster shots in the right time frame. Large numbers of people need to be inoculated for the US population to reach herd immunity.

“If only 40 percent of the population gets vaccinated, this thing will not disappear,” said Hughes, the air cargo expert at IATA. Otherwise, he added, the vaccine is “a bit like a fire break when you have a wildfire.” It might slow the spread, but it won’t save the forest.

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