Coronavirus (Covid-19) and vaccine production: What are the supply chain weaknesses?

Filed Under: Providers

syringe and vial

The start of the pandemic showed just how fragile medical supply chains can be as the United States saw shortages in basics like personal protective equipment and nasal swabs to administer tests. Now, as the nation enters the next phase – mass vaccination – experts are raising alarm bells at potential shortages of other kinds of supplies.

What is needed to administer the vaccine, and how is the U.S. preparing? Here’s what you need to know.

WHAT SUPPLY CHAIN CHALLENGES PRESENT THEMSELVES GLOBALLY?

The vaccine isn’t just the solution itself: needles, glass vials, shipping materials and other medical supplies like swabs will be needed in high volume  to administer the vaccine quickly to the world population. A representative from the Coalition for Epidemic Preparedness Innovations (CEPI), which is working with the World Health Organization (WHO) on a global vaccine supply initiative, laid out in an email some of the roadblocks and solutions the coalition was exploring:

With billions of doses needed to end the COVID-19 pandemic, this will be the largest global immunisation campaign ever run. We need to ensure that we have sufficient availability of vaccine ingredients, tools, manufacturing materials, and volunteers…

[…]

Very early on into the COVID-19 outbreak, CEPI’s Sustainable Manufacturing Team explored what manufacturing materials and conditions are necessary to rapidly and equitably manufacture billions of doses of eventual COVID-19 vaccine.

We quickly realised that there was a shortage of tubing glass, an essential component to store and deliver vaccines. We talked with every glass producer, including the Italian-based Stevanato Group, a leading producer of pharmaceutical glass containers and integrated provider of drug delivery systems. Stevanato Group were the only group with unlimited glass vial capacity.

[…]

CEPI is also supporting the manufacturing of COVID-19 vaccines through securing other primary packaging components like rubber stoppers and aluminium flip-offs – which act as a lid to a COVID-19 vaccine in a glass vial. These seals must match the specifications of the glass vials that Stevanato Group are producing.

Because of the glass vial shortage, we are also exploring innovative alternatives to glass. We are currently looking into a ‘vaccine delivery bag’, that could be filled with up to 200 doses of a safe and effective vaccine. While our programme of work in this area is in its exploratory phase, if such devices go onto be used to store and distribute vaccine also have an advantage in terms of filling speed and cold-chain footprint [sic].

HOW WILL THE VACCINE BE DISTRIBUTED IN THE UNITED STATES?

States and the federal government are working together to distribute the vaccine based on an  existing framework used to vaccinate children, Kim Martin, director of immunization policy at the Association of State and Territorial Health Officials, said in an interview.

“They’re kind of taking what’s already in place, and kind of just amplifying it,” Martin said.

First, Martin said, providers will enroll with the state health department and confirm they have the correct procedures in place – like cold areas to store the vaccines and record-keeping measures to ensure vaccinations are recorded. Based on this enrollment period and numbers given by providers, states will then order the vaccine from the federal government.

“It will go from CDC to a distribution site, and then to the provider,” Martin said.

The government isn’t just sending doses of vaccines to states – providers are receiving “kits” that include a vaccination card, needle and syringe, and alcohol pad. These kits mean that the federal government is responsible for the bulk of the supply chain associated with administering the vaccine.

HOW IS THE FEDERAL GOVERNMENT PREPARING?

The federal government has made some investments in the vaccine supply chain that have raised eyebrows. In May, the Defense Department granted a company called ApiJect, currently based out of Stamford, Ct.,  a $138 million contract to jumpstart production of prefilled plastic syringes, with the goal of producing “more than 100 million prefilled syringes for distribution across the United States by year-end 2020” with a slated start date of October 2020. In November, the government loaned ApiJect an additional $590 million to construct a “gigafactory” in North Carolina to produce its single-dose disposable plastic injectors, which act as alternatives to traditional glass vials and needles. The new factory is scheduled to open in 2022, according to the ApiJect site.

As part of both contracts, ApiJect has chosen a South Carolina-based company called Ritedose as a subcontractor to help produce the injectors. Ritedose is a major manufacturer of products that use what’s called blow-fill-seal (BFS) technology, used to create sterile single-dose pharmaceutical products. In the summer, ApiJect said it would work to repurpose a Ritedose BFS facility to help fill the government’s May order. “In just a few months, the teams from ApiJect and Ritedose repurposed and upgraded equipment that provides the capacity to fill and finish up to 45 million prefilled syringes per month,” a Ritedose November release reads.

Doses of vaccines are being shipped now without this technology.

We’ve reached out to ApiJect to see if they met the May goal of producing the 100 million prefilled syringes, which vaccine is in the syringe, and if any syringes are currently being sent to states, and will update if they get back to us.

“The commitment to ApiJect dwarfs the other needle orders the government has placed with a major manufacturer and two other small companies,” Frontline reported in July, noting that the company had only produced 1,000 prototypes of its product when it was granted the first contract.

“The fact of this matter is, it would be crazy for people to just rely on us. I would be the first to say it,” ApiJect CEO Jay Walker told PBS in July. “We should be America’s backup at this point, but probably not its primary.”

In August, the government awarded $104 million for the procurement of syringes from existing manufacturers Duopross Meditech Corporation ($48 million), Cardinal Health Inc. ($15 million), Gold Coast Medical Supply, LP ($14 million), HTL STREFA Inc. ($12 million), Quality Impact, Inc. ($9 million), and Medline Industries, Inc. ($6 million). Needle supplier BD said this summer the US government had also placed an order for needles.

The government has also put in an $143 million order for plastic vials from SiO2, an Alabama-based company.

“We went from producing 10 million vials per year to 12 million vials per month,” Lawrence Ganti, SiO2’s Chief Business Officer, told a local outlet in November.

WHAT ABOUT LOCAL SUPPLY CHAINS?

States have some concerns about other points in the supply chain – especially how to transport the vaccine. ASTHO sent a letter to the federal government in October with a breakdown of funding that would be needed to be distributed to states to effectively administer the vaccine – including $1.2 billion needed for transportation and supply chain management for “cold storage.”

The cold storage issue is particularly acute with the Pfizer vaccine, which must be stored at -70°C, an extraordinarily low temperature. The Moderna vaccine will need storage at -20°C, which can be accomplished with easily available freezers that most hospitals already possess.

“If needed, state health departments, in coordination with local health departments, will potentially set up mass vaccination sites,” Martin said – a move that could potentially create additional demand for more supplies.

Transportation needs have already set up unexpected stresses on the supply chain: dry ice manufacturers in various states say that they are being inundated with calls as providers work on solutions to keep the vaccines cold.

“I think there will be a lot of maneuvering as time goes to see adjustments up and down to supply [providers],” Mark Weaver, a dry ice producer in Virginia, told a local news outlet.