Drugmakers are racing to develop a vaccine for the Covid-19 virus – a complex feat in itself – but what might be even trickier is getting it to the public.
The quest to combat a deadly pandemic is exposing bottlenecks in the pharmaceutical supply chain. The world has neither enough glass vials to house the vaccine nor the facility capacity to fill and package them, experts say.
“The demand is going to far outstrip the supply,” Vijay Kumar, an Evercore analyst who focuses on the medical device and life sciences sectors, told CNN Business in an interview.
The Covid-19 pandemic has consistently shown what happens when supply chains are blindsided by spikes and drop-offs in demand and how an unexpected bottleneck can affect the integrity of the entire system.
The US is coming up short in acquiring “basic but critical” supplies to administer a coronavirus vaccine, said Rick Bright, the former director of the Biomedical Advanced Research and Development Authority, in his whistleblower complaint in May.
He said that Strategic National Stockpile has only 2% of the 650 million to 850 million needles and syringes needed and that officials aren’t addressing the global shortage of glass vials.
“It could take up to two years to produce enough vials for US vaccine needs, while some therapeutics will also require vials,” Bright said, according to the complaint.
Using the entire current inventory of vials for a Covid-19 vaccine isn’t reasonable because it would create supply woes for ongoing needs such as the annual flu and kids’ vaccinations, Evercore’s Kumar said.
The pharmaceutical industry started Covid-19 in a tight spot from a packaging perspective, as a medical glass shortage was just starting to even out, he said.
Medical glass isn’t made from your typical beach sand, and the vials aren’t your everyday soda-lime glass found in many household items.
Medical vials are traditionally made with borosilicate glass, which is highly resistant to extreme temperatures changes and more chemically durable than commercial glass. It has been shown to preserve vaccine potency and pH stability. That’s important in making sure that a vaccine does what it’s supposed to.
But supplies of the glass have been impacted by shortages in silica sand, the highly pure quartz sand that is the standard raw material used in glass-making, Kumar wrote in an April 26 research note.
“Glass shortage stems from sand shortage: There are [fewer than] 1,000 sand mines in the US,” Kumar and Evercore colleagues wrote in an April 26 research note. “Desert sand is too smooth to use for glass; most [quartz] sand comes from rivers, and mining it can have ecological and infrastructure consequences.”
In recent days, spigots of government funding have been turned on to increase the numbers of vials in the Covid-19 vaccine supply chain and invest in alternative vaccine packaging. Glassmaker Corning (GLW) received a $204 million federal contract on Tuesday to ramp up production of its glass vials. And privately-held SiO2 Materials received a $143 million contract Wednesday to increase production of its hybrid containers that use a medical-grade plastic wrapped around a glass-like lining that is 50 times thinner than a human hair, said Lawrence Ganti, its chief business officer.
Pharmaceutical firms are exploring and devising workarounds that include packing a few doses into larger vials versus single-dose vials. The move saves on bottles, but it drastically raises the chances of the vaccine going to waste, said Prashant Yadav, a healthcare supply chain expert and senior fellow at the Center for Global Development.
Multiple dose vials could also raise health risks if they’re used improperly, notably via reuse of needles, said Jay Walker, said chief executive officer and chairman of ApiJect Systems, which makes pre-filled syringes.
ApiJect, a public benefit corporation, has been one of the companies tapped in recent weeks to help address potential supply chain challenges – notably the vial shortage as well as the capacity constraints in filling and packaging the vials. The process is complex in nature, costly, and takes time to build because it requires precision and regulatory scrutiny to ensure quality and safety.
In March, ApiJect was awarded $10 million by the US Department of Health and Human Services, out of an authorized total of $456 million, in addition to a more recent award of $138 million from the US Department of Defense to research, develop and produce more than 100 million of the pre-filled syringes by year’s end. The syringes are made via a manufacturing process in which sterile plastic containers are created, filled and sealed in a matter of seconds. ApiJect’s system is expected to produce about 500 of the pre-filled syringes every minute.
The product serves as an alternative to traditional glass vials for vaccine distribution.
The money will also go toward the retrofitting of existing manufacturing facilities with a goal of producing more than 500 million of the pre-filled syringes in 2021. By 2022, the goal is to have a production capacity of 330 million finished units per month, an HHS spokesperson told CNN Business.
“We’re part of the answer, but we’re not the whole answer,” ApiJect’s Walker said.
Update: This article has been updated to include how much money from the federal award ApiJect has received.