- Experts tell Business Insider that a glass vial shortage, as well as cargo restraints, could limit the mass rollout of a coronavirus vaccine.
- The vials are only made by a few companies, and boosting production could prove tricky. "The supply chain for vials is particularly challenging because manufacturing capacity ramp up takes longer, and is capital intensive," says Harvard Medical School lecturer Prashant Yadav.
- While many of world's leading vial manufacturers are up for a challenge, several experts tell Business Insider that several factors including time, demand uncertainty, temperature control, transport, and storage issues could also curb production.
- "The challenge of getting vaccines to the public will depend on the availability of cold storage and aircraft capacity around the world," says Sam Roscoe, senior lecturer in operations management at the University of Sussex.
- Visit Business Insider's homepage for more stories.
Even if scientists find a coronavirus vaccine, we will need a supply of little glass tubes like never before — and experts are worried something could go badly wrong.
Those warning that a glass vial shortage could slow the roll-out of any coronavirus vaccine include Bill Gates, pharmaceutical giant AstraZeneca boss Pascal Soriot, the head of the Coalition for Epidemic Preparedness Innovations, and the director general of drug makers' lobby group IFPMA. Each step of making vials could create a bottleneck, just as we're on the cusp of delivering the vaccine that saves us, they say.
These are not new warnings. Experts said in May that the right glassware could be in short supply — and four months later, little has changed. Instead, concerns are mounting that various parts of the vaccine supply chain, from vials to cold-storage containers to cargo planes, could hamper efforts to distribute the lifesaving jabs.
Vaccine vials aren't standard glass tubes. They require tailor-made production lines, plus a supply of borosilicate glass to keep vaccines in the requisite stable state during storage and transportation. This glass is only made by a handful of companies, such as Corning in the US and Schott in Germany.
"In the long run, we need new technology for vaccine packaging so that we don't rely exclusively on glass vials," says Harvard Medical School lecturer Prashant Yadav, who is also a senior fellow at the Center for Global Development and affiliate professor of technology and operations management at business school INSEAD. "However, our short-to-medium outlook for COVID-19 vaccines has to rely predominantly on glass vials."
Vaccine is siphoned from giant vats into these vials, which each need to be checked for quality. The supply chain also needs specialist stoppers, again only made by a few companies.
The world's leading vial manufacturers are, perhaps unsurprisingly, optimistic. Their joint statement from June was upbeat, if short on details. "We will do everything to support any upcoming COVID-19 vaccine campaigns," said Dietmar Siemssen, chief executive of Gerresheimer AG. Schott chairman Dr Frank Heinricht promised his company would "do our utmost to provide the required containers."
But mere assurances may not quell concerns — especially after similar promises over personal protective equipment (PPE) were broken in many countries. The UK government, for example, repeatedly promised millions of items of PPE would be distributed quickly and efficiently to the frontline, but nurses and doctors were constantly caught short. They found ways to make do — at one point nurses cleaned old gowns with alcohol wipes — but no one can improvise a vial.
Digging into the vial makers' statements doesn't boost confidence. Fabian Stocker, a senior Schott vice-president in charge of global strategy and pharmaceutical systems, spoke of a $1 billion investment plan to boost glass tubing and vial production by an extra seven billion doses — but included the qualifier, "by 2025."
Vial makers are, at least, readying themselves to massively ramp up production for any COVID-19 vaccine. Brendan Mosher, Corning's vice president and general manager of pharmaceutical technologies tells Business Insider it will quadruple production by the end of the year. The US government awarded them $204 million to boost capacity, including to build a new specialist glass furnace.
The Oslo-based Coalition for Epidemic Preparedness Innovations has paid 19.7 million euros ($22 million) to Italy's Stevanato Group for 100 million glass vials that can hold up to two billion doses, while Schott has opened a factory in China to make glass for around 7 billion vials by the end of 2020.
But Harvard's Yadav adds a cautionary note. "The supply chain for vials is particularly challenging because manufacturing capacity ramp up takes longer, and is capital intensive. We know that for products which require long time and significant capital to build capacity, if manufacturers bear the full risk of demand uncertainty, they may under-invest in manufacturing capacity as compared to what society needs."
Vial confidence rests on big assumptions
Even the manufacturers themselves don't fully know what to expect. The size of vials required if giant orders come is one area of uncertainty. Some countries operate vaccination programmes based on single-dose vials (2ml), while others like the US will likely want large vials holding up to 15 doses. Others still may want vaccines in ready-to-use glass syringes.
While manufacturers stress they cope regularly with flexible formats, some concede potential issues. "At this point there is much we still don't know regarding the number of doses required and doses per vial," Corning's Mosher says. Dr Paul Stoffels, chief scientific officer at Johnson and Johnson, was blunter when he spoke to Biopharma Dive in May: "Getting to five or 10 vaccines per vial is probably going to be essential to be able to cope with the volume. The capacity is not there to do it in the billions."
Glass vials aren't the only worry. Sam Roscoe, senior lecturer in operations management at the University of Sussex, and a fellow of the UK Trade Policy Observatory group of experts, tells Business Insider that temperature control is tricky. "Vaccines are highly temperature sensitive — almost all need to be stored and transported between 2 degrees and 8 degrees celcius [36 and 46 degrees fahrenheit] from manufacture to administration.
"This makes the maintenance of a cold chain a key for the COVID-19 vaccination programme. Strategically located cold chain facilities — near major airports or major population centres — will therefore be in high demand."
Read more: There are 176 coronavirus vaccines in the works. Here's how top drugmakers see the race for a cure playing out in 2020 and 2021 and when the first shots might be available.
This transport and storage chain will be complex. "Companies will require cross-docking operations where vaccines can be safely handled and stored between each leg of their journey," Roscoe says. "Currently, warehouse space is being retrofitted to handle high volumes of COVID-19 vaccines, with large freight forwarders opening new temperature-controlled sites."
Vaccines will need to be moved by cargo planes and the air freight industry has hugely scaled back when demand plummeted in lockdown. "The majority of vaccine distribution will therefore need to be by cargo aircraft or in retrofitted passenger planes," he says. "The challenge of getting vaccines to the public will depend on the availability of cold storage and aircraft capacity around the world."
Roscoe says cold-storage shortages at African and Middle Eastern airports could hinder vaccines reaching those regions."The World Health Organization, UNICEF and USAID will have an important role to play in ensuring the current lack of cold storage does not impede the vaccine being distributed around the world," he adds.
Politicians will play their part too — which worries some experts. While nations might form an orderly queue for supplies, a senior Trump administration official told the Washington Post in July: "Our priorities are very clear. Let's take care of Americans first." And when Rick Bright — then head of the Biomedical Advanced Research and Development Authority, the US body overseeing procurement and development of medical countermeasures — filed a report warning about glass vial shortage in May, the Trump administration fired him.
The numbers that key players throw around don't inspire confidence. Schott's Fabian Stocker told Outsourced Pharma that the "worst-case assumption" was the whole world would need 2 billion doses, which seems to be a shortfall on a planet of around 7.5 billion.
Adar Poonawalla, chief executive of the Serum Institute of India, the world's largest vaccine producer, said on September 14 that the world will need 15 billion doses if the COVID-19 vaccine requires two jabs, as measles does. Roscoe says demand could be much higher than expected if there are repeated waves of infections. "Shortages are not likely in the initial wave of vaccinations — but may follow in the second and third round of vaccine distribution."
Yadav agrees. The first phase for people who are high priority might be fine, but "when we get to late 2021 and 2022 and start looking at a global demand of over 10 billion doses — assuming vaccines which require two doses — that's when vial capacity becomes tight."
Source: Read Full Article