A volunteer receives an experimental coronavirus vaccination in a clinical trial at the University of Maryland's medical school.
  • More than 100 teams around the globe are racing to find a vaccine for the coronavirus, with a handful conducting human trials.
  • But even when a vaccine gets approved, an immediate global rollout still looks unlikely, due to a shortage of the glass vials needed to store it.
  • People on the front lines of coronavirus vaccine research, like Bill Gates, Dr. Rick Bright, and Professor John Bell of the University of Oxford, have already sounded alarms of a vial shortage.
  • Business Insider spoke to four experts who warned that the vial supply chain is straining, and will affect the release of a coronavirus vaccine.
  • For more stories go to www.BusinessInsider.co.za.

At this moment, more than 100 coronavirus vaccines are being developed at breakneck speed in labs around the world, with a handful eagerly awaiting early readouts from human trials.

But when a vaccine is approved - which looks to be September at the earliest - manufacturers will struggle to source enough glass vials to bottle enough for a global immunisation drive, experts say.

If this happens, Covid-19 will continue to infect people around the world - even while a vaccine exists - because of delays not in science, but the manufacturing supply chain.

A researcher works on a coronavirus vaccine at the University of Copenhagen's research lab on March 23, 2020.
Getty
Vaccine vials are shaped from specialised glass - suppliers like ThermoFisher Scientific and Schott trademark their glassware - and tend to house between 2 ml and 100 ml of liquid. They measure, on average, 45 mm tall by 11.5 mm wide.

They have to withstand cold temperatures, and survive the wear and tear of being transported around the world.

The process of bottling vaccines is known in the industry as "fill-and-finish," and is invariably the main reason for vaccine delays.

It's an arduous process, where machines siphon fluid into millions of vials and syringes before each one is hand-checked for quality.

And to produce nearly 8 billion doses of a vaccine - one for each person in the world - is no mean feat, especially when there may not be enough vials for everyone.

"Quite clearly there will be a need to ramp up production of those vials," Professor Jeffrey Almond, a former vice president of research at Sanofi and current fellow at the University of Oxford's pathology department, told Business Insider.

"I'd be amazed if the people who are producing these things aren't already on it flat out, going at it all night long," he added.

Warnings pile up

In a whistleblower complaint publicly released Tuesday, Dr. Rick Bright - who was recently fired as the head of the US Biomedical Advanced Research and Development Authority (BARDA) - said he had warned the Department of Health and Human Services of a "critical shortage" of glass vials.

"It could take up to two years to produce enough vials for US vaccine needs," Bright said, according to the complaint.

And on April 30, Sir John Bell, Regius Professor of Medicine at the University of Oxford, told the BBC's "Today" radio program: "There's only 200 million vials left in the world now because they've all been sucked up by various people who can anticipate a vaccine."

Bell works with the Oxford Vaccine Group, whose vaccine is currently undergoing human trials.

The director of the UK's Wellcome Trust, Sir Jeremy Farrar, also told Channel 4 News this week: "There's apparently a glass shortage at the moment. So if the vaccine has to be put into glass vials, we need to make sure we have that available."

And Bill Gates, whose foundation has poured hundreds of millions of dollars into coronavirus vaccine research, told "The Ezra Klein Show" in late April: "Even the bottles, the fill-finish... the world doesn't have enough of that."

The first human trial of the Oxford Vaccine Group's ChAdOx1 nCoV-19 experimental vaccine.
YouTube/University of Oxford
Other vaccine development groups include pharmaceuticals company Janssen, a division of Johnson & Johnson, which told Business Insider it plans to "provide a global supply of more than one billion vaccine doses." It hopes to fit five doses in a single vial to save glass, The New York Times reported.

J&J has declined to say how many glass vials it had access to. But James Robinson, vice president of the Coalition for Epidemic Preparedness Innovations (CEPI), told FiveThirtyEight last month Janssen had preordered 250 million vials.

"That might be all that's out there," Robinson said, adding that CEPI - which finances vaccine research - is hurrying to source 200 million vials itself.

The vial shortage could hold up a global vaccine release

It's not clear how many glass vials exist in the world, because there is no central authority.

In the US, vaccine makers are obligated to notify the the Food and Drug Administration (FDA) about any material shortages.

However, the FDA told Business Insider that "manufacturers of glass vials are not."

Meanwhile, the UK Vaccine Network, a government-mandated expert group, has warned that fill-and-finish is often the cause of delays in the production of vaccines.

"Identifying a suitable fill finish site could be a bottleneck that adds delays to the manufacturing process," it has said. "Finding a suitable production slot within the site's production calendar can also become limiting."

A researcher works on virus replication to develop a vaccine against the coronavirus COVID-19, in Belo Horizonte, Brazil, on March 26, 2020.
Getty
Vijay Samant, former head of vaccine manufacturing at Merck, told The New York Times: "The manufacturing task is insurmountable. I get sleepless nights thinking about it."

Business Insider asked the big-four vaccine manufacturers - GlaxoSmithKline, Merck, Sanofi, and Pfizer - to outline their supplies of glass vials. The quartet are responsible for around 90% of all the world's vaccines.

GSK told Business Insider: "We continue to work closely with suppliers, including of glass vials, in respect of current and future needs."

Merck, Sanofi, and Pfizer did not respond to requests for comment.

'The critical weak link in this whole supply chain'

Glass vials are extremely hard and time-consuming to make.

"They take months to manufacture and the world has only created a capacity for what it uses for everyday treatments, so there is no surge capacity," Marc Koska, the inventor of a self-destructing syringe that helped reduce HIV transmission, told watch company Bremont, for which he is an ambassador.

"If we went to China now, or indeed anywhere in the world, to ask for a billion glass vials to inject everyone in Europe twice, it would be many months or years before we got supply. That has become the critical weak link in this whole supply chain."

Vial makers will have to work relentlessly to boost production, said Prashant Yadav, a healthcare supply chain expert at the Center for Global Development.

"For workers on the fill-and-finish line, companies will have to incentive all these peoples to work their lives the same way as the scientists, 20 hours a day to make more vials and increase capacity," he told Business Insider.

How often and how much people need to get vaccinated will also affect supply chains

Whether the vaccine is bottled in multi-dose vials, which can house from two to 20 doses, or single-use vials - which house just one dose - will impact vial stocks too.

Multi-dose vials are more economical than single-use vials in terms of glass per dose and other production costs. But singles are necessary for pharmacies and drugstores to vaccinate people who miss an initial mass vaccination drive.

"Logically, you're going to put it in multi-dose vials. Getting into individual syringes is a hell of a job, much slower, [and] would put huge demand on pack-and-fill facilities," Almond told Business Insider.

Dose sizes will also affect the demand for vials.

Yadav, the supply chain expert, told Business Insider: "The extent of the shortage will depend on what type of vaccine comes out, as multi-dose vials will mean less of an issue."

"But, if you open a vial, and you don't have enough patients, that vaccine is wasted."

He added of efforts to address the shortage: "We don't know if vial makers, which is a concentrated market, have received clear signals of what to expect from distributors."

Single- vs double-dose?

Another key factor distributors need to consider is the fact that people may need to vaccinate themselves more than once to boost their immunity against Covid-19.

"It's also likely that annual boosters may be needed," Robin Shatlock, head of Mucosal Infection and Immunity at Imperial College London, told Business Insider.

A volunteer receives an experimental coronavirus vaccination in a clinical trial at the University of Maryland's medical school.
University of Maryland

Almond, the former Sanofi VP, said it's more likely that a double-dose vaccine - two smaller doses taken separately - will be needed, which means using more glass per dose.

"Be prepared on the two-shot route to risk even more shortages," he said. "The probability is that it is going to be significantly better with two doses than one. If you have a dose and then another dose, say, two months later, you boost your response."

It's not yet clear whether a single- or double-dose coronavirus vaccine will best immunise people against Covid-19. Labs that are doing human trials, like Pfizer and the Oxford Vaccine Group, are still expecting early results.

Dr Paul F. McKay, a senior infectious-diseases researcher at Imperial College London, told Business Insider: "My personal opinion is to get as many doses to the public as quickly as possible, and if that requires multi-dose vials, then that's what we should do."

Glass vials are still needed to produce vaccines for other diseases

While the coronavirus is indisputably the most pressing heath issue in the world, the constant supply of other key vaccines - like meningitis, influenza, and typhoid - must be maintained.

"The vaccines industry is used to producing hundreds of millions of doses of flu vaccines every year, and hundreds of millions of other vaccines," Almond told Business Insider.

"The materials and the facilities are there but, of course, you don't want to distort things by stopping doing all those things. Otherwise you're going to have to a whole load of deaths in kids who don't get the proper vaccines."

The current outbreak of "Covid-19 on top of all that creates some logistical issues and probably some supply problems as well," he said.

Cardinal Health, a US vial manufacturer, also told The New York Times that the pandemic is creating supply-chain issues like "delays in inventory replenishment for certain products."

GAVI, the vaccine alliance, told Business Insider it is "working with partners" to ensure a vaccine "can be made available to countries as soon as possible," but did not comment on global levels of vials.

The Oxford Vaccine Group declined to comment on distribution and manufacturing.

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