Coronavirus vaccine rollout could be delayed due to glass vial shortage
It could take up to two years to produce enough vials for US vaccine needs, one expert warned.
By DONNA RACHEL EDMUNDSAn employee of German biopharmaceutical company CureVac, demonstrates research workflow on a vaccine for the coronavirus (COVID-19) disease at a laboratory in Tuebingen, Germany(photo credit: REUTERS/ANDREAS GEBERT)
As scientists around the world race to develop a vaccine for COVID-19, experts are warning that distribution of that vaccine may be delayed when it does become available due to a global shortage of one component: the glass vials needed to distribute it in.So far more than 100 potential vaccines are in development, with at least eleven having already progressed to human trials. But while researchers hope that a vaccine may be approved as early as September and have calling for millions of doses to be manufactured in advance to get the vaccine out globally as quickly as possible, an American official has said that it could take up to two years to manufacture enough vials merely to cover demand in the United States alone.A whistleblower complaint by Dr. Rick Bright, who was fired as head of the US Biomedical Advanced Research and Development Authority (BARDA) earlier this year, detailed that he had warned the US Department of Health and Human Services of critical shortages of materials in the supply chain, including the vials.Bright discussed with officials "his growing alarm about the shortage of syringes, needles and vials necessary to administer vaccines if and when one became available," the complaint reported.It also detailed that Bright had "raised concerns about a global shortage of glass vials that are required for vaccine production. According to major glass producers, all major pharmaceutical tubing suppliers are sold out of borosilicate tubing. It could take up to two years to produce enough vials for US vaccine needs, while some therapeutics will also require vials."Bright's warnings have been echoed by other experts working in the field.Speaking to the BBC Radio 4's flagship 'Today' program, Sir John Bell, Regius Professor of Medicine at the University of Oxford said: "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 is part of the Oxford Vaccine Group, one of the teams already embarking on human trials of a vaccine. And in late April, Bill Gates told the Ezra Klein Show: "Even the bottles, the fill-finish... the world doesn't have enough of that," Business Insider reported. Manufacture of the vials is a specialist process as the glass needs to be able to withstand extremes of temperatures and withstand transportation. Consequently, only a handful of companies currently supplying the market. In addition, the process of filling the vials with the vaccine, known as 'pack-and-fill,' is a time consuming process as each one must be hand-checked for quality control, meaning that this stage in the manufacture is often responsible for delays in supply.
But the process cannot be rushed if standards are to be maintained. The glass market is therefore fairly inflexible."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," inventor Marc Koska 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."In an online press conference organized by PhRMA last week, Genentech CEO Alexander Hardy explained that he was calling on the government to take steps to cover the gap."We're really dependent on this supply chain to remain free and available," he said. "I intersperse my day, in between helping my kids with their homework, with calls to legislators and policymakers because this supply chain topic is really a critical one right now."BARDA has already announced $204 million for 164 million extra vials to be produced by Corning annually, and has invested a further $143 million in Sio2 Materials Science to increase production capacity for glass-coded plastic containers, ABC News reported.Meanwhile, vial manufacturers are also working on ways to conserve glass. Schott AG, the world's largest producer of specialized glass, has told Reuters that it is waiting to see which vaccine emerges as the likeliest candidate for global dispersion before committing its stock, while Janssen, a division of Johnson & Johnson, hopes to fit five doses of the vaccine inside a single vial to save glass. The company has ambitions to "provide a global supply of more than one billion vaccine doses," it told Business Insider.Placing the vaccine inside larger vials, some of which can hold up to 20 doses, also reduces the time-frame for pack-and-fill. But single-dose vials will still be required for those who miss a vaccine drive."There's definitely a role for us to be talking about post-pandemic how we can make supply chains more resilient, reduce dependencies on particular countries, but right now we need to make sure these supply chains are open and working effectively," Hardy said.
