As the Covid-19 crisis stretches into its seventh month, researchers around the world are continuing to work frantic hours to develop a vaccine against the coronavirus, which has so far infected 9.5 million people and killed nearly 500,000. More than 140 vaccine candidates are currently in testing, mostly in preliminary stages. A handful have reached early human studies, with three progressing to Phase III clinical trials designed to measure whether or not they confer immunity to the virus.
But the science of producing a safe, broadly effective vaccine is just the first step. Actually exiting the pandemic will require the subsequent manufacturing of the best-performing ones, bottling them up, shipping them around the world, and doling them out to vulnerable populations. In the case of Covid-19, that’s pretty much everybody on the planet, which means making somewhere between 7 and 15 billion doses. (Many vaccines have to be given in two doses—a primer and a boost.) No one has ever tried to do that before. And as these historic efforts to produce an unprecedented number of shots in so short a time are ramping up, vaccine makers say the biggest bottleneck they’re encountering is a cruelly literal one.
“The challenge is not making the vaccine itself, it’s filling vials. There just aren’t enough vials in the world,” Pascal Soriot, the executive director and CEO of AstraZeneca, told reporters in a press briefing last month. AstraZeneca is working with the University of Oxford on one of the front-runners in the Covid-19 vaccine race. But it’s just one of many pharmaceutical firms scrambling to source containers for that critical bottling step. Executives from AG Schott, one of the world’s major medical glass producers, recently told The Wall Street Journal that the company has received requests from vaccine makers for a billion vials—double what it can produce this year.
Medical glass is strong, but it’s still breakable. So manufacturers typically don’t make lots of excess inventory. They make what pharmaceutical companies order. And pharmaceutical companies typically don’t put in those orders until they know they’ve got a vaccine that works, plus distribution contracts in place to provide bulk doses to customers. But nothing about these times is typical. Governments and nonprofits are pumping money into ramping up vaccine manufacturing capacity in parallel with clinical testing so that individual companies don’t have to assume so much risk for paying for trials and production themselves. They’re also experimenting with nanotechnology borrowed from the semiconductor industry to make an end run around traditional forms of glass.
In the US, this concerted effort has been dubbed Operation Warp Speed. The US government’s Biomedical Advanced Research and Development Authority, or Barda, has so far invested approximately $2.2 billion in Covid-19 vaccine makers, including AstraZeneca, Johnson & Johnson, and Moderna Therapeutics, according to the agency’s portfolio. In partnership with the National Institutes of Health, these companies are planning to start Phase III trials this summer. Their goal is to not have a long gap between the time they prove that a vaccine works and when they can start making it available to lots of people.
Avoiding a scenario in which an effective vaccine gets rationed to a chosen few also means overcoming the glass bottle shortage. The issue was on the US government’s radar early on in the pandemic, according to a 60-page whistleblower complaint filed by Rick Bright, the former director of Barda who was abruptly ousted from his post in April. In it, Bright claimed that between January and March he repeatedly and unsuccessfully urged administration officials to secure supplies needed for a mass immunization campaign, including needles, syringes, and glass vials.