Chasing a virus, glass shortages, and cold storage: 4 top execs leading the coronavirus vaccine race reveal how they're tackling the greatest challenges standing in their way
A coronavirus vaccine faces several major challenges to actually end the pandemic, top pharmaceutical executives said Thursday. Execs for four major pharmaceutical companies working on vaccines — Johnson & Johnson, Pfizer, AstraZeneca, and GlaxoSmithKline — outlined key problems. A vaccine needs to be tested, mass-produced and globally distributed to halt the coronavirus crisis. Each of these steps will require efforts that will test the world. The companies plan to chase the virus around the world, package multiple doses into each glass vial, and work with global nonprofits on a fair distribution plan. Visit Business Insider's homepage for more stories.
A widely available coronavirus immunization faces a slew of challenges that will test the world over the next year, top pharmaceutical executives said Thursday. Determining if a vaccine candidate actually works in humans is just the first step. Other significant hurdles include mass-producing an effective vaccine and then distributing it around the world. Four leaders at some of the largest drugmakers in the world — Johnson & Johnson, Pfizer, AstraZeneca, and GlaxoSmithKline — revealed how they are now planning for these challenges at a Thursday press conference hosted by an industry trade group. Across the pharma and biotech industries, dozens of companies are aiming to develop a coronavirus vaccine in record time. There are 125 ongoing vaccine research efforts, with 10 now being tested in humans, according to the World Health Organization. A Business Insider review found nearly 30 experimental vaccines are slated to be in clinical trials by the end of 2020. In condensing the develpment timeline, these companies are now simultaneously thinking through issues that will arise from each stage of vaccine development: how to rapidly test a candidate in humans, how to manufacture hundreds of millions, if not billions, of doses, and how to distribute an effective vaccine to the world. Read more: The untold story of Moderna as the biotech's coronavirus vaccine faces a test that could make it one of the most consequential startups of all time Problem #1: Chasing the virus First and foremost, researchers need to vet the potential vaccines to see if any of them actually work. A good vaccine will have to clear two bars. First, it will have to be safe and tolerable for healthy humans to take, without causing serious side effects. Secondly, it has to either prevent infection, or at a minimum, reduce the likelihood of severe disease. In order to demonstrate a vaccine works, researchers need to test large numbers of people in areas where the virus is actively spreading. As clinical trials often require months to plan and run, that is turning into a major issue for testing a vaccine against a fast-moving virus.
"The problem we will all have, I think, is we are running against time a little bit," AstraZeneca CEO Pascal Soriot said. AstraZeneca has partnered on a vaccine candidate developed by University of Oxford researchers. Soriot added that there will soon be data available from the first phase of its UK-based clinical trial, which is now working to expand into a 5,000-person trial. Recently, the researchers running the UK study have warned there's now a 50% chance it won't be able to determine if the vaccine works because of the dropping rate of new infections in Britain. "Very soon, the disease intensity will be low and it will become difficult, so we have to move quickly," Soriot said. The Oxford candidate will also be tried in several other trials around the globe. Soriot said studies in Kenya, South Africa, Brazil and several other countries will start soon. A 30,000-person trial in the US will likely start in July, he added. The other executives also raised this concern, including Johnson & Johnson Chief Scientific Officer Paul Stoffels. J&J, the largest healthcare company in the world, is aiming to start human trials of a vaccine in September to be ready for potential emergency use in early 2021. "We plan to do two large Phase 3 studies, as typically is required in the world to get to full approval," Stoffels said. "Hopefully that can be done in the north. If not, we'll have to go to the south." Read more: Scientists are racing to create a coronavirus vaccine that can halt the pandemic in its tracks. Here are the top 3 candidates from Moderna, Pfizer, and AstraZeneca aiming to be ready this fall. Problem #2: Running out of glass
Before knowing if the vaccines work, the leading programs are already ramping up manufacturing capability. A critical constraint to producing hundreds of millions or billions of doses in such a short amount of time will be a final portion of the manufacturing process of putting the serum into glass vials. Several of the executives raised concerns about simply running out of glass. Pfizer's Bourla said they are now talking with government officials to see if they could put five or 10 doses into a single vial. Traditionally, vaccines are delivered in single-dose vials. Bourla said this could "resolve a significant part of the bottleneck in manufacturing." J&J's Stoffels added that it will "probably be essential" to put multiple doses into each vial. "The capacity is not there to do it in the billions otherwise," he added. Problem #3: Distributing a vaccine, particularly to lower-income areas of the world In working through the first two problems, the world could have hundreds of millions, or potentially billions, of doses of an effective vaccine. But there still needs to be a plan on how it will be delivered to people across the world. In particular, there's been a rising fear of 'vaccine nationalism,' where each nation's leaders will try to secure a vaccine for its country first instead of pursuing a global approach. GlaxoSmithKline CEO Emma Walmsley said the drug industry is "committed to access," in particular by working with a new World Health Organization group called the ACT Accelerator. She emphasized the role of leading nonprofits like the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI), and the global vaccine organization Gavi. "That is going to be a mechanism with multiple stakeholders, whether it's heads of state or organizations like CEPI, and the Gates Foundation, Gavi and others, and the WHO of course, where we can actually look at these principles of access," Walmsley said. But demand is still expected to vastly exceed supply for coronavirus vaccines. This will be an even tougher challenge for some vaccines that require cold storage. Pfizer's Bourla said its experimental vaccine will likely go to the "Western world" first, mainly because it needs to be stored at -8 degrees Celsius (about 18 degrees Fahrenheit). "It's a technology that is not very convenient for Africa, for example, because they will likely lack basic infrastructure that can be applicable," Bourla said, adding Pfizer would work on a second wave of products that wouldn't require extreme temperatures. AstraZeneca's Soriot said the US government has effectively placed an advance order for 300 million doses of its experimental vaccine, as part of $1.2 billion in funding made available to the company by the US Biomedical Advanced Research and Development Authority.Join the conversation about this story » NOW WATCH: Drugmakers are developing coronavirus vaccines in record time — but it will still be months before one is available
More like this (3)
At least three companies close to revealing results of phase three trials, but to be approved...At least three companies close to revealing results of phase three trials, but to be approved for use safety has to be ensuredCoronavirus – latest updatesSee all our coronavirus coverageThe race for a Covid vaccine is reaching a crucial stage, with the glimmer of a possibility that one of the leading contenders will be approved by Christmas.In an interview with the Guardian, Kate Bingham, who heads the UK’s vaccine taskforce, said the UK was in “a very good place”. Continue reading...
AstraZeneca and Johnson & Johnson have restarted their late-stage trials after finding that serious illnesses in...AstraZeneca and Johnson & Johnson have restarted their late-stage trials after finding that serious illnesses in a few volunteers appeared not to be related to the vaccines.
The rollout of a COVID-19 vaccine is under threat: Leading experts tell us they're worried about a shortage of glass vials, cargo planes, and cold-storage units
Summary List Placement Even if scientists find a coronavirus vaccine, we will need a supply of...Summary List Placement 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." 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. 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." 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."SEE ALSO: Why a coronavirus vaccine won't be ready for public distribution until 2021, according to a top virologist READ ALSO: Why COVID-19 vaccines should be given to kids before the elderly, according to 3 professors Join the conversation about this story » NOW WATCH: Why thoroughbred horse semen is the world's most expensive liquid