Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
“I’m hoping that memory is not short,” Mike Piccarreta, a partner at global consulting firm Kearney, told BioWorld.
Following past disasters and potential pandemics in the U.S., Congress and industry spoke of lessons learned and then eventually went back to business as usual. As a result, “clearly we were not prepared for this type of pandemic” in terms of government response and manufacturing capacity, Piccarreta said.
It didn’t have to be that way. Had the government and industry followed through with the R&D of therapies and vaccines for SARS, a related coronavirus that infected thousands of people in nearly two dozen countries 17 years ago, the world would have been better prepared for COVID-19, Piccarreta noted while acknowledging the difficulty of conducting clinical trials when the spread of an infectious virus subsides as it did with SARS.
In congressional hearings, lawmakers have admitted that the U.S.’ COVID-19 response was hindered by mistakes made when Strategic National Stockpile supplies weren’t replenished following previous emergencies.
Given such mistakes in the past, the concern is that once COVID-19 becomes an unpleasant memory, the U.S. government and industry will move on to new priorities, leaving the country only a little more prepared for the next pandemic.
A dose of reality
At the moment, COVID-19 is generating a lot of policy talk, as politicians from both political parties use it to score points for the upcoming presidential and congressional election. Unfortunately, policy often doesn’t go hand-in-hand with reality, especially when it comes to the manufacturing of complex drugs to take on a global pandemic.
For starters, the additional drug and vaccine manufacturing capacity needed to address a global pandemic can’t be wished, or ordered, into instant existence. It’s not as if there are idle manufacturing facilities that can be cranked up to produce complex new drugs or vaccines on demand.
Even without the economic and logistic limitations of COVID-19, it would take five to 10 years and up to $2 billion to develop a new FDA-approved manufacturing facility in the U.S. under current regulations, according to the Association for Accessible Medicines. “Even shifting production from one facility to another requires FDA approval, a minimum of 18 months and an investment of several million dollars,” the trade group added.
In normal times, the demand for a new drug gradually builds, giving the sponsor time to scale up manufacturing in keeping with the demand, Piccarreta said. But with COVID-19, a huge global demand already exists, giving manufacturers no time to scale up.
“Given the volumes [needed], there’s just not enough capacity,” Piccarreta said, adding that the capacity can’t be ramped up overnight.
Gilead Sciences Inc., of Foster City, Calif., is demonstrating that with its Veklury (remdesivir), one of the first therapies to get emergency use authorization (EUA) to treat COVID-19. Even before the EUA was granted, Gilead was ramping up production at risk and rapidly building its supplies of the investigational drug.
To do that, Gilead had to invest in process improvements to shorten what had been a lengthy manufacturing timeline and expand its global network of internal and external manufacturing sites to add manufacturing capacity around the world. That included partnering with industry peers and signing licensing agreements with nine generics manufacturers.
As of last week, Gilead said, its Veklury manufacturing network included more than 40 companies in North America, Europe and Asia and its supply of remdesivir has increased more than 50-fold since January. Even at that, Gilead will not be able to meet real-time global demand until October. By the end of the year, it expects to have produced more than 2 million treatment courses.
But that’s not good enough or fast enough for some government officials. Citing the limited supplies and the pricing of Gilead’s drug, nearly three dozen U.S. states and territories last week demanded that the federal government march in on the company’s patents for remdesivir or allow them to do so.
With companies worldwide scrambling for manufacturing capacity to address COVID-19, state and federal governments would be hard-pressed to ramp up manufacturing faster than what industry is doing, especially since much of the manufacturing space is already spoken for.
For instance, companies working on potential coronavirus vaccines are aggressively securing capacity through take-or-pay contracts, either reserving existing capacity or funding new capacity, Piccarreta said. They’re doing this at risk even though “the true capacity requirements may not be fully known until the technology to produce the vaccine is finalized and the number of doses required are known,” he added.
The challenge for vaccine developers isn’t just floor space. Manufacturing capacity includes the systems and all the materials that will be needed in the manufacturing process. Even before the pandemic, companies were experiencing delays in getting necessary bioprocess materials such as single-use assemblies, cell culture media and filters. In the 12 months preceding the pandemic, the lead time for some of those products was nearly 40 weeks, Piccarreta said. He expected those materials to be further constrained as manufacturers scale up for COVID-19 plus other products in the pipeline.