At ProPublica Isaac Arnsdorf and Ryan Gabrielson explain that we’re producing vaccines against COVID-19 as fast as we can and there’s nothing we can including using the DPA to order more that will change that:
Vaccine supply chains are extremely specialized and sensitive, relying on expensive machinery, highly trained staff and finicky ingredients. Manufacturers have run into intermittent shortages of key materials, according to the U.S. Government Accountability Office; the combination of surging demand and workforce disruptions from the pandemic has caused delays of four to 12 weeks for items that used to ship within a week, much like what happened when consumers were sent scrambling for household staples like flour, chicken wings and toilet paper.
People often question why the administration can’t use the mighty Defense Production Act — which empowers the government to demand critical supplies before anyone else — to turbocharge production. But that law has its limits. Each time a manufacturer adds new equipment or a new raw materials supplier, they are required to run extensive tests to ensure the hardware or ingredients consistently work as intended, then submit data to the Food and Drug Administration. Adding capacity “doesn’t happen in a blink of an eye,” said Jennifer Pancorbo, director of industry programs and research at North Carolina State University’s Biomanufacturing Training and Education Center. “It takes a good chunk of weeks.”
And adding supplies at any one point only helps if production can be expanded up and down the entire chain. “Thousands of components may be needed,” said Gerald W. Parker, director of the Pandemic and Biosecurity Policy Program at Texas A&M University’s Scowcroft Institute for International Affairs and a former senior official in the Department of Health and Human Services office for preparedness and response. “You can’t just turn on the Defense Production Act and make it happen.”
Even if the companies had started building new facilities back in September, they still wouldn’t be online yet. Raw materials are a bottleneck, too:
Raw materials for the Pfizer and Moderna vaccines are also in limited supply. The manufacturing process begins by using common gut bacteria cells to grow something called “plasmids” — standalone snippets of DNA — that contain instructions to make the vaccine’s genetic material, said Pancorbo, the North Carolina State University biomanufacturing expert.
Next, specific enzymes cultivated from bacteria are added to cause a chemical reaction that assembles the strands of mRNA, Pancorbo said. Those strands are then packaged in lipid nanoparticles, microscopic bubbles of fat made using petroleum or plant oils. The fat bubbles protect the genetic material inside the human body and help deliver it to the cells.
Only a few firms specialize in making these ingredients, which have previously been sold by the kilogram, Pancorbo said. But they’re now needed by the metric ton — a thousandfold increase. Moderna and Pfizer need bulk, but also the highest possible quality.
“There are a number of organizations that make these enzymes and these nucleotides and lipids, but they might not make it in a grade that is satisfactory for human consumption,” Pancorbo said. “It might be a grade that is satisfactory for animal consumption or research. But for injection into a human? That’s a different thing.”
And that doesn’t address additional bottlenecks like the possibility that Moderna and Pfizer are in competition with one another for some equipment and materials and that some of the equipment requires components that are only available from overseas.
I’ve been pointing this stuff out for months but it’s nice to see people better-informed than I saying it, too.