Vaccine and Operation Warp Speed

 

MANUFACTURING How the Magic Happens Francis Scialabba Maybe Thanksgiving is getting us sentimental, but the concept of a vaccine is kind of...amazing? Someone injects a distorted version of a virus into you and then your body learns how to defend against it. It’s not not magical.  Here’s how those painful miracles of science come to be The process that generates the lifesaving poky boys is grounded in cold, hard science and logistics. But, it’s mind-numbingly complicated; think Christopher Nolan film plus Gillian Flynn novel times your flightiest friend’s romantic status.  From a business POV, it’s also extremely risky. Regulators license the process behind making a vaccine in addition to the biological product itself. That means that any major tweaks to that process trigger another round of tire-kicking. As a result, the failure rate in vaccine manufacturing is high and supply often runs short.  Plus, it’s not cheap. The total costs of vaccine development can run up to $500 million, one study found.  Methodologies vary, but the overall breakdown goes something like this:  Step 1: Create an antigen (a substance that provokes your immune system). Scientists do this by literally growing it in a cell—like the basil plant on your window, but tiny.  Step 2: Take the baby antigen out of the cell where it was grown. Basil’s gotta become pesto at some point.  Step 3: Next, the antigen is purified through processes that sound like words you’d make up when lying about doing science homework: chromatography and ultrafiltration.  Step 4 (optional): In some cases, some extra spices are added to strengthen the antigen, or to add shelf life.  Step 5: Distribution—mix up all the components in vials or syringes, load those suckers on trucks, and get them in some arms.  Vaccine manufacturing is Isla de Muerta  It’s an island that cannot be found, except by those who already know where it is. The field is dominated by legacy players, because only those with significant existing scale can foot the bill for the necessary raw material, facilities, regulatory compliance, and labor.  Did you know there’s currently a shortage of sand needed to make glass vials for vaccine storage? Or that one ingredient used in vaccines comes from the bark of the Quillaja saponaria Molina tree in South America that’s only harvested two months of the year? Probably not, but Pfizer does.  Zoom out: The companies currently vying to get a Covid-19 vaccine to market are pursuing different biological methods, in the hopes that a “throw everything against the wall” approach will lead to a few sticking.

 

GOVERNMENT It’s Not Quite Ludicrous Speed... U.S. Dept. of Defense ...but it’s pretty dang fast. After the Manhattan Project and training dolphins to locate sea mines, Operation Warp Speed (OWS) could go down as one of the most successful government initiatives in recent memory. So what is it exactly?  The goal: To deliver 300 million doses of a safe and effective vaccine by Jan. 2021. It was created as a sort of “project manager” to coordinate all the moving parts between government agencies and private companies.  Budget: Up to $18 billion. More than $12 billion has already been doled out in vaccine-related contracts. Why it matters: As you can see in the graphic above, OWS is trying to squeeze what’s typically a 73-month process into just 14 months. So far, it appears to be working.  Looking ahead...OWS leadership has said they can deliver a Covid-19 vaccine to every state less than 24 hours after FDA approval.