This was no small feat. Until the very end of last year, no mRNA vaccine had been authorized to date and no such vaccine had been developed by any company to scale.
Pfizer has now shipped more than 100 million doses to the U.S. and said this week that it has successfully met its target of 120 million doses by the end of March.
Mike McDermott, president of Pfizer’s global supply chain, said the mission is even more dosage. Billions of them.
“Our goal is to run 24/7, make as much as possible. I don’t even have a production goal,” McDermott told CNN’s Chief Medical Correspondent Dr. Sanjay. Sanjay Gupta said during a special tour of his production facility in Kalamazoo. Michigan, in March. “Our goal is to produce as many as 2 billion doses as early as possible this year.”
Pfizer / Bioentech’s global target is 2.5 billion doses by the end of the year.
Big gamble
Fifizer achieved its first goals with a significant explicit investment, and there is no guarantee of that.
Pfizer was part of Operation Operations as a potential supplier for the Covid-19 vaccine and signed a purchase agreement for the initial 100 million doses. However, the company has not received federal funding for vaccine research or development.
So while Pfizer may resurrect some of its devices at its main production site in Kalamazoo, most of the devices there no longer existed a year ago.
“Pfizer has spent about 2 2 billion on the overall program at risk. From manufacturing, my team spent 500 clinics, before we got out of the clinical trials. So all are completely at risk. We didn’t know we had a product that was going to work.” Was, ”McDermott said.
Before Pfizer decided on his final vaccine candidate, he was looking for four different options. That meant McDermott and his team had to be prepared to go in any direction.
“I think, we’ll have dinner tonight, and we need to prepare dessert, but I don’t know what dessert we have. So you just start buying the ingredients.” “Maybe we’re making cakes, maybe we’re making brownies. Let’s bring the standard material we want. So filling this pantry was quite expensive.”
One of the biggest rate-limiting measures of this product, according to McDermott, is the availability of raw materials and especially lipids, a fatty substance that protects mRNA until it reaches our cells.
“Lipid nanoparticles are not used in large commercial products. So the lipid suppliers were not very large. And so we work very closely with them to create more lipid capacity, and indeed make lipids at this site in Kalamizu, Michigan,” McDermott said.
The heart of mRNA
Pfizer / Bioentech’s Covid-19 vaccine can be described as having an MPRN in a lipid coating, but its successful production by millions of people came in a quarter of the size.
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The heart of this whole machine is what’s called the impingement jet mixer, ”McDermott said as it rolled around his fingers again.
Impingement jet mixers, also known as tea steerers, work by pumping lipids on one side and mRNA on the other, pushing them with a pressure of 400 pounds. It is he who makes the lipid nanoparticles that are essentially vaccinated.
These are not just lipids, Pfizer / Bioentech had to create the right combination of four different lipids that would protect the mRNA on the way to the cells, but then release the mRNA once it got there.
While the process of making lipid nanoparticles is not new, McDermott said the challenge is exacerbating the process.
“The first time someone showed me this Imgenjet jet mixer, I said, ‘You can’t be serious?’ Like how can you put billions of doses here? So my confidence level was really quite low. It can’t be done, I knew it worked on this basis, but how can you increase it? ”
The first idea of McDermott was to get bigger, to make a large tea streak so that more volume could pass. When that didn’t work, they finished copying quarter-sized mixers and put in technology to ensure efficiency to increase production.
“There is a computer system that runs the whole device that assures you that you have a certain amount of flow and pressure. And that gives us more product. Even though the size is small, we were able to actually increase this to our original for this machine. Design. We’re currently working on four times the capacity. ”
Make it modular
Part of allowing Pfizer to make room for these new formulation suites is its strategy of using prefabricated constructions.
In its 1,300-acre Kalamazoo facility, Pfizer is installing about 13,000 square feet of modular rooms that were first built in Texas and then shipped to Kalamazoo.
“We plan to expand our ability to create. The question was how can we do it quickly? If we had built it wall by wall, it would have taken us a year. By modulating this, we could cut it. “Half,” says McDermott.
Moving each room into place is surprisingly easy. With the help of compressed air – think of an air hockey table – you can easily slide it into place. The rooms are then electrically connected, sterilized and ready for use.
With each of these improvements, Pfizer says it has produced 13 million doses a week, producing 3 to 4 million doses of the vaccine a week. They expect it to double by the middle of the year. That means about 100 million doses a month and by July the U.S. The government will have the capacity to hit the target of 300 million total doses delivered.
What’s next
McDermott says the last 12 months “have never been anything like this in my career.”
“As a child, my dad worked for NASA.” “He was lucky enough to be in Mission Control in Houston when Neil Armstrong set foot on the moon at this wonderful moment.
“I could never have imagined such a moment in my life. Well, what are the difficulties like that something like that never happens again?”
Then came December 13, 2020 – the day the United States’ first coronavirus vaccine, the first step in ending the epidemic, left the facility.
“The day we sent the first dose out of this dose, it came over me like it was my moment,” McDermott said. “That was our moonshot.”
But McDermott says his brain always has a vaccine supply, and they have to prepare for the future – and that means coronavirus variants.
Although there is no evidence that people vaccinated with the Pfizer vaccine will be less protected against current types, the company has begun testing a third dose of its current vaccine.
Pfizer and Bioentech say they are in discussions with regulators about the possible testing of an improved vaccine to protect against various types in a phase 1/2 study.
The company’s next big leap is to be ready to deliver to patients, if necessary.
Pfizer’s goal, McDermott says: to be able to develop a new variant-specific vaccine, get it by product and deliver it to patients months later.
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