During the depths of the pandemic this year, when lockdowns and shutdowns were being imposed across the world in the desperate fight against the coronavirus, the situation seemed about as bleak as it could possibly be.
In the dark days of the spring, when it appeared we might be facing a worldwide depression and hundreds of millions dead across the globe, it seemed implausible at best to even begin to imagine that there would be a vaccine ready to go before the close of this terrible year.
Normally, the medical field, especially in the West, proceeds at a deliberate and measured pace, with numerous trials, beginning with animal testing and proceeding on with human testing, for every possible medication before it is granted approval.
But Dr. Albert Bourla, a Thessaloniki native and graduate of the city’s Aristotle University, simply refused to accept this model of normal business practice in coronavirus times. Driving his team of scientists sometimes beyond their limits, he produced the world’s first coronavirus vaccine within an incredible 336 days after the genome of the virus was first shared by Chinese scientists.
More than 150 coronavirus vaccines have been in development all over the world during 2020. But what would have normally have taken approximately ten years under the rigorous drug trial regulations of the US was tested and brought before the FDA in less than one year by the extraordinary scientists at Pfizer and BioNTech.
Naturally, this didn’t happen without many tense moments and some hard driving from Pfizer CEO Bourla, who wasn’t afraid to push his scientists further than they had ever been made to go before. Interviewed over the past seven months, Pfizer executives and managers explained just how difficult the last year has been and how much the process required of them.
Superhuman effort demanded from Bourla
A new report from the Wall Street Journal recapped the superhuman effort undertaken at Pfizer to make the vaccine a reality.
Setting their sights on gene-based technology, rather than traditionally-based vaccines, was part of what made it possible, as well as untold hours of work, but the firm hand of Bourla — who made the decision to dedicate more than $2 billion to produce it — helped make it happen.
The trained veterinarian from Thessaloniki rose through the ranks of the Pharma giant, beginning in Greece and moving on to several European countries until he was pegged for the position of Chief Operating Officer in Pfizer’s New York office in 2018, later being named CEO in 2019.
Known for his ease in dealing with employees and his chatty manner, Bourla also quickly became known for his dogged inability to give up on unsuccessful products, rescuing some of them from the trash heap.
Perhaps it was this inability to accept defeat that honed Bourla’s unbending determination to produce a vaccine in this most difficult year of his career.
He told interviewers “I’m a true believer that people, they don’t really know their limits,” he said in an interview. “And usually, they have the tendency to underestimate what they can produce.”
Health officials from the US had stated publicly that there simply was no way that a vaccine could be produced during this calendar year and that the best they could shoot for was sometime during the second quarter of 2021.
Amazingly, the fastest vaccine ever created prior to 2020 took four years — for the mumps, back in 1967.
The “vaccine miracle” of 2020 is partly due to the small biotech firm of BioNTech, out of Mainz, Germany — which was already working with Pfizer to produce a shot for the annual outbreak of influenza. Founded in 2008, the company had only 1,000 employees at the beginning of the pandemic.
But it was on BioNTech’s ambitious radar screen to create a vaccine from messenger RNA, or MRNA, which are molecules that instruct cells exactly which proteins to produce. Scientists there believed that they could alter the virus itself to force it to make inert versions of the spike proteins that protrude from its surface.
These harmless versions of the proteins would then help the body’s own immune system to create antibodies, allowing it to defend itself against the actual coronavirus.
Virus’ genome input into software
In a mind-blowing event all in itself, made possible by the advanced technology available today, BioNTech CEO Ugur Sahin created ten vaccine candidates on his own on January 25, 2020, just by inputting the virus’ genome into the software the company uses.
The firm would eventually go on to create a total of twenty versions of the vaccine, collaborating with Pfizer beginning in the first week of March 1, after Bourla gave the thumbs-up during one of the company’s first meetings on the vaccine.
But just a couple weeks later, after he heard that his scientists predicted a vaccine rollout in mid-2021, Bourla had already heard enough. “Sorry, this will not work,” he declared to them. “People are dying.”
He then stated flatly that there had to be a vaccine by October, when it was predicted that the dreaded second wave of the coronavirus would be at its worst. Not only that, but he said that they must somehow produce 100 million doses — with two shots each, enough for 50 million of the most vulnerable people to be inoculated.
At last count, approximately half of that will actually be produced, but it should be enough so that health care workers and nursing home residents will be protected by Christmas of this year.
Twice-weekly brainstorming sessions
Taking the reins in his hands, Bourla held twice-weekly meetings, with no set agendas, in order to allow participants to share their ideas freely — brainstorming all possible venues that could be used to produce an effective vaccine as fast as humanly possible.
Working together with BioNTech, primarily through video conferencing, the scientists quickly whittled down the twenty vaccine candidates despite working with the groundbreaking technology of mRNA.
Passing on data to the Food and Drug Administration almost every day, keeping it abreast of all developments, the researchers were able to pare down the number of vaccine candidates to just four by April 12.
Testing the vaccines in mice and monkeys for years, however — the normal course of action for vaccine trials — wasn’t going to be enough to stop this scourge. Human testing had to begin, and quickly.
Dr. Kathrin Jansen, the head of the vaccine program at Pfizer, who leads a team of 650 scientists, explained to interviewers “We needed speed, and with speed, you have to rethink how you normally go.”
By April 23, just a month after the initial lockdowns in the United States, two of the potential vaccines began to be injected into human volunteers in Germany.
The two other vaccine candidates, one promoting the creation of partial-spike proteins on the surface of cells, and the other, prompting full-spike proteins, then began to be tested in the United States.
On June 1, Dr. Jansen received the results from the first trials of the first vaccine, designed to proceed partial protein spikes, which indeed showed that an antibody response was created in subjects after they received the shot.
The results from the full-spike vaccine wouldn’t be available until July 1, however.
By mid-June, Bourla declared to his team that he was pleased enough with how testing was going that he wanted them to increase the commercial production of the vaccine — tenfold. He asked them flatly, “Why can’t we make more and why can’t we make it sooner?”
“What we’re doing already is a miracle,” protested Mike McDermott, who is in charge of Pfizer’s global manufacturing network. He added “You’re asking for too much.”
In a prescient move, Pfizer and BioNTech agreed to produce vaccines prior to FDA approval — and even before the studies were concluded — so that they would be ready to go the instant the go-ahead was given by the US officials.
First mRNA-based vaccine in the world
A major problem presented itself, however — the fact that Pfizer had never manufactured an mRNA-based vaccine ever before.
Intricately specialized machines were designed and purchased, to the tune of $500 million, in order to produce the vaccine. A plant in Andover, Massachusetts was retrofitted to produce the vaccine, and a St, Louis factory was also put into production for the creation of raw materials for it. Pfizer made the brilliant decision to use disposable bags as vessels for the vaccine components instead of the usual giant stainless steel vats — which bought them valuable time.
Pfizer also bought gigantic machines the size of one-car garages which are designed to deposit the mRNA vaccine inside a lipid envelope which is used to transport the vaccine to its destination on the cell. Without this fatty envelope surrounding it, the vaccine would break down prior to even reaching the cell.
Each such machine costs $200 million — and Pfizer bought seven of them. But the company’s problems weren’t over. On June 30, US and European regulatory authorities suddenly informed Pfizer that they needed to increase the number of subjects in the late-stage trials — from 8,000 to 30,000.
Undeterred, the companies ramped up to make all the additional vaccines needed, for both candidates, since at that point, they were still testing two separate vaccines.
Needing yet another injection of cash to make this happen, McDermott asked Pfizer’s Chief Financial Officer Frank D’Amelio if this would be a problem, telling him “I got an idea, and I need $10 million. Is it an issue?”
“Just do it,” D’Amelio answered.
Since there wasn’t enough time to even test exactly how long the vaccine would last before breaking down, Pfizer decided to go with storing it at subarctic temperatures just to be safe — which meant the creation of dedicated, suitcase-sized storage containers which would hold 5,000 doses.
Shipped all around the world, including Africa and Dubai, the cases were found to have indeed kept the vaccine at the optimal temperature.
“Find a way”
But it was Dr. Bourla who figured out that the large suitcases weren’t exactly the appropriate size for existing needs. Just before July 4, McDermott’s team proudly demonstrated the performance of the chilled suitcases to the Greek-born CEO.
“What in the hell is CVS going to do with 5,000 doses?” he asked McDermott. Pharmacies and doctor’s offices would need far fewer doses than that, and the vaccines were now the most precious things on earth. McDermott’s team accordingly resized the suitcases to hold a more manageable load of 125 doses.
However, when the second vaccine candidate was chosen over the first, that presented another problem, since there were fewer doses available of the second shot — and each dose was physically larger.
McDermott, tasked with all storage issues for the vaccine, asked Bourla if he would agree to produce fewer doses in order to use the same amount of vials. Pfizer had already set the bar at 100 million doses by the end of this year. But that was a no-go.
“Find a way,” Bourla told him flatly.
By July 23, Pfizer received the even more promising results from the second shot — and just one day later the firm told the FDA that this second vaccine would be the one used in the final trials.
The late-stage trials began at lighting speed, just four days later, when the first volunteers lined to receive the shots at the University of Rochester Medical Center in upstate New York. And by August, 20,000 volunteers were taking part in the brave experiment.
Additional thousands of subjects were added to the trial, so that by November, 44,000 individuals across the world were participating. Early last month, Pfizer received the incredibly gratifying news that thus far, the vaccine was proving to be 90% effective — and it was safe.
“Landing in the stars”
When Dr. Bourla received the call with these findings, he immediately relayed them on a call to senior company officials. Bourla later related that some of them jumped up from their chairs in excitement at the news.
Ramping up production in the US and in its facility in Belgium, the company already had more than 1.5 million doses frozen and ready to go. However, technical issues and certifications for the new machines made production lag behind Bourla’s projections — and exhortations — meant that Pfizer would bring forth a total of 50 million doses this calendar year instead of the original target of 100 million.
But the indomitable CEO of the company, who started out his professional life as a veterinarian in his native Greece, has done what no one on earth really thought was possible ever before — and certainly not in the darkest days of this pandemic-ravaged year.
“I always try to shoot for the stars, because I know that even if you miss it, you will land somewhere on the moon,” he explained to interviewers. “But right now it looks like we landed, more or less, in the stars.”
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