WASHINGTON — It can take 10 years to research, develop, test, trial, trial, trial and get a vaccine approved for use. It took Pfizer, under Chief Executive Albert Bourla less than one to get the COVID-19 shot out and in use.
In June, he was told by Mike McDermott, who oversees the US pharmaceutical giant's global manufacturing network – as Bourla was pushing his team of doctors, scientists and technologists to get it done to fast save lives it couldn't happen.
Bourla wanted them to increase commercial production at least 10-fold, said The Wall Street Journal in a review of how Pfizer went from square one to distribution during the pandemic.
“Why can’t we make more and why can’t we make it sooner?” demanded Bourla, born into a Thessalonian Jewish family, a Greek executive and veterinarian who left his homeland at 34 and lived in four countries before launching a career in the US.
McDermott said his team was working like crazy under impossible conditions and trying to find a solution to save lives as the Coronavirus was tearing through the world like a wraith in the night, scooping up souls.
“What we’re doing already is a miracle,” he said he told Bourla. “You’re asking for too much.” The miracle happened in December when the vaccine got emergency approval from the Food and Drug Administration, after already being okayed and used in the United Kingdom.
How it happened is the stuff of science fiction movies like the Andromeda Strain as the world's best scientists, doctors and pharmaceutical experts worked feverishly to find the answer, some 13 vaccines now in review or use.
As the story by Jared S. Hopkins revealed, Pfizer – with its German partner BionTech, won the race for the first approval after some anxiety over trials and worry about safe transfers with special storage freezers keeping the vaccine at -70 degrees Celsius (-158 degrees Fahrenheit) for safety and efficacy.
That has a lot of people saying they won't take it, fearing the vaccine was developed too fast even though it's been approved and could save countless lives and suffering.
The New York City-based Pfizer and BionTech were able to do it, the paper said, by betting on gene-based technology under demanding management that was racing the clock against an invisible enemy and other companies trying to pull off the same feat, as did Moderna, in Cambridge, Mass.
Bourla was in the driver's seat and he had the pedal to the metal, wanting the vaccine by October and 100 million doses by year's end, missing that deadline and able to produce only 50 million, spending $2 billion in the effort.
It “achieved more, faster, than outside experts and even its employees thought possible,” said the story, based on interviews during the pandemic with senior Pfizer executives and other managers to show how it was done in record time.
Even Pfizer's vaccine researchers thought they wouldn't be able to pull it off until the middle of 2021 as the number of cases and deaths and people in Intensive Care Units (ICUs) soared, the US having the world's worst record as President Donald Trump and Republican Governors blocked lockdowns, dismissed health measures like masks and tried to save the economy instead.
Pfizer couldn’t have done it without BionTech, where two Turkish scientists, Dr. Ugur Sahin, and Dr. Özlem Türeci, who founded the company provided the crucial technology to bring the vaccine.
Scientists at the company, based in Mainz, Germany, canceled vacations and set to work on what they called Project Lightspeed, said The New York Times in a feature on their critical role.
BioNTech wanted to make vaccines out of messenger RNA, or mRNA, the molecules that carry genetic instructions telling cells what proteins to make and researchers there thought they could use the genetic sequence of the coronavirus, which had recently been published, to synthesize mRNA that would instruct cells to make a harmless version of the spike protein that protrudes from the surface of the virus.
GET IT DONE
The defanged spike proteins would prompt a person’s immune system to produce antibodies that could fight off the real virus.Unlike the months it takes to cultivate a vaccine in test tubes, designing an mRNA vaccine would be quick, The Journal said.
BioNTech plugged the genetic code for the spike protein into its software. On Jan. 25, before the pandemic began rampaging, Sahin designed 10 candidates himself and began the trial-and-error to find something that would work.
The relatively small company, that had never rolled out a product, needed a pharmaceutical giant as a partner and found one in Pfizer when Sahin proposed a coronavirus vaccine collaboration with Kathrin Jansen, Pfizer’s vaccine-research chief.
“This is a disaster, and it’s getting worse,” Dr. Jansen told Sahin. “Happy to work with you.” Bourla gave the go-ahead a week later but upped the pressure when told in mid-March it would take a year to bring out a vaccine.
“Sorry, this will not work,” he said. “People are dying.”
Bourla, who had joined Pfizer in 1993 as Doctor of Veterinary Medicine and Technical Director for the company's Animal Health Division in Greece, rose rapidly through the managerial ranks where the paper said he gained a reputation for friendliness but achievement, taking the top job in 2019.
“I’m a true believer that people, they don’t really know their limits,” Bourla said in an interview. “And usually, they have the tendency to underestimate what they can produce.”
The companies worked through a series of variations of the vaccine with Bourla on the backs of the scientists always pushing, pushing for results as the deaths rose like mercury in a thermometer left in the sun.
They tested vaccines in monkeys, but simultaneously with humans. “We needed speed, and with speed, you have to rethink how you normally go,” said Jansen, who leads a team of 650.
After trials on volunteers in Germany in April showed some subjects getting fever and chills, signs the vaccine wouldn’t be tolerated, other experiments went to producing a partial-spike protein and full-spike at varying doses.
In June, the results of trials bettered, the findings showed the experimental shot produced an antibody response in study subjects, a good sign it could protect against COVID-19. “Really, really encouraging,” she replied to the researchers by email. “When can I see the next data?”
It took more months of arduous work, through a second vaccine candidate in July, Pfizer working simultaneously to make supplies for testing and to begin making vaccines for use.
Pfizer didn’t have the equipment to make an mRNA vaccine, a new and different manufacturing process and decided to fund it without any money from the Federal government, not wanting to give the Food and Drug Administration under Trump’s thumb any input.
With McDermott an engineering catalyst, by early November, Pfizer said its latest trials showed the vaccine was more than 90 percent effective and looking safe, Bourla revealing the findings to senior company officials on a video call that had them jumping out of their chairs in joy.
There won’t be as many doses as he wanted, the US and German team collaboration overseen by Bourla had brought the world some hope ahead of what was predicted to be a dark and deadly winter in the US.
“I always try to shoot for the stars, because I know that even if you miss it, you will land somewhere on the moon," said Bourla. “But right now it looks like we landed, more or less, in the stars."