- The giant drugmaker Pfizer and a German biotech called BioNTech have developed the world's first effective coronavirus vaccine.
- The COVID-19 shot is an unprecedented scientific accomplishment: The vaccine was created and tested in record time. Vaccine research has historically been a multiyear process.
- Here's how Pfizer and BioNTech did it — and what comes next.
- For more stories like this, sign up here for Business Insider's daily healthcare newsletter.
After three decades in the drug industry, Mikael Dolsten, a Pfizer executive, knew better than to be overconfident about what had become one of the most closely watched experiments in history.
He was with other top executives of the pharma giant on Sunday at an office in Connecticut for one of the biggest moments in his career. Results were available for the final-stage clinical study of Pfizer's coronavirus vaccine, and Dolsten, sitting next to CEO Albert Bourla, was about to learn on a Webex call whether it worked.
"On one hand, you had cautious optimism," Dolsten told Business Insider. "On the other hand, you have respect for that you can never be certain on the outcome of a clinical trial."
Two senior research leaders popped up on the screen to relay what they had just heard from the independent board of experts overseeing the trial: The trial was a success.
That was topped by more astonishing news a few moments later that spurred some of the Pfizer executives out of their chairs in celebration: The early data suggested overwhelming efficacy of more than 90%. A few days later, final study data showed the vaccine was 95% effective at preventing COVID-19.
Many virologists were realistically hoping for a vaccine that was about 70% or 80% effective at preventing COVID-19, the disease caused by the coronavirus.
'Nothing comes close to this when you've seen the suffering'
Dolsten said that learning that the study succeeded was the best moment of his 30-year professional career.
"Nothing comes close to this when you've seen the suffering," Dolsten said, reflecting on the time he'd spent with healthcare workers in New York City, an early epicenter of the outbreak in the US.
"We can really change the course of this pandemic," he said.
Eight months after officially announcing their vaccine research plan, Pfizer and a German partner, BioNTech, had pulled off an unprecedented feat in science, developing an effective vaccine less than a year after the discovery of the novel coronavirus.
To be sure, the pandemic is far from over. The immediate impact of the vaccine is unclear, as quantities will be extremely limited. Pfizer faces formidable logistical challenges in distributing the shots, particularly as the vaccine needs to be stored at extremely cold temperatures and given as two doses spaced three weeks apart.
Specifics from the study are not yet been published in a medical journal. While Pfizer applied for emergency authorization in the US on November 20, regulators still need to review the data and approve the shot before it can be used widely.
But even reaching this point — success in a late-stage trial for a vaccine — is a remarkable accomplishment. Pfizer and BioNTech were able to shorten a process that has always required multiple years, effectively writing a playbook for future epidemic responses while helping guide the world's exit from this crisis.
Any good news related to the pandemic is desperately needed, as much of the world prepares for a harsh, deadly winter. Over the past week, the US has averaged more than 110,000 new COVID-19 cases per day, an all-time high.
Here's how the world's first successful coronavirus vaccine came to be.
A report of infections in a family of 6 in China spurs an investor call
In late January, Ugur Sahin read a journal article that hinted at the death and misery that 2020 had in store for the world.
Sahin, a 55-year-old biotech entrepreneur who's one of BioNTech's founders, was riveted by how researchers described a curious case of a new virus infecting a family of six in China, FiercePharma reported. The researchers showed a prescient understanding of the risks posed by the novel coronavirus, including its ability to rapidly spread from person to person and region to region.
After reading the article in The Lancet, Sahin called one of his biggest shareholders, the German billionaire Thomas Strüngmann. Sahin told Strüngmann of an imminent pandemic that would close schools, and he pitched his plans to start developing a vaccine.
"After the weekend he went on Monday to his team, and although most of them were in oncology, he switched most of his team to the vaccine," Strüngmann recalled in an interview with Forbes.
Days earlier, Sahin had introduced BioNTech to a room full of investors at the biggest healthcare-investment conference of the year as a next-generation cancer-immunotherapy company. Since starting the company in 2008, Sahin has had the ambition of developing cancer drugs.
Now the company had shifted its scientific talent to designing a vaccine for a brand-new infectious disease.
With just a sliver of the attention that would eventually come, the race for a COVID-19 vaccine was underway.
Pairing an untested technology with a 170-year-old drugmaker
While several dozen scientists at BioNTech started researching a COVID-19 vaccine in late January, the German biotech's work got a massive boost from a previous research-and-development partner.
BioNTech started working with Pfizer in 2018 on a flu vaccine. While that work has not started human testing, Sahin took advantage of the connection, calling Pfizer's head of vaccine research, Kathrin Jansen, in February.
Jansen discussed a collaboration with Dolsten, the company's chief scientist. Jansen's big question was whether this outbreak would last longer than previous epidemics, which usually vanished before a vaccine was close to ready, Dolsten said.
On the evening of March 1, the night before Dolsten appeared at the White House for a roundtable on the industry's COVID-19 efforts, a group of Pfizer execs convened a call, ultimately deciding that the virus was here to stay and that they should work on a vaccine.
Two weeks later, Pfizer and BioNTech announced their partnership.
The two firms complement each other.
Pfizer has a multinational presence, manufacturing might, and regulatory know-how from more than 170 years of making and selling medicine — but no vaccine technology that could quickly respond to a pandemic.
BioNTech had never sold a drug in its brief history, but it did have a promising tech platform for vaccines.
That platform is based on mRNA, the genetic material that carries information into cells, spurring the immune system. Because mRNA is based only on genetic codes, scientists could craft an mRNA vaccine candidate using the genetic sequence of the virus. Traditional methods of vaccine development require live samples and, often, slower cultivation processes of growing chicken eggs or cells.
While mRNA is promising, it's also unproven, with no federally approved mRNA-based therapeutics or vaccines. Other biotechs, most notably the Massachusetts upstart Moderna and Germany's CureVac, have been working on the technology as well.
On November 16, Moderna announced equally exciting results with its vaccine program, just a week after Pfizer's initial news. Moderna's vaccine appeared to be 94.5% effective in preventing COVID-19, the biotech said.
Their early successes have excited investors. Before the pandemic, BioNTech and Moderna commanded market values of $8 billion and $6 billion. Now the two businesses are valued at $25 billion and $39 billion.
Moderna and BioNTech emerge as vaccine frontrunners
Over the course of 2020, the coronavirus-vaccine frontrunners winnowed down to Moderna and Pfizer/BioNTech.
Moderna had a critical head start: By late January, it had already made its vaccine candidate. On January 13, scientists at Moderna and the US National Institutes of Health finalized the sequence for its experimental shot, dubbed mRNA-1273.
The Massachusetts biotech had already laid out plans to eventually start human testing, even as the virus seemed like a distant, obscure threat to most Western countries.
Read more: 'Crazy hours, short nights': The inside story of how a buzzy biotech upstart developed a potential coronavirus vaccine in record time
While BioNTech had Pfizer as a key partner, Moderna turned to the NIH, building on the two organizations' research on a different coronavirus that was responsible for Middle East respiratory syndrome, or MERS. (Moderna is expected to later this month deliver results showing whether its coronavirus vaccine works.)
On the same day that Moderna dosed participants with the world's first experimental coronavirus vaccine, Pfizer CEO Albert Bourla spoke to a group of top executives at his company about Pfizer's COVID-19 strategy, Forbes reported.
"This is not business as usual," Bourla told the executives. "Financial returns should not drive any decisions."
The following day, Pfizer and BioNTech publicly announced the expanded research deal.
By the end of April, the program had a name that encapsulated its ambitions: Project Lightspeed.
Project Lightspeed steered clear of Operation Warp Speed
Pfizer and BioNTech started human studies in late April, trailing Moderna by a little over a month. Even then, Dolsten offered an ambitious timeline: He said the company would aim for an emergency use authorization by the fall, possibly even in October.
Speed has always been a priority of coronavirus-vaccine research. In May, when the US government launched its vaccine initiative, dubbed Operation Warp Speed, the goal was to deliver 300 million doses by January.
Pfizer and BioNTech chose to not participate in Warp Speed. In June, Bourla described the risk that taking government money would slow down research and said Pfizer was content to fund trials itself. By not taking government cash, Pfizer was also able to design its own late-stage trial.
Speed is a key part of a 'new Pfizer'
The pandemic was also an opportunity for Bourla, who became CEO in 2019, to demonstrate the success of his vision of a "new Pfizer."
Bourla framed the company's quick pandemic response as evidence of this new Pfizer, a contrast to the way massive companies usually work.
"How fast we moved is not something you could expect from the big, powerful pharma," Bourla told Forbes in May. "This is speed that you would envy in an entrepreneurial founder-based biotech."
In June, Bourla said Pfizer's speed in responding to the coronavirus could be applied to future research endeavors.
"Pretty soon the question 'Why only COVID?' will come," the CEO said at a Goldman Sachs healthcare conference. "If we prove that you can make vaccines in less than a year, OK, why can't we do that with other medicines, with cancer medicines?"
A politicized timeline for pre-Election Day results fell short
Over the summer, results began to trickle in for the four vaccine versions the companies were testing.
By the end of July, they had selected an mRNA candidate targeting the full spike protein — the same target choice as Moderna — and launched a 30,000-person final-stage trial.
Even though Pfizer didn't take research funding from Warp Speed, the US government signed a deal to pay $2 billion for 100 million doses of Pfizer and BioNTech's vaccine, with the option to buy even more.
As the vaccine race heated up, so did the surrounding politics.
President Donald Trump repeatedly talked up the likelihood of having a vaccine by Election Day, a politically driven timeline that was widely viewed as unlikely. Polls suggested that the public was increasingly concerned about a rushed vaccine process.
While independent scientists fretted over the politicization of the vaccine process, Bourla doubled down on the October timeline. In September, Bourla appeared on the "Today" show and CBS's "Face the Nation" to predict that "we will have an answer by the end of October."
No other drugmaker put forward such a bold prediction.
October came and went, with no results from Pfizer's study. On an earnings call on October 27, as Wall Street analysts asked him about the latest on the trial, Bourla asked for patience from investors and the public.
Pfizer learned of the positive results on Sunday, a day after Joe Biden was widely named the president-elect and less than a week after the election.
Validation for Pfizer and BioNTech and much-needed positive news for the world
The initial results suggest strong efficacy for Pfizer's vaccine; the company said it was found to be more than 90% effective at preventing COVID-19.
Pfizer plans to apply for an emergency use authorization with US regulators in the second half of this month, after collecting more safety data.
It's unclear how long the US Food and Drug Administration would take to review the application and make a decision. It also remains to be seen whether an emergency use authorization would be limited to high-risk groups, such as frontline healthcare workers or older people with underlying health problems.
Even with the trial's success, it's not mission accomplished by any means. The pandemic is still raging across the world, and Pfizer and BioNTech's vaccine has some significant limitations.
For one, there won't be many shots to go around. Pfizer and BioNTech are hoping to deliver 50 million doses across the world by the end of 2020, with production ramping up in 2021 to produce more than 1 billion.
The doses need to be kept at ultra-cold temperatures — about negative 94 degrees Fahrenheit — making distribution a challenge. And the vaccine is given as two doses, three weeks apart; it could be challenging to make sure people get their second doses.
We also don't know how well the vaccine will work in the real world. Tracking its use across millions of people will be the only way to learn exactly how protective the shots are and whether there are any rare but serious side effects.
People should expect to keep wearing masks and social distancing for a while longer.
But even if a vaccine on its own won't immediately halt a pandemic, it's an invaluable tool in charting the way out.
The next era of the pandemic has begun, and society just might finally have the upper hand.
Get the latest Pfizer stock price here.
Do you have a personal experience with the coronavirus you’d like to share? Or a tip on how your town or community is handling the pandemic? Please email [email protected] and tell us your story.
Get the latest coronavirus business & economic impact analysis from Business Insider Intelligence on how COVID-19 is affecting industries.
Source: Read Full Article