After three decades in the pharmaceutical industry, Mikael Dolsten, a senior Pfizer executive, knew it was better not to be overconfident in the face of arguably the most closely watched clinical tests in history.
On Sunday, for one of the greatest moments of his career, he found himself hanging out with other top executives at the pharmaceutical giant in a Connecticut office. Results were available for the final phase of the Pfizer coronavirus vaccine clinical trial. Dolsten was sitting next to managing director Albert Bourla when he received a call from Webex to find out if the vaccine was working.
“On the one hand, there was cautious optimism,” Dolsten told NewsABC.net. “On the other hand, we also had respect for the fact that we can never be sure about the result of a clinical study”.
Two senior research leaders appeared on-screen to share what they had just heard from the independent panel of experts overseeing the process: The study was a success.
Moments later, this was crowned by more amazing news that tore some of Pfizer’s executives from their chairs: Initial data indicated an overwhelming effectiveness of more than 90 percent. In fact, many virologists were hoping for an effective vaccine that could prevent 70 or 80 percent of the Covid-19 disease caused by the coronavirus.
‘Nothing comes close when you’ve seen all the suffering’
Learning that the study was successful was the best moment of his 30-year professional career, said Dolsten. “Nothing comes even close, especially when you’ve seen all the suffering,” said Dolsten. He means the time he spent with health care workers in New York City, an early epicenter of the coronavirus outbreak in the United States. “We can really change the course of this pandemic,” he said.
Eight months after the official announcement of their vaccine research plan, Pfizer and its German partner Biontech have made an unprecedented achievement in science to develop an effective vaccine. Less than a year after the novel coronavirus was even discovered.
Of course, the pandemic is far from over. The immediate effects of the vaccine are still unclear as the quantities available will be extremely limited. Pfizer faces enormous logistical challenges in distributing the vaccine, especially since the vaccine has to be stored in extremely cold temperatures and given in two doses three weeks apart.
No detailed information can yet be provided from the study. Pfizer did not publish the data in a medical journal, and Monday’s press release contained only a comprehensive success story. It did not contain any information on the level of safety, apart from the fact that no serious side effects have been observed. The vaccine also has to be tested and approved by the authorities before it can be widely used.
Still, just getting to that point – success in a late-stage vaccine study – is a remarkable achievement. Pfizer and Biontech were able to shorten a process that used to take several years. In doing so, they create a new basis for effectively combating future epidemics and at the same time help to lead the world out of the current crisis.
Good news related to the pandemic is badly needed, especially given that much of the world is preparing for a harsh winter. In the past week, there were an average of more than 110,000 new Covid-19 cases per day in the United States alone – an all-time high. And so the world’s first effective vaccine against the coronavirus was developed.
A report of infections in a family of 6 in China prompted an investor call
At the end of January, Ugur Sahin read a newspaper article that pointed to the death and misery 2020 holds in store for the world. Sahin is a 55-year-old biotech entrepreneur and one of the founders of Biontech. He was intrigued by a report from researchers describing the strange case of a family of six in China who became infected with the novel virus, FiercePharma reported. The researchers demonstrated a forward-looking understanding of the risks posed by the novel coronavirus, including its ability to spread rapidly from person to person and from region to region.
After reading the article in “The Lancet”, Sahin called one of his largest shareholders, the German billionaire Thomas Strüngmann. Sahin told Strüngmann of an impending pandemic that would lead to the closure of schools and presented his plans to develop a vaccine.
“After the weekend, he contacted his team directly on Monday. And although most of them worked in oncology, he switched most of his team to the vaccine, ”Strüngmann recalled in an interview with Forbes.
A few days earlier, Sahin had presented his company Biontech at the largest healthcare investment conference of the year as a next-generation cancer immunotherapy company – to an audience full of investors. Since the company was founded in 2008, Sahin’s ambition has been to develop cancer drugs.
But now the company had shifted its scientific talent to developing a vaccine for a novel infectious disease. With just a fraction of the attention Biontech ultimately received, the race for a vaccine against Covid-19 was on.
Pairing an untested technology with a 170 year old pharmaceutical manufacturer
Several dozen scientists at Biontech began researching a Covid-19 vaccine at the end of January. The work of the German biotech company was massively promoted by a previous research and development partner.
Biontech started working with Pfizer on a flu shot in 2018. Even if the work has not yet been tested on humans, Sahin used the connection and called Kathrin Jansen, the head of vaccine research at Pfizer, in February.
Jansen discussed the cooperation with Dolsten, the company’s chief scientist. For them, the key question was whether this outbreak would last longer than previous epidemics, which disappeared shortly before a vaccine was completed, Dolsten said.
On the evening of March 1st – the next day Dolsten was invited to the White House to talk about the pharmaceutical industry’s Covid-19 efforts – Pfizer’s executives spoke on the phone and finally saw that the virus would be around for a long time and they were on a vaccine should work. Two weeks later, Pfizer and Biontech announced their partnership. The two companies complement each other.
Pfizer has an international market presence, production capacity and regulatory expertise from more than 170 years of experience in the manufacture and sale of drugs. However, they have no vaccine technology that could respond quickly to a pandemic.
Biontech has never sold a drug in its short history. However, the company had promising technology for vaccine manufacturing.
This technology is based on mRNA. This is genetic material that transports information into cells and strengthens the immune system. Since the mRNA is based only on the genetic code, the scientists were able to produce an mRNA vaccine candidate from the genetic sequence of the virus. Conventional methods of vaccine development require live specimens and often slow cultivation processes for growing chicken eggs or cells.
The mRNA is promising, but it is also untested. There are still no state-approved mRNA-based therapeutics or vaccines. Other biotechs, notably Massachusetts-based upstart Moderna and German company Curevac, are also working with this technology.
Many investors were already enthusiastic about their early successes. Before the pandemic, Biontech and Moderna had market values of eight and six billion dollars, respectively. Now the two companies are valued at $ 25 billion and $ 30 billion, respectively.
Moderna and BioNTech are proving to be vaccine front runners
In the course of 2020, Moderna and Pfizer / Biontech prevailed as favorites in the race for a coronavirus vaccine.
Moderna had a clear lead: it had already manufactured its vaccine candidate at the end of January. On January 13, scientists from Moderna and the US National Institutes of Health finalized the final formula for the experimental vaccination, named mRNA-1273.
The Massachusetts-based biotech company was even planning to start testing on humans. At the time, the virus still seemed a distant, obscure threat to most western countries.
While Biontech worked with Pfizer, Moderna reached out to the NIH. Moderna built on two of the institution’s research on another coronavirus responsible for Middle Eastern Respiratory Syndrome (MERS). (Moderna is expected to deliver results later this month to show if its coronavirus vaccine is working).
On the same day people were given the world’s first experimental coronavirus vaccine from Moderna, Pfizer CEO Albert Bourla spoke to a group of executives from his company about Pfizer’s Covid-19 strategy, Forbes reported. “This is not business as usual,” Bourla told executives. “Financial profitability should never influence decisions.”
The following day, Pfizer and Biontech publicly announced that they had signed an agreement to expand research. And at the end of April the program was given a name that summarized its ambitions: ‘Project Lightspeed’.
Project Lightspeed did not participate in Operation Warp Speed
Pfizer and Biontech began human studies in late April, a little more than a month behind Moderna. Even then, Dolsten presented an ambitious schedule: He stated that the company would aim for emergency approval by autumn, possibly even in October.
Speed was an early priority in coronavirus vaccine research. In May, the US government launched its vaccine initiative called Operation Warp Speed. Its goal was to deliver 300 million doses of vaccine by January.
Pfizer and Biontech decided not to participate in Warp Speed. In June, Bourla spoke of the risk that receiving government funding would slow down research. He said Pfizer was content to self-fund the studies. By foregoing government funding, the company was able to independently design the late-stage clinical trial process.
Speed is a key element of the “new Pfizer”
Bourla has been Pfizer’s boss since 2019. The pandemic was also an opportunity for him to demonstrate the success of his vision of the “new Pfizer”. Bourla sees the company’s quick response to the pandemic as evidence of the “new Pfizer” – a contrast to the way large companies normally operate.
“How quickly we acted is not something that a big, powerful drug company would expect,” Bourla told Forbes in May. “That is a speed that one would envy an entrepreneurial biotech founder”.
In June, Bourla said the speed with which Pfizer responded to the coronavirus could be carried over to future research efforts. “Pretty soon the question ‘Why just Covid?’ Will arise,” he said at a Goldman Sachs health conference. “If we can prove that vaccines can be made in less than a year, why can’t we do the same with other drugs, like Cancer drugs, do? “
A politically motivated schedule to deliver the results before election day was not adhered to
During the summer, the first results for the four versions of the vaccine that Biontech and Pfizer were testing became known. By the end of July, they had selected an mRNA candidate that focused on the spike protein – Moderna also chose this basis. They then started the final phase of the clinical study, which included 30,000 people.
Pfizer did not receive any research funding from Warp Speed. However, the US government signed a $ 2 billion deal for a 100 million dose of vaccine from Pfizer and Biontech – with the option to buy more.
Just like the race for the vaccine, politics around this topic also heated up. President Donald Trump repeatedly spoke of the likelihood of having a vaccine by election day – a politically driven schedule that was widely considered unlikely. Surveys also indicated that the public was becoming increasingly concerned about an over-speed vaccination process.
Independent scientists resented the politicization of the process of making a vaccine. Bourla announced an even faster schedule for October. In September, Bourla appeared on Today and CBS’s Face the Nation, predicting that “we will have an answer by the end of October.” No other pharmaceutical company has made such a bold prediction.
October came and went without the results of the Pfizer study. During a quarterly earnings conference call on October 27th, Wall Street analysts asked him about the latest results of the study, prompting Bourla to ask investors and the public to be patient.
Pfizer learned of the positive results on Sunday. One day after Joe Biden was widely elected US President and less than a week after the election.
An award for Pfizer and Biontech and much-needed positive news for the world
Initial results suggest that Pfizer’s vaccine is highly effective. According to the company, it has been found to be more than 90 percent effective in preventing Covid-19.
Pfizer plans to apply to the US authorities for an emergency permit in the second half of this month. But first they want to collect more data on security.
It is unclear how long it will take the US Food and Drug Administration to review the application and make a decision. In addition, it remains to be seen whether an emergency permit would be restricted to high-risk groups, for example to employees in the healthcare sector or older people with health problems and previous illnesses.
Even with the success of the study, the mission is far from over. The pandemic is still raging around the world, and the Pfizer and Biontech vaccine has some significant limitations.
For one thing, there won’t be a lot of vaccinations. Pfizer and Biontech hope to deliver 50 million doses of vaccine worldwide by the end of 2020. Production is expected to increase to more than 1 billion in 2021.
In addition, the vaccine must be stored at ultra-cold temperatures – around minus 70 degrees Celsius. That makes distribution a challenge. In addition, the high effectiveness of the vaccine is only guaranteed by two doses at an interval of three weeks; so it could also be difficult to make sure people can get a second vaccination.
We don’t know how well the vaccine will work in the real world. Only when millions of people get vaccinated can we find out how effective and safe the vaccine is, and whether there are any rare but serious side effects.
People should expect to wear masks and stick to social distancing for a while longer. Even if a vaccine alone cannot stop the pandemic immediately, it is an indispensable tool in paving the way out of the pandemic. The next era of pandemic has begun and society may finally get the upper hand.
This article was translated from English and edited by Ilona Tomić. You can read the original here.