How a risky bet on experimental biotechnology led to a COVID-19 vaccine: 60 minutes

More than 15,000 members of our family, friends and neighbors fell for the coronavirus last week. So we almost heard a sigh of national relief when the pharmaceutical company, Pfizer, began administering the first doses of its vaccine nationwide. Pfizer, a frequent advertiser of this issue, and its German partner, BioNTech, were the only major vaccine developers to reject federal money for research and development, although they were the first to obtain the FDA emergency use authorization. On Friday, permission was also granted to the Modern Biotechnology Company. Under Operation Warp Speed, the federal government set a target of 20 million inoculations by the end of the year. But that goal can be ambitious; the launch of the vaccine has been rocky. However, for the first time since the success of the pandemic there seems to be an end in sight, thanks to a revolutionary breakthrough in biotechnology.

Bill Whitaker: This is a global pandemic, the worst in a century. A vaccine with this technology had never hit the market before. It’s a big bet you made for this to work.

Kathrin Jansen: Yeah, I didn’t see it that much, maybe as a gamble because we’re scientists. This is what we do to live each day. We discover new things. Everything is new.

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Kathrin Jansen

Kathrin Jansen is the head of vaccine research and development at Pfizer. Based in New York, it is one of the largest pharmaceutical companies in the world. Jansen, who had an interest in science as a child in Germany, grew up developing vaccines against pneumonia and the HPV virus. So when he first learned about the coronavirus, his thoughts immediately became a vaccine.

Bill Whitaker: When you started this mission, New York was on fire with this virus.

Kathrin Jansen: Yes. We lived in a hot area in New York. And we saw first hand what was happening, every day. And Bill, the scariest thing for me was when we were walking our dog. And you see one refrigerated truck after another appearing in parking lots in front of hospitals.

Bill Whitaker: Refrigerated Truck Cell Phones?

Kathrin Jansen: Morgues, right. This absolutely fueled the desire to introduce a vaccine, regardless of what was needed.

Bill Whitaker: Was that a personal thing?

Kathrin Jansen: I took it very personally. I wanted to fight her, beat her, fight her. It was … nothing else mattered.

Across the Atlantic, in Mainz, German doctors Ugur Sahin and Ozlem Tureci also focused on the fight against coronavirus. Founders of a leading biotech company called BioNTech, had collaborated with Pfizer on a flu vaccine when Sahin read an article (January 24) about a mysterious disease in Wuhan, China.

Dr. Ugur Sahin: We knew we were likely to encounter a global pandemic. And we knew we didn’t have time to waste.

Dr. Ozlem Tureci: We started thinking, how to implement, a vaccine development program basically from scratch, and so we had to pivot the whole company.

Bill Whitaker: Did you have any doubts about doing that?

Dr. Ugur Sahin: I had no doubts. The only thing that worried me was that we might arrive too late.

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Ugur Sahin and Ozlem Tureci

The married couple’s company, BioNTech, is doing pioneering work in vaccines made with mRNA, molecules in our cells that transmit genetic instructions from our DNA to particles that make proteins, the basic components of life. .

Dr. Ugur Sahin: We felt the responsibility to start developing a vaccine, because we knew the power of our technology.

Manipulation of mRNA molecules in the laboratory to fight disease has been considered a promising technology for over 30 years, but has never produced a proven vaccine. With the spread of the coronavirus throughout Europe, Sahin and Tureci redoubled their efforts. By February, BioNTech had produced 20 different versions of mRNA that triggered immune responses in mice and monkeys. Sahin knew his small business would need help to take the research beyond the lab, so he picked up the phone and called his Pfizer friend Kathrin Jansen.

Dra. Ugur Sahin: And he said, “Ugur, why are you calling me?” And I said, “Kathrin, we started getting a vaccine against COVID-19. I wanted to ask you if you think Pfizer would join us.” And he said, “Of course, Ugur, I really wanted to call you because we’re also interested in developing a vaccine and it will become our most important project.”

It became more of an obsession for Pfizer CEO Albert Bourla …

Albert Bourla: What I thought was if, if not us, then who? We have a lot of experience with vaccines. We have a lot of manufacturing capacity with vaccines. I went and said, “We need to do something to see if we can help develop a medical solution.”

Since March, he has been pushing Pfizer scientists to develop a vaccine quickly. He set a deadline for October.

Albert Bourla: Then, of course, I also gave them some tools in their hands. I told them they should think this is not normal. The return on investment is not taken into account. This is considered w– to have an open checkbook, true –

Bill Whitaker: An open checkbook.

Albert Bourla: Yes.

Bill Whitaker: Did you have any idea what you would be willing to spend?

Albert Bourla: It will cost us about $ 2 billion. And I knew that if we failed and we had to write it down, it would be very painful. But it will not remove Pfizer.

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Albert Bourla

Kathrin Jansen convinced her boss, Albert Bourla, that mRNA technology had the best chance of meeting its deadline. From her work with BioNTech on an influenza vaccine, she was convinced that mRNA was at the peak of a breakthrough. Thus, the CEO of Pfizer, Bourla, signed the partnership and rolled the dice on experimental technology.

Bill Whitaker: There were a lot of chances of not being successful.

Albert Bourla: I believe in the power of science. I believe in the power of the private sector. And I believe in the miracles that private sector science can do for humanity.

Unlike old-school vaccines made with real viruses that often grow slowly in eggs, these mRNA molecules are quickly produced in a laboratory, programmed with a bit of the virus’s genetic code. We’ve all seen images of the coronavirus with its spike protein crown. The mRNA vaccine tells healthy cells to replicate the tips. They may not make you sick, but they do teach the immune system what the virus is like. If the real virus appears, the antibodies in the immune system will attack.

In May, Pfizer was ready to start testing the vaccine in different parts of the US

Dr. Mark Mulligan: And I raised my hand and said yes.

They played Dr. Mark Mulligan, director of the NYU-Langone Vaccine Center in Manhattan.

Dr. Mark Mulligan: I’ve worked on HIV / AIDS vaccines, Zika, pandemic vaccines against Ebola and the flu. So this is the time when we dedicate ourselves to saying and saying, “Okay, let’s do it. Let’s try to be part of the solution.”

Nearly 44,000 people worldwide volunteered for the phase-blind double-blind trials, which tested placebo vaccines; most were between 16 and 85 years old. Researchers faced some skepticism when looking for African-American and Hispanic volunteers.

Bill Whitaker: Were these communities well represented in the trials?

Dr. Mark Mulligan: I think so. If you add the Hispanic population, the black African American and the Native American population, it would reach a little less than 40%. We wish we had done a little better, especially with African Americans. We were just under 10%. But I think overall it’s good and we’ve had several town halls with community partners in Harlem. It’s important that we can say, “Yes. We tested it in your community. Yes, it was equally tolerated, safe, and just as protective.

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Dr. Mark Mulligan

Phase trials are usually performed sequentially. To expedite the process, the FDA allowed these trials to run simultaneously. Dr. Mulligan told us he had never seen him so fast.

Bill Whitaker: What do you say to people who worry that this was going too fast and that it’s being launched?

Dr. Mark Mulligan: Given the huge public health emergency we are experiencing internationally, it was convenient to use full speed. I’ve been doing vaccine tests for 30 years and I promise I haven’t cut corners in the usual safety assessments.

Volunteer blood samples were taken to this Pfizer facility in Pearl River, New York, where these robots ran day and night helping to analyze the effectiveness of the vaccine. They will continue to collect and analyze samples for two years.

Kathrin Jansen: These robots have probably handled over 180,000 tests.

When the critical results of the third phase were revealed last month, Kathrin Jansen was taking a break in the country with her husband. He received a call from Pfizer CEO Albert Bourla.

Kathrin Jansen: And I said, “What’s up, Albert?” He said, “Well, Kathrin, we’ve talked to the FDA. We can say the vaccine is over 90% effective.” And I said, “What? (LAUGHS) That’s great.” So my husband and I were standing right next to me, we … jumping up and down.

Dr. Mark Mulligan: Having a much-needed vaccine that was 95% protective and produced so quickly is incomparable in my experience.

Bill Whitaker: Can we all say goodbye to our masks?

Dr. Mark Mulligan: I’m afraid not. We are not yet sure that vaccines will prevent asymptomatic infection. Probably the vaccine will not make a difference in this current wave that we are.

Bill Whitaker: We’ll still be having a while.

Dr. Mark Mulligan: Absolutely. This will not be like a light switch that is on / off, but rather like those darker switches that we turn slowly to turn on the lights. 5%, 10%, 20% 50% of people vaccinated for months. But to end the pandemic in 2021, we need to vaccinate probably 75% of people and then we can stop it.

There are still a number of unknowns about this vaccine: how long it lasts; there are long-term safety issues, why have some people had severe allergic reactions? It is still to be tested in young children and pregnant women. But the most urgent issue: rugged deployment. The development of the vaccine was rapid, but so far the distribution has been anything but. Pfizer reduced the planned number of doses by 2020 by more than 50%, citing a shortage of raw materials. States complain that they do not receive clear guidelines from Operation Federal Warp Speed ​​from the federal government on what they receive and when. At the moment, the light at the end of the tunnel is still dim.

Last week, when the number of U.S. deaths from the pandemic reached 300,000, the bells of Washington, DC’s national cathedral rang 300 times, once for every thousand Americans killed by the virus.

Bill Whitaker: This vaccine has been called a miracle. How would you describe it?

Kathrin Jansen: We can say a miracle. But a miracle always makes sense just happened. It just didn’t happen. Right? It was a deliberate thing. It was with passion, done with passion. It was urgent. I always had this devastating disease in front of me.

Produced by Marc Lieberman. Associate producer, Ali Rawaf. Partner of the broadcast, Emilio Almonte. Edited by Sean Kelly.

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