Coronavirus Report: The Hill's Steve Clemons interviews Pfizer's Mikael Dolsten

The Hill's Steve Clemons interviews Pfizer's chief scientist Mikael Dolsten. 

Excerpts from the interview below:

On what he thinks the pharmaceutical world can produce to fight COVID-19.

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MIKAEL DOLSTEN: Thank you, Steve, for inviting me and Pfizer to share some of our thoughts on this unique opportunity to come together in the ecosystem between industry, federal agencies, and academia to take on this vicious virus. It's only been some four months or so that since the virus has emerged as a new disease that didn't have a name before as it didn't exist. And I must say it has been a tremendous rally of science and progress to provide hope that what looks like difficult trouble in time can be combated to get back as close as we can to a new normal. And I think right now I'm very encouraged by progress in both vaccines, therapeutics and look forward to sharing some of this promise and underlying data with you.

 

Clemons: Normally, there is a calendar challenge in developing and releasing new drugs and therapies, but I've read that you're optimistic that we're changing that and speeding up this drug development process in historic ways. 

DOLSTEN: Yes, I think given that we have such a new challenge — it's been an opportunity to explore new, more transparent ways to work together. And I think it's inspired the dialogues we have with the regulatory agency to be more facilitating, while at the same time, they want to ensure that the process incorporates the best advise for safe and effective vaccines or medicines. But I think it's moving to a level where we jointly look at the needs of the patient, and as the clock is ticking, trying to make months to weeks, weeks to days, and days to hours. And between companies, we're looking at ways to create a transparent pairing of experiences to learn quickly together, and that has been very stimulating — this reset of the system.

 

Clemons: I know that you have a partnership that you've announced with BioNTech on a potential vaccine. I know you've been working on antivirals as well and across different parts of the COVID-19 attack spectrum. Can you give us some idea of the various initiatives that Pfizer has in place now?

DOLSTEN: Yeah, at the onset off this pandemic, our CEO Albert Bourla defined a five-point plan to stimulate the way we work to get in the ecosystem and how Pfizer can contribute and bring forward its capability, experiences and resources. And one part included for us to leverage the two years of experience we had with a German biotech company BioNTech in bringing forward a new technology that's more rapid and agile and particularly suitable to address viruses that either emerge fast ... and also may change unexpectedly. And this is the technology that we then expanded our original flu partnership into a COVID-19 partnership to advance rapidly. And I'm pleased to say that we announced [yesterday] morning in a press release that our partnership got approved in Germany. We are starting clinical trials with a novel mRNA vaccine technology against COVID-19 and we expect them to start shortly and even imminently in Germany. And at the same time we are finding the requirements to start similar studies in the U.S. and they would be very much going hand in hand.

 

Clemons: In the article that you wrote in Forbes, you you shared a historical analogy about penicillin being pushed by the British government and the U.S. government as something that had to be developed and scaled during World War II. I didn’t now about this previously. What is similar about that experience to today?

DOLSTEN: While a crisis like this is are extreme and unfortunate and sad for all those that suffer, I think sometimes they can stimulate and catalyze, that we find new ways of overcoming obstacles because of the devastating threat we're facing. And if you look at the many tens of thousands of casualties, and even much larger passing a million of infected people. I think it forced us to think outside the box on how we can come together and make sure that we learn quickly and find new ways to bring vaccines and security. And I wanted to actually mention a statement by CDC Director [Robert] Redfield yesterday that while we feel that we have had a tremendous hard time the last few months, we need to take that learning and prepare for — who knows — an even bigger challenge as the flu season this fall will break in maybe September or October. And what if the [coronavirus] comes back, which is highly likely because it will not be expelled by that time because there is no vaccine. I think exactly the same kind of plan was emerging in our preparations here that we want to move swiftly against [COVID-19] now. But we can't wait to have credible and documented with faith in efficacy vaccine no later than October, when we may be hit by multiple viruses, and that enabled us to go backward, to say if we are to have a vaccine in millions of doses to protect people in the greatest need by October, what needs to happen every week until then? And that's the type of dialogue we have had with U.S. and German regulators. And I think this moon shot allows us to find new ways together. I'm optimistic that even though nobody thought it would be possible, that everyone said it will take 12-18 months at least — we now have a plan that's about half that time. And I think pending, you know, positive outcome in clinical studies, pending productive regulatory dialogue, there is a plan that could with a mix of extremely hard work — and no harm to have some luck — could enable you to have a solution that would expel the virus from the public society and bring back the confidence for those in greatest need that they may be protected. And that's really what we're working with.

 

Clemons: Mikael, the world is watching how this ecosystem of science and pharmaceutical firms responds to this crisis. As a vaccine and antivirals emerge, what are you views on accessibility and pricing for those who need these drugs?

DOLSTEN: I think accessibility for patients in need globally is very important for us. It's always important for us, but of course, with a pandemic, it puts this at the head. So, while we think there is a way forward to spend at risk before we have clinical data, manufacturing and assembling resources to be able to have millions of doses in October — and that is just to help those that are most vulnerable to the virus. The front linepeople of society and those that suffer from other diseases that make them fragile. So we think about bringing our resources together. And I think it was a sign of this partnership that we're working with a cutting edge biotech on the technology, but Pfizer’s experience going all the way back to penicillin, which you mentioned, and over many many decades to master this manufacturing network across the globe and without a partner to be able to think about hundreds of millions and even billions of doses. And I welcome the ecosystem to have more than one vaccine because we face this global pandemic. But it's really our vision here to step it up from millions to tens of millions, to hundreds of millions and even billions as we gather the experience and the momentum in this effort. That's the only way to bring back something that looked at least somewhat like we used to call a normal day. Although I think this pandemic, the biggest in a century for us, will change the world. Hopefully some aspect of what was normal when it comes to social networking, when it comes to be able to go in a grocery, when it comes to being able for patients to go to an emergency room, when it comes to what our intensive care unit looks like — that feeling of somewhat back to normal can only be brought back by the vaccine.

 

Clemons: This week we saw the NIH issue a report that a hydroxychloroquine study had no demonstrable positive impact on patients. We also have tensions over how to reopen the economy and protect public health. What are the illusions of progress we need to be careful of?

DOLSTEN: I think to really change this threat to public health, it's only vaccines and therapeutics that can really do that. But as we think about this threat and how we spend our life between that moment and now, it's always important to retain hope that we will be able to change this current very difficult time, that science will win. That's important to keep that hope. But to navigate cautiously. And I think the balance between not having a collapsing business and unemployment versus ensuring that we don't lose tens of thousands of lives — it is a delicate task. I just encourage that there is broad participation of all the necessary voices to make those difficult decisions. And when I was at the White House, I was really encouraged that we were some 20 different experts around the table, and that's my own advice to people — to continue inclusiveness in views and make sure that all aspects of societal concerns, sciences, and the business aspect of keeping society going is weighted equally in the final decision. And I do think it's important to think about today and move cautiously. I think rapid change from working at home to suddenly seeing people at restaurants and shops in kind of a historical way — that would not be a good way. But there may be a midpoint, where one can keep social distancing, where you can keep careful opening up of certain sectors and certain regions while monitoring through testing — and being willing to say we're moving cautiously and constantly incorporating scientific, medical and other social sciences into navigating through these crisis while the solution of a vaccine is the only way to get to a world where we can come back more to normal life. Security is what the physicians and patients need at the hospital. So while this was not a perfect one guiding principle, I think it reflects that cautious move and constantly taking feedback from the environment — and progress in science. Our contribution here is to accelerate the science and continue to give promise that in October we’ll start to have one of several vaccines that could be part of the changing society. And I hope that at the same time or even earlier, the therapeutics will help those with the greatest need. So, Steve. I hope that gave you a bit of a sense of the urgency and that there is progress.