Interview with Dr. Luciana Borio – Part 2

Dr. Luciana Borio (LB)
Randy Larsen (RL)
May 4, 2020

Part 2 – Vaccines for COVID-19

RL  I’ve been hearing people say we can have a vaccine within a year to 18 months, but others are not so optimistic. What is your prediction?

LB  Well … we’ve never developed a vaccine from start to finish in 18 months. It’s certainly going to take a concerted effort by major pharmaceutical companies. But it is worth remembering that the science of vaccine development has progressed a lot in the last decade. All of the candidates that are in development right now are the result of years and years of funding and support for biomedical research. 

Some of them are highly innovative, including the first vaccine candidate that entered clinical studies, manufactured by Moderna. The candidate is an mRNA vaccine. Unlike more traditional vaccines which introduces an antigen into the body to stimulate the immune response, mRNA vaccines work by introducing an mRNA sequence that is coded for the antigen of interest. The body itself produces the antigen from the mRNA sequence, and the antigen then stimulates the immune system to fight the infection of interest. This type of vaccine can be developed faster than traditional vaccines.

The origins of an mRNA vaccine go back to research at DARPA—the Defense Advanced Research Projects Agency. In theory, this could be a game changer, but we won’t know if it will work until we complete clinical studies on people to test for safety and efficacy. These clinical studies are already underway.

RL  Okay. I understand that Moderna is a rather small company. And actually I think the government has provided substantial funding to prepare for large-scale production… close to a half a billion dollars … in case it does prove to be a safe and effective vaccine, because this small company has no capability to rapidly make hundreds of million doses.

LB  There are several companies working on several candidate vaccines.  It seems to me that in the case of COVID-19, nobody is waiting for the completion of clinical trials to start manufacturing product at risk … which is fascinating because it’s the first time … that I know of …that developers are ramping up large-scale production capacity while still in early stages of testing … before they know if it is safe and effective. They are doing this “at risk” because we are in the midst of a deadly pandemic, and every day counts. We don’t want to be in a position of where we find a safe an effective vaccine, but not ready to produce large quantities. So there is a lot of ongoing dialogue and new industry partnerships happening on a scale never seen before.

In addition to Moderna, Johnson & Johnson has a well establish technology for making vaccines that they are leveraging for COVID-19. They’ve announced they will start clinical trials in September. And even though J&J is a pharmaceutical industry partner, they are also establishing partnerships to augment their manufacturing capacity. 

There is also a vaccine developed by Oxford, which has established  agreements with manufacturers in the UK and with the Serum Institute of India, so a large number of doses can be manufactured for quick distribution should their vaccine advance in clinical studies.

These are just a few examples. There are many more. I keep track of new developments on the Biocentury website, available at https://www.biocentury.com/coronavirus. They have removed the paywall, which is great. 

RL  Let me, let me interrupt. You used the term “at risk” and I want to make sure everybody understands what you mean. You said they are developing this vaccine “at risk” … and that is going to get a lot of attention if taken out of context.  When you say “at risk” you mean they’re investing money in the capability to mass-produce a vaccine before they know whether it’s going to be FDA approved. It’s not “at risk” to the people who would the get vaccine, right?  

LB  YES! That’s really important. It’s “at risk” for the company … a business risk. Some companies are spending millions of their own money so they will be ready to mass produce vaccines if it turns out their vaccine is proven safe and effective in clinical trials. 

And in that regard, I think you know, we can’t lose sight of the fact that a vaccine that may be given to millions, hundreds of millions, or even billions of people around the world to curtail the pandemic really needs to have a strong safety record. 

The best way to establish safety and efficacy … at the same time, which is very efficient … is through adaptive randomized controlled clinical studies that start fairly small and continue to grow as more data accrue. The beauty of these studies … they’re so efficient because they allow early fielding of the product through the clinical study.  For example, the study can target highest risk individuals like healthcare workers … and you can also monitor the safety and efficacy in a single trial. The World Health Organization proposed these adaptive clinical trials be launch globally. The idea that to have one common protocol where individuals are randomized to placebo or the vaccine that is being tested, and as soon as you establish that one is a winner, it can become the new control arm and the placebo can go away. Other vaccines can be added or removed from this trial as you learn what works and what doesn’t. 

This proposal is creative, adaptive, innovative, but requires global cooperation.

RL  Okay, good to know … great to know you are pretty confident that we will have a vaccine for COVID-19. Now, I’m going to ask you to step away from your role as a scientist, and ask you as a friend …how long do you think it’s really going to be until we have a large percentage of the U.S. population vaccinated?

LB   Well, I can’t predict that.   

I will say we should set ambitious goals. I think we should set very aggressive goals. And I think we should put our plans on paper … and of course be prepared to adjust midway, but we need to be ambitious. We have to really push the envelope because we need a vaccine to be able to control this pandemic and resume our lives.