Alumnus Evan Anderson ’95 on Managing Clinical Trials for COVID-19 Vaccines

Back in April 2020, we spoke to Dr. Anderson ’95, a Chemistry major at Wheaton, about his work in managing a clinical trial for the Moderna COVID-19 vaccine. Recently, we were able to catch up with Anderson again about his ongoing work with the clinical trials, including the Moderna mRNA-1273 COVID-19 vaccine which recently received an Emergency Use Authorization from the U.S. Food and Drug Administration. We also asked him some pertinent questions about vaccines in general. Here’s what he had to say:

How is the progress on the clinical trials?

The initial Phase 1 Study is still ongoing with the first people who received the mRNA vaccine. We have then been involved with two Phase 3 studies—one was the Moderna mRNA vaccine study, and the other was the Janssen Ad26.COV2.S study.

Initial results are out for the Moderna study showing a high degree of efficacy—94.1 percent, with complete prevention of severe COVID-19 infection. Obviously, this is great news, and we’re very grateful for some good news right now. The Moderna study is still ongoing with trial participants getting unblinded [In other words, those who received the placebo during the trial are now getting the actual vaccine]. This is quite exciting for our participants, and they’ll be followed up for two years following their second dose to follow safety and for any breakthrough infections in which vaccinated individuals contract the virus. The Janssen study is ongoing. It’s a single-dose vaccine study without data yet about its safety and efficacy.

What does it mean for you to be a part of this groundbreaking research—particularly the Moderna vaccine?

It’s really quite exciting to have been a part of developing the Moderna vaccine from almost the very beginning all the way through to provisional licensure (that’s the Emergency Use Authorization that the vaccine is currently under). Hopefully, it will receive full licensure in a few months.

What would you say to people who are questioning the safety of the preventative COVID-19 vaccines?

These are huge clinical trials. With the Moderna vaccine study, there were 30,000 people that received either vaccine or placebo and then were followed in a blinded fashion for safety and efficacy. [In other words, trial participants don’t know whether they’ve received the actual vaccine or the placebo]. As such, it’s very high-quality scientific data that is now published and available for anyone to read. For both the Moderna and Pfizer vaccine, the phase 3 clinical trials have been conducted with a remarkable amount of transparency, including their presentations to the FDA and Advisory Committee on Immunization Practices. It’s really remarkable to have this high degree of efficacy for the vaccine in comparison to those that received the placebo. 

There are local symptoms or systemic side effects people will experience shortly after receiving the vaccine. That’s what we call "reactogenicity," when the immune system becomes active and recognizes the spike protein. Those local symptoms would be pain, redness, swelling, tenderness or soreness at the site of the injection. There are also systemic side effects—fever, chills, achiness, headache, nausea, or joint aches—that may be experienced during the few days after receiving the vaccine. Those symptoms are expected in some people that receive the vaccine. That’s when the immune system turns on and begins to do its job in developing an immune response. This immune response now clearly correlates with protection from COVID-19 infection. 

Can you describe why this vaccine was able to be produced so much more quickly than other vaccines?

This is a good example of a true medical advance. It’s a new technology, which had been previously studied in small trials, and it had looked promising, but it had never made it all the way to licensure. There had been efforts on the part of NIH and other groups to investigate mRNA vaccines. Moderna had done several prior studies and then BioNTech had also done some prior work. People had been thinking about pandemic preparedness, assuming we will see additional pandemics in the future—probably from flu in particular—and mRNA was considered a potentially rapid strategy for vaccine manufacturing. So, when SARS-CoV-2 was identified and the sequence was known, it was then very easy to use the technology and move forward quickly to clinical trials.

Additionally, the composition of the vaccine and the way it works in the body also allow for quicker production unlike two other protein vaccine studies that have received substantial federal funding—the Novavax and Sanofi / GSK. With the mRNA vaccine, there aren’t time-consuming issues such as creating a protein and making sure it’s in the right shape and that it has a very high degree of purity. Vaccines using this older technology are just now beginning to move into Phase 3 clinical trials.  

Instead, with the mRNA vaccine, it’s just using the genetic sequence from the spike protein, along with some cholesterol and some lipids that allow the vaccine to get into the cells. That’s where it does its job of turning on the cellular [functions] and then the body itself just produces the protein from the mRNA. The body doesn’t distinguish between the mRNA from the vaccine and the mRNA that the cells are normally generating every second. Since you just need the sequence for the protein of interest, you can start generating the vaccine the same day you have the sequence. It’s really a remarkable advance. After a very difficult year, it is good to have some good news as we enter 2021.  

The viral vectored vaccines (e.g., Janssen) are also moving quickly towards having data from their Phase 3 studies. Hopefully, this data will be positive. I think the more safe and effective vaccines that we have fully tested and FDA approved, the sooner everyone can get vaccinated. The sooner this happens, the sooner we can move past COVID-19 and towards a "new normal" that looks something like 2019.

Are you concerned about the new virus strains that are coming out of England and South Africa?

The virus is doing what all RNA viruses do, which is to develop new mutations. Some of these could allow the virus to spread more quickly. You see this in other RNA viruses as well. Most of these mutations are occurring in small areas of the virus. The immune responses produced by the vaccines are fairly broad—so though it’s possible—it’s unlikely that any of single mutation is going to confer complete resistance to the vaccine, but we don’t know that for sure yet. Individual mutations are not something that keeps me up at night worrying. 

The South African variant is more concerning as multiple mutations have accumulated. In data just released, it does appear that the vaccine still results in antibodies that bind this virus.

If there was resistance that started to develop, one of the nice things about an mRNA vaccine is that you can very rapidly change the vaccine just by changing the genetic sequence in the vaccine. Obviously, you’d want to repeat clinical trials with the change of the vaccine, but that’s one of the potential upsides of the mRNA vaccine. It’s much more flexible than many of the older technologies. 

What are your thoughts on the vaccine rollout?

It’s just a huge challenge to begin to roll out the vaccine, even with a lot of smart people working on it. With states already taxed with COVID-19 response efforts, there were always going to be challenges with relying on state infrastructure to roll out the vaccine. We’re going to have more bumps and it’s not going to be smooth, but hopefully vaccine production and distribution will continue to ramp up, making it more broadly available to people over the coming months.

How does your faith intersect with your work?

I think it certainly provides a lot of hope. I know a lot of people that are very depressed and fearful of COVID-19 and of death. I have found it a great source of strength in the midst of these trying times. At times the whole situation has been incredibly discouraging and overwhelming. My wife, Catherine Barnes Anderson ’96 has been a great encourager during these days and provided me with a much-needed external perspective. I’m also very grateful for my church, in particular, for their efforts to step into addressing the incredible challenge of COVID-19.

Any advice for Wheaton students?

We need really bright people to go into science and medicine. I think a Wheaton education provides really outstanding training for future scientists, physicians, and leaders. Personally, I would love to see more Wheaton graduates going into academic careers where they are educating the next generation of physicians and scientists along with advancing medicine and science. A Wheaton education prepares you well for doing this.