The first vaccine in the United States has been granted emergency use authorization (EUA), with distribution underway and inoculation already begun among frontline healthcare providers and assisted-living facility residents. The mRNA vaccine technology has never before been approved, even for emergency use. The vaccine, from Pfizer and BioNTech, has received full approval in Canada and Saudi Arabia, as well as emergency use approval in Mexico and the United Kingdom. Questions remain, however, about Pfizer’s data and long-term studies. To learn more, we chatted with Pfizer’s vice president and chief scientific officer for viral vaccines, Philip Dormitzer, MD, PhD, who leads Pfizer’s research and development. You can listen and subscribe on Apple, Stitcher, and Spotify. And if you like what you hear, a five-star rating goes a long way toward helping us Track the Vax! Serena Marshall: We’ve heard so much about the mRNA vaccine process, from identifying the virus to development and distribution, all happening in less than a year. I’ve heard this referred to as the medical equivalent of a moon shot. How would you describe the process for Pfizer? Philip Dormitzer: Internally, it was called project Lightspeed. This has gone extraordinarily quickly. It’s the result of a couple of things. One is preparation. We’d started working on RNA vaccines before COVID-19. Second was a level of commitment, from both companies, to really do whatever is necessary to be able to address the pandemic quickly Serena Marshall: That’s quite a nickname that you gave the project. Do you feel that it lived up to it? Philip Dormitzer: I don’t know if it’s literally light speed, but it is certainly much faster than vaccine development has usually taken. A lot of that has been achieved by doing things in parallel that we would normally do sequentially. A lot of it is not just the physical things that need to be done. It’s making sure that if you need to get a group of very senior people together to make decisions, that happens right away. Serena Marshall: When you saw the efficacy results, were you surprised they were so high? Philip Dormitzer: We had designed our trial around an assumption … that we would see something on the order of 60 percent to 70 percent efficacy. So when it came back at 95 percent efficacy, we were obviously delighted, and also surprised. Serena Marshall: One of the questions that people have is, If I get the vaccine, can I still spread the virus? Philip Dormitzer: We don’t yet know if it prevents infection and will prevent spread. We hope that it will. But we don’t have the direct evidence in people yet. So certainly we do advise people who get the vaccine to continue with social distancing, mask wearing, and the other precautions. Serena Marshall: Do you know how long after getting the vaccine you have the antibody protection for? You submitted two months of data to the FDA. Do you have any data that goes beyond that at this point? Philip Dormitzer: We do not at this point, so we will be continuing to follow our trial participants for two years. Serena Marshall: When are you doing your next data collection of the current study participants? Philip Dormitzer: Data collection is really pretty continuous. The question is how often do you sort of dip in and analyze the data? We have a data safety monitoring board; and with the people in the trial, they meet every week to review the safety data. If a safety issue comes up, they can even meet more often than that if it is necessary. Serena Marshall: We’ve heard about some effects — that it does hurt, that you do have fatigue, headaches, muscle pain, chills. But that’s also a sign that your body’s responding to the vaccine. Philip Dormitzer: Not everybody experiences all those things. Some pain at the injection site, as with other vaccines, is certainly a very common thing. Of course, we always try to strike the balance between immunogenicity, the level of immune response you get, and tolerability. Serena Marshall: We have seen a couple of cases of severe allergic reactions in the UK. Philip Dormitzer: With the two individuals in the UK who did appear to have some reactions, it’s being investigated. So we need to find out more. Serena Marshall: The UK did not recommend it for pregnant women. But the American College of Obstetrics and Gynecology said that they encourage the use of the vaccine. So what do you say to those women when it comes to deciding whether or not to take this vaccine? Philip Dormitzer: Women who are pregnant should have a conversation with their doctor on receiving the vaccine. We have a lot of data in nonpregnant women. But we excluded pregnant women from enrolling in the trial, in a trial of 44,000 people. That is a precaution that’s generally taken, that we want to first test in nonpregnant people before we test in pregnant women. We also wanted to get some of these preclinical data on developmental and reproductive toxicity before we started to intentionally immunize in pregnancy. These are the usual precautions we do just to be very careful as we first introduce something new to people. Of course, we know much more about the vaccine than when we first started that trial. Serena Marshall: One of the logistical concerns is the incredibly cold temperatures that this vaccine needs to be stored at. Are you working to create a more practical vaccine in the future that doesn’t require such cold storage? Philip Dormitzer: We have a couple of types of activity in this area. One is that we’re doing ongoing testing of the vaccine around storage and transportation. We’re very, I’d say, conservative. The temperatures that we recommend for transportation storage are those that we have proved preserve the vaccine with potency. As we gather more data on how the vaccine does at more mild temperatures of storage and distribution, we may be able to change those recommendations. But it’s going to be data-driven.
