What Does It Take to Make a COVID-19 Vaccine?

So much about COVID-19 isn’t fully understood, like how exactly it spreads or when it will end. One of the few certainties, however, is that humans have little immunity to the SARS-COV-2 virus strain responsible for the COVID-19 pandemic. Researchers around the world are racing to develop a vaccine to change that.

One company at the forefront of COVID-19 vaccine research is Johnson & Johnson. On January 29, 2020, the brand announced its pharmaceutical division, Janssen Pharmaceutical Companies, would begin vaccine research. Since then, Johnson & Johnson has stated a vaccine could be available as soon as early next year. 

In the world of vaccine production, a matter of months is an unheard-of turnaround time. The vaccine testing and approval process usually takes years. How is Johnson & Johnson fast-tracking the process and how feasible is this timeline? Anisa Arsenault, senior editor at Verywell Health, spoke with Richard Nettles, MD, Vice President, Medical Affairs, Janssen Infectious Diseases, Janssen Scientific Affairs, LLC, to find out. 

Verywell Health: Can you give us a little bit of background on Johnson & Johnson’s role in vaccine research so far?

Dr. Nettles: Using our vaccine platform, we have been developing vaccines against Ebola, HIV, RSV, and Zika. We took notice of the coronavirus infection in December 2019 as it spread in China. An important landmark for us was the release of the genetic code of COVID-19 from China in January 2020. That allowed us to begin producing and experimenting with a vaccine. 

Verywell Health: What is the intended timeline of a COVID-19 vaccine? 

Dr. Nettles: Last week [March 30], we announced that we had selected our lead candidate for a vaccine against COVID-19. We will take that lead candidate into a Phase 1 human clinical trial by September of 2020. We’ve also announced that we have begun production of the vaccine at risk with a goal of having an emergency use distribution of our vaccine as early as the first quarter of 2021. 

Verywell Health: What does it mean to say you’re producing the vaccine “at risk?” Does this speed up the process?

Dr. Nettles: What I mean when I say we’re producing it “at risk” is we’re not waiting until we see the results of the Phase 1 clinical trial to show that the vaccine works before producing large amounts of it. 

In vaccine and drug development, you march through a series of large human clinical trials. You start in a Phase 1 clinical trial, which is a small number of people, then you move into a phase 2 clinical trial, which is a medium number of people, and a phase 3 clinical trial, which is a large number of people. Then you seek approval of the product from health authorities. 

Traditionally, it’s not until the latest stages of those [human] clinical trials that you begin to produce large amounts of your product—in this case, of your vaccine. But we’re accelerating and ramping up production as fast as we can right now. 

Verywell Health: So a vaccine will be produced even if clinical trials are unsuccessful? 

Dr. Nettles: In that Phase 1 clinical trial, we might show that the vaccine doesn’t work, or that it’s not safe, in which case we will have built up a large amount of vaccine that we can’t use in humans. Clinical trials are important to show that the vaccine is successful in producing an immunologic response that could protect individuals against COVID-19. We’ll also be able to evaluate the safety of that vaccine in humans. That’s a critical step before vaccinating large numbers of people.

Verywell Health: How was the genetic code of COVID-19 determined when vaccine research began? What was step one? 

Dr. Nettles: What you need to do is isolate the coronavirus (COVID-19) itself, and then understand the structure of the virus and how it is coded with a genetic sequence. That’s important because to make a vaccine, you need to be able to produce a portion of the virus for your immune system to begin to make antibodies against it. In other words, the genetic sequence of COVID-19 allows us to modify our vaccine so that once it’s administered into your body, your body will produce antibodies against that coronavirus. 

Verywell Health: Do you need someone who has been infected to figure out this genetic sequence in the first place?

Dr. Nettles: I wouldn’t say you necessarily need somebody who has been infected in the past; you need the virus. The virus exists all over the environment in different types of animals. But typically, with a virus that’s important for human health, yes, you would get the virus and its genetic sequence from a human who’s infected.

Verywell Health: What exactly goes into a vaccine? Does it involve repurposing an older vaccine? 

Dr. Nettles: Vaccines are produced differently among different manufacturers. With Johnson & Johnson, we use something called AdVac technology, which relies on an adenovirus—a virus that causes common colds. We cut out a piece of the adenovirus’s genetic sequence, making it unable to reproduce itself. Then, we plug in the genetic code from COVID-19.

This AdVac technology is what Johnson & Johnson uses with our HIV, Zika, and Ebola vaccines, which have been used safely in over 50,000 individuals. We are leveraging that AdVac platform—that adenovirus platform—but we’ve plugged in a specific part of COVID-19 instead of the other diseases.

Verywell Health: Why is it important to still have a vaccine for COVID-19 even months after the peak of the pandemic? 

Dr. Nettles: The closest analogy to use to explain the situation is another respiratory infection, like influenza, that tends to come up over and over again as it circulates around the globe. Just because you’ve had the flu one time doesn’t mean you can never get it again. At this time, we don’t actually know how COVID-19 is going to behave, or if it will be something that behaves like influenza. But let’s assume that it will. Even if you’ve now contracted COVID-19 and recovered, it’s important to receive vaccinations in the future to make sure that your immune response stays strong and hopefully prevents you from getting it again.

Verywell Health: Are there criteria determining how initial batches of the vaccine would be distributed? 

Dr. Nettles: Johnson & Johnson would partner with local and international government and regulatory non-governmental organizations to make the vaccine available. In an optimal situation, those groups would provide the prioritization of who gets the vaccine first.  

Verywell Health: Speaking of government organizations, can you explain Johnson & Johnson’s partnership with BARDA? 

Dr. Nettles: BARDA—the Biomedical Advanced Research and Development Authority—is a part of the U.S. federal government whose mission is to prepare for situations like this, including pandemics, bioterrorism, or nuclear attack. We have partnered with BARDA in the past on things like preparing for an influenza pandemic. Now, Johnson & Johnson and BARDA have committed to a billion dollars worth of investment to develop a COVID-19 vaccine, conduct clinical trials, and support the upscaling of production. We’re also partnering with BARDA to screen a series of compounds to try and find a treatment for COVID-19 for individuals who are already infected. 

Verywell Health: What does treatment look like at this phase? 

Dr. Nettles: We will start with compounds or medications that are already approved for other uses. This is because they’ve been shown to be safe and effective for other uses. So if we could find a drug that is already approved for something else that has antiviral activity against COVID-19, that would be wonderful, because we could just repurpose it and use it in people who are very ill. As we screen our library, we’ll look at compounds that are already in development for other things, and then compounds which may not be in development at all. And we’ll do that in a sequential way to try to find something as fast as we can that would be available to as many people as possible. 

Verywell Health: Are you hopeful about vaccine research so far? 

Dr. Nettles: It’s very inspirational to see my colleagues and their teams working 24 hours a day to try and move this forward as fast as we possibly can. As the largest healthcare company in the world, we view this as something we must do. It’s really promising that other academic and pharmaceutical companies are all working on different vaccines at the same time because we’re going to need all of them. If some of them don’t work, others will. The goal is to make sure we have several vaccines that are safe and effective. Johnson & Johnson plans to have backup vaccines in development too, in the event that the first one chosen doesn’t work.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.