Should a COVID-19 vaccine be released prior to Phase 3 results? One doctor says no. Here’s why.

INDIANAPOLIS (WISH) – The Food and Drug Administration is considering releasing a COVID-19 vaccine to the public prior to Phase 3 clinical trial results. 

News 8 spoke with Dr. Suresh Mittal, distinguished professor of virology at Purdue University to get his thoughts. 

Gillis: The FDA is willing to emergency authorize a coronavirus vaccine making it available to the public prior to results of Phase 3 clinical trials. What are your thoughts?

Mittal: During any pandemic of infectious disease, we like to see any therapeutics or vaccines in this case as early as possible because a vaccine for any viral disease is key. We cannot get enough antibodies that fast to be effective. In a bacterial disease, we will be looking for antibodies more than a vaccine. So, for a viral disease a vaccine is key. So, that is our focus–one of our focuses–in addition to treatments, social distancing, wearing masks and hand hygiene. 

We’d like to get the vaccine as soon as possible, but as you see in the media, this can come with disadvantages. Suppose we want to get those vaccines out there and we start using them in people and find out it is not effective. That’s one thing. Also, what if they have side effects? And we use vaccines for healthy people…it’s not like a cancer treatment that we use for sick people. So, for healthy people we want to have the utmost safety and the second part comes the efficacy. 

If the safety is not there that leaves a big question mark and the efficacy–the second part–I think at this point the FDA is considering an efficacy of 50% and let it get released. When we need to have a vaccine at a faster pace…what is the main thing we look at there? A faster pace. But first we need safety and then we need efficacy. The way we define efficacy is–because we can challenge the people with the virus–so we have to come up with some parameter where we define efficacy. So, in this case the efficacy parameter is…are people developing antibodies? And how many antibodies are there that can fight the virus?

The second part would be if that vaccination is good enough to prevent the disease and if it can prevent the transmission because transmission is one of the important things. If a vaccine is not preventing the disease and not preventing the transmission, a person with the vaccine can get infection and virus replication and that person can spread infection to other people without knowing it. The same way we have asymptomatic people right now. So, that also has to stop transmission from the infected individual to other people. 

Gillis: The FDA is willing to fast-track the vaccine and in a report suggested distribution based on need into four phases: 1. frontline workers and high risk vulnerable populations; 2. Essential workers needed for society to function such as teachers and school staff and those with moderate underlying health conditions; 3. Essential workers not necessary for society to function; and 4. The general public. But participants in these clinical trials are conducted in healthy people. What are your thoughts on this?

Mittal: The way I am looking at this is through preparation so every hospital and every county is ready when the vaccine is proven safe and effective. I think it’s preparation and when it’s ready to go in people we need to have everything in place. And then you can set some parameters at a local level and decide the people who will get it first.

I think it’s not a good idea to use in a vulnerable population upfront. I think people at the front line should get it first. Doctors, nurses, EMS workers, firefighters–our first line defenders because they work in a difficult situation. 

And then there are those that may have a condition that prevents them from having a vaccine…it should not be mandatory that those people go through it. Somebody may be on some type of medication which infects the immune system and is on an immunosuppressive drug. 

The way I’m looking at it…I think the U.S. has signed for one company to distribute 300 million doses. We are not going to get all of those vaccines at one time. Because even if we look at the maximum of those we know there’s a chance we might need two vaccines and that turns into 150 million. So, 300 million we may get in the long-term, but initially we may not get them at the same time. 

I think by that time the data and the vaccine is labeled and it is solid and that this vaccine can be used…then it will be used…that is my hope for the general public that it is efficacious and safe. And not because we want to have a vaccine as soon as possible. And there are multiple reasons. We don’t know which vaccine is going to be the best one because the data are not out. 

Gillis: According to a recent Gallup poll one third of Americans indicate they will not get this vaccine. Do you think this number will change?

Mittal: I think that number is higher. I was surprised by that number because if thirty percent of people are unwilling and we can’t forcibly ask people to take the vaccine–they have to take it by their own will. But I think that number will go down as they see the safety and efficacy of those vaccines and when the Phase 3 trial data will be out on the TV and the newspaper and publications then I think many will change their mind and we will come up with a decent percentage of people willing to take the vaccine. 

At this time they are thinking the vaccine is not ready. We don’t know what kind of vaccine it’s going to be and what harm it might do–all of those issues are there. So, because of those questions that’s why those numbers are there. And things always happen when we try to look at anything that’s a new thing. It is harder to spread the good message. But when we are so focused on negative messages that get a lot of attention–and I think the anti-vaccine people are making that message…that negative message stronger. We don’t hear people who are on the vaccine side and that is not unusual. 

But my guess is those numbers are going to change once we start looking at the data. And the sooner that data comes out, well be in a better situation. 

News 8’s medical reporter, Dr. Mary Elizabeth Gillis, D.Ed., is a classically trained medical physiologist and biobehavioral research scientist. She has been a health, medical and science reporter for over 5 years. Her work has been featured in national media outlets. You can follow her on Instagram @reportergillis and Facebook @DrMaryGillis.