How an EUA for the Johnson & Johnson’s Single-Dose COVID-19 Vaccine May Impact Vaccine Distribution, Administration

Pharmacy Times^® interviewed Amesh Adalja, MD, FIDSA, FACP, FACEP, a senior scholar at the Johns Hopkins Center for Health Security, on how the issuance of the proposed emergency use authorization (EUA) for Johnson & Johnson’s single-dose vaccine may impact the current COVID-19 vaccine distribution and administration process.

Alana Hippensteele: Hi, I'm Alana Hippensteele from Pharmacy Times. Today, I’m speaking with Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, on the implications of the recently released results of a new analysis by the FDA that show that the COVID-19 single-shot vaccine candidate by Johnson & Johnson provides strong protection against severe disease and may reduce the spread of the virus. With these results, the FDA could issue the EUA for this third COVID-19 vaccine candidate quite soon.

So, Dr. Adalja, how might the issuance of the proposed EUA for this single-dose vaccine from Johnson & Johnson impact the current COVID-19 vaccine distribution and administration process in the US?

Amesh Adalja: In the short term, we won't probably see a major impact because there's not a lot of doses on hand. But as we get further along, closer to spring, I do think there's a significant benefit of having a third vaccine on the market, especially a vaccine that is only a single dose that doesn't require onerous cold chain requirements. So, it will be just another item on the menu that is going to get us closer to herd immunity, closer to protecting all our vulnerable populations, and closer to putting the pandemic behind us.

Alana Hippensteele: Will administration of this new vaccine still need to follow state guidelines regarding priority groups for vaccinations, and how might this affect the opportunity to ramp up the current rate of vaccinations in the country?

Amesh Adalja: This vaccine is going to kind of fit back into those guidelines for priority groups that each state has developed because, right now, this vaccination program is really a government effort, so it's going to be just another candidate that they use.

I do think in general what we're finding is that some of the priority groupings have served as sort of a constraint to getting vaccines into people's arms. There needs to be a good faith effort to kind of stick to the priority groups because we're trying to reduce the damage the virus causes by protecting those who are most likely to have serious disease, need hospitalization, or die because that's really why this virus even came to light is because it was causing serious illness. So, that's really important.

But I do think we have to have flexibility at the vaccine clinic level, so that we can just get as many people vaccinated as quickly as possible and worry less about the process and more about actually the action of getting vaccine into people, even if they may fall off a priority group if, for example, there are leftover doses available or whatever it might be—I think that's going to be a key moving forward is having that flexibility.

Alana Hippensteele: Johnson & Johnson announced that once the EUA is issued, 2 million doses will be available to ship to the US immediately, with supply set to increase to approximately 20 million doses by the end of March. How might this quantity of additional vaccine affect the current speed of immunization in the country and prospects regarding future reopenings?

Amesh Adalja: I do think that any amount of vaccine we get to combat this virus, even if it's just 2 million up front, is going to get us closer to where we want to go. Like I said, this is something that's going to have more of an impact as we get farther along, as more doses are delivered, but the more people that are vaccinated, especially those vulnerable populations, the ones that are most likely to be hospitalized, that makes it much easier for public health authorities to relax guidance when they know that there's no way that the virus can compromise hospital capacity again.

We're already starting to see that when you look at the nursing home data, for example, nursing home cases are down significantly, nursing home deaths are down significantly, and hospital capacity is becoming less of a concern because nursing home patients were one group of individuals that really could threaten the hospital's capacity, and that’s when you remove them from the equation. We're dealing with sort of a different type of an infectious disease, and more of that will be coming as we get more of our community-dwelling high-risk individuals vaccinated as well.

Alana Hippensteele: Right. Currently, the proposed EUA for the vaccine is for adults 18 years of age and older. Might this proposed population expand in the future, and what does this mean for vaccination prospects for children?

Amesh Adalja: I do think that the vaccination population is going to expand in the future, but it's going to be data-driven because, remember, every vaccine is a risk-benefit calculation, and it's very different if you're deciding to vaccinate a 14-year-old versus vaccinating a 71-year-old because the risk of severe disease is usually in children very, very low, and they've not been shown to be major magnifiers of spread.

So, there's a lot of different calculations you have to make when you're vaccinating a child to make sure that it's actually worth it for them, and it may not be these first-generation vaccines that ultimately is what we use as a pediatric formulation. It might be some second-generation vaccine that we don't know about because there are some considerable side effects, and if children aren't likely to get severe disease and there aren't major spreaders, it may not be one of these original vaccines that we use in children.

I think, again, this has to be data-driven. There are studies going on with some of the other vaccines in pediatric populations, so I think we'll come to an answer for this soon, and I do suspect down the road children will be vaccinated against COVID-19. I just don't know which vaccine formulation will be the most optimal one for them.