Duke experts discuss the need for COVID-19 vaccine trials in children

The FDA is set to review Pfizer's COVID-19 vaccine for emergency use authorization next week, following UK regulators' decision to approve its use.

Approval of the vaccine is just part of the task ahead, with officials readying distribution efforts.

"We know the data is suggesting that they're good efficacy signals in the short-term. But how does that hold up six months, nine months, twelve months? And is this something that we're going to have to keep doing as we go forward," said Dr. Thomas Denny, the Chief Operating Officer of the Duke Human Vaccine Institute.

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Even a vaccine rollout won't stop the need for mask wearing and social distancing.

"Slowly, we'll begin to come out of the social distancing behavior, maybe less masking, or less social distancing. But I do think that the majority of 2021 I think we're still behaving like we're behaving right now, so we can make sure we get people vaccinated and then truly begin to understand the long-term efficacy," said Dr. Denny.

The COVID-19 pandemic has disproportionately impacted underserved populations, who are more likely to work jobs they cannot perform from home and face inequities in healthcare access.

Dr. Gavin Yamey, the director of the Center for Policy Impact in Global Health at Duke, notes it's important to perform outreach to these communities, who may have hesitancies stemming from troubling past experiences, such as the Tuskegee syphilis experiment.

"One of the most powerful predictors of whether a community will take up a vaccine is whether the health providers in that community take it themselves, and go out there and say 'hey, look watch - it's going in my arm,'" said Dr. Yamey.

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"I believe we need what I'm calling vaccine ambassadors for every community setting. It has to go down to every level, into local communities where community leaders, church leaders, other people that have status within a community say, 'This is safe, this is good, we must do it.' If you see that, I think you'll see people more willing to take the vaccine early on," said Dr. Denny.

Another disparity is found in geography, where smaller, rural areas are facing a challenging situation

"We've learned from the H1N1 pandemic that resource-challenged areas have difficulties with refrigeration or storing of samples or running laboratories where refrigeration and consistent electricity is important," said Dr. Denny.

Vaccine trials have focused primarily on adults, leading to some questions about how children will respond to the vaccine; data shows children are typically less likely to spread the virus or become severely ill.

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"It will be key to get clinical trials performed in children to learn if vaccines are safe and effective. One day this may be part of a well-baby immunization schedule, where at a certain age you'd receive this vaccine as you would receive other vaccines," said Dr. Denny.

"My pediatrician colleagues have tried to convince me, and I think I am convinced now, that we are going to be asleep at the wheel if we don't think about children. We have excellent vaccination programs and delivery channels for reaching children, ready to go now. And one way to reach herd immunity more quickly would be to vaccinate children. It could take a long time to set up these delivery channels for older people. They don't really exist now."

Fortunately, despite existing challenges to health care access, Duke Law professor Arti Rai does not anticipate pricing being a concern.

"Overall the pricing issue is not going to be an issue, at least in the rich world. In general it appears that the rich world will be able to pay what's necessary so individual people in the rich world don't have to pay exorbitant prices or any price at all. This is basically what the U.S. government and other rich governments have done by hoarding these vaccines, they've just put in so many orders that price isn't going to be an issue," said Rai.
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