Duke University School of Law issued the following announcement.
The recent, well-publicized success of two COVID-19 vaccines offers a glimmer of hope in a year of darkness for so many. As the U.S. and nations everywhere scramble to figure out the logistics of getting the vaccine out broadly, four Duke experts Thursday discussed the various hurdles involved.
Scholars in vaccine development, law, business and global heath discussed myriad issues related to vaccine development and distribution as well as the inherent inequities present when rich and poorer countries all want the panacea at once.
(Editor’s note: New research from panelists Dr. Gavin Yamey and David McAdams on incentivizing richer countries to help poorer ones with vaccine distribution is available here. New research from panelist Arti Rai on vaccine knowledge transfer is available here.)
Watch the briefing on YouTube.
Here are excerpts:
ON WHERE WE ARE RIGHT NOW
Thomas Denny, chief operating officer, Duke Human Vaccine Institute
“We need to be excited and pleased where the science has got us in a very short period of time … we’ve made a remarkable achievement.”
“Manufacturing and scale-up is a challenge. Whenever you do something of this size there’s probably going to be setbacks along the way. Batches that don’t meet quality control and won’t be able to be released.”
“We still have work to do. We need to be thinking about the long-term efficacy of these vaccines. We know the data is suggesting good efficacy signals in the short term, but how does that hold up? Is this going to be something we’re going to have to keep doing moving forward?”
“We still have a lot of challenges, but it’s also time to be happy that we are starting to see some light in this tunnel and hopefully some bright spots going forward into 2021.”
ON WHY DRUG COMPANIES HAVE LIABILITY PROTECTIONS
Arti Rai, law professor
“After the concerns of bioterror back around the time of Sept. 11, there was a lot of concerns that developing emergency vaccines at either pandemic speed or terrorist speed would challenge companies because they would be concerned about liability if a vaccine had to be developed very, very quickly, as we’ve seen in this case.”
“We do have to be concerned about side effects, and companies are concerned about liability.”
“The scope of liability protection is extremely broad. It covers any vaccine, but also any antiviral drug, biologic, diagnostic device. The only exception is willful misconduct.”
“This is something the United States has done very well. I don’t think there’s any meaningful reason for manufacturers to be concerned about liability.”
ON CHALLENGES OF GLOBAL VACCINATION
Dr. Gavin Yamey, professor of the practice, global health and public policy
“An adage in global health and public health … is that an outbreak anywhere can become an outbreak everywhere. We’re really not going to really bring this pandemic under control until we control viral transmission everywhere. It cannot just be in the rich world.”
“Based on previous pandemics, we were concerned the vaccine would not be distributed fairly, globally, equitably.”
“In 2009 during the H1N1 pandemic we did develop a vaccine and rich nations entered into these … direct deals with vaccine manufacturers. So the rich countries got more of it quicker and poorer countries were left behind. They got fewer doses, slower.”
“I’m very sad to say that behavior has repeated itself. Rich countries are hoarding the vaccine. Over 80 percent of the (Pfizer and Moderna) vaccines have already been purchased by rich nations. Poor nations left behind. That is an enormous concern.”
ON INCENTIVES FOR RICH COUNTRIES TO HELP POORER ONES
David McAdams, business administration professor
“This race to develop vaccines around the world has the potential to take on the flavor of what we call a zero-sum game, where something we do here to benefit us in the United States may harm others by limiting its access.”
“But it doesn’t have to be that way. Things rich countries do to benefit themselves could also benefit poor parts of the world.”
“The most important is through transferring know-how and capabilities. We’ve already seen this in the relationship between the Oxford vaccine with the SERUM institute in India. That’s a planned relationship where AstraZeneca is scrambling to produce doses … the SERUM Institute is standing up facilities for a planned billion doses that will go to people in India and other low-income countries.”
“What’s going to happen to the facilities currently producing vaccines … that fail? There are facilities all around the world right now that are churning out doses of vaccines that won’t be distributed because they’re not going to be safe or effective. What happens to those facilities? Will we be able to re-purpose those to produce an effective vaccine?
“If we can lay the groundwork for that kind of tech transfer, we can stand up those facilities faster and get more doses out to the world faster and that will benefit poor people everywhere.”
ON VACCINES AND CHILDREN
Thomas Denny
“The current trials have been mostly done in adults or older children. There are protocols being developed right now … where we will begin to look at clinical trials in younger children.”
“This is not unusual. Most clinical trials of new products start out in healthy adults. As we go through that process and learn they’re safe we move into other age groups.”
“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.”
Dr. Gavin Yamey
“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.”
“I think there is some urgency about knowing the safety and efficacy of children.”
ON VACCINE PRICING, AFFORDABILITY
Arti Rai
“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.”
“Price may be an issue in the developing world and that’s a very important issue.”
ON THE EFFECT OF A NEW US PRESIDENT ON VACCINE PROGRESS
Dr. Gavin Yamey
“I do think partisan politics aside, I do think we’re going to see a sea change not just in terms of competence -- we’ve had the most incompetent federal response of any high-income country I can think of … -- but also I do think we’ll be returning to the international global health system. We’ll return to the World Health Organization; I predict the USA will join COVAX (international vaccine alliance). I do think that the U.S. will be returning to the international system in that way.”
ON RACIAL AND INCOME DISPARITIES REGARDING VACCINE ACCESS
Dr. Gavin Yamey
“The same inequities that we’ve been talking about globally could happen here on these shores if we’re not careful. The data are very clear that Black Americans, Latinx Americans, Native Americans, the death rate from COVID-19 is higher than in the general population.” “That is related to deep-seated racism. That is related to Jim Crow, redlining, that is related to who is taking jobs that put them at higher risk.”
“These inequities were present before COVID-19; they’ve been more starkly exposed.”
“The people who are at higher risk should be vaccinated early. There’s a lot of thinking now, a lot of scholarship, particularly amongst scholars of color themselves, about how we might do that.”
“We have to of course recognize at the same time there are communities that might be suspicious of the notion of early vaccination.”
“When people talk about vaccine hesitancy, we have to figure out what’s going on. In some communities, that suspicion is completely understandable. Working with communities is key.”
ON CONVINCING PEOPLE TO TAKE THE VACCINE
Thomas Denny
“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.”
ON HOW LONG WE’LL ALL BE WEARING MASKS
Thomas Denny
“I see 2021 as a transition year. As we begin to get more people vaccinated -- and I think it’ll take us at least into the second quarter, end of second quarter to see large numbers there -- slowly we’ll come out of the social distancing, and less masking.”
“I do think the majority of 2021 we’ll still be behaving like we’re behaving now. We’ll get people vaccinated and then truly understand the long-term efficacy.”
ON HOW LONG VACCINE PROTECTION WILL LAST
Thomas Denny
“There will be studies that will continue. What we call the long-haulers type of approach where you continue to follow people and look for long-term protection. But until we get more markers of protection, antibody levels … and understand that, we’re not going to know if you’re going to have to be boosted once a year, or be boosted every five years.”
“This could end up being a cocktail piggy-backed with the annual flu vaccine.”
ON FDA’s EMERGENCY USE AUTHORIZATION PROCESS, COMPARED TO UK EQUIVALENT
Arti Rai
“When it was politicized prior to the election, the FDA took a bold step and put out guidance regarding how it would implement EUA (emergency use authorization); that guidance, in addition to the fact that it’s generally more cautious than the UK, that guidance specifically said it would require clear and compelling evidence. It was a clear response to the politicization and may have some consequences downstream. It was a bold and I think very necessary move on the part of the FDA to push back on the White House.”
Meet the experts:
Thomas N. Denny
Thomas Denny is chief operating officer of the Duke Human Vaccine Institute, a professor of medicine at the Duke University School of Medicine and an affiliate member of the Duke Global Health Institute.
David McAdams
David McAdams is a professor of business administration at The Fuqua School of Business at Duke and a professor of economics in the university’s economics department. He has proposed a mechanism to help ensure equitable distribution of COVID vaccines.
Arti Rai
Arti Rai is a professor at the Duke Law School and faculty director of The Center for Innovation Policy at Duke Law, which promotes technological advances to enhance long-term social welfare. She recently wrote about the need for information-sharing among vaccine manufacturers.
Dr. Gavin Yamey
Dr. Gavin Yamey is a professor of the practice of global health and public policy at the Duke Global Health Institute. He is also director of the Center for Policy Impact in Global Health at Duke, which addresses challenges in financing and delivering global health. Yamey worked with David McAdams on vaccine distribution research.
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Duke experts on a variety of other topics related the coronavirus pandemic can be found here.
Original source can be found here.
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