Despite the excitement and relief brought by news of highly effective COVID-19 vaccines that will likely soon be approved by U.S. regulators, their large-scale manufacturing and distribution is wrought with issues and complexities.
At a Thursday media briefing, four Duke experts discussed the challenges involved in both the manufacture and distribution of a COVID-19 vaccine and the inequities that could arise in the process.
Thomas Denny, chief operating officer of the Duke Human Vaccine Institute, acknowledged the remarkable achievement in the recent announcement of high-efficacy vaccines by Pfizer and Moderna, but acknowledged that many challenges lie ahead.
“Manufacturing and scale-up is a challenge. Whenever you do something of this size there’s probably going to be setbacks along the way,” Denny said. “Batches that don’t meet quality control won’t be able to be released.”
He added that there is still work to do, and 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?” he said.
Gavin Yamey, a professor of the practice of global health and public policy, noted that bringing the coronavirus pandemic under control relies on the global vaccination of not just rich countries but also poor countries. He said that currently, the pattern resembles that of pandemics of the past—one of inequitable distribution to mostly wealthy nations.
“Rich countries are hoarding the vaccine,” Yamey said. “Over 80% of the [Pfizer and Moderna] vaccines have already been purchased by rich nations. Poor nations left behind. That is an enormous concern.”
David McAdams, professor of business administration at the Fuqua School of Business, noted that this global race for vaccine development does not have to be a “zero-sum game,” and that there were things richer countries could do to benefit both themselves and poorer parts of the world.
“The most important is through transferring know-how and capabilities,” McAdams said. “We’ve already seen this in the relationship between the Oxford vaccine with the SERUM institute in India.”
As with any novel vaccination distribution effort, a major logistical concern is cost. Arti Rai, Elvin R. Latty professor of law, said that costs vary by country—often inequitably.
“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,” Rai said. “Price may be an issue in the developing world, and that’s a very important issue.”
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Yamey added that the COVID-19 pandemic has seen a disproportionate amount of deaths of Black, Latinx and Native Americans, and vaccination efforts could see disparities along these same lines. He outlined these challenges and emerging measures to combat this.
“[The National Academy of Medicine] recommended that people of color should be early in prioritization,” Yamey said. “They also recommended people who are in jails, prisons, ICE detention centers, juvenile detention centers, those who are homeless—people who are at higher risk should be vaccinated early.”
Beyond racial and income disparities in vaccine access, Denney noted that there are hurdles in vaccination efforts because some communities may be suspicious of early vaccination because of the legacy of medical experimentation.
“I believe we need what I’m calling vaccine ambassadors for every community setting,” Denny said. “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.”
Denney added that the process of the vaccine’s approval may still take some time—even after late-stage trial results showed astounding levels of efficacy. Although the United Kingdom has already deemed the Pfizer vaccine safe to use, the United States still awaits, due to differences in each country’s regulatory approach, said Greg Phillips, director of global communications and the moderator at the briefing.
“[The] FDA digs a lot deeper to look at all the records coming in, to look at source documentation, where the U.K. system is a bit more … take what is given to them and [they] don’t necessarily go back to source documents,” Denney said.
The vaccine serves a beacon of hope, but precautionary measures like social distancing and wearing masks are likely here to stay in the near future until enough people become vaccinated, Denney said. He said that with two vaccines with 95% of efficacy, getting 50% of the population covered would “put us on a great trajectory” to start eliminating the coronavirus. He added that through the majority of 2021, he believes “we’ll still be behaving like we’re behaving now.”
“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,” Denny said.