Vaccine Rollout, Ensuing Commercialization Offer Lessons for Pharma, Experts Maintain

One year into the COVID-19 pandemic, the U.S. has three effective vaccines with Emergency Use Authorizations (EUAs), and manufacturers are considering post-pandemic plans for when these vaccines transition into the commercial market, according to experts at consulting firm Avalere Health.

To date in the U.S., the federal government has purchased vaccine doses for distribution to the states. But that’s likely to change in the next year or two, said Avalere’s Loren Becker, associate principal of vaccine policy and market access.

“If we look at our current government purchase commitments, they’ve secured enough doses theoretically to cover demand well into 2022,” Becker told a Feb. 24 webinar audience. “It remains to be seen whether some of those doses might be donated to other countries or placed in a government stockpile, in which case that might accelerate the shift to a commercial market.”

If those doses aren’t stockpiled or donated, that likely will push back into 2022 the date when a true commercial market for COVID-19 vaccines starts, she said. “In that case, manufacturers might want to consider whether there are some opportunities to sell vaccines to end users, despite the existing government purchase channels. That’s one thing we’re starting to think about within our teams.”

In addition, said Becker, there’s growing consensus among experts that COVID-19 will become an endemic disease, and so periodic re-vaccination likely will be required, either to address waning immunity or new virus variants. “One scenario we’re tracking quite closely is whether the COVID-19 vaccine market might evolve to be more like the market for a flu vaccine, which requires annual reformulation of the vaccine and re-vaccination of the population.”

If that occurs, she stated, it will spur multiple questions for manufacturers. “They will have to predict demand for a given season, since the excess doses would need to be discarded at the end of the season,” she said. “So there’s really some interesting thinking that needs to be done there to prepare for that market.”

And if COVID-19 does become endemic, it’s likely that some countries will require proof of vaccination for entry, Becker said. “We’re looking at how one might then set up the system to be able to prove that you have been vaccinated — things like electronic vaccination passports or other mechanisms.”

Companies Offer Vaccination Incentives

Becker said that there’s legal precedent for various kinds of vaccination requirements. Still, according to Jasmaine McClain, Ph.D., Avalere senior manager, employers aren’t requiring their workers to get the vaccine yet, although they are beginning to offer incentives for their workers to get the vaccine: “You know, $100, $200 for their employees to be vaccinated. There are some who are offering additional vacation time, if you’re able to document that you’ve received the vaccine once it’s more broadly available.” Some employers also are offering paid time off for workers to get vaccinated during their typical work hours. Ultimately, any requirements for vaccination likely will depend on the industry in question, she said.

Despite a slow beginning to the vaccine rollout in late 2020 and January 2021, manufacturers were able to ramp up production even ahead of schedule, altering the supply-demand calculus, noted Becker. “As that supply increases, we’re rapidly approaching a point where supply could eclipse demand in the U.S., and we really have to start to address some of the demand-side issues.” Polling has shown a slow but steady increase in the number of adults willing to get the vaccine, but “it still shows a huge gap from what we need to achieve broad population-level immunity,” she said. “So we really do need to start to think about how to reach communities where there may be some hesitancy, and that in particular affects specific communities, including communities of color and other communities that may be more vulnerable to COVID-19 in the first place.”

Recent data show that the vaccine rate among white Americans is around double the rate of vaccination among Black Americans and triple the rate among Hispanic and Latino populations, noted McClain. “I think as the plans for vaccine rollout rolled out at the beginning of the year, it really became clear that we needed a strategy to address some of the potential disparities around vaccine distribution,” she told the webinar audience.

There are multiple reasons why vaccine distribution to communities of color has been challenging, said McClain, including persistent problems on access to health care and limitations in the locations where people actually can receive the vaccine. There’s also “just a longstanding legacy of mistrust in the health care system,” she pointed out. “So I think those things together have really undermined the rates of vaccination for communities of color.”

Still, there are communities that are looking for “trusted resources” to learn more about the vaccines, McClain said. “One way I’ve heard this framed is, those individuals are ‘slow yeses,’” she stated, noting that they need more information delivered from a trusted source. “We’re not just going to be able to close the deal with just the data.”

Other issues with vaccine rollout have included the need for everyone — including less technology-savvy seniors — to navigate a sometimes-clunky registration and scheduling process, said McClain. “A lot of that was done online, and there are limitations in the amount of broadband access that particularly older adults have access to,” she explained, adding that these issues will continue to impact vaccine rates “over the foreseeable period.”

As one of his first acts in office, President Joe Biden formed the COVID-19 Health Equity Task Force, which is aimed at identifying and eliminating health and social disparities that result in disproportionately higher rates of exposure, illness, hospitalization and death related to COVID-19. McClain said that the task force targets not only Black and brown communities but also incarcerated populations and homeless populations as the nation moves toward pandemic recovery: “We’re looking forward to seeing how they shape the plans nationwide.”

Overall, the pandemic has hit communities of color hard, noted McClain. “What we’re seeing in terms of the impact of COVID-19 when it comes to hospitalizations and deaths among communities of color has been particularly stark,” she said. “Black and African-American populations are nearly three times as likely to be hospitalized from COVID-19 and are nearly twice as likely to die as a result of COVID-19. Those numbers are actually even worse in Hispanic and Latino populations.”

In addition, Black and brown communities — particularly women of color — were particularly impacted by job loss when compared with other populations, said McClain. “And that impacts not only an individual’s ability to care for your family and provide food on the table and the resources you need during this pandemic, but it also impacts your health insurance status. And I think that’s something that we really have to keep a close eye on.” An Avalere analysis from last September showed that Asian, Black and Hispanic populations were nearly twice as likely to lose health insurance as a result of losing their employment, she pointed out. Finally, it’s been particularly difficult for Black populations and Hispanic/Latino populations to receive mental health treatment or substance-use treatment during the pandemic, she said.

Avalere has put together a framework around responding and investing in health disparities, stated McClain. The first element in the framework is inclusive infrastructure. For example, the clinicians who ran the COVID-19 vaccine trials proactively reached out to communities of color to talk about the importance of participating, and that “was hugely impactful, and a place where we want to continue to make investments over the coming years,” she said.

Gillian Woollett, Avalere principal research scientist, said that news about declines in the numbers of infections and hospitalizations could spur reluctant U.S. residents to get the vaccine, particularly since the shot would allow them to meet with their families and do other things they want to do. “We’ll begin to get confidence across the system, because just as we’ve seen the deaths and the tragedies, we will see that people are going back to the gym, and they’re not getting sick,” she told webinar attendees. This may take some time, she added, and public health officials will need to show those who are reluctant how easy it is to get vaccinated and that the vast majority of people experience minimal side effects.

Vaccine Development Offers Lessons

Putting aside the challenges in vaccine distribution, the rapid development and deployment of the vaccines should be considered a significant victory for the pharmaceutical industry and the companies involved, said Woollett. It also offers lessons for pharma and the industry’s regulators.

“If you remember, we were hoping for a vaccine that showed 50% efficacy, and they’re all way up there in the eighties and nineties,” stated Woollett. “And most of them are showing a level of efficacy against the variants so far, but that is why it is so key to get those vaccines out in arms, because that reduces the load of virus reproducing in people, which is where the variants come from.”

Woollett added that vaccines “are notoriously difficult. If we look at the technology of the first two, the mRNA [i.e., messenger RNA] was dreamed of back in the ’80s, and it never quite worked. So when we first heard the two companies, Moderna and Pfizer, were taking a risk on mRNA, I thought, ‘That’s a long shot.’ But they’ve done it. And one of the reasons I have to emphasize that they’ve done it is the science is always the best it’s ever been — it’s cumulative. The collaboration worldwide has been phenomenal. The data-sharing on the sequences of the viruses means we know what we’re up against.”

The collaborative nature of the process was key, she asserted, adding that it “jump-started everything we were doing. All of these tools of how you develop the product, what is a good vaccine, a good therapy, all of these are moving leaps and bounds. And I do think we should give credit to our regulators — the FDA here in the U.S. and elsewhere in the world — for being very, very creative on how they are going to reach their metrics of safe and effective, if used as indicated, in a manner that gives us multiple options. This pandemic has taught us that one is not enough. Future pandemics, whether the coronavirus or something else, will need this sort of expeditious, efficient development, too.”

Normally, medicines and particularly vaccines take more than a decade to be developed — often 12 to 15 years, Woollett explained. “So risks had to be taken but not risks that impact the quality of the vaccines. They were risks in terms of sharing of the information, just making it available everywhere. There were also investment risks in manufacturing vaccine candidates before you knew they would work. That is now coming home to be our opportunity to have these vaccines deployed very, very quickly. So on all fronts — and including with our regulatory authorities and their imagination in how they’ve evaluated these products on all fronts — we’ve shown just how much faster we can develop key products. And I think that’s an opportunity we can use going forward.”

The difficult pandemic year has offered multiple hard-learned lessons, she maintained. “The treatments are getting better, even if we don’t have cures. And understanding transmission and ways to mitigate it are also much, much better than they were in the beginning.” The virus isn’t about to disappear, leaving nothing to worry about, but medicine and public health are able to handle the virus better, Woollett said.

There have been other indirect effects. For example, the pandemic initially led to a steep drop in immunization rates for all ages, ranging from pediatric to adult, Becker said. “That has rebounded in certain markets, and I think children have come back up pretty close to normal levels, but it has not come back to the same degree in the adolescent and adult populations. We’ve seen some rebounding, but not nearly enough to cover the gap that was lost in the very early months of the pandemic.” Still, flu vaccination rates rose significantly year-over-year, she noted, likely as a result of public health messaging urging people to get the flu vaccine as a way to lessen the burden on the health care system overall.

There’s even some possibility that the COVID-19 pandemic and the vaccines to prevent the disease could spur more interest and uptake in vaccines generally, said Woollett. “I would hope so, because even flu was killing 30,000 to 40,000 a year in the U.S. even in a comparatively not-so-bad year, and up to 80,000 in a really bad year. But people don’t like needle sticks.” Therefore, new technologies that deliver vaccines without needle sticks could play a role in encouraging vaccine uptake, she said, adding, “I’ve realized it’s 30 years since I had a tetanus vaccine — you know, maybe it’s time to update it. So I think there’s an opportunity created here that we can take, we just have to use it.”

There are still challenges. For example, testing has been “a bit of a conundrum from the beginning — how many people we test, who, when, where, what it allows you to do, what it doesn’t allow you to do,” Woollett said. “But I think the most important aspect of testing that we should be looking to right now is tracking these variants and knowing what we’re up against in terms of whether we’ve really got new pathogens out there that are going to escape our ways of handling them.”

Becker asserted that it’s important to take a global perspective on the pandemic. “While the U.S. and select high-income countries have been ramping up vaccinations, there’s been almost no availability to date in the rest of the world,” she said. However, she said this is starting to change, as the COVID-19 Vaccines Global Access (COVAX) begins to ship doses. “COVAX expects to distribute about 100 million doses in the first half of 2021. Still, to put that in perspective, it’s enough to vaccinate just 3% of the population in those participating countries. So that’s really just dipping their toe in the water.”

As currently projected, available supply for the rest of the world will remain insufficient well into 2022, said Becker, adding, “this isn’t just a problem for the rest of the world — it’s a problem for us here in the U.S. as well. If the virus is left to run rampant anywhere, that creates opportunity for mutation. And as we’re already seeing with the South Africa variant, that has the potential to make vaccines less effective in some cases — maybe not completely ineffective, but it lessens the efficacy. So to make sure our tools remain effective, we really need to make sure that vaccines are widely available around the world.”

In addition, the world needs effective therapies against COVID-19, Woollett contended. “We cannot afford a complacency on vaccines if we don’t have good therapies, because as we’ve seen with some of these new variants with high infection rates, you’re going to see very rapid pop-ups of populations that are infected and the associated hospitalizations.” Researchers into COVID-19 treatments have focused heavily on secondary uses of current medicines that manage the immune system, but “we’ve seen much less in terms of effective antivirals,” said Woollett. Gilead Sciences, Inc.’s Veklury (remdesivir), a broad-spectrum antiviral, “helps to some degree,” but more options are needed.

The United Kingdom is considering conducting challenge studies that would enable clinicians to compare different drugs and vaccines head-to-head, which would provide data currently lacking, Woollett stated. “The importance of that is, even though we seem to have some inordinately effective vaccines in a year — a remarkable achievement — perhaps we can do better.”

Finally, supply chain management for the vaccines will be critical in countries that don’t have the ability to distribute the shots at the very cold temperatures required for the Pfizer Inc./BioNTech SE and Moderna, Inc. products, Woollett said. The Johnson & Johnson shot — which requires only normal refrigeration temperatures — will “be critical in some of these countries that don’t have the ability to distribute at very, very cold temperatures,” she explained.

View the archived webinar at https://bit.ly/31qNdww. Contact Becker at lbecker@avalere.com, McClain at JMcClain@avalere.com and Woollett at gwoollett@avalere.com.

by Jane Anderson

Freelance Reporter Freelance Reporter

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