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J&J's COVID vaccine will bring relief—and new challenges—to Illinois - Crain's Chicago Business

Illinois is gearing up for the potential launch of a third COVID-19 vaccine that would help boost supply—but not without adding another layer of complexity to the state’s logistically challenging vaccination campaign.

The anticipated approval of Johnson & Johnson’s vaccine in the U.S. is generating excitement among health officials and providers grappling with a limited supply of doses. Still, the advent of a single-dose regimen with a unique set of storage and handling requirements raises new questions about which vaccination sites—and, subsequently, which residents—would get access to it.

Johnson & Johnson’s vaccine—which cleared a regulatory hurdle on Wednesday—consists of one shot and can be stored in a regular refrigerator. Meanwhile, authorized vaccines from Pfizer and Moderna require two doses administered several weeks apart and typically are shipped frozen (in Pfizer’s case, at ultracold temperatures).

The differences don’t end there. While Johnson & Johnson’s shot was 66 percent effective in preventing moderate to severe cases of COVID-19, Pfizer’s was 95 percent effective and Moderna’s was 94 percent. However, experts warn against making comparisons due to differences in clinical trials.

Federal authorization of Johnson & Johnson’s vaccine would boost the number of available doses as troubling new variants circulate, and as some Illinois counties struggle to expand eligibility due to limited supply. Plus, with just one dose and a more flexible shelf life, the shot might ease some pain points that have hobbled the vaccine rollout so far. But that could come with even more confusion as people try to get access to particular shots.

Johnson & Johnson’s vaccine “is really badly needed” to increase supply and simplify operations, says Dr. Paul Casey, chief medical officer at Rush University Medical System. “But because of the difference in efficacy … some patients will probably have a preference for one or the other.”

Indeed, the very features that make the Johnson & Johnson vaccine well-suited to distribute in underserved neighborhoods—namely, its one-dose formula and its need for mere standard refrigeration—could also set up another flashpoint for public health administrators: Will people getting those doses feel they're being short-changed by receiving a vaccine that, at 66 percent efficacy, is still excellent by epidemiological standards but less iron-clad than the Pfizer and Moderna regimens? The perception that Black and Brown communities might have access to a less-effective vaccine than people in predominantly white areas could touch off debates about health equity—setting up a potential messaging and logistical challenge for elected officials and their public health teams.

Local public health departments decide which vaccinators get certain shots based on their capacity to store and administer doses. For the most part, the departments funnel one vaccine type to each individual location to avoid confusion and simplify the process. But that could change as more vaccines get approved.

“You’re dealing with three different products that need to be reconstituted in three different ways. There’s more potential for error,” says Dr. Robert Citronberg, executive medical director of infectious disease and prevention at Advocate Aurora Health. “We really can’t afford to make mistakes with these vaccines because they’re such scarce resources.”

The U.S. Food and Drug Administration on Wednesday said Johnson & Johnson’s COVID-19 vaccine meets safety and efficacy requirements for emergency use authorization. An independent group of experts, which is scheduled to review the data on Friday, will make a recommendation to the FDA about whether to green-light the shot. A final decision will come shortly thereafter, but industry observers say the agency typically follows the panel’s recommendation.

Even with additional doses coming into the state (Johnson & Johnson aims to have enough shots to cover 20 million Americans by the end of March), it’s unlikely that residents will have an opportunity to choose which vaccine they get. Who gets which shot most likely will be determined by the vaccination site. For example, large hospitals with ultracold freezers are better equipped to handle Pfizer vaccines than retail pharmacies with limited cold storage.

The Chicago Department of Public Health, which manages its own vaccination campaign, did not respond to an interview request, but Commissioner Dr. Allison Arwady addressed the issue during today’s “Ask Dr. Arwady” segment: “We may think here, for example, about potentially starting with a single-dose vaccine more in essential worker groups who may be younger, statistically not have as many of the underlying conditions, healthy enough to be working. Maybe that’s where we would start with a really good vaccine where you’re done in one dose but where the protection is a little bit less.”

The Illinois Department of Public Health declined to make someone available for an interview.

“We really can’t operationalize a plan until we know what supply we’re going to have,” Citronberg says. “But, in theory, a single-shot vaccine that doesn’t require special refrigeration is ideal for populations that are hard to get. Whether it’s homebound patients, people who might have transportation issues, perhaps clinics in underserved areas where you really only have one chance to (inoculate people), a vaccine like that would be ideal.” 

While the uncertainty makes it difficult for health care providers to plan in advance, it’s not unique to the new shot. Even now, vaccinators don’t know how many Pfizer or Moderna doses they’ll get until shipments arrive, which makes scheduling appointments a challenge.

During a Wednesday press briefing, Gov J.B. Pritzker said the state is getting closer to widespread vaccine availability with the promise of at least 100,000 doses per day by mid-March—that’s in addition to doses from Johnson & Johnson, should its vaccine get approved.

While there are a number of differences between Johnson & Johnson’s vaccine and others, experts caution against getting hung up on efficacy.

Among people who got the Johnson & Johnson vaccine, there were two hospitalizations starting 14 days after vaccination and no new hospitalizations after 28 days, according to the FDA's report. Among those who got a placebo, there were 29 hospitalizations starting at 14 days and 16 hospitalizations after 28 days. Meanwhile, all seven COVID-related deaths were among those in the placebo group.

It’s hard to make direct comparisons among the shots due to differences in clinical trials. For example, the Johnson & Johnson vaccine was being tested as new variants spread, including one in South Africa. Moderna now is working on booster shots to address various strains of the virus that weren’t present during its initial clinical trial.

“I do worry that people will get wrapped up in the numbers,” Casey says. “The most important point that helps us recover substantially from this pandemic is decreasing hospitalizations and deaths—all of these vaccines have proven safety and efficacy in that realm.”

Reporter A.D. Quig contributed. 

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