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J&J’s One-Dose Shot Seen as All-or-Nothing for Underserved Areas

Feb. 26, 2021, 10:12 PM

Johnson & Johnson’s one-dose Covid-19 vaccine offers the chance to reach vulnerable populations who might not have access to the other shots on the market.

The J&J vaccine’s easier dosage and storage requirements will play a critical role in ramping up inoculations for people who may have trouble getting a second dose of the shots by Pfizer Inc. and Moderna Inc. This includes people in rural areas, homeless shelters, or those getting vaccinated in an emergency room.

For those communities, it’s an all-or-nothing situation, public health experts say.

“In the perfect world, in my view, J&J would be used, would be really targeted to the people for whom it is their best opportunity to be vaccinated,” Nancy E. Kass, a bioethicist and vice provost at Johns Hopkins University, said. “So that the comparison does not become who gets Pfizer, who gets Moderna, or who gets J&J. But it becomes: who’s getting nothing?”

J&J’s vaccine is expected to become available within the coming days. A Food and Drug Administration panel of scientific advisers on Friday gave the shot its blessing, and a decision from the FDA will likely come shortly thereafter. The Centers for Disease Control and Prevention panel charged with recommending vaccine distribution has scheduled a meeting for Feb. 28 and March 1.

The J&J shot demonstrated 72% efficacy in U.S. trials and 100% efficacy against preventing deaths. It’s estimated to remain stable for two years at minus 4 degrees Fahrenheit, and can stay at 36–46 degrees (refrigerator temperatures) for at least three months.

Vaccines from Pfizer and Moderna both require two doses, are about 95% effective, and generally must be stored at ultra-cold temperatures of minus 94 and minus 4 degrees Fahrenheit, respectively. But the FDA recently approved more flexible storage requirements for Pfizer, saying Thursday that undiluted frozen vials of the Pfizer shot can be stored at standard freezer temperature for up to two weeks.

‘Gentle Requirements’

If authorized, J&J’s vaccine would become the third available in the U.S. after the FDA cleared Pfizer Inc.'s and Moderna Inc.'s shots in December. It’s expected to boost vaccine rates by increasing supply and ensuring people can get fully immunized without having to go back for a second dose.

“J&J becomes an opportunity to reach people who wouldn’t have been reached,” Kass said. “Thanks to either the one-dose regimen, or the more gentle requirements for refrigeration, we now can provide access to people who have had no access or limited access.”

The Moderna and Pfizer vaccines’ special storage and double-dose requirements make the vaccination process more difficult “because you have to be so careful with them,” Jennifer Tolbert, director of State Health Reform at the Kaiser Family Foundation, said.

The eased requirements for the J&J vaccine opens the door for states “to adopt slightly different strategies for targeting vulnerable populations,” she said.

For example, states and local governments can set up mobile clinics with J&J’s vaccine because it’s more stable on a shelf, Tolbert, said.

“You can go into a community with a smaller number of vaccines and target vulnerable communities,” she said. “You can’t do that as easily with Pfizer and Moderna vaccines.”

Getting a Choice

Ideally when vaccine supply ramps up, people have a choice in deciding which shot to get, Keisha Ray, a bioethicist at the University of Texas Health Science Center in Houston, said. But J&J’s vaccine likely will go out to more vulnerable populations that have been hit hardest by the pandemic and inequities in the health care system.

“We wish that there weren’t these life barriers that prevented someone from getting the more effective brand of vaccination,” Ray said. “If a person chooses it for various reasons that fit their life, I think that’s a little bit different than saying, ‘We only have this one. This is what you’re forced to take even though we are totally aware that this will not protect you as much.’”

Designating the J&J vaccine only to vulnerable communities also creates a risk that those communities will “continue to feel they’re disadvantaged,” Tolbert said.

But Dan Barouch, director at Center for Virology and Vaccine Research at the Beth Israel Deaconess Medical Center who’s been collaborating with J&J in its vaccine development, said people likely won’t get a choice because supply is the primary challenge right now.

“I don’t think people will be able to go to their pharmacy and pick which vaccine they want,” Barouch said. “All these vaccines are safe and effective.”

No Data Across Studies

No clinical trial has compared the efficacy of all three vaccines in a single study, Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, said Friday. Data on each vaccine is based on three different studies with different endpoints and trial designs, she said.

“We need to be careful not to read into the data to look across the studies, when they are so different, but instead to take each vaccine individually,” Messionnier said at a JAMA live event.

“I expect that a lot of the considerations that our state health departments are having around these vaccines is more about the ease of use of the J&J vaccine, and how it might be better suited to some populations where, for example, logistics of getting into a community is harder or getting folks to come back for a second dose might be harder,” she said.

As the CDC’s Advisory Committee on Immunization Practices prepares to deliberate J&J’s vaccine, Kass said it’s essential that the panel articulate whether and how certain groups can benefit from a specific vaccine. If it makes a statement about the importance of taking the first available vaccine, it needs to explain it clearly, she said.

“There has been a fair amount in the media saying it’s good, but not as good,” Kass said, adding that she wished the message emphasized the J&J vaccine is is also 100% effective in preventing hospitalization and deaths.

It’s “such a different message. Like, wow, good news, we have a new vaccine that is 100% effective,” Kass said.

To contact the reporters on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com; Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

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