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J&J COVID-19 Vaccine Is Here. Now Come the Questions - MedPage Today

Now that Johnson & Johnson has joined Pfizer and Moderna in having a COVID-19 vaccine authorized in the U.S., the question on many people's minds is: who gets which vaccine?

Much of the discussion has focused on the differing vaccine efficacy numbers for the three products: those given for the J&J vaccine are in the 70% range, versus more than 90% for Pfizer's and Moderna's.

But the Biden administration and independent public health specialists insist that those figures aren't strictly comparable and the public shouldn't pay much attention to them.

Johnson & Johnson's "is not an inferior vaccine, and we should not talk about who shouldn't get it; we should talk about how we can immunize hard-to-get populations," said Sarah Long, MD, a pediatric diseases physician at Drexel University College of Medicine in Philadelphia and a member of the CDC's Advisory Committee on Immunization Practices (ACIP), during an emergency meeting of the committee Monday.

J&J's COVID-19 vaccine was authorized as a single-dose regimen, does not need to be reconstituted, and can be stored in an ordinary refrigerator for months. That's in contrast to the Pfizer/BioNTech and Moderna vaccines, which both require two doses and involve deep-freeze storage at some stages. Plus, the Pfizer/BioNTech vaccine needs to be reconstituted.

Long said she favors targeting allocations of the J&J vaccine to homeless individuals, those with poor access to transportation, those who can't easily leave work for appointments, and those without easy Internet access.

Importantly, ACIP stated "no preference" for any one COVID-19 vaccine. All three authorized vaccines are safe and highly effective in preventing "very serious illness and death," said Marcella Nunez- Smith, MD, director of the White House COVID-19 Health Equity Task Force, during a press briefing on Monday.

At a hearing of the House Committee on Science, Space, & Technology in February, witnesses and lawmakers discussed potentially targeting the one-dose J&J vaccine towards Americans in rural parts of the country, homeless people, migrants, and even homebound individuals, but the speakers also explored concerns that a vaccine that is based on current data may appear less effective would trigger equity concerns.

Sonja Hutchins, MD, DrPH, professor of community health and preventive medicine at Morehouse School of Medicine in Atlanta, told ACIP members during the meeting that she worries that if the J&J vaccine is intentionally targeted to mobile clinics, for instance, its putatively lower efficacy -- widely reported in the media, both social and mainstream -- could "introduce a level of mistrust" and increase vaccine hesitancy.

She urged the committee to carefully consider "unintended consequences" for communities of color, noting that those allegedly "hard to reach" populations are often reachable.

Without naming the J&J vaccine specifically, Nunez-Smith allowed for the possibility of expanding access to vaccines "in some temporary clinics, some pop-up mobile sites, and those locations that do not have cold storage capacity." The J&J vaccine is the only authorized vaccine that can be stored.

While every vaccination site will not have every vaccine, the response team expects that vaccine distribution will be equitable across communities, and tracked by zip code and "social vulnerability," she said.

When pressed by a reporter about the perception that the government was distributing certain vaccines to certain populations, Nunez-Smith said that if one company's products are consistently going to certain communities the federal government would "intervene and correct the issue if and when needed."

However, she called on Americans to be accepting of what's made available to them during the pandemic.

"As a physician," Nunez-Smith said, "I strongly urge everyone in America to get the first vaccine that is available to you, when it is your turn ... Time is of the essence. Getting vaccinated saves lives."

MedPage Today asked a handful of clinicians and medical ethicists and one public health expert whether it made practical or ethical sense to target certain populations with the J&J vaccine and others with the Pfizer/BioNTech and Moderna vaccines.

While on certain measures the J&J vaccine appears statistically inferior than the Moderna or Pfizer/BioNTech, several experts argued that the vaccines are comparable, and all the experts interviewed tended to agree with Nunez-Smith that the first authorized vaccine Americans can get is the best one to take.

Targeting Homeless, Rural Patients

Peter Gulick, DO, of Michigan State University's College of Osteopathic Medicine in Lansing, sees a definite benefit in reserving some J&J vaccines for homeless individuals: "Here, at the health department, some people we have to get bus tokens, and find transportation for, just for them to come in for a visit," Gulick said.

By the time their next appointment comes up a few weeks later, patients can be hard to find, he added.

"If they're homeless, they might have disappeared or ... gone out of the community," Gulick said, emphasizing the benefit of a one-dose regimen.

In the Upper Peninsula and areas of central Michigan, where there are few big cities, smaller pharmacies could benefit from the J&J vaccine because it doesn't require "really low temperatures," he explained.

Chris Martin, MD, MSc, of West Virginia University School of Public Health in Morgantown, also said he could easily see a reason to prefer the J&J vaccine for the homeless patients at his clinic as well as other rural residents.

"Distances are an issue," he explained. "Weather, at this time of year, remains an issue," and getting time off from work during immunization appointment hours can also be a challenge.

"So, the advantage of a one-dose vaccine is clear," Martin said.

As to the question of reaching homebound patients, Hemi Tewarson, JD, MPH, a visiting senior policy fellow at Duke Margolis Center for Health Policy, said this often involves sending out emergency medical services to patients' homes.

"Operationally, it would be easier to use the J&J vaccine," because, for one thing, transporting the vaccine to different neighborhoods would be easier, she said. "You get the one vaccine. They're all set. You don't have to have the cold storage."

And the same benefit would hold for homeless individuals, Tewarson added. "However, I do think states want to be thoughtful and careful because of these concerns around 'is it less effective?'"

Regarding data on hospitalization and death, she said, it should not be a concern -- "it's really quite good."

Messaging Matters

Kyle Ferguson, PhD, a postdoctoral fellow in the division of medical ethics at NYU Grossman School of Medicine in New York City, suggested a thought experiment for those concerned about equity: "If we say everyone is going to get two doses of Pfizer no matter where you live and no matter ... whether you are homeless or not ... you'd have to do that infrastructure development in rural communities and you'd have to ... track and then coerce homeless people so that they'd come back for their second dose."

If the only option is Pfizer/BioNTech or nothing, then some people won't get vaccinated at all, he said.

"One alternative is unrealistic, and the other alternative is unacceptable," Ferguson said.

Arthur Caplan, PhD, director of the medical ethics division at NYU Grossman School of Medicine in New York City, said media coverage and messaging around how vaccines are allocated will certainly affect people's thoughts and beliefs.

"If we say, 'Gee, only homeless people are getting Johnson & Johnson all around the country, and everybody who lives in a rich neighborhood gets Pfizer,' it will obviously give the impression ... that there's a difference between the two, and the rich do better."

While that may not be true, people's perceptions matter, Caplan said. "The rich have done far better than the poor at getting vaccines so far. They've all had Pfizer and Moderna ... So, there's already a class skew."

But physicians' views also matter, he added: "If your doctor says, 'No, this is perfectly fine, it's gonna keep you from dying, it's gonna keep you from going to the hospital,'" most Americans will trust that.

Efficacy Data: 'Apples to Oranges'

The idea that the J&J vaccine may be viewed as less effective than the mRNA vaccines and therefore not the preferred option is concerning for clinicians and ethicists.

The J&J vaccine was found to be 66.9% effective against moderate to severe COVID at 14 days and 66.1% effective at 28 days after vaccination. In U.S. clinical trials, the vaccine demonstrated higher efficacy rates of 74.4% at 14 days following vaccination and 72% at 28 days following vaccination, according to data the company shared at last week's FDA advisory committee meeting.

Results from the Moderna vaccine's pivotal trial showed an overall efficacy rate of 94.1% in preventing clinical illness with confirmed infection. Similarly, the overall efficacy of the Pfizer/BioNTech vaccine 7 days after the second dose was 95%.

But Johnson & Johnson defined COVID illness differently from Pfizer and Moderna. Also, said Meera Mehta, PharmD, a clinical infectious diseases pharmacist at West Virginia University Medicine in Morgantown, the vaccines weren't compared directly in head-to-head trials. Each one was tested against a placebo, and studied during different phases of the pandemic, she noted.

The mRNA vaccines were studied before many of the variants of concern emerged, whereas the J&J trial came later and included participants in South Africa, where the B.1.351 variant is prevalent and believed to be more contagious, Mehta said.

Mehta said she hopes that people won't get "hung up on" the 95% efficacy of the mRNA vaccines compared with the J&J vaccine.

At Monday's press briefing, Anthony Fauci, MD, director of NIAID and President Biden's chief medical advisor, pointed out that "even though the [J&J] vaccine itself was not specifically directed against those [emerging] variants, it did extremely well when it came to preventing severe critical disease."

And globally, the J&J vaccine, which was tested in Brazil, in addition to the U.S. and South Africa, was 85% effective against severe COVID-19, Fauci noted.

WVU's Martin went even further, arguing that the J&J vaccine and the mRNA vaccines were tested against "significantly different viral strains," which could impact their efficacy.

"In other words, if you repeated the Moderna and the [Pfizer/]BioNTech trials now, maybe their efficacy has declined because of variants? We don't know that," he said.

'Everybody Wants to Be Gold'

In terms again of educating the public about vaccines, Ferguson said, "it really matters which number you focus on."

Those focused on overall efficacy rates "look at those three numbers and then they rank them, gold, silver, bronze," he said. "Everybody wants to be gold."

But the numbers that matter are 85% and 100%, Ferguson said, referencing the J&J vaccine's efficacy against severe illness and against hospitalization and death, respectively. That was similar to the numbers for the Pfizer/BioNTech and Moderna vaccines.

If the J&J vaccine is used to target rural or vulnerable populations, policymakers aren't "lowering the bar or saying that they deserve second-best. This vaccine ... has met the conditions that we agreed on from the beginning," he said.

Caplan called comparing overall efficacy rates "a little distorted." Other measures that we don't yet have data for -- which vaccine offers longer immunity, which one requires a booster or prevents asymptomatic transmission -- may all take on more significance in the future, he added.

"Until we fill in some of those issues, I think we should distribute the vaccines where we can get them, and people should feel comfortable taking them," he said.

Mehta agreed: "The longer you allow this virus to circulate, the more opportunity it has to mutate, and that's why it's very important to give as many people as possible immunity as early as possible."

'The Worst of All Possible Worlds'

Yet, Martin was not optimistic that message will be received, saying that he anticipates that many Americans will cling to the overly simplistic idea that "I'm getting a second-rate vaccine, I want the best."

In Germany, that scenario has already played out, with some residents there rejecting the AstraZeneca vaccine because they believe the Pfizer/BioNTech one is superior, he noted.

For people to wait for a "superior" vaccine while letting another one sit unused, "that is the worst of all possible worlds," Martin said.

But Americans are unlikely to have the option to choose their vaccine, at least for the next few months, he said.

To that end, he recommends taking a page from Pinkalicious, one of his 11-year-old daughter's favorite book characters, who says, "You get what you get, and you don't get upset."

"We're going to be in a 'Pinkalicious phase' for the next few months," he predicted.

Molly Walker, MedPage Today associate editor, contributed to this article.

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    Shannon Firth has been reporting on health policy as MedPage Today's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team. Follow

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