America’s new monkeypox vaccine strategy is based on a single study

Again, the US is screwing up its approach to vaccines. Three months after his monkeypox outbreak, Jynneos had only her 620,000 doses of vaccine with her two shots. shipped to the stateis not enough to immunize 1.6 million to 1.7 million Americans What the CDC considers the most risky.The next arrival from the manufacturer is undecided as early as SeptemberFor now, we’re sticking with the stocks we have.

That’s why the federal government turned to Immunization Plan B. A dose of Jynneos he divides into five and pierces the skin, not the fat layer underneath. FDA Emergency Use Authorization Issued About yesterday afternoon’s strategy.

This dose-saving tactic will allow far more people to sign up for doses before summer is over. If successful, it could help contain the outbreak in the United States. Nearly one-third of documented monkeypox cases worldwideHowever, this decision was based on scant data and the degree of protection offered by intradermal injections is limited. No warrantyThe FDA is now making high-stakes bets on the health and confidence of those most vulnerable to monkeypox — those who are already marginalized. Call it a bold decision. It’s a risky gamble: it may be the best option the US has right now, but it’s an option that could have been avoided if the US had put together a stronger response sooner.

Read: America could have dealt with monkeypox

Little is known about how Jynneos works against monkeypox. Predetermined administration regimen, the so-called subcutaneous route; the new method, intradermal injection, is still a dark proposition. “We are in a very data thin zone,” says Jean Marazzo, an infectious disease specialist at the University of Alabama at Birmingham.

the shot is approved It is planned for use against smallpox and monkeypox in 2019. But so far, researchers don’t have a strong sense of how well it wards off disease and infection, or how long the protection lasts. Scientists know that 2 doses of Gineos can Induces as many antibodies as older poxvirus vaccinesno estimates of the true efficacy of vaccines from large clinical trials exist. human research in the Congo I haven’t reported my results yet.And although more solid data show that vaccines persist Labozal “We don’t necessarily trust ourselves to make clinical decisions,” says Mark Slifka, a vaccinologist at Oregon Health and Science University. It’s not even clear if Jynneos can stop the virus from spreading. skin-to-skin contact during sexa poorly studied diffusion form.

An emergency switch to low-dose intradermal administration has been tested with other vaccines. yellow fever When influenzaBecause the skin is full of specialized defense cells that can snatch up fragments of the vaccine and carry them to other immune combatants, it is possible to get a similar response to a full-sized subcutaneous injection with “a smaller dose.” You can,” says Jacinda Abdul Mutakabir, a pharmacist at Loma Linda University in California.

lonely study Research from 2015 suggests that this logic also applies to Jynneos. It’s very encouraging,” said Kathryn Edwards, a Vanderbilt University vaccinologist who helped conduct the study. And what happened in that single study doesn’t necessarily play out in the real world, especially in the context of the current outbreak. This differs from previous studies in demographics and scale. “I think these data need to be confirmed,” Edwards told me. Most of the cases so far men having sex with men, many of them are living with HIV— a community whose immune system does not look the same as the general population, and to whom vaccination may not take as well, or all the time, Slifka told me. Yet the FDA billed it upfront.”completely Based on that 2015 study,” said Alexandra Yonts, a pediatric infectious disease physician at the National Children’s Hospital.and statementthe agency explained, “We have determined that the known potential benefits of Gynneos outweigh the known potential risks” for giving the go-ahead to the intradermal route.

Vaccine delivery to the skin leaves little room for error. A tuberculosis skin test is also given intradermally. Marazzo has seen “dozens of messes”. People are bleeding and bruised. The needle may be too deep to compromise its effectiveness, or too shallow to ooze out the liquid. Intradermal injection is an uncommon and difficult procedure, requiring additional training and specialized needles. “There will be some margin of error,” says Kenneth Cruz, a New York community health worker. “People will wonder if they are protected, and it will be difficult to verify.”

Bogma Kavisen-Titanzi, an infectious disease specialist at Emory University, says providers already have “staffing problems in vaccination clinics for subcutaneous injections.” A switch to intradermal vaccination could exacerbate these deficiencies and further raise barriers to vaccination for people without access to reliable health care. Intradermal injections can also come with more troublesome side effects. As a 2015 study suggestsThose who get the first dose may not come back further, which defeats the point.

Yonts told me that splitting the dose is “a much better way” than skipping or significantly delaying the second dose. New York; washington dc; When San Francisco— to save supplies. Elsewhere it is very difficult to get a second appointment. “I don’t know anyone who got a second dose,” says Nick Diamond, one of the investigators behind it. response dummy, an LGBTQ-led survey of monkeypox symptoms and networks. This isn’t great: after just his one injection, antibody levels “very little change,” leaving people vulnerable until he’s two weeks after the second injection is complete. increase. (another vaccine, ACAM2000is available, but can cause serious side effects and is not recommended for immunocompromised people, including those with HIV.)

Dose splitting is the only way out because there are no other good options. “There are no other viable options,” Marrazzo told me. That doesn’t erase the fact that the country squandered its chances with Program A. It will utilize its considerable resources to deploy tests, treatments, and vaccines to contain the outbreak early, and continue to vie for subcutaneous injections. About 9,500 infections have been recorded among Americans nationwide— clearly underestimated — that door was closed. Adhering to a strategy of two full subcutaneous doses for everyone was predicted to “run the vaccine by October.”

However, Plan B may have real costs and reduce demand and confidence in the vaccine. Already “the question about the level of protection has not been answered,” Mr Diamond told me. The best words Abdul-Mutakabir was able to convey to his patients is that “having this vaccine has a better chance of preventing it than not having it”. Cruz told me it doesn’t do much to “soften the Especially after more than a year of confusion and conflicting messages about his vaccination against COVID.

Read: What Most Americans Should Worry About Dealing With Monkeypox

NYU microbiologist and RESPND-MI investigator Joseph Osmundson told me he believes the Biden administration did not properly consult members of vulnerable communities before proceeding with dose fractionation.And if subcutaneous injections produce better results than intradermal injections, he fears there could be a disparity. , will receive the first dose. Worse Inequalities the outbreak has already begun to exploitNumbers alone can make you sick. “If I had been standing in line to get his fifth of the vaccine, I would have wondered why my health was so undervalued,” Diamond told me.

Dose fractionation is a stopgap, not a sustainable “solution,” says Luciana Borio, former Acting Scientist at the FDA. Outbreaks of monkeypox can last for many months. become endemic in animals. Ultimately, you may need a boost. ACAM2000 could play an even bigger role. The United States will need clinical trials to understand which dosing strategies actually work best and for whom. Also, the most affected groups, especially men who have sex with men, need to be involved in these decisions along the way. Yes,” he said, adding, “We need to make a deliberate effort to close those gaps.”

Yet, as news of the dose splitting decision continues to permeate the public, an inadvertent message may already be sent. “But we are in this position because the government has failed.” It will be the nail in the coffin,” Osmansson said.