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White House strategy for monkeypox vaccines causing ‘chaos out in the field’

These officials have had to make an effort to reorganize their vaccination efforts – canceling clinics, rescheduling staff and postponing plans to expand eligibility.

And, Although the federal government made more vaccines available on Monday for states to order, states warn they still don’t have enough doses to contain a rapidly spreading outbreak that has infected nearly 16,000 people so far, as public health experts fear the chance to stop the spread of the virus is closing.

“The federal government has patted itself on the back for the way they are accelerating vaccine delivery,” said Patrick Ashley, senior deputy director of the Department of Health in Washington, DC. “What they did is they moved songs.”

In Washington, DC, which has more cases of monkeypox per capita than anywhere else in the US, health officials expected the new dosing strategy — in which a smaller amount of vaccine is injected into the outer layer of the skin — would allow them propose to stretch the 12,000 vials they were promised to 60,000 doses; instead, they received 2,400 vials, a fifth of the original number. And when the last vaccine assignment came early this week, they were assigned about 4,000 vials.

DC has that with just over half the bottles it expected. And providers are only “occasionally” able to get five doses from a vial, Ashley said.

It’s the latest hiccup facing the government amid widespread criticism of the monkey pox response, reporting to LGBTQ communities about the risks of the virus and failing to deliver enough vaccines to immunize those most susceptible. to walk it up.

“This week has been frustrating just because you think you’re getting a certain amount, it’s not that much, and then you can’t get that many doses out of the vial,” said Marcus Plescia, medical director for the Association of State and Health Care. territorial health officials. “This will likely result in some chaos in the field where people will be turned away because they run out.”

Federal health officials emphasize that this is not a static public health response and say they are constantly working with states and cities to ensure they have the vaccines they need.

“We’re working hard to make it clear that if you’re in a limited supply atmosphere, you’re going to get more supply,” a senior government official told POLITICO, speaking on condition of anonymity to provide sensitive details of the monkeypox response from to discuss the administration.

Although states get vaccines based on a calculation of five doses per vial, the administration acknowledges that some practitioners do not receive all five doses, and encourages states to submit data on the administration of the vaccines so it can adjust its response as necessary, the official said.

Nevertheless, some public health experts are criticizing the federal vaccination strategy of forcing state and local health departments to scale back their vaccine coverage when they should be ramping it up. And some fear the approach could widen the already stark racial disparities in monkeypox cases, as black and Hispanic people have higher rates than their white counterparts of a skin condition that makes them ineligible for intradermal administration.

“The move to intradermal was intended to increase supply so that public health officials could quickly protect as many people as possible,” said Caitlin Rivers, senior scientist at the Johns Hopkins Center for Health Security. Instead, “state and local health departments and their constituents are diminishing.”

In Seattle, health officials have limited the number of first doses they planned to administer and postponed second doses. In Portland, Oregon, the health department warns that the supply is “still very limited.” And in Philadelphia, city officials plans they had made to significantly ramp up their vaccine business in preparation for the switch to intradermal dosing were scuttled.

“Our plan was ready to do this massive expansion, and we had to call everyone back and say, ‘Stop that. We don’t get extra doses of this. We get the same number of doses, we just have to use them in this split way,” said James Garrow, a spokesperson for the Philadelphia Public Health Department. “Everyone expected to see this broad expansion of eligibility and now it’s not happening.”

And while federal health officials created an extra 360,000 vials, or up to 1.8 million doses, will be available for states to order Monday — ahead of schedule — states say the allotment represents just a fraction of the vials they were counting on a week ago.

“The challenge we are most concerned about [is] general restrictions on vaccine delivery,” said Jess Nelson, a spokesman for the Washington State Department of Health.

Federal health officials say they are trying to respond nimbly to a rapidly changing situation. They say the new fractional dosing strategy, and associated policy changes, are necessary steps to respond to an evolving outbreak with limited vaccine stock.

The plan is based in part on a 2015 study by the National Institutes of Health that found that administering a series of two doses of one-fifth of a vial of monkeypox vaccine between layers of skin is at least as effective as a subcutaneous injection of the dose of monkeypox. one vial.

Last week, the federal government began sending vaccine orders to states based on the calculation that there should be five viable doses in each vial. At this time, a jurisdiction cannot order more vaccines until it has used 85 percent of its current supply.

In some places, practitioners say the rollout is working as planned.

In Los Angeles, St. John’s Community Health has administered hundreds of vaccine doses per day under the new strategy at clinics in Black and Latino neighborhoods, both communities disproportionately affected by the outbreak.

Jim Mangia, president and CEO of St. John’s, said the clinic’s staff easily transitioned to intradermal administration because they were already familiar with the technique of a similarly administered TB test. He said they have also consistently extracted five doses per vial because they have syringes with the appropriate specialized needles on hand. (Some more common types of needles leave a small amount of vaccine after each dose, making it more difficult to get the full five doses from each vial.)

“It’s a total game changer,” said Mangia. “We were able to vaccinate more than 1,500 people in the past week.”

In other clinics, where staff are not trained in intradermal administration, or who don’t have the right needles on hand, it’s been harder to catch up with changing federal guidance.

In North Carolina, which required all practitioners to switch to intradermal dosing starting next week, David Wohl, a professor of infectious diseases at the UNC School of Medicine, said UNC hospitals are “clambering” to train clinic staff to administer the vaccine. to be submitted by the deadline. .

“Is it impossible? No,” Wohl said. “Is it another series of hoops that we have to jump through? Yes.”

Some local health officials and providers are particularly concerned about the impact of the new federal strategy for vaccine allocation on black and Hispanic men, who account for the majority of known cases of monkeypox in the U.S. but have the least chance of being vaccinated.

Wohl said he thinks the intradermal dosing may work, but the sudden shift has left communities of color questioning whether they’re being offered an inferior vaccine.

“If we change things halfway through the course – if we move the goalposts or change the rules of the game – people get frustrated,” he said. “People are now saying in some of our outreach efforts, ‘Wait a minute, you’re reaching out to black and Latino communities now and you’re giving us a fifth of the dose you gave to the whites? What about that?'”

Others worry that the new federal allocation strategy assumes states can get five doses from each vial when some people may not be able to get the vaccine intradermally — including those with a history of keloid scarring. Keloids are more common in dark-skinned people of African, Asian, and Hispanic descent, where the incidence of the skin condition ranges from 4.5 to 16 percent.

People with a history of keloid scarring can still get the monkeypox vaccine, but a fifth of the dose will not be enough. Local health officials said that wouldn’t be a problem if they got the full allocation they expected, but with limited vaccines, repeated injections under the skin could quickly deplete supplies — especially as they work to increase vaccination coverage in communities of color.

“There are internal conversations that we’ve had about how best to go about that, because in Philadelphia, according to the data we just published, most of our cases are in Black Philadelphians, and they’re more likely to have keloids, Garrow said. “We don’t want to say, ‘Well, you’re just not getting one right now.'”

The government has said it will work with states to adjust vaccine orders if they need to administer a large number of full doses.

And since the Food and Drug Administration’s emergency approval for the vaccine earlier this month, the Centers for Disease Control and Prevention have released information to help states and cities train providers on how to administer the new dose, and how to keep track of it. training conversations with practitioners.

“I hope that as healthcare providers become more adept at the technique, this will improve,” said Claire Hannan, executive director of the Association of Immunization Managers.

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