New US monkeypox vaccine strategy could be huge boost for supply, but much is unknown - CNN
Aug 11, 2022 2 mins, 57 secs

The new federal strategy still calls for two doses of the vaccine given 28 days apart, and it says people who get their first dose subcutaneously can receive their second dose either intradermally or subcutaneously.

But some people have concerns about the shift to a low-dose intradermal strategy.

"While we appreciate that the federal government is finally willing to look for solutions to help rectify the shortage of vaccines, no effort to protect people's health should come without proper due diligence and research," David Harvey, executive director of the National Coalition of STD Directors, said in a statement Tuesday.

"We have grave concerns about the limited amount of research that has been done on this dose and administration method, and we fear it will give people a false sense of confidence that they are protected.

This approach raises red flag after red flag, and appears to be rushed ahead without data on efficacy, safety, or alternative dosing strategies."

The Chicago Department of Public Health said Wednesday that it will be going along with the federal plan to stretch out the supply of monkeypox vaccine by changing to smaller doses given in a different way -- but it won't happen overnight.

"I do think it'll be a couple of weeks until we're rolled out more broadly," Chicago Department of Public Health Commissioner Dr.

Allison Arwady said.

Other city health departments, like Columbus Public Health in Ohio, are still reviewing the new federal strategy and what it means for their local response.

"Because this guidance is new, we are currently reviewing it to determine the impact on our vaccine effort, staffing and supplies," Kelli Newman, a spokesperson for Columbus Public Health, wrote in an email to CNN on Wednesday.

A need for 'formal clinical efficacy data'

The efficacy of Jynneos for the prevention of monkeypox originally was tested in animals that were exposed to the virus, and it can be inferred from antibody responses seen in people who participated in smallpox clinical studies.

But the Jynneos vaccine was originally developed to contribute to the nation's defense against smallpox as a bioterrorism response effort -- so there still isn't much data on exactly how well it protects against monkeypox infection, even with a subcutaneous dose.

"There is no formal clinical efficacy data with the monkeypox vaccine -- but that's not a criticism of the vaccine.

Half of them received ACAM2000, and half got Jynneos.

The US Centers for Disease Control and Prevention estimates that the Jynneos and ACAM2000 smallpox vaccines are at least 85% effective in preventing monkeypox.

"Although we don't have clinical efficacy data, it is likely that Jynneos will be highly effective, because of what we know about the smallpox vaccine and because of the efficacy with Jynneos against monkeypox in animals," Barouch said.

Stacy Lane, a clinician at the Central Outreach Wellness Center in Pittsburgh, said Tuesday of the demand for the monkeypox vaccine at her clinic.

The US Department of Health and Human Services has delivered more than 670,000 doses of the Jynneos vaccine from the Strategic National Stockpile to support local monkeypox response efforts on the ground.

"I ordered those this afternoon," she said Tuesday, before the FDA issued its authorization.

Lane said many of her patients are worried about getting monkeypox, and she refers them to the ACAM2000 vaccine data as a reference point for how well the Jynneos vaccine may protect against monkeypox.

"What we're educating people on is that we know from historical data that the ACAM2000 vaccine that was historically given in Africa was about 85% protective against monkeypox.

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