State and local health officials have taken a new step in the response to monkeypox after the Food and Drug Administration (FDA) approved a five-fifth dose split of the Jynneos vaccine to expand available supplies. facing obstacles.
The FDA last week approved a new dosing regimen for the Jynneos smallpox vaccine, which is used to prevent monkeypox in the ongoing epidemic, to expand availability of the current dose in the United States. Between layers of skin, not muscle, where most vaccines are administered.
According to the FDA, it “has become clear to all of us that the current supply cannot meet the current demand,” so it considered approving this method. It also appears to be based on a 2015 study that found that administration of the drug elicited an immune response equivalent to that of a complete administration to muscle.
Although this guidance will increase the dosage of Jynneos five-fold, many state and local health officials in the areas most affected by the monkeypox outbreak have yet to adopt the new strategy.
Several hurdles stand in the way for local governments to follow the federal government’s new guidance. For example, workers are not trained to perform intradermal injections, lack of specific needles used for this type of injection, and lack of funds to procure more supplies. etc..
A representative for the New York City Department of Health and Mental Health said it was “considering new guidance,” without saying whether the Jynneos vaccine would be split in five.
Other local health officials have indicated that they are postponing the new method for the time being until further information and resources are shared.
The Chicago Public Health Department called the FDA’s decision “great news” but noted that the vaccination method was “not very common.”
“The coming weeks will require significant changes in our operations. For example, CDPH is currently ordering thousands of small needles and syringes that we need,” the agency said, referring to the Centers for Disease Control and Prevention (CDC). and the Illinois Department of Health to facilitate training. Realign reporting and information infrastructure for immunization campaigns.
The San Francisco Public Health Department likewise said it was “awaiting federal and state guidance” on its latest strategy. The agency also acknowledged that it needs to provide workers with additional training.
Although not as frequently used as injections injected into muscle, intradermal injections are not unheard of in healthcare. Create a “pocket”.
A representative from the Texas Department of Health Services said TB nurses are familiar with intradermal injections, but among private providers, who may not be as familiar with the injection method as some public health workers, ” He said he needed to do some training.
A representative said the state of Texas had ordered more syringes and suitable needles to be sent to local health departments, but said state officials would leave it up to local governments to decide whether to use the new method. rice field.
One such local health department that recently adopted the one-in-fifths strategy was the Austin Department of Public Health, which began administering a reduced dose of intradermal injections on Monday. According to Austin Public Health, nurses were “extremely adept” in administering intradermal injections, intradermal needles were readily available to the department, and more had already been ordered.
Some clinics in large cities such as Los Angeles have been able to adapt quickly to the new guidance.We were able to start a St. John’s Community Health Clinic reduce intradermal injections Within one week of FDA approval.
The Los Angeles County Department of Public Health said it could “quickly update” stakeholders on the FDA’s decision and update its own information on alternative dosing methods.
“Public Health has said it will implement these changes when it receives the next dose tranche, but if providers feel ready to implement the new strategy, they can continue. ‘ said the agency.
Adrian Casarotti of the National Association of County and City Health Officials told The Hill that while the updated guidance partially addresses the limited supply of available vaccines, He said there were logistical problems of the type that tend to be “lost” at the federal level. Implementation.
“So getting the right syringes is a big problem,” she said, noting that, in addition to not having those syringes yet, local health officials said, “Because they don’t come with vaccine vials, they’re being sold.” We face further complications when trying to obtain it.”
“But also there is no additional funding approved for monkeypox.
Aside from costs and logistics, there are also uncertainties surrounding FDA guidance. His CEO of Bayern Nordic, which makes Jynneos, said in a letter to FDA Commissioner Robert Calif and Health and Human Services Secretary Xavier Becerra last week that he had “some reservations” about the approach.
Bavarian Nordic chief executive Paul Chaplin cited “very limited safety data available” in expressing his reservations, noting that his company is “a state government in the United States”. “We are inundated with calls from interested parties with questions and concerns.”
Chaplin said he supported the approach to maintaining limited supplies of the vaccine, but said it would have been “wiser” to launch a new strategy with more comprehensive guidance.
Casalotti agreed with these sentiments, saying communication and outreach were also key factors, in addition to additional resources. She said news of Bavarian Nordic concerns over the new method could spark similar concerns among affected communities.
“Additional communication is needed to ensure that not only the public health department, but also the affected individuals themselves understand what alternative therapies mean,” she said.
