The Food and Drug Administration (FDA) plans to green light plans to make the US stockpile of monkeypox vaccines last longer by cutting the dose by 80 percent and changing the way it is given to patients.
Bloomberg reports that in order to curb the shortage of Jynneos monkeypox vaccine, officials plan to supply doses of the vaccine that are only 0.1 milliliters (ml), a massive drop from the standard dose of 0.5 ml. He believes that using an intradermal injection – which injects the vaccine between the layers of skin instead of under the fat – will ensure that the injection is just as effective.
The FDA is poised to approve plans to reduce the dose of Jynneos monkeypox vaccine by 80% and deliver it intradermally in an effort to address America’s vaccine shortage (file photo)
It comes in response to a massive shortage of monkeypox vaccines available in the US. So far, officials have distributed only 600,000 benefits to state and local jurisdictions across the country. When the beats became available in major population centers like New York City, appointments filled up within minutes due to extremely high demand.
However, the science behind this step is limited. A single 2015 study funded by the National Institutes of Health shows that vaccines may be just as effective by the intradermal route, but no other data exist. That would be a massive shift in America’s response to the virus, based on the limited evidence that exists.
The move comes as the US reported a record 1,424 cases on Monday, the highest total since the global epidemic first hit the states in May. A total of 8,934 infections have been recorded in the US – the most of any country.
This epidemic could also get worse soon. Colleges and universities across the United States are set to begin a new school year in the coming weeks. Young students are more likely to engage in reckless sexual behavior, creating the perfect storm for potential monkeypox outbreaks across the country.
Officials wrote in an email obtained by Bloomberg that the FDA will soon issue an emergency authorization for the rationing strikes.
The Jynneos vaccine was developed by Bavarian Nordic against smallpox, but it is also effective against monkeypox.
Last week, FDA chief Robert Califf explained that this new approach will allow the nation to make the most of its resources without losing efficiency.
“The advantage is that you can stretch the doses,” Dr. John Moore, a virologist at Cornell University, told the New York Times about the plan.
“The downside is that if you cut it too far or take too much leeway, you reduce efficiency. And how do you want to know? It’s an educated guess.’
Federal officials currently have access to approximately 1.1 million images—not enough to cover America’s vulnerable population.
Last week, the Department of Health and Human Services declared the virus a public health emergency, opening the door for regulators to implement these types of measures.
Former FDA chief Dr. Scott Gottlieb (pictured) told CBS Face the Nation that America’s monkeypox epidemic can still be controlled.
However, there are some questions as to whether this is the right move.
In 2015, researchers found that smallpox vaccines were just as effective when given in smaller doses when injected intradermally.
However, there was only one study conducted on 524 participants and using a different vaccine.
Currently, the shots are mainly reserved for men having sex with other men – although some exposed people have been allowed the shot as a precaution.
There may be a need to expand access to footage soon. Some officials fear that the virus has already escaped from this sex network and is now in other groups as well.
“There is potential to get it back in the box, but it’s going to be very difficult at this point,” Dr. Scott Gottlieb, the FDA’s outgoing chief, told CBS’ Face the Nation over the weekend.
“We’re continuing to look for cases in the MSM community, it’s primarily spread in that community, but there’s no question that it’s spread outside of that community at this point and I think we need to start looking for cases.” more widely.’
Although exact federal figures are not available, Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky said during a briefing last week that gay and bisexual men still make up the majority of cases.
The CDC has greatly expanded its testing capacity in recent weeks and is now able to conduct 80,000 per week through its own testing and agreements with private partners.
Last week, Walensky said only about ten percent of America’s testing capacity is being used, opening the door for a significant expansion of the number of people who should be tested.
Gottlieb said any person with an atypical case of shingles or herpes should be tested for monkeypox at this time.
Expanded testing will either find more cases – giving officials more information they can use to control the outbreak – or confirm more people as negative and confirm areas where the virus is not spreading.
He also believes the CDC should begin surveillance of wastewater — which can provide more general pictures of where the virus is spreading without individual testing.
Despite his concerns, Gottlieb doesn’t think the virus has reached a point where the average American should be concerned.
“I don’t think it’s something that people should worry about in general,” he explained.
“I think the incidence of this infection in the wider community is still very low. Your risk of coming into contact with monkeypox is still extremely low outside of certain social networks where you see higher cases.
“If you want to contain it… we need to start looking for it widely.