After a bumpy start, the Biden administration is trying to smooth out the vaccination campaign aimed at controlling the country’s growing monkeypox epidemic.
The effort now relies on a new, untested strategy of dividing up what were previously full doses in order to stretch the limited vaccine stock in the United States.
It comes like cases of monkeypox have climbed well above 14,000 in the United States – a higher number of cases than in any other country in the world – and yet many local health departments are still reporting that they do not have enough vaccines to reach all those considered to be at increased risk of contracting the disease.
“We’re definitely in what we still call ‘The Hunger Games’ phase – where there aren’t enough doses for demand,” said Dr. Mark Del BeccaroDeputy Deputy Chief of Public Health – Seattle and King County.
Already faced with the logistical hurdles expected of running a vaccination campaign in a public health emergency, health officials now face another challenge: how to extract five doses from single-dose vials.
“It’s great that we can increase the number of people we can vaccinate with the current supply,” said Claire Hannan, head of the Association of Immunization Managers. Still, “when you make a change like that, it’s kind of like turning the barge around in the middle of the sea.”
The change poses messaging and logistical challenges — training providers and getting the right equipment — and it raises concerns among some about fairness as early vaccine data arrives showing significant racial disparities.
Stretch a limited supply
The US government’s plan to bring the disease under control relies heavily on the distribution of the JYNNEOS vaccine, a two-shot monkeypox series made by Bavarian Nordic.
But one series of missteps early in the response left the United States with a major vaccine shortage. The federal government has been slow to order vaccines, allowing other countries to skip the queue, and distribution has been chaotic for states and cities.
So far, the United States has shipped about 700,000 vials of monkeypox vaccine to states and territories for distribution. The Centers for Disease Control and Prevention said the first priority was to vaccinate the 1.7 million people considered most at risk.
Faced with a shortage of vaccines, the Food and Drug Administration authorized a new dosing strategy last week: The vaccine can now be given by “intradermal injection” – where the vaccine is injected into the skin – rather than the typical method of injecting into the layer of fat under the skin.
“This action serves to dramatically increase the vaccine supply,” CDC director Dr. Rochelle Walensky said in a statement. video posted this week. “The intradermal delivery of the JYNNEOS vaccine allows vaccinators to administer up to five separate doses in total from an existing single-dose vial.”
Federal officials are adamant that this smaller amount of vaccine should not be considered a “partial dose” because it is still capable of producing a level of immunological response similar to the original method of administering the vaccine.
However, evidence for this method is sparse, although it has worked for vaccination against other diseases.
The theory is based on the fact that there are many immune cells embedded in the skin. “When a vaccine is delivered into this tissue, you can generate a robust immune response using a smaller amount of vaccine,” said Dr John Brooksa CDC medical epidemiologist in the video, citing a 2015 study on the vaccine. Brooks also pointed out that the method has been studied on other vaccines, including those against influenza and rabies.
One vial equals five doses? not so fast
There’s also a practical problem with the plan to squeeze five doses out of what was once a single dose:
“It’s just mechanically difficult to do,” says Del Beccaro of Seattle & King County. “The federal announcement of five doses per vial was, I think, incredibly optimistic and what we’re seeing in real life is three to four doses per vial.”
Hannan, head of the Association of Immunization Managers, heard the same concerns.
“Hopefully we’ll start to see more vials with five doses, but we’re not seeing that consistently right now,” she says.
And yet, it appears the federal government is assuming five doses per vial as it distributes vaccine supplies and sends them to health departments, Del Beccaro says.
Much of the U.S. vaccination campaign so far has focused on people who are unvaccinated and at increased risk of contracting monkeypox, but soon health services will also need to be ready for the influx. people returning for their second doses 28 days later.
In the Seattle area, that could be around 4,000 people in the last week of August. And while it’s always difficult to predict how the federal supply might change, Del Beccaro says currently it looks like they won’t be getting enough vaccine to do second shots while providing first shots at a rate raised.
The change also requires new supplies and training, says Janna Kerins, medical director at the Chicago Department of Public Health. “That means using a different syringe, a different needle,” she says, “so it took a bit of time to make sure people got the supplies.”
Additionally, providers need technical training on how to administer a dose into the skin. And “we must also educate [providers and the communities they serve] on the data that supports this change,” although not much is available, she says.
Distrust and feelings of disrespect
The new dosing strategy is also fueling a strong sense of inequality among some members of communities most at risk of contracting the disease.
The overwhelming majority of cases in the United States are still detected among “men who have reported recent sexual contact with other men,” CDC Director Rochelle Walensky told reporters Thursday.
Although the data is imperfect, what is currently available shows another trend: a disproportionately high number of black and Latinx members of the gay and queer community are contracting monkeypox – and they have also struggled to access vaccines .
On August 10, the North Carolina Department of Health published results that 70% of the state’s cases have been detected in black men, but only 24% of monkeypox vaccines have gone to this group.
Chicago is also seeing immunization gaps among men of color. 30% of city cases were found in Latino men, but only 15% of the vaccines went to the Latino population, according to Kerins, in Chicago. “We have work to do to try to better align vaccine doses with those who are [at risk of] become cases,” she says.
National data indicates that black and brown queer communities experience high rates of monkeypox: 33% of cases occur among Hispanics and 28% among blacks.
While no national data has been shared on vaccinations, lack of access for these groups is a problem across the board, says Joseph Osmundson, microbiologist at NYU and queer community organizer in New York. The new dosing strategy could contribute to this.
“We expect the data in New York and elsewhere to be similar,” Osmundson said. “What is that [dosing strategy] is using a different dosing schedule for those who get the vaccine late – who are more likely to be working class and more likely to be black and brown, who haven’t had the privilege yet, the ability to access the vaccine.
Disparities in vaccine access have sown suspicion and distrust in communities of color, says Kenyon Farrowwith the advocacy group Prep4All.
Farrow says public health officials still need to do more to explain why this new strategy isn’t necessarily inferior. He says one sentiment he’s seen online, particularly among gay people of color, is that “they let white gay people take all the first full doses. And so we’re now supposed to believe that one-fifth of this dose will do us just as well.”
Federal health officials say they are working to close those disparities.
On Thursday, the White House Monkeypox Response Team announced a pilot program to bring vaccines to Pride festivals and events where they can reach gay, bisexual and queer communities most at risk of contracting the virus. .
“A lot of the events that we’re focusing on are events that focus on populations that are overrepresented in this epidemic,” including blacks and Latinos, Dr. Demetre Daskalakis, deputy national monkeypox response coordinator, said Thursday during a briefing with federal health officials.
“It’s really about positioning messages and biomedical interventions where people can reach them, and also making sure we’re going to the right places and talking to the right people.”