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FDA allows splitting into five single doses of monkeypox vaccine

The Food and Drug Administration on Tuesday issued an emergency use authorization that allows health care providers to reduce the dose of the monkeypox vaccine to one-fifth of what has been given so far.

To make this lower dose possible, the Jynneos vaccine should be administered intradermally, under the top layer of the skin. This is a change from the way it has been given so far: those who have already received the vaccine have received it subcutaneously, which means that a needle has been inserted into a diaper fat between skin and muscle.

The vaccine is designed as a two-shot regimen, 28 days apart. The FDA said Tuesday that health care providers should continue to give two injections of Jynneos per recipient, but in the future, each dose may be reduced so that more people can access monkeypox vaccines. Those who have already received a dose subcutaneously can receive their second dose intradermally.

Emergency clearance also allows providers to administer subcutaneous injections to people under 18 who are at high risk for monkeypox infections.

“Over the past few weeks, the monkeypox virus has continued to spread at a rate that clearly shows that our current vaccine supply will not meet current demand,” FDA Commissioner Robert Califf said in a statement. a statement. “The FDA quickly explored other scientifically appropriate options to make the vaccine more accessible for all affected people. By increasing the number of doses available, more people who want to be vaccinated against monkeypox will now have the opportunity to do so. ”

Health and Human Services Secretary Xavier Becerra issued an emergency declaration on Tuesday that allowed the FDA to authorize the intradermal method.

In general, vaccines given intradermally rely on a lower dose to stimulate an immune response because the skin contains more immune cells than the fatty tissue underneath.

“Basically, you get more for your money,” said William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health.

Dawn O’Connell, assistant secretary for preparedness and response at HHS, said the new vaccine strategy would allow health care providers to extract 2.2 million doses from the 441,000 vaccine vials currently available in the national strategic stock.

But some medical experts worry that the immune response from a lower dose will last less.

“Is this going to put us in a situation where we have to go back and make additional plans?” said Arthur Caplan, professor of bioethics at NYU Grossman School of Medicine.

Caplan said he feared a scenario where “we expand the vaccine, we get an immediate response and people stop getting sick, but three weeks later we’re back to where we were.”

A pharmacist prepares a dose of the Jynneos monkeypox vaccine
A pharmacist prepares a dose of the Jynneos monkeypox vaccine at a pop-up vaccination clinic in West Hollywood, California on August 3.Mario Tama/Getty Images

Moss said that as long as people receive both injections in the two-dose schedule, an intradermal injection would likely produce a similar immune response to a subcutaneous injection.

“It’s with a single dose that I think there would be more concern about the duration of immune protection,” he said.

Supply shortages led to dose saving

The United States has recorded nearly 9,000 cases of monkeypox this year.

Rochelle Walensky, director of the Centers for Disease Control and Prevention, estimated last week that there are currently up to 1.7 million people most at risk of contracting monkeypox. This figure is based on the number of men who have sex with men living with HIV or eligible for HIV preventive treatment.

As of Tuesday, more than 620,000 of the 1.1 million doses available have been shipped nationwide. Cities and states with the highest number of cases and at-risk populations receive the largest allocations.

But the Biden administration was slow to order additional doses early in the outbreak, experts said. Although monkeypox began to spread in May, the United States did not order more doses of Jynneos to add to its stockpile until June. More than a million doses were also stuck at a manufacturing plant in Denmark until the end of July.

Caplan said White House officials “seem to be at an impasse because they’re outnumbered, but they kind of got themselves into this situation.”

“We created a crisis that we might have been able to avoid,” he said.

Moss said the discussion of splitting vaccine doses “is driven by the shortage of supply, not the sense that it’s some sort of superior method of administering a vaccine, even though it might be.”

Still, he said, the intradermal approach makes sense in an emergency.

“When you’re in a situation where you need the vaccine, where the demand far exceeds the supply, that’s always been one of the strategies,” he said.

The World Health Organization, for example, called for partial doses of vaccine in response to yellow fever outbreaks in Africa in 2016.

“You are trying something experimental”

Intradermal injections are not common in the United States

“Administering a vaccine intradermally is a bit more difficult technically,” Moss said. “It may require additional educational materials and training, but I think it’s something healthcare workers in the United States can handle.”

People line up for the monkeypox vaccine
People line up for the monkeypox vaccine at the Balboa Sports Center in Los Angeles on July 27, 2022.Robyn Beck/AFP via Getty Images File

He added that healthcare providers who perform skin testing for TB may be familiar with the practice. Medical experts widely agree that administering the Jynneos vaccine intradermally will not pose any new safety risks.

Although the method was not tested in Jynneos clinical trials, a 2015 study found that people who received one-fifth of the standard dose intradermally produced a similar immune response to those who received a full dose intradermally. subcutaneous route.

Moss said intradermal injections might produce a little more redness, pain, or discoloration at the injection site compared to a subcutaneous injection. The 2015 study found that 36% of people who received the Jynneos vaccine intradermally had mild skin discoloration at the injection site for six months or longer.

Caplan said it’s important to follow people who get a lower dose to make sure their protection doesn’t wane too quickly. Health care providers should tell patients they are not administering the standard diet, he added.

“If you do that, you’re basically going to have to tell people, ‘You’re trying something experimental,'” Caplan said.


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