WASHINGTON — The Biden administration has decided to extend its limited supply of monkeypox vaccine by allowing a different injection method that uses a fifth for each shot, according to people familiar with the discussions.
For the Food and Drug Administration to authorize the so-called intradermal injection, which would involve injecting one-fifth of the current dose into the skin instead of a full dose into the underlying fat, the Department of Health and Human Services will have to issue a new emergency declaration that allows regulators to invoke the FDA’s emergency use powers. This statement is expected as early as Tuesday afternoon.
The move would help alleviate a vaccine shortage that has become a growing political and public health issue for the administration.
In less than three months, more than 8,900 cases of monkeypox have been reported. The disease is spread primarily through skin-to-skin contact during sexual intercourse between gay and bisexual men. Federal officials are concerned both about the current infection rate and the risk that the disease could spread to other parts of the population.
What you need to know about monkeypox virus
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What is monkey pox? Monkey pox is a virus similar to smallpox, but the symptoms are less severe. It was discovered in 1958, after outbreaks occurred in monkeys kept for research. The virus was found primarily in parts of central and western Africa, but has recently spread to dozens of countries and infected tens of thousands of people, mostly men who have sex with men.
How does it spread? Monkeypox virus can be spread from person to person through close physical contact with infectious lesions or pustules, touching items, such as clothing or bedding, that previously touched the rash, or through respiratory droplets produced by coughing or sneezing. Monkeypox can also be transmitted from mother to fetus through the placenta or by close contact during and after birth.
I’m afraid I might have monkey pox. What should I do? There is no way to test for monkeypox if you only have flu-like symptoms. But if you start to notice red lesions, you should contact an urgent care center or your primary care doctor, who may order a chickenpox test. Isolate at home as soon as you develop symptoms and wear high-quality masks if you must come into contact with others for medical care.
I live in New York. Can I get the vaccine? Adult men who have sex with men and have had multiple sexual partners in the past 14 days are eligible for a vaccine in New York City, as well as close contacts of infected people. Eligible people who have conditions that weaken the immune system or who have a history of dermatitis or eczema are also highly recommended to get vaccinated. People can book an appointment through this website.
Despite investing more than $1 billion in developing the two-dose vaccine known as Jynneos that works against both smallpox and smallpox, the government has only 1.1 million vaccinations on hand. It takes about three times as many doses to cover the 1.6 million to 1.7 million Americans who, according to the Centers for Disease Control and Prevention, are at high risk of contracting monkeypox.
The vaccine is currently given in two 0.5 millimeter doses 28 days apart, with immune protection reaching its “maximum” 14 days after the second dose, according to the CDC.
The CDC recommends the vaccine for people who have been exposed to monkeypox and those who may be likely to get it. Those in the latter category include people identified as a contact of someone with monkeypox, those who know that a sexual partner in the past 14 days was diagnosed with the disease, and those who have had “multiple” sexual partners in that period of time in an area with “known monkeypox”.
Federal health officials said last week that they have so far distributed about 600,000 doses of the vaccine to state and local jurisdictions.
The Department of Health and Human Services last week also issued a broader public emergency declaration that allowed the federal government to more easily allocate money and other resources to fight the virus.
What we consider before using anonymous sources. How do sources know the information? What is your motivation for telling us? Have they proven reliable in the past? Can we corroborate the information? Even with those questions satisfied, The Times uses anonymous sources as a last resort. The reporter and at least one editor know the identity of the source.
Research on the intradermal injection of monkeypox vaccine is essentially limited to one study. It showed that when the vaccine was injected between the layers of the skin, it induced an immune response comparable to that of a standard injection into the fat under the skin. Federal officials have consulted with several outside groups about switching to the intradermal injection approach, including the Infectious Diseases Society of America, according to people familiar with the discussions.
Some outside experts have criticized the data backing up the monkeypox method as too thin and unfocused. The government’s decision to do so is based largely on a 2015 study sponsored by the National Institutes of Health.
Dr. John Beigel, associate director of clinical research at the NIH who has briefed federal health officials and the World Health Organization, said switching to the intradermal method was a better option for preserving the vaccine than giving just one of the two recommended doses as some now do jurisdictions. One shot doesn’t elicit as strong an immune response as two, he said.
“The advantage is that you can stretch the doses,” said John P. Moore, a virologist at Weill Cornell Medicine. “The downside is that if you cut it too much or take too many liberties, you reduce the effectiveness. And how will you know? It’s educated guesswork.”
The intradermal method can be tricky for vaccinators, who have to guide a needle through a thin space. If a vaccinator digs too deep and gets the dose into the fat, the patient may not get enough vaccine, experts say. But if the needle isn’t inserted far enough, some of the vaccine could leak back out.
These shots typically induce more redness and swelling, but are less painful than a standard injection, the 2015 study showed.
They have previously been used in polio vaccination campaigns, for rabies and with tuberculosis skin tests.
The National Institutes of Health had planned more studies of how these shots work with the monkeypox vaccine, but results weren’t expected until late fall or early winter. Over the weekend, top federal officials reached a consensus that the government needed to take the approach now.