In order for the Food and Drug Administration to approve 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 would have to issue a new emergency declaration which allows regulators to invoke the FDA’s emergency use powers. This statement is expected on Tuesday afternoon. The move will help ease a vaccine shortage that has become a growing political and public health problem for the administration. In less than three months, more than 8,900 cases of monkeypox have been reported. The disease is spread mainly through skin-to-skin contact during sex between gay and bisexual men. Federal officials are concerned both about the current rate of infection and the risk of the disease spreading to other parts of the population.
What you need to know about monkeypox virus
Card 1 of 7 What is monkey pox? Monkeypox is a virus similar to smallpox, but the symptoms are less severe. It was discovered in 1958, after outbreaks in monkeys kept for research. The virus was found mainly in parts of Central and West Africa, but has recently spread to dozens of countries and infected tens of thousands of people, the vast majority of them men who have sex with men. How does it spread? Monkeypox virus can be spread from person to person through close physical contact with infected lesions or blisters, by touching objects – such as clothing or bedding – that have 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 through close contact during and after birth. I’m afraid I might have smallpox. What should I do? There is no way to test for monkeypox if you only have flu 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 monkeypox 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 treatment. I live in New York. Can I get the vaccine? Adult men who have sex with men and who have had multiple sexual partners in the past 14 days are eligible for vaccine in New York, as well as close contacts of infected people. Eligible individuals who have conditions that weaken the immune system or who have a history of dermatitis or eczema are also strongly encouraged to get vaccinated. People can book an appointment through this website. Despite investing more than $1 billion to develop the two-dose vaccine known as Jynneos that works against both monkeypox and smallpox, the government only has 1.1 million vaccines on hand. It takes about three times as many doses to cover the 1.6 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 a “maximum” 14 days after the second dose, according to the CDC. The vaccine is recommended by the CDC for people who have been exposed to monkeypox and those who might get it. Those in the latter category include people identified as having had contact with monkeypox, those who know a sexual partner within the past 14 days of being diagnosed with the disease, and those who have had “multiple” sexual partners during that time in an area with “known monkey pox.” Federal health officials said last week that so far, they have 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.
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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 elicited an immune response comparable to that from a standard injection into the fat under the skin. Federal officials have consulted with various outside groups about switching to the intradermal injection approach, including the Infectious Diseases Society of America, according to people familiar with the talks. Some outside experts criticized the data supporting the monkeypox method as too thin and narrowly focused. The administration’s decision to pursue it is based largely on a 2015 study funded by the National Institutes of Health. Dr. John Beigel, the NIH’s associate director of clinical research who has briefed federal health officials and the World Health Organization, said switching to the intradermal method was a better option for maintaining the vaccine than giving only one of the two recommended doses, such as jurisdictions now. One shot doesn’t elicit nearly as strong an immune response as two, he said. “The upside is that you can spread out 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 efficiency. And how will you learn this? It’s an educated guess.” The intradermal method can be complicated for vaccinators, who must drive a needle into a thin space. If a vaccinator goes too deep and injects the dose into the fat, the patient may not get enough vaccine, experts say. But if the needle is not inserted far enough, some of the vaccine could leak back out. Such shots usually cause more redness and swelling, but are less painful than a standard injection, the 2015 study showed. They have been used in the past in vaccination campaigns against polio, for rabies and for skin tests against tuberculosis. The National Institutes of Health had planned further studies of how well such vaccines work with the monkeypox vaccine, but results were not expected until late fall or early winter. Over the weekend, top federal officials agreed the government should adopt the approach now.
