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Officials grapple with whether to allow new monkeypox vaccination strategy




WASHINGTON — Seemed like a simple solution to the monkeypox vaccine shortage. The federal government simply changed the dosage so he could vaccinate five times as many people with the supply on hand.

But the approach of injecting one-fifth of the current volume into the skin, rather than all of it into subcutaneous fat, isn’t really that simple, experts say. And even though the head of the Food and Drug Administration, Dr. Robert M. Calif, described the proposal as promising on Thursday, some federal officials said they would change the method without further research. I am concerned that

Some outside experts are also cautioning. “From a basic science standpoint, this should work,” said Dr. Jay K. Varma, director of Cornell University’s Center for Pandemic Prevention and Response. “But of course, there are many things in life and in science that you think should work, but when you actually try it, it doesn’t work.”

Expanding the dosage of the vaccine, Gynneos, could help the federal government solve a partially self-created predicament. Despite investing over $1 billion, the government only has 1.1 million injections on hand.

That supply is enough to cover 550,000 people, but about three times the dose is needed to cover the 1.6 to 1.7 million Americans at high risk of monkeypox, according to the Centers for Disease Control and Prevention. Is required. According to the CDC, for now, the virus is mainly spread through skin-to-skin contact during sex among gay and bisexual men.

Some federal officials hope that by injecting small amounts of the vaccine between layers of skin, called intradermal injections, the Biden administration can quell the outbreak before it spreads more widely.

However, some experts argue that this approach is understudied. They also warn that some vaccinees will need training to inject properly, which could delay vaccination efforts. On the contrary, you may end up wasting it.

Intradermal injection involves carefully inserting a needle into the skin layer, the thin space where immune cells reside. If the vaccinated person goes too deep and inserts the dose into the fat, the patient may not receive enough vaccine, experts say. part of the may leak out.

“If the dose is small and you don’t inject it into the skin properly, you may inject it in the wrong place. You may not have the preventive vaccine.” Worked on getting Jynneos licensed by the agency. “When you ask people to do this millions of times nationwide, it’s easy to make mistakes in administering vaccines.”

Methods, on the other hand, have a proven track record.used in polio vaccination campaign As with skin tests for rabies and tuberculosis, if dose-limited.

Dr. Anthony S. Fauci, Chief Medical Advisor to President Biden, said: “I was thinking of this as a strategy in the event of a vaccine shortage years ago.”

Vaccines used special bifurcated needles in smallpox vaccination campaigns to make intradermal injections more uniform and cheaper to perform.

Dr. John Beigel, Associate Director of Clinical Research at the National Institutes of Health, said: Government-sponsored study on Jynneos published in 2015 We compared the intradermal approach to standard injection methods and found that it elicited similar levels of neutralizing antibodies, a measure of the strength of the immune response. The intradermal method caused more redness, swelling and itching, while the standard injection was more painful.

Dr. Beigel said switching to the intradermal method is a better option for storing vaccines.

“A single dose is likely to be ineffective,” he said, adding that the intradermal method “is an acceptable method.”

The 2015 trial involved hundreds of participants, but some experts say it was a single study that was limited in what it measured. , planned to test Jynneos’ intradermal strategy. trial It was due to start in a few weeks. However, results aren’t expected until late fall or early winter, and that plan is currently up in the air.

H. Clifford Lane, M.D., clinical director of Dr. Fauci’s National Institute of Allergy and Infectious Diseases at the NIH, said researchers can gain insights by tracking people who have been vaccinated, but traditional clinical trials do not. It provides a clearer picture, he said.

“As long as it’s very clear why it’s being done, I can understand doing it,” he said of the intradermal strategy. , how we can expand the current supply.”

Another question is how effective the vaccine actually is. It was licensed for use against both monkeypox and smallpox in 2019 after studies showed it elicited a stronger immune response than previous vaccines. The drug itself was approved because it had advantages over previous vaccines, federal officials said.

Monkeypox is rarely fatal and no deaths have been reported in the United States. Usually the symptoms he disappears within 2-4 weeks. However, the outbreak surged from eight cases reported in late May, Currently 7,510the administration is scrambling to improve vaccination coverage and the availability of testing and treatment.

For now, the outbreak is almost entirely confined to men who have sex with men, and men who have multiple partners are thought to be particularly at risk. announced that an adult working at has tested positive for monkeypox, and that children and other staff members are being tested.

Thursday’s declaration of a public health emergency allowed the federal government to expedite monkeypox investigations and approve grants, but it did not exercise the FDA’s emergency powers.Changing the injection mode requires two types of emergencies declarationgiving the Food and Drug Administration room to issue an Emergency Use Authorization.

federal regulators can be issued Expedited approval of a product if we believe the potential benefits outweigh the potential risks. Early in the coronavirus pandemic, the Trump administration issued the same type of emergency declaration to allow the FDA to make a Covid-19 vaccine available to Americans, months before regulators issued full approval. Did.

FDA commissioner Dr. Caliph said on Thursday that regulators will continue to ensure vaccines are delivered in a safe and effective manner. He said he would make a decision on whether to hire him, but said it “seems to be going well so far.”

Emily Cochrane When Tracy Tully contributed to the report.




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