FDA clears strategy to stretch supplies of monkeypox vaccine: 4 outbreak updates

The FDA on Aug. 9 issued an emergency use authorization for a strategy that will expand the nation's supply of the Jynneos monkeypox vaccine and allow high-risk children under the age of 18 to receive it. The move comes as confirmed U.S. cases near 9,000. 

The newly authorized dose-sparing strategy allows for a single-dose Jynneos vial to be split into up to five different doses and be administered through an intradermal injection rather than the subcutaneous injection for which it was approved, according to the FDA. Two doses, given four weeks apart, are still needed. 

"This will increase the total number of doses available for use by up to five-fold," HHS Secretary Xavier Becerra said during a press conference. 

The EUA only allows for the intradermal approach in adults 18 and older, though it did clear the way for the vaccine to be administered as a subcutaneous injection in children considered to be at high-risk for infection. 

Three more updates: 

1. The U.S. recorded a new daily record of 1,424 cases, bringing the total number of confirmed cases to 8,934 as of Aug. 8. Data as of Aug. 7 showed just over 7,500 cases. A new daily record was also set globally, with more than 2,000 new cases recorded, bringing the total to more than 30,000 as of Aug. 8. 

2. As the outbreak grows, access to tecovirimat, or Tpoxx, remains limited. Because it's an investigational drug that's only been approved for smallpox, physicians can only prescribe Tpoxx to people infected with monkeypox by going through a lengthy and complicated series of steps, including registering as an investigator in a clinical trial. Physicians have said it can take three to four hours to go through the whole process, which isn't feasible to continue in busy urgent care centers and hospital EDs, where many infected patients have sought medical attention. 

Some physicians have had to turn down writing a prescription for patients because they were unable to deal with the lengthy process, The New York Times reports. 

"This doesn't need to be held back the way it's being held back," Stacy Lane, DO, the founder and medical director of a network of clinics in Pennsylvania and Ohio that serves LGBTQ patients, told the Times. "It would be ideal if we can get this Tpoxx treatment at local pharmacies just like we can get anything else, especially as this thing continues to explode." 

Tpoxx is considered experimental since it hasn't been largely studied as a monkeypox treatment in humans. A CDC spokesperson told the Times its use as an investigational drug will "ensure we have data from patients who use this drug," adding it will help the agency "understand who will benefit most, what the true benefits are and potential risks there might be." 

3. The monkeypox virus likely circulated for years before the current outbreak, genetic analysis suggests. The Wall Street Journal in an Aug. 9 article cited a report from U.K. researchers that traces the current outbreak to an animal-to-human infection from April 2016. Undetected spread likely continued until a person or group traveled to large international events in Europe, caught the virus and brought it back to their home countries, spurring the current global outbreak. 

"You have a virus that was able to establish itself in a dense social and sexual network and transmit efficiently because there’s no immunity,” Anne Rimoin, PhD, professor of epidemiology at the University of California in Los Angeles, told the WSJ

 

 

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