More than 780,000 monkeypox vaccines for the U.S.- POLITICO

FDA CLEARS ADDITIONAL MANUFACTURING SITE FOR MONKEYPOX VACCINE — The Food and Drug Administration cleared an additional facility in Denmark to finish manufacturing monkeypox vaccines, allowing more doses to be distributed and administered across the U.S., your host reports.

In an announcement on Wednesday, the agency said it had completed an expedited inspection of Bavarian Nordic’s fill-finish plant for the Jynneos vaccine, which is cleared to prevent monkeypox and smallpox. Previously, the vaccine manufacturer had outsourced the process of dispensing the product into vials, but now with the FDA’s blessing, the company can finish vaccine production quicker.

HHS will make more than 780,000 monkeypox vaccines available to states today: With Bavarian Nordic’s production capacity increased, more vaccines will be available to state and local health care providers, POLITICO’s Daniel Payne reports.

Since May, the U.S. has recorded more than 4,600 cases of monkeypox, 99 percent of which are in people assigned male at birth who have sex with men. HHS Secretary Xavier Becerra told reporters Thursday he is not yet ready to declare monkeypox a public health emergency, though some officials believe the outbreak could spread beyond the MSM community if it is not controlled.

Meanwhile, the CDC takes its own actions: The Centers for Disease Control and Prevention is slated to increase its surveillance capacity by making monkeypox a nationally notifiable condition on Aug. 1, POLITICO’s Adam Cancryn and Erin Banco report. Although the designation will increase the agency’s ability to count cases nationwide, it doesn’t compel states to report the vaccinations they distribute.


Source: More than 780,000 monkeypox vaccines for the U.S.- POLITICO