(Photo from Centers for Disease Control and Prevention/GSA)
Rochelle Walensky, director of the Centers for Disease Control & Prevention, warned July 15 the spread of monkeypox, an outbreak that has occurred primarily among gay and bisexual men, would increase in the coming weeks.
“Now as we closely monitor cases, I would like you all to understand that we anticipate an increase in cases in the coming weeks,” Walensky said in a conference call with top Biden administration health officials and reporters.
The increase, Walensky said, is due to three factors: 1) The CDC streamlining its reporting process to allow states to report new cases more quickly and accurately; 2) With more cases in the United States, an increase in the resulting exposure of these cases in the coming weeks; and 3) A significant increase in the number of people seeking laboratory tests and the number of specimens being submitted for testing.
Monkeypox cases in the United States, Walensky said, have reached 1,470 reported cases documented across 44 jurisdictions as of July 14.
Younger gay and bisexual men are primarily affected: The median age is 36 with a range of 18 to 76 years of age, and the vast majority of cases happen among those who identify as men who have sex with men based on demographic information local health departments provided to CDC, Walensky said.
The Biden administration on the same day Walensky disclosed the new data announced an order for another 2.5 million doses of Bavarian Nordic’s JYNNEOS vaccine to respond to the current monkeypox outbreak.
The vaccines, however, won’t arrive soon: According to the Department of Health & Human Services, they’re coming in 2023 as part of the plan for the U.S. government’s available supply of vaccine to reach 7 million by mid-2023, which would be several months after the outbreak has begun.
The Biden administration has been faulted for moving too slowly in responding to monkeypox in criticism reminiscent of inaction during the coronavirus and HIV/AIDS epidemics, including being too slow to distribute vaccines and make testing available. Monkeypox is transmitted by skin-to-skin contact, unlike the other two diseases, and isn’t fatal.
Walensky during the call acknowledged “the demand for vaccines from jurisdictions is higher than our current available supply,” but pushed back on other criticisms as “points of confusion where we’ve been hearing from the public, our partners and media.” The availability of tests, for example, is and has been meeting capacity, Walensky said.
“We have the testing capacity needed,” Walensky said. “We expanded the nation’s monkeypox testing capacity this week, and now have four commercial labs with combined capabilities along with CDC laboratory Response Network … we’ve gone from being able to test 6,000 samples a week to 70,000 samples per week. Having commercial lab testing for monkeypox will also make it more convenient for providers to access tasks by using existing providers to lab relationships, and we have not yet received anywhere near that demand of tests as our capacity now permits.”
Also during the call health officials announced efforts to work on delivery of 786,000 doses currently located in Denmark, which they said will be available pending FDA clearance by the end of July. The inability of the Biden administration to move the vaccines from Europe in a timely fashion has been a source of criticism of the FDA.
Peter Marks, director of the Center for Biologics Evaluation & Research at the FDA, pushed back on that criticism in response to a question from the Washington Blade, insisting the FDA had taken a timely approach to obtaining those vaccines.
“First of all … quite contrary to missing a chance for approval, FDA actively reached out using contacts with the Biomedical Advanced Research & Development Authority to actually move up the submission that was necessary and all of the other events that were necessary to get those doses to be able to be used from what was originally going to be this fall,” Marks said. “And we did that actually, pretty shortly after we realized there was a monkeypox outbreak.”
Marks also said the United States was unable to rely on the European Union’s certification of the vaccines because the FDA relies on its own safety protocols for approval of medication for use domestically.
“We do not in the United States recognize — we don’t have mutual recognition of vaccine inspections for initial licensure from other countries, and that’s because we have our quality standards that have to be maintained,” Marks said. “And we have with all due diligence to make sure that the necessary procedures were undertaken, so that these will be available before the end of July but these doses were originally not scheduled to be approved until sometime in the fall, and that was moved up.”
