Gay rights activists, who have sharply criticized the administration, had been pushing for a state of emergency for weeks. “It’s too late,” said James Krellenstein, founder of PrEP4All, an advocacy group working to expand treatment for people with HIV. “I really don’t understand why they didn’t do this weeks ago.”
The FDA’s plan to consider fractional doses of Jynneos surprised some federal scientists.
There is some data to suggest that injecting one-fifth of the regular dose of Jynneos between the layers of the skin would be as effective as the approach that is now used, giving the full dose under the skin. The skin is rich in immune cells that mediate the response to vaccines, so this approach is sometimes used, especially in vaccine shortages, although it requires more skill.
Researchers at the National Institutes of Health planned to test the strategy for Jynneos in a clinical trial that was set to begin in a few weeks, with results expected later in the fall.
“That was our plan, so we’ll have to see how it fits into the new landscape that’s changed,” said Dr. Emily Erbelding, who heads the NIH’s Division of Microbiology and Infectious Diseases. “We thought there was a desire to get a more robust data set, but if it’s a race against time, then that’s a different situation.”
“Things are moving fast,” she added.
Declaring an emergency gives the CDC more access to information from health care providers and from states.
During the outbreak, federal health officials regularly shared information about testing capacity or the number of vaccines sent to states. But the CDC’s data on the number of cases lags that of local public health departments, and the number of people vaccinated or their demographic information is mostly unavailable.
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