Gay rights activists, who have been highly critical of the administration, have been demanding an emergency declaration for weeks. “This is all 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 a few weeks ago.”
The FDA’s plan to consider fractional doses of Jynneos caught some federal scientists by surprise.
There is some data to suggest that injecting a fifth of a regular dose of Jynneos between the layers of the skin would be as effective as the approach now used, delivering a full dose under the skin. The skin is rich in immune cells that are involved in the response to vaccines, so this approach is sometimes used, especially when vaccines are in short supply, although it requires more skill.
Researchers at the National Institutes of Health had planned to test the strategy for Jynneos in a clinical trial that was scheduled 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, which has changed,” said Dr. Emily Erbelding, director of the NIH division of microbiology and infectious diseases. “We thought there was a desire to get a more robust dataset, but if it’s a race against time, then this is a different situation.”
“Things are moving fast,” he added.
Declaring an emergency gives CDC more access to information from health care providers and states.
During the outbreak, federal health officials regularly shared information about testing capacity or the number of vaccines shipped to states. But the CDC’s data on the number of cases is lower than that from local public health departments, and the number of people vaccinated, or their demographic information, is largely unavailable.