Gay rights activists, who have been strongly critical of the authorities, have been demanding an emergency declaration for weeks. James Krellenstein, founder of PrEP4Allan advocacy group working to expand treatment for people living with HIV “I really don’t see why they didn’t do this a few weeks ago.”
The FDA’s Jynneos fractional dosage review plan has caught some federal scientists by surprise.
There is some data showing that injection 1/5 of the usual dose of Jynneos between layers of skin would be as effective as the approach being used today, using a sufficient dose subcutaneously. The skin is rich in immune cells that mediate the response to vaccines, so this approach is sometimes used, especially with deficient vaccines, although it requires more skill.
Researchers at the National Institutes of Health plan to test the strategy for Jynneos in a clinical trial that will begin in a few weeks, with results expected in late fall.
“That’s our plan, so we’ll have to see how it fits into the new context, where it’s changed like this,” said Dr. Emily Erbelding, who directs the NIH’s microbiology and infectious diseases division. how. “We think it’s desirable to have a stronger dataset, but if it’s a race against time, this is a different situation.”
“Things are moving fast,” she added.
Declaring an emergency gives CDC greater access to information from health care providers and from states.
During the outbreak, federal health officials have frequently information sharing on testing capacity or on the number of vaccines shipped to states. But CDC data on the number of cases is lower than that of local public health departments, and the number of people vaccinated, or their demographic information, is barely available.