China on Wednesday approved phase I human testing for the nasal spray vaccine, which is co-developed by researchers at Xiamen University and Hong Kong University, as well as by vaccine maker Beijing Wantai Biological Pharmacy Enterprise Co.
Intranasal spray has previously been developed as a vaccine for the flu and is recommended for use among children and adults who want to avoid the more common needle injection.
While it is not the most frequent choice for delivery, scientists around the world are working to develop sprays as an alternative to muscle jabs for all sorts of vaccines.
Meantime, AstraZeneca Plc’s halt of its vaccine trial after a patient became ill is a good wakeup call for everyone to recognize that there are ups and down in research and clinical development, the World Health Organization’s Chief Scientist Soumya Swaminathan said at a briefing.
Every clinical trial protocol has an operating procedure for how to manage side effects.
“This is normal procedure, this is good clinical practice, because safety is the highest priority in any clinical trial,” she said. “It’s not always a fast or a straight road.”
Separately, the WHO said there’s currently no way of predicting which vaccine candidates are going to be effective, but that the data from Phase 1 and 2 studies has been quite promising for most.
In the US drugmakers seeking an emergency authorization for a Covid-19 vaccine will have to meet a higher standard of efficacy than normally would be required for such a clearance, the head of the U.S. Food and Drug Administration’s office that handles vaccines said.
Typically, an emergency use authorization, or EUA, would require a company to show their product may be effective.
Peter Marks, director of the FDA’s biologics office, said Thursday that the agency will require more robust data about how well a coronavirus vaccine works before granting an emergency waiver — something he called “EUA plus.”
