-- Federal health officials warned that without additional government funding, a critical part of the Zika vaccine trial could be delayed.
The National Institute of Allergy and Infectious Diseases has started testing a candidate for its first Zika vaccine yesterday. On a call with reporters, NIAID Director Dr. Anthony Fauci said that this Phase I part of the trial will involve 80 volunteers between the ages of 18 to 35.
This first step in the trial is designed to test the vaccine's safety. If that is successful, the trial will progress to a Phase II part of the trial, where many more people will be studied in various locations across the globe to see if the vaccine is safe and effective.
Fauci told reporters that without additional funding, this critical Phase II part of the trial could likely be delayed.
"When I say we're going to run out of money soon I mean really soon," Fauci said. He pointed out that normally researchers would start to prepare clinics and subjects for a Phase II trial to start in January, on the assumption the Phase I trial goes well.
"We cannot afford to delay the work to develop a safe and effective vaccine," Fauci said.
A push for $1.9 billion by President Barack Obama to fight the Zika virus has remained stalled in Congress, which is currently out of session for the August recess.
The vaccine uses DNA fragments of the Zika virus to prime the immune system to recognize and fight the virus. A similar vaccine was developed by NIAID for the West Nile Virus.
Fauci cautioned that even if all the trial goes well, a Zika vaccine will likely not be approved for widespread use soon. Should the Phase II trial start on time in January, it will not be until the following year that researchers get the results. The Phase II trial would then be followed by a Phase III trial before getting final approval by the U.S. Food and Drug Administration.
The NIAID vaccine is one of a number of vaccine candidates being studied as a possible way to stop the spread of the Zika virus. Fauci said even if the vaccine is not approved for years, researchers anticipate the virus will likely return in future years in countries where the virus has reach epidemic levels.