File photo: Aedes aegypti mosquitoes are seen at the Laboratory of Entomology and the Ecology of the Dengue Branch of the U.S. Centers for Disease Control and Prevention, San Juan
(Copyright Reuters 2017)
CHICAGO – Researchers have begun the second phase of testing of a Zika vaccine developed by U.S. government scientists in a study that could produce preliminary results as early as the end of 2017.
Dr. Anthony Fauci, director of the National institute of Allergy and Infectious Diseases (NIAID), said on Friday the $100 million trial is already funded and will proceed, regardless of the $7 billion in cuts at the National Institutes of Health (NIH) budget proposed by the Trumpet Administration over the next 18 months.
In a conference call with reporters, Fauci would not comment on the proposed cuts, because it is not yet clear what the actual budget will be. Both the Democratic and Republican legislators oppose budget cuts at the NIH, which funds 21 institutes, including NIAID.
NIH Director Dr. Francis Collins is scheduled to speak with President Donald Trump later on Friday. “I will definitely talk with Francis Collins, when he returns from the White House,” Fauci said.
Zika usually causes mild symptoms, but when the virus infects a pregnant women, they can pass on to her fetus, causing a variety of congenital anomalies including microcephaly, in which the head of the baby is very small.
Fauci said the current Zika vaccine candidate had cleared provisional safety hurdles, and would now test for efficacy, which would occur in two phases.
The first phase will continue to test the safety and evaluate the vaccine’s ability to stimulate the immune system to develop antibodies to fight Zika. It will also be testing different dosages to see which works best.
The second phase, starting in June, will try to determine whether the vaccine can actually prevent Zika infection.
Different companies develop Zika vaccines, including Sanofi SA, GlaxoSmithKline Plc and Takeda Pharmaceuticals.
In the NIAID study, researchers want to enrol at least 2,490 healthy volunteers in areas with confirmed or potential active transmission of Zika by mosquitoes. These are parts of the continental United States, Puerto Rico, Brazil, Peru, Costa Rica, Panama and Mexico. They will receive either the vaccine or a placebo, and followed for two years.
If enough people are exposed to the virus, Fauci said that she could get an effectiveness signal as early as at the end of this year. The trial is expected to be completed in 2019.
Fauci said that the government is already in talks with the pharmaceutical companies, that would be the share of the costs of the last phase of the testing and handling of the production.
Zika is primarily transmitted by mosquitoes, but it can also be transmitted sexually. According to the Centers for Disease Control and Prevention, 5,182 people in the continental United States have been infected by the Zika locally or by traveling to places where the virus spreads. Another 38,303 cases have been reported in the areas of the U.S., including Puerto Rico.