No Major Side Effects In Merck & Co., NewLink Genetics VSV-ZEBOV Ebola Vaccine Test
December 2, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
A second vaccine for Ebola has shown encouraging results in protecting volunteers without producing serious side effects, said Swiss researchers who had tested the Merck drug Tuesday.
The shot, developed by Merck and NewLink, produced only a mild fever in some of the 34 volunteers fast-tracked to test the drug at the University of Geneva in a clinical trial earlier this fall. Dubbed VSV-ZEBOV Ebola vaccine, the World Health Organization (WHO), had been overseeing the drug’s progress in the hopes of fighting the still-raging Ebola epidemic in West Africa.
"After his or her injection, each volunteer was kept under observation for 1.5 hours at the clinical trials unit," said scientists. "To date, no major side effects have been observed after the injections, which triggered the expected inflammatory responses. They (the inflammatory responses) have been weak to moderate, with limited cases of mild fever.”
Merck and NewLink said that trials on the drug have already started in the U.S., Canada, Germany and Gabon. Merck announced last month that it would buy the rights to NewLink's vaccine for $50 million. Merck bought the rights to NewLink's vaccine for $50 million in November.
The news follows an announcement last week that GlaxoSmithKline and the National Institutes of Health have seen promising results from an Ebola vaccine candidate and will speed the new drug into the next phase of clinical trials.
The results for the monovalent vaccine were published in the New England Journal of Medicine and the agency has said that it now hopes to begin testing the vaccine on healthcare workers and other groups at high risk for infection as soon as January.
Drugmakers and regulators worldwide have been rushing to find a vaccine or cure for Ebola as the epidemic continues.
The monovalent vaccine was tested on 20 American volunteers this fall and all 20 developed antibodies against Ebola, with no side effects, said the clinical paper. The volunteers ranged in age from 18 to 50 and were split into two groups, with half receiving an intramuscular injection of vaccine at a lower dose, and 10 receiving the vaccine at a higher dosage level. All 20 then developed antibodies within four weeks of receiving the vaccine, and those given the higher-dose vaccine had more antibodies.
That bodes well for the future of the vaccine, which is meant to help end the Ebola epidemic raging in West Africa, where at least 5,689 people have died, though the actual number is thought to be much higher, said experts.