New Link Genetics Corp (NASDAQ:NLNK), with support from Merck (NYSE:MRK), could be the first company to bring a viable and marketable vaccine for Ebola. Shares of New Link were trading 3.3% higher this morning.
The VSV-EBOV vaccine was first developed by Canada’s Public Health Agency and licensed by NewLink, which then signed an exclusive licensing agreement with Merck to develop the vaccine candidate.
“We hope the interim data published today contribute to the successful registration of our vaccine candidate, which we believe can play an important part in diminishing the threat of Ebola,” said NewLink’s chairman, CEO and chief scientific officer Dr. Charles Link.
VSV-EBOV, as a vaccine it acts ‘preemptively’. Unlike serums vaccines are generally designed to be used to prevent an infection before it occurs. VSV-EBOV, similar to an anti-rabies vaccine, may also have success if used on patients already affected by Ebola, because anti-rabies vaccines have shown to be effective if used quickly – that is they can cause an immune response if they are adopted before the virus ‘wins’. Injected after exposure to virus, the VSV-EBOV proved somewhat effective in animals.
The World Health Organization (WHO), following the publication of the intermediate results from trials of the VSV-EBOV vaccine, developed by Canadian public research with production and distribution to be handled by Merck, suggest the vaccine is 100% effective. Researchers are now free to launch an immediate vaccination campaign for all persons who have been or are in contact with Ebola patients.
A marketing authorization application is expected shortly, said WHO’s assistant director-general Dr. Marie-Paule Kieny, warning, however, that such a procedure would take "several weeks or months, even in an emergency context”.
None of the 4,123 people vaccinated immediately after being included in the study were infected with Ebola more than ten days later, as was the case of 16 patients in 3,528 people in the control group vaccinated within a period of three weeks, representing a 100% effectiveness.
According to Dr. Kieny, while some volunteers became ill during the ten days following immunization with VSV-EBOV, this occurred because “a patient who falls ill within 10 days after vaccination was likely infected before being vaccinated, given the incubation time of the disease”.
The researchers used a "belt" strategy for vaccinating people who came into contact with patients whose infection with the Ebola virus was confirmed in the laboratory, as well as all persons who had contact with the first "perimeter" of vaccinated patients. Between April 1 and July 20, 7651 volunteers were recruited from a group of about 100 Ebola patients. Half of them were vaccinated immediately and the other half were vaccinated three weeks after inclusion in the study.
Given these interim results, the independent committee monitoring the trial has stopped randomization said Dr. Kieny but testing will continue with subjects aged 13 to 17 years and possibly subjects aged 6 to 12 years – children had been excluded from the trial because of a lack of data about the safety and immunogenicity of the vaccine in younger patients. The favorable results from a recent study in Gabon suggests testing can proceed.
This work is part of different vaccine trials set up at the beginning of the year on the VSV-EVBOV and CAD3 EBOZ-developed by GlaxoSmithKline, one of Merck’s main competitors, whose evaluation began in Liberia and will soon continue in Guinea.
In June, Tekmira Pharmaceutical (NASDAQ:TKMR), a Canadian firm, suspended clinical trials of a drug compound to fight the Ebola virus disease previously seen as promising.
The Ebola outbreak shows no sign of stopping and 500 new case have been identified since Canada promised to a hundred doses of an experimental vaccine to the World Health Organization (WHO). The doses remain at the National Microbiology Laboratory in Winnipeg.
This latest Ebola epidemic started in Guinea in early 2014 and then spread quickly to Liberia and Sierra Leone, threatening Nigeria, Africa’s most populous country.
As cynical as it may sound, there is no doubt that the Ebola epidemic has stimulated the biotech sector to work on specialized vaccines. The outbreaks in West Africa has enabled private and government research facilities to measure the effectiveness and safety of the vaccines or serums allow for development with international partners and gain an understanding of the risks and side effects as compared to benefits.Apart from Tekmira and the successful NewLink, the companies with experimental drugs to treat Ebola have included Tekmira Pharmaceuticals include BioCryst Pharma (NASDAQ: BCRX) and Sarepta Therapeutics (NASDAQ:SRPT).
It should be noted that much of the advancements made in the search for an Ebola vaccine have come thanks to Canada’s Department of National Defence, which invested several million dollars into programs aimed at protecting Canada from Ebola and other diseases considered to be security threats.Defence Research and Development Canada (DRDC) has supported the National Microbiology Laboratory in contributing to the development of Winnipeg, ZMapp and Tekmira.