World / Reporter's Journal

Race for an Ebola vaccine is heating up, and in a good way

By Chris Davis (China Daily USA) Updated: 2014-12-23 08:00

China announced late last week that its Academy of Military Medical Sciences has developed an Ebola vaccine that has been approved to enter the human test stage. The drug is specifically designed to target the strain of Ebola that has killed more than 7,370 people - with more than 18,000 confirmed cases - in West Africa in recent months.

"This follows American and Canadian vaccines to become the third Ebola vaccine to enter clinical trials," Xinua reported on Dec 18. There was no official word on when Phase I clinical trials would begin, but other media outlets were saying it could be as early as this month.

Race for an Ebola vaccine is heating up, and in a good wayThe two front runners so far are British pharma giant GlaxoSmithKline and a Canada-based joint project between Merck & Co and NewLink Genetics Corp, both of which are already in clinical trials, Reuters reported.

The Merck-NewLink study, which is being held in Geneva, hit a bump in the road last week when four of the 59 people participating reported joint pain in their feet and hands and the injection schedule was shut down. The clinic said, however, that joint pain was common in these kinds of tests and the injections would resume in January.

The GalxoSmithKline Phase I tests - being conducted in Great Britain, Mali, the US and Switzerland - also had its issues, with 80 percent of volunteers reportedly having some kind of an adverse though mild event at the high dose, a reaction Ebola researcher Dr Thoman Geisbert of the University of Texas said "was kind of surprising".

Nevertheless, GalaxoSmithKline's Ebola vaccine is expected to move into the second, larger scale phase in February, which is later than was previously expected, because health officials from the countries where the trials were planned - Senegal, Nigeria, Mali, Cameroon and Ghana - requested more data on the compound, the World Health Organization reported.

A statement from WHO did not specify exactly what information the countries wanted, but added that "If these steps are completed to the satisfaction of the national authorities, Phase II trials are likely to begin in February".

To further heat up the race, US President Barack Obama last week signed into law a small bill that could have a big impact on the effort. Entitled "Adding Ebola to the FDA Priority Review Voucher Program Act", the new law basically offers fast track priority review vouchers for drugs being developed to combat Ebola and other pathogens in the filovirus family.

The voucher is in effect a promise that the US Food and Drug Administration will process the licensing application within six months. It doesn't guarantee it will be approved, only reviewed and swiftly by the agency's notoriously glacial pace.

Which, of course, can lead to big profits for a drug company, if it can get its product to market before a competitor, get into pharmacies first and be there longer with patent protection. "The monetary gains could be huge, much more than $125 million," Rui Sanjuan, manager and legal policy adviser for Doctors Without Borders, told the Canadian Press.

Started in 2007, the priority voucher program is an effort to entice pharmaceutical companies to develop treatments for diseases that usually don't attract industry attention because of dim prospects for profits, according to the NIH.

On Monday, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services announced it was awarding a grant of $30 million to the NewLink/Merck effort.

The grant will ramp up production of the vaccine and support a 330-person study once the vaccine clears the smaller Phase I trials and is proven safe.

"The current funding provided by BARDA is key to the rapid development of this Ebola vaccine candidate," said Dr Charles Link, CEO and chief science officer of Ames, Iowa-based NewLink. "These funds will support multiple facets of the accelerated Ebola vaccine program including the expansion of critical vaccine supplies and larger clinical studies."

Dr Mark Feinberg, chief public health and science officer at Merck Vaccines, said: "Governments and industry are effectively collaborating in an unprecedented effort to accelerate the development of Ebola vaccine candidates."

News of the grant sent NewLink Genetics' (NLNK) stock price surging 2.7 percent on the Nasdaq. Merck traded down 0.5 percent.

China's announcement of its own Ebola vaccine noses out Johnson & Johnson, which was expected to announce clinical trials shortly and become the third horse in the race. Chinese biotech firm Tianjin CanSino Biotechnology is also developing an Ebola vaccine.

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