Why the World Needs More Than OneEbola Vaccine
By Reuters · May 23, 2018 LONDON — - Inthe life-and-death race to make the first effective vaccine against Ebola, onecompany - Merck - seems bound to win. But othersdrugmakers, such as Johnson & Johnson and GlaxoSmithKline, are also in therunning - and must stick with it even though they are unlikely to make aprofit, experts say, because the world needs more than one Ebola vaccine. Immunisationswith Merck's VSV EBOV experimental shot began in Congo this week - a big momentin a 40-year fight against a disease that until now could only be tackled byisolation and strict hygiene. Having this vaccine means the world isbetter placed now than it was in 2014-2016, when the haemorrhagic fever killedmore than 11,300 people in history's worst Ebola outbreak in West Africa. Still, relyingon one potential vaccine from one company does not make sense, either in termsof ensuring resilient supply or the best protection against the virus, saysJeremy Farrar, director of the Wellcome Trust global health charity. "It'scritical that we encourage companies to keep working on this," he toldReuters. "Firstly,it may be that two vaccines may have very different characteristics. "And wealso need more than one manufacturer. You can't expect one company to carry theburden of the whole production facility for an Ebola vaccine." Ebola is afearsome disease but it is also still rare, making the potential market for anemergency vaccine highly sporadic and very likely unprofitable. This poses a dilemma for drug companies:With no real prospect of a financial return, can they justify the investment,even when they get support from government agencies and charities. GSK's put itsEbola vaccine work on hold after it was unable to progress its product throughclinical trials towards the end of the 2014-16 epidemic, due to the dwindlingnumber of Ebola cases. A spokesman said it is monitoring the situation. J&J ispushing ahead. Since the big West African outbreak, the company has gone on totest its vaccine on 5,000 volunteers in 11 separate trials, confirming itssafety and ability to generate an immune response. "We arenot doing this for a commercial purpose," said Paul Stoffels, J&J'sChief Scientific Officer told Reuters in an interview. "If youhave technology that can help fight the most deadly virus in the world, thenyou can't stand back and not do this. "Thereare also benefits to us. We are also learning all the time about vaccinetechnology, which has advanced our science." COMPLEMENTARY J&J'stwo-part vaccine - being developed with Danish biotech Bavarian Nordic - worksdifferently to Merck's and its protection, if confirmed, is expected to belonger lasting. Merck's shot is well suited for "ringvaccination" of people in recent contact with new Ebola cases, but along-lasting option would be a good bet for healthy support workers coming into fight the crisis. "Certainlyfrom what we know about the J&J vaccine, it could have a very complementaryuse," said Peter Salama, the World Health Organization's deputy director-generalfor emergency preparedness and response. "It lookslike it takes a little longer to develop the immune response, but at the sametime it may last a lot longer ... it could be an ideal vaccine for healthcareworkers, for example, who you could proactively vaccinate and know that theyare protected for 10 years or so." One problemremains the lengthy, complex and expensive process of getting new vaccineslicensed by Western regulators, like the U.S. Food and Drug Administration(FDA). Merck - whosevaccine was originally developed by the Public Health Agency of Canada and thenhanded to NewLink Genetics, before Merck took it on in 2014 - does not expectto be ready to seek an FDA marketing authorisation licence for VSV EBOV until2019. This is inpart due to "unforeseen facility and engineering issues" at amanufacturing plant being built in Germany, Merck's spokeswoman Pamela Eiselesaid. "We ...are focused on getting vaccine manufacturing on-line as quickly aspossible." The companycould get a pay-off when the vaccine is finally licensed, in the form of an FDApriority review voucher, which can be used with another product of its choiceor sold on. The FDA issues such vouchers for innovativedrugs or vaccines tackling neglected or rare diseases, including Ebola, andpast examples have been sold for up to $350 million (262.2 million pounds). The onlylicensed Ebola vaccines come from separate groups in Russia and China. Theirproducts have been approved by local regulators only on the basis of limitedclinical data. An FDA licence is widely regarded as the definitive stamp ofapproval. BEYOND EBOLA Large drugcompanies remain the only realistic vehicles for manufacturing vaccines atscale and the problem of incentivising them to work on non-profitable diseasesin poor countries stretches beyond Ebola. "In anyvaccine market, at some point the manufacturers assess whether its a viablemarket to continue, and they may stop," Salama told Reuters. Sanofi, forexample, dropped development of a Zika vaccine last year, despite promisingearly clinical results, following a row over future pricing of the product,which was originally developed by U.S. Army researchers. Such hesitancyby drug companies is going to need to be overcome, experts say, especiallysince a crowded world can expect an increasing number of deadly encounters withmicrobes. In the past 60years, the number of new infectious diseases affecting humans has increasedfourfold and the number of outbreaks per year has more than tripled, accordingto report from the International Vaccines Task Force. Only this week India has been hit by the brain-damagingNipah virus, killing 10 people, while Nigeria had its worst Lassa feveroutbreak on record earlier this year. There arecurrently no vaccines for either of these, but both are on a WHO research anddevelopment priority list alongside Ebola, Zika, MERS and Crimean-Congohaemorrhagic fever. (Reporting by Kate Kelland and BenHirschler, editing by Anna Willard)
|