From the 10\/26\/2022 PROMED Digest email, in an entry on the current Ugandan\u00a0 Sudan Ebola outbreak, is this snippet from a longer release. It seems “a long, tortured history” is an apt description of the efforts for an ebola vaccine.<\/p>\n
<\/p>\n
Small market But pharmaceutical companies took little interest in Ebola vaccines Then came West Africa’s Zaire outbreak, which engulfed the capitals of In late September 2014, scientists at the US Centers for Disease Other major vaccine makers jumped in to develop their own candidates, Merck’s Ervebo is now a standard part of the response during outbreaks But Merck has no interest in developing the vaccine for Sudan Those vaccines are still at early stages of development, and when the Conflicting emails After Feinberg left Merck in 2015, virologist Richard Peluso, who then When and how the company came to realize those stocks still exist In response to follow-up questions, Merck acknowledged on 20 Oct 2022 The bulk product Merck has now disclosed had reached “the end of its Coller says she initiated a search to see if any Sudan Ebola vaccine Merck never ran human studies with the Sudan Ebola vaccine. “That was From the 10\/26\/2022 PROMED Digest email, in an entry on the current Ugandan\u00a0 Sudan Ebola outbreak, is this snippet from a longer release. It seems “a long, tortured history” is an apt description of the efforts for an ebola vaccine. Small market ———— Ebola vaccines have a long, tortured history. The VSV platform used … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3061,6,2520,13,14,15],"tags":[3785,4085,4083,3765,4088,4087,3385,4086,4084],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-sergneri","4":"post-4917","6":"format-standard","7":"category-environment","8":"category-ethical-and-green-living","9":"category-pandemic","10":"category-politics","11":"category-racism","12":"category-science","13":"post_tag-ebola","14":"post_tag-ebolavirus","15":"post_tag-infectious-diseases","16":"post_tag-merck","17":"post_tag-pharmaceutical","18":"post_tag-pharmaceutical-companies","19":"post_tag-vaccines","20":"post_tag-vsv-platform","21":"post_tag-zaire"},"_links":{"self":[{"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/posts\/4917","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/comments?post=4917"}],"version-history":[{"count":3,"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/posts\/4917\/revisions"}],"predecessor-version":[{"id":4920,"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/posts\/4917\/revisions\/4920"}],"wp:attachment":[{"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/media?parent=4917"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/categories?post=4917"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.sergneri.net\/wordpress\/index.php\/wp-json\/wp\/v2\/tags?post=4917"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n————
\nEbola vaccines have a long, tortured history. The VSV platform used in
\nMerck’s shots was first developed nearly 20 years ago by virologists
\nHeinz Feldmann, then with the Public Health Agency of Canada (PHAC),
\nand Thomas Geisbert, then with the US Army Medical Research Institute
\nof Infectious Diseases. They showed that a single dose of a vaccine
\nprotected 100% of monkeys against an otherwise lethal dose of Zaire
\nebolavirus given 28 days later. Smaller animal studies showed a
\nvaccine against the Sudan ebolavirus based on the VSV platform had
\npromise as well. (In 2016, Science published a survey
\n[https:\/\/www.science.org\/doi\/full\/10.1126\/science.351.6268.16<\/a>] of 50
\nleading vaccine researchers who ranked the Sudan ebolavirus vaccine as
\nthe number one R&D priority based on feasibility and need.)<\/p>\n
\nbecause the market is so small. For decades, outbreaks involved a few
\nhundred cases at most, usually in rural areas in Africa where the
\nvirus spread slowly, so there was little incentive to invest in the
\nshots. In 2010, PHAC licensed the vaccines to NewLink Genetics, a
\nsmall biotech that did nothing with it.<\/p>\n
\nGuinea, Sierra Leone, and Liberia in 2014 and sickened tens of
\nthousands of people in a matter of months, including a handful in
\nMali, Senegal, Nigeria, the United States, and Europe. Geisbert and
\nFeldmann were deeply dispirited because their vaccine had languished.
\n“It was really frustrating because we had vaccines that were developed
\nback in the early 2000s, and we knew that they would work, but we’re
\njust lab guys,” says Geisbert, who now has a lab at the University of
\nTexas Medical Branch.<\/p>\n
\nControl and Prevention projected that if control measures didn’t
\nimprove, Sierra Leone and Liberia together could have between 550 000
\nand 1.4 million Ebola cases by January 2015. That’s when Merck decided
\nto license the vaccine from NewLink Genetics, Feinberg says. “Merck
\nknew from the very beginning, that it was not going to be a profitable
\nproduct,” he says. “They were moving it specifically for public health
\nreasons.”<\/p>\n
\nbut by then public health measures and behavior changes began to put
\nthe brakes on West Africa’s epidemic, causing cases to fall. (All
\ntold, nearly 29 000 people fell ill and more than 11 000 died.)
\nMerck’s ring vaccination trial in Guinea, conducted with WHO and local
\nhealth officials, crossed the finish line in mid-2015, just before the
\nepidemic ended, but other candidates were too late. GSK later decided
\nto give away its vaccine to the Sabin Institute.<\/p>\n
\nof Zaire ebolavirus. More than 300 000 people were vaccinated during
\nthe world’s 2nd largest Ebola outbreak, for example, which caused 3470
\nreported cases in a conflict-riven area of the Democratic Republic of
\nthe Congo between 2018 and 2020.<\/p>\n
\nebolavirus. In 2017, it gave the license for that vaccine back to
\nPHAC, which subsequently cut a licensing deal with IAVI. In 2021, the
\nUS government’s Biomedical Advanced Research and Development Authority
\n(BARDA) awarded IAVI a grant worth up to USD 126 million to use
\nupgraded technology to develop VSV-based vaccines for both Sudan
\nebolavirus and the related filovirus that causes Marburg disease,
\nanother rare but often lethal infection. (BARDA awarded a similar
\namount to Sabin to develop the same vaccines using its chimp
\nadenovirus platform.)<\/p>\n
\nUganda outbreak began in September 2022, Geisbert was once again
\nbeside himself. “I sent an email to my boss and said, Look, we are in
\nthe same situation as in 2014,” he says. “The VSV vaccine we know
\nworks in ring vaccination, and it would be perfect to stop this.”
\nGeisbert also now has unpublished data showing that the VSV Sudan
\nebolavirus vaccine provides robust protection in the monkey model.<\/p>\n
\n——————
\nNow, it has become clear that a big batch of Merck’s Sudan Ebola
\nvaccine is available and could soon be ready for clinical trials.<\/p>\n
\nran vaccine bioprocessing for the company, says he told his boss,
\nsenior vice president of R&D Joe Miletich, that if the Zaire Ebola
\nvaccine was safe and effective, the company had “an obligation to the
\nworld” to use the VSV platform to also make a stock of Sudan Ebola
\nvaccine. Merck proceeded to make the vaccine under strict “good
\nmanufacturing practices” and also produced a large batch of a
\nVSV-based Marburg vaccine.<\/p>\n
\ntoday is not entirely clear. Science asked Merck on 13 Oct 2022
\nwhether the company had produced the Sudan Ebola vaccine and retained
\nstocks of it. A spokesperson emailed back that Merck had made
\napproximately 70 000 vials of it in 2015-16. “The vials of Sudan
\nebolavirus (SUDV) vaccine candidate expired in 2021 and were
\ndestroyed,” the email added. (The email also said Merck had destroyed
\n96 000 filled vials of its Marburg vaccine.)<\/p>\n
\nthat the company did retain bulk quantities of the frozen Ebola
\nvaccine and arranged an interview with Coller. She says Merck
\ndestroyed the fill-and-finished doses of the Sudan Ebola vaccine
\nbecause the vials had used rubber stoppers. “The stoppers become
\nbrittle when they’re stored frozen,” she explains.<\/p>\n
\nshelf life,” she adds. The vaccine was destined for destruction as
\nwell, but to the surprise of company scientists, it still was in the
\nfreezer. “Frankly, fortuitously, it hadn’t yet been destroyed,” she
\nsays. “We immediately looked at that and said, Oh, my goodness, we can
\nperhaps do something to help.” (Bulk Marburg vaccine, Coller says, was
\ndestroyed.)<\/p>\n
\nremained after attending a WHO meeting that ended on 6 Oct 2022 in
\nwhich she learned Uganda’s outbreak was rapidly growing. Asked why the
\ncompany did not mention the find in response to Science’s 13 Oct 2022
\nemail, she says Merck was still conducting tests to assess whether the
\nvaccine had remained free of contaminants. “We were not sure about
\nwhether or not we would be able to use that bulk material and didn’t
\nwant to speak out of turn until we knew that there was something that
\nwe could actually do with it,” Coller says.<\/p>\n
\nnot something that was ever really put on the table,” said Coller,
\nnoting that there has not been an outbreak of this virus anywhere
\nsince Uganda’s last one in 2012. “With hindsight, perhaps it could
\nhave been done better.”<\/p>\n","protected":false},"excerpt":{"rendered":"