88-517: Recombinant vesicular stomatitis virus–Zaire Ebola virus ( rVSV-ZEBOV ), also known as Ebola Zaire vaccine live and sold under the brand name Ervebo , is an Ebola vaccine for adults that prevents Ebola caused by the Zaire ebolavirus . When used in ring vaccination , rVSV-ZEBOV has shown a high level of protection. Around half the people given the vaccine have mild to moderate adverse effects that include headache, fatigue, and muscle pain. rVSV-ZEBOV
176-574: A Marketing Authorization Application (MAA) to the EMA for approval of Ad26.ZEBOV and MVA-BN-Filo. In May 2020, the EMA CHMP recommended granting a marketing authorization for the combination of Ad26.ZEBOV (Zabdeno) and MVA-BN-Filo (Mvabea) vaccines. Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster. This prophylactic two-dose regimen is therefore not suitable for an outbreak response where immediate protection
264-586: A DTRA task force was identifying, collecting, and securing radiological material in Iraq as part of Operation Iraqi Freedom , including almost two tons of low-enriched uranium (LEU), several hundred tons of yellowcake (a type of uranium powder), and other radioactive sources. Code-named Project MAXIMUS, DTRA, and the United States Department of Energy moved 1.77 metric tons of LEU and approximately 1,000 highly radioactive sources out of Iraq by
352-524: A Phase I clinical trial in Australia. The Lipid nanoparticle (LNP)-encapsulated siRNAs rapidly adapted to target the Makona outbreak strain of EBOV and are able to protect 100% of rhesus monkeys against lethal challenge when treatment was initiated at three days post-exposure while animals were viremic and clinically ill. The top line Phase I human trial results showed that the adjuvanted Ebola GP Vaccine
440-631: A clinical trial of the GamEvac-Combi vaccine in Russia, concluded said vaccine to be safe and effective and recommended proceeding to Phase III trials. In September 2019, a study published in Cell Reports demonstrated the role of the Ebola virus VP35 protein in its immune evasion. A recombinant form of Ebola virus with a mutant VP35 protein (VP35m) was developed, and showed positive results in
528-837: A conditional marketing authorization. The WHO prequalification came fewer than 48 hours later, making it the fastest vaccine prequalification process ever conducted by WHO. It was approved for medical use in the European Union in November 2019. It was approved for medical use in the United States in December 2019. The most common side effects include pain, swelling and redness at the injection site, headache, fever, muscle pain, tiredness and joint pain. In general, these reactions occur within seven days after vaccination, are mild to moderate in intensity and resolved in less than
616-609: A day or two. Other common side-effects were pain at the site of injection, myalgia, and fatigue. The trial was temporarily halted in December 2014 due to possible adverse effects, but subsequently resumed. As of April 2015 , a Phase III trial with a single dose of VSV-EBOV began in Liberia after a successful Phase II study in the West African country. On 31 July 2015, preliminary results of a Phase III trial in Guinea indicated that
704-564: A division of GlaxoSmithKline . For the trial designated VRC 20, 20 volunteers were recruited by the NIAID in Bethesda, Maryland, while three dose-specific groups of 20 volunteers each were recruited for trial EBL01 by University of Oxford, UK. Initial results were released in November 2014; all 20 volunteers developed antibodies against Ebola and there were no significant concerns raised about safety. In December 2014, University of Oxford expanded
792-706: A large-scale ring-vaccination scheme in the DRC outbreak, the WHO published the preliminary results of its research, in association with the DRC's Institut National pour la Recherche Biomedicale , into the effectiveness of the ring vaccination program, stating that the rVSV-ZEBOV-GP vaccine had been 97.5% effective at stopping Ebola transmission, relative to no vaccination. Systemic side effects include headache, feverishness, fatigue, joint and muscle pain, nausea, arthritis, rash, and abnormal sweating. Injection-site side events include injection-site pain, swelling, and redness. rVSV-ZEBOV
880-564: A law in 2004 that funds a national stockpile of vaccines and medicine for possible outbreaks of disease. A number of companies were expected to develop Ebola vaccines: GlaxoSmithKline , NewLink Genetics , Johnson & Johnson , and Bavarian Nordic . Another company, Emergent BioSolutions , was a contestant for manufacturing new doses of ZMapp , a drug for Ebola virus disease treatment originally developed by Mapp Biopharmaceutical . Supplies of ZMapp ran out in August 2014. In September 2014,
968-690: A lower dose. In March 2015, a Phase II clinical trial and a Phase III started in Guinea at the same time; the Phase II trial focused on frontline health workers, while the Phase III trial was a ring vaccination in which close contacts of people who had contracted Ebola virus were vaccinated with VSV-EBOV. In January 2016, the GAVI Alliance signed an agreement with Merck under which Merck agreed to provide VSV-EBOV vaccine for future outbreaks of Ebola and GAVI paid Merck US$ 5 million ; Merck will use
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#17327877531931056-646: A rVSV vaccine. In July 2023, the FDA expanded the approval of Ervebo for use in people aged 12 months through 17 years of age. Ervebo was approved for use in people aged 18 years of age and older in December 2019. During an outbreak in the Democratic Republic of the Congo in 2018 , the ZEBOV vaccine was used, and what was once contact tracing which numbered 1,706 individuals (ring vaccination which totaled 3,330)
1144-607: A social network of individuals and locations that might include dwellings or workplaces where a patient spent time while symptomatic, or the households of individuals who had contact with the patient during that person's illness or death. In a comparison of cases of EVD among 2,108 individuals in the "immediate" vaccination arm and 1,429 individuals in the "delayed" vaccination arm, Ervebo was determined to be 100% effective in preventing Ebola cases with symptom onset greater than ten days after vaccination. No cases of EVD with symptom onset greater than ten days after vaccination were observed in
1232-507: A steering committee among the interested parties, including PHAC, the NIH, and the WHO, to plan the clinical development of the vaccine. In October 2014, Newlink Genetics began a Phase I clinical trial of rVSV-ZEBOV on healthy human subjects to evaluate the immune response, identify any side effects and determine the appropriate dosage. Phase I trials took place in Gabon, Kenya, Germany, Switzerland,
1320-522: A successful Phase 2 study in West Africa countries. At the 8th Vaccine and ISV Conference in Philadelphia on 27−28 October 2014, Novavax Inc. reported the development in a "few weeks" of a glycoprotein (GP) nanoparticle Ebola virus (EBOV GP) vaccine using their proprietary recombinant technology. A recombinant protein is a protein whose code is carried by recombinant DNA . The vaccine
1408-549: A tropical disease priority review voucher, and breakthrough therapy designation. The US Food and Drug Administration (FDA) granted approval for Ervebo to Merck & Co., Inc. Merck discontinued development of the related rVSV vaccines for Marburg virus ( rVSV-MARV ) and Sudan ebolavirus ( rVSV-SUDV ). Merck returned the rights on these vaccines back to Public Health Agency of Canada. The knowledge on developing rVSV vaccines which Merck gained with GAVI funding remains Merck's, and cannot be used by anyone else wishing to develop
1496-623: A veteran is a confirmed participant in these events, NTPR may provide either an actual or estimated radiation dose received by the veteran. The Department of Veterans Affairs (VA) and the Department of Justice (DOJ) may request this information from DTRA as required. DTRA is responsible for US reporting under the New START Treaty and the Intermediate-Range Nuclear Forces Treaty . DTRA
1584-626: A weakened form of the Ebola virus provides some measure of protection to non-human primates. This study was conducted in accordance with a protocol approved by an Institutional Animal Care and Use Committee of the National Institutes of Health. The new vaccine relies on a strain of Ebola called EBOVΔVP30, which is unable to replicate. A study published in Human Vaccines & Immunotherapeutics in March 2017, analyzing data from
1672-981: A week. It was developed by the Public Health Agency of Canada , with development subsequently taken over by Merck Inc . In October 2014, the Wellcome Trust , who was also one of the biggest UK founders, announced the start of multiple trials in healthy volunteers in Europe, Gabon, Kenya, and the US. The vaccine was proven safe at multiple sites in North America, Europe, and Africa, but several volunteers at one trial site in Geneva, Switzerland, developed vaccine-related arthritis after about two weeks, and about 20–30% of volunteers at reporting sites developed low-grade post-vaccine fever, which resolved within
1760-410: Is a recombinant , replication-competent viral vector vaccine . It consists of rice-derived recombinant human serum albumin and live attenuated recombinant vesicular stomatitis virus (VSV), which has been genetically engineered to express the main glycoprotein from the Zaire ebolavirus so as to provoke a neutralizing immune response to the Ebola virus. The vaccine was approved for medical use in
1848-657: Is a live, attenuated recombinant vesicular stomatitis virus (VSV) in which the gene for the native envelope glycoprotein ( P03522 ) is replaced with that from the Ebola virus ( P87666 ), Kikwit 1995 Zaire strain. Manufacturing of the vaccine for the Phase I trial was done by IDT Biologika. Manufacturing of vaccine for the Phase III trial was done by Merck , using the Vero cell line , which Merck already used to make its RotaTeq vaccine against rotavirus . Scientists working for
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#17327877531931936-972: Is also responsible for reducing the threat of conventional war , especially in Europe , by participating in various arms control treaties to which the United States is a party, such as the Conventional Forces in Europe treaty , the Transparency in Armaments activity of the United Nations , and the Wassenaar Arrangement , as well as the Chemical Weapons Convention , the Plutonium Production Reactor Agreement,
2024-512: Is based on the newly published genetic sequence of the 2014 Guinea Ebola (Makona) strain that is responsible for the 2014 Ebola disease epidemic in West Africa. In animal studies, a useful immune response was induced and was found to be enhanced ten to a hundred-fold by the company's "Matrix-M" immunologic adjuvant . A study of the response of non-human primate to the vaccine had been initiated. As of February 2015 , Novavax had completed two primate studies on baboons and macaques and had initiated
2112-639: Is derived from human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein, while the second component MVA-BN is the Modified Vaccinia Virus Ankara – Bavarian Nordic (MVA-BN) Filo-vector. This product commenced Phase I clinical trial at the Jenner Institute in Oxford during January 2015. The preliminary data indicated the prime-boost vaccine regimen elicited temporary immunologic response in
2200-472: Is necessary. As a precautionary measure for individuals at imminent risk of exposure to Ebola virus (for example healthcare professionals and those living in or visiting areas with an ongoing Ebola virus disease outbreak), an extra Zabdeno booster vaccination should be considered for individuals who completed the Zabdeno-Mvabea two-dose vaccination regimen more than four months ago. Efficacy for humans
2288-473: Is not yet known as the efficacy has been extrapolated from animal studies. In late 2014 and early 2015, a double-blind, randomized Phase I trial was conducted in the Jiangsu Province of China; the trial examined a vaccine that contains glycoproteins of the 2014 strain, rather than those of the 1976 strain. The trial found signals of efficacy and raised no significant safety concerns. In 2017,
2376-481: The 2018–20 Kivu Ebola outbreak , with over 90,000 people vaccinated. Nearly 800 people were ring vaccinated on an emergency basis with VSV-EBOV when another Ebola outbreak occurred in Guinea in March 2016. In 2017, in the face of a new outbreak of Ebola in the Democratic Republic of the Congo , the Ministry of Health approved the vaccine's emergency use, but it was not immediately deployed. In April 2019, following
2464-648: The Biomedical Advanced Research and Development Authority (BARDA) entered into a multimillion-dollar contract with Mapp Biopharmaceutical to accelerate the development of ZMapp. Additional contracts were signed in 2017. Defense Threat Reduction Agency The Defense Threat Reduction Agency ( DTRA ) is both a defense agency and a combat support agency within the United States Department of Defense (DoD) for countering weapons of mass destruction (WMD; chemical , biological , radiological , nuclear , and high explosives ) and supporting
2552-699: The China Food and Drug Administration (CFDA) announced approval of an Ebola vaccine, co-developed by the Institute of Biotechnology of the Academy of Military Medical Sciences and the private vaccine-maker CanSino Biologics . It contains a human adenovirus serotype 5 vector (Ad5) with the glycoprotein gene from ZEBOV. Their findings were consistent with previous tests on rVSV-ZEBOV in Africa and Europe. In September 2014, two Phase I clinical trials began for
2640-824: The Dayton Peace Accords , the Vienna Document and the Global Exchange of Military Information program under the auspices of the Organization for Security and Co-operation in Europe . DTRA has the responsibility to manage and integrate the Department of Defense chemical and biological defense science and technology programs. In accordance with the Recommendation 174 (h) of the 2005 Base Closure and Realignment Commission, part of
2728-673: The Defense Intelligence Agency After the end of the Cold War , DTRA and its predecessor agencies implemented the DoD aspects of several treaties that assist former Eastern Bloc countries in the destruction of Soviet era nuclear weapons sites (such as missile silos and plutonium production facilities), biological weapons sites (such as the Soviet biological weapons program ), and chemical weapons sites (such as
rVSV-ZEBOV vaccine - Misplaced Pages Continue
2816-609: The GosNIIOKhT ) in an attempt to avert potential weapons proliferation in the post-Soviet era as part of the Nunn–Lugar Cooperative Threat Reduction program. The Nuclear Test Personnel Review (NTPR) program is the DoD program that confirms veteran participation in U.S. nuclear tests from 1945 to 1992, and the occupation forces of Hiroshima and Nagasaki , Japan. Members of this group are sometimes referred to as atomic veterans or atomic vets. If
2904-630: The National Institute of Allergy and Infectious Diseases (NIAID) of the United States Department of Health and Human Services and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) to fund research on the drug now called ZMapp , which has since been used on several patients. DTRA also funded and managed the research on the EZ1 assay used to detect and diagnose
2992-549: The Public Health Agency of Canada (PHAC) created the vaccine, and PHAC applied for a patent in 2003. From 2005, to 2009, three animal trials on the virus were published, all of them funded by the Canadian and U.S. governments. In 2005, a single intramuscular injection of the EBOV or MARV vaccine was found to induce completely protective immune responses in nonhuman primates ( crab-eating macaques ) against corresponding infections with
3080-779: The United States Army Edgewood Chemical Biological Center (ECBC) to develop the FDHS and then modify it for ship-borne operations after Syrian President Bashar al-Assad agreed to turn over his country's poison gas arsenal and chemical weapon production equipment to the Organisation for the Prohibition of Chemical Weapons (OPCW), but no country volunteered to host the destruction process. Two FDHS units destroyed more than 600 tons of Sarin and mustard agents, completing
3168-498: The World Health Organization 's (WHO) assistant director-general of health systems and innovation, announced that the vaccines cAd3-EBO Z and VSV-EBOV had demonstrated acceptable safety profiles during early testing and would soon progress to large-scale trials in Liberia, Sierra Leone, and Guinea. The trials would involve up to 27,000 people and comprise three groups – members of the first two groups would receive
3256-694: The Zaire ebolavirus . The first vaccine to be approved in the United States was rVSV-ZEBOV in December 2019. It had been used extensively in the Kivu Ebola epidemic under a compassionate use protocol. During the early 21st century, several vaccine candidates displayed efficacy to protect nonhuman primates (usually macaques ) against lethal infection. Vaccines include replication -deficient adenovirus vectors , replication-competent vesicular stomatitis (VSV) and human parainfluenza (HPIV-3) vectors, and virus-like nanoparticle preparations. Conventional trials to study efficacy by exposure of humans to
3344-528: The "immediate" cluster group, compared with ten cases of EVD in the 21-day "delayed" cluster group. In additional studies, antibody responses were assessed in 477 individuals in Liberia, some 500 individuals in Sierra Leone, and about 900 individuals in Canada, Spain, and the US. The antibody responses among those in the study conducted in Canada, Spain and the US were similar to those among individuals in
3432-438: The "immediate" cluster group, compared with ten cases of EVD in the 21-day "delayed" cluster group. In additional studies, antibody responses to Ervebo were assessed in 477 individuals in Liberia, approximately 500 individuals in Sierra Leone and approximately 900 individuals in Canada, Spain, and the US. The antibody responses among those in the study conducted in Canada, Spain and the US were similar to those among individuals in
3520-494: The 1970s. The trial will continue to assess whether the vaccine is effective in creating herd immunity to Ebola virus infection. In December 2016, a study found the VSV-EBOV vaccine to be 95–100% effective against the Ebola virus, making it the first proven vaccine against the disease. The approval was supported by a study conducted in Guinea during the 2014–2016 outbreak in individuals 18 years of age and older. The study
3608-586: The 2018-2020 outbreak in the Democratic Republic of the Congo , providing 84% protection to individuals vaccinated at least 10 days prior to exposure. This finding, detailed in a study published in The Lancet Infectious Diseases , marks the first peer-reviewed evaluation of the vaccine, Ervebo , under real-world conditions. The two-dose regimen of Ad26.ZEBOV and MVA-BN-Filo, sold under the brand names Zabdeno and Mvabea,
rVSV-ZEBOV vaccine - Misplaced Pages Continue
3696-726: The Chemical Biological Defense Research component of the DTRA was relocated to Edgewood Chemical Biological Center, Aberdeen Proving Ground , Maryland in 2011. This represented a move of about ten percent of the staff of the Chemical Biological Defense Research component of DTRA to Aberdeen Proving Ground; the rest of the staff remain at Fort Belvoir. DTRA has spent approximately $ 300 million on scientific R&D efforts since 2003, developing vaccines and therapeutic treatments against viral hemorrhagic fever , including Ebola . Starting in 2007, DTRA partnered with
3784-701: The DTRA to award a $ 4 million contract to MRIGlobal to "configure, equip, deploy and staff two quick response mobile laboratory systems (MLS) to support the ongoing Ebola outbreak in West Africa ." The labs were deployed to Sierra Leone . DTRA was the program manager for designing, testing, contracting, and producing the Transport Isolation System (TIS), This sealed, self-contained patient containment system can be loaded into United States Air Force (USAF) C-17 Globemaster and C-130 Hercules cargo planes for aeromedical evacuation. The TIS
3872-533: The Ebola virus, making it the first proven vaccine against the disease. However, the design of this study and the high efficacy of the vaccine were questioned. In November 2019, the European Commission granted a conditional marketing authorization to Ervebo (rVSV∆G-ZEBOV-GP, live) and the WHO prequalified an Ebola vaccine for the first time. In July 2023, the FDA expanded the indication for Ervebo to cover people aged 12 years of age and older. Merck ’s Ebola vaccine demonstrated significant effectiveness during
3960-420: The European Commission granted a conditional marketing authorization to Ervebo and the World Health Organization (WHO) prequalified an Ebola vaccine for the first time, indicating that the vaccine met WHO standards for quality, safety and efficacy, and allowing UN agencies and GAVI to procure vaccine for distributions. In December 2019, Ervebo was approved for use in the United States. The approval of Ervebo
4048-470: The European Union and the United States in 2019. It was created by scientists at the National Microbiology Laboratory in Winnipeg, Manitoba , Canada, which is part of the Public Health Agency of Canada (PHAC). PHAC licensed it to a small company, Newlink Genetics, which started developing the vaccine; Newlink in turn licensed it to Merck in 2014. It was used in the DR Congo in a 2018 outbreak in Équateur province , and has since been used extensively in
4136-791: The Joint Improvised-Threat Defeat Agency (JIDA) became part of DTRA and was renamed the Joint Improvised-Threat Defeat Organization (JIDO) in accordance with the 2016 National Defense Authorization Act (NDAA). In Section 1532 of the NDAA, Congress directed the DoD to move JIDA to a military department or under an existing defense agency. DTRA requested a base budget of $ 2.0 billion for fiscal year 2023 (FY23), including $ 998 million for Operation and Maintenance, $ 654 million for Research, Development, Test and Evaluation, $ 342 million for Cooperative Threat Reduction, and $ 14 million for Procurement. In her February 2024 Director’s Strategic Intent 2022-2027, DTRA Director Rebecca Hersman noted that DTRA would transition its intelligence resources and authorities to
4224-439: The MOP to fulfill a long-standing Air Force requirement for a weapon that could destroy hard and deeply buried targets. The MOP is a 30,000-pound, 20.5-foot-long bomb dropped from B-52 and B-2 bombers at high altitude that can reportedly penetrate 200 feet of reinforced concrete. The MOP contains a 5,300-pound explosive charge, more than ten times the explosive power of its predecessor, the BLU-109 "bunker buster." In 2003,
4312-418: The On-Site Inspection Agency, the Defense Technology Security Administration, and selected elements of the Office of Secretary of Defense were combined to form the Defense Threat Reduction Agency (DTRA). DTRA employs approximately 1,400 DoD civilians and 800 uniformed service members at more than a dozen permanent locations worldwide. Most personnel are at DTRA headquarters at Fort Belvoir. Approximately 15% of
4400-555: The TIS; St. Louis -based Production Products was awarded a sole-source contract to produce 25 TIS units. DTRA was one of the key United States Department of Defense agencies that developed the Field Deployable Hydrolysis System (FDHS) used to destroy Syria's chemical weapons aboard the U.S.-flagged container ship MV Cape Ray in the summer of 2014 after Syria agreed to give up its chemical weapons stockpile under international pressure and in accordance with United Nations Security Council Resolution 2118 . DTRA partnered with
4488-449: The U.S. military's Combatant Commands , the National Guard Bureau , the FBI and other U.S. government interagency partners. In 2005, the United States Strategic Command (USSTRATCOM) was designated as the lead Combatant Command for the integration and synchronization of DoD's efforts in support of the government's "Combating WMD" objectives. It was at this time that the SCC-WMD was co-located with DTRA. The Combat Command designation
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#17327877531934576-410: The US, and Canada. In November 2014, Newlink exclusively licensed rights to the vaccine to Merck for US $ 50 million plus royalties. The Phase I study started with a high dose which caused arthritis and skin reactions in some people, and the vaccine was found replicating in the synovial fluid of the joints of the affected people; the clinical trial was halted because of that, then recommenced with
4664-408: The WHO ruled that offering people infected with Ebola the RVSV-ZEBOV vaccine (which at the time was untested on humans) was ethical, and the Canadian government donated 500 doses of the vaccine to the WHO. In October 2014, Newlink had no vaccine in production and no human trials underway, and there were calls for the Canadian government to cancel the contract. In September or October 2014, Newlink formed
4752-424: The activation of the RIG-I-like receptor signaling. Non-human primates were challenged with different doses of VP35. This challenge resulted in the activation of the innate immune system and the production of anti-EBOV antibodies. The primates were then back-challenged with the wild type Ebola virus and survived. This potentially creates a prospect for a future vaccine development. In January 2015, Marie-Paule Kieny,
4840-417: The administration of the vaccine to healthy human subjects to evaluate the immune response, identify any side effects and determine the appropriate dosage. VSV-EBOV or rVSV-ZEBOV , sold under the brand name Ervebo, is a vaccine based on the vesicular stomatitis virus which was genetically modified to express a surface glycoprotein of Zaire Ebola virus . In November 2019, the European Commission granted
4928-525: The commencement of the trials on 9 August 2017, at the Rusal -built Research and Diagnostic Center of Epidemiology and Microbiology in Kindia . The trials were slated to continue until 2018. As of October 2019, Russia licensed the vaccine by local regulatory authorities and was reportedly ready to ship vaccine to Africa. In 2014, Credit Suisse estimated that the US government will provide over $ 1 billion in contracts to companies to develop medicine and vaccines for Ebola virus disease. Congress passed
5016-453: The data resulting from the trials. The committee found that data from the Phase III Guinea trial were difficult to interpret for several reasons. The trial had no placebo arm; it was omitted for ethical reasons and everyone involved, including the committee, agreed with the decision. This left only a delayed treatment group to serve as a control, but this group was eliminated after an interim analysis showed high levels of protection, which left
5104-411: The disestablishment of the Manhattan Engineering District (MED) in 1947, AFSWP was formed to provide military training in nuclear weapons' operations. Over the years, its sequential descendant organizations have been the Defense Atomic Support Agency (DASA) from 1959 to 1971, the Defense Nuclear Agency (DNA) from 1971 to 1996, and the Defense Special Weapons Agency (DSWA) from 1996 to 1998. In 1998, DSWA,
5192-428: The funds to complete clinical trials and obtain regulatory approval. As of that date, Merck had submitted an application to the World Health Organization (WHO) through their Emergency Use Assessment and Listing (EUAL) program to allow for use of the vaccine in the case of another epidemic. It was used on an emergency basis in Guinea in March 2016. Results of the Phase III Guinea trial were published in December 2016. It
5280-471: The households of individuals who had contact with the patient during that person's illness or death. In a comparison of cases of EVD among 2,108 individuals in the "immediate" vaccination arm and 1,429 individuals in the "delayed" vaccination arm, Ervebo was determined to be 100% effective in preventing Ebola cases with symptom onset greater than ten days after vaccination. No cases of EVD with symptom onset greater than ten days after vaccination were observed in
5368-454: The new agency. In 2002, DTRA published a detailed history of its predecessor agencies, Defense's Nuclear Agency, 1947–1997 , the first paragraph of which makes a brief statement about the agencies which led up to the formation of DTRA: Defense's Nuclear Agency, 1947–1997 , traces the development of the Armed Forces Special Weapons Project (AFSWP), and its descendant government organizations, from its original founding in 1947 to 1997. After
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#17327877531935456-629: The nuclear enterprise. Its stated mission is to provide "cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to Deter strategic attack against the United States and its allies; Prevent, reduce, and counter WMD and emerging threats; and Prevail against WMD-armed adversaries in crisis and conflict." DTRA is headquartered in Fort Belvoir, Virginia . The DTRA mission, organization and management, responsibilities and functions, relationships, authorities, and administration are defined in DoD Directive 5105.62, Defense Threat Reduction Agency (DTRA). DTRA
5544-475: The otherwise typically lethal EBOV or MARV. In 2010, PHAC licensed the intellectual property on the vaccine to a small U.S. company called Bioprotection Systems, which was a subsidiary of Newlink Genetics, for US $ 205,000 and "low single-digit percentage" royalties. Newlink had funding from the U.S. Defense Threat Reduction Agency to develop vaccines. In December 2013, the largest-ever Ebola epidemic started in West Africa, specifically, in Guinea. On August 12,
5632-433: The pathogen after immunization are not ethical in this case. For such situations, the US Food and Drug Administration (FDA) has established the " animal efficacy rule " allowing licensure to be approved on the basis of animal model studies that replicate human disease, combined with evidence of safety and a potentially potent immune response (antibodies in the blood) from humans given the vaccine. Clinical trials involve
5720-449: The presence of the Ebola Zaire virus in humans. EZ1 was given Emergency Use Authorization by the Food and Drug Administration (FDA) in August 2014. DTRA first developed EZ1 as part of a 2011 "bio-preparedness initiative" for the United States Department of Defense to prepare for a possible Ebola outbreak. EZ1 was used to identify infected patients in West Africa . The Nunn-Lugar Cooperative Threat Reduction program provided for
5808-410: The ring trial after spending time in April at one of the Ebola treatment units where trial participants are taken if they become ill, the centre in Coyah, about 50 km from the capital of Conakry. The Russian Foreign Ministry announced in 2016, the intention to conduct field trials of two Russian vaccines involving 2000 people. According to local media reports, the Guinean government authorized
5896-399: The studies conducted in Liberia and Sierra Leone. The safety was assessed in approximately 15,000 individuals in Africa, Europe, and North America. The most commonly reported side effects were pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue. In December 2016, a study found the VSV-EBOV vaccine to be 70–100% effective against
5984-399: The studies conducted in Liberia and Sierra Leone. The safety of Ervebo was assessed in approximately 15,000 individuals in Africa, Europe and North America. The most commonly reported side effects were pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue. The application for Ervebo in the United States was granted priority review ,
6072-415: The summer of 2004. DTRA task force members also secured the yellowcake in a bunker in Tuwaitha , Iraq, which was turned over to the Iraqi Ministry of Science and Technology; the remaining 550 tons of yellowcake were sold in 2008 to Cameco , a uranium producer in Canada . In late 2019, DTRA established the Discovery of Medical Countermeasures Against Novel Entities (DOMANE) program. Shortly afterwards,
6160-410: The task several weeks ahead of schedule. The remaining materials were then taken to Finland and Germany for final disposal. DTRA was awarded its third Joint Meritorious Unit Award for successfully destroying Syria's declared chemical weapons. DTRA funded, managed, and tested the Massive Ordnance Penetrator (MOP) bomb until February 2010, when the program was turned over to the USAF. DTRA developed
6248-452: The team appeared unlikely due to lack of funding. Vaxart Inc. is developing a vaccine technology in the form of a temperature-stable tablet which may offer advantages such as reduced cold chain requirement, and rapid and scalable manufacturing. In January 2015, Vaxart announced that it had secured funding to develop its Ebola vaccine to Phase I trial. A study published in Science during March 2015, demonstrated that vaccination with
6336-441: The trial even more underpowered . The committee found that under an intention-to-treat analysis , the rVSV-ZEBOV vaccine might have had no efficacy, agreed with the authors of the December 2016 report that it probably had some efficacy, but found statements that it had substantial or 100% efficacy to be unsupportable. In April 2019, following a large-scale ring-vaccination scheme in the DRC outbreak, preliminary results showed that
6424-411: The trial to include a booster vaccine based on MVA-BN, a strain of Modified vaccinia Ankara , developed by Bavarian Nordic , to investigate whether it can help increase immune responses further. The trial which has enrolled a total of 60 volunteers will see 30 volunteers vaccinated with the booster vaccine. As of April 2015 , Phase III trial with a single dose of cAd3-EBO Z begins in Sierra Leone after
6512-466: The two candidate vaccines, while the third group will receive a placebo . Both vaccines have since successfully completed the Phase 2 studies. The large scale Phase 3 studies have begun as of April 2015 , in Liberia and Sierra Leone, and in Guinea in March 2016. In addition, a medical anthropologist at Université de Montréal , had been working in Guinea and raised further questions about safety in
6600-450: The vaccine cAd3-EBO Z , which is based on an attenuated version of a chimpanzee adenovirus (cAd3) that has been genetically altered so that it is unable to replicate in humans. The cAd3 vector has a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion. It was developed by NIAID in collaboration with Okairos, now
6688-412: The vaccine appeared to be "highly efficacious and safe." The trial used a ring vaccination protocol that first vaccinated all the closest contacts of new cases of Ebola infection either immediately or after 21 days. Because of the demonstrated efficacy of immediate vaccination, all recipients will now be immunized immediately. Ring vaccination is the method used in the program to eradicate smallpox in
6776-557: The vaccine had been 97.5% effective at stopping Ebola transmission, relative to no vaccination. In September 2019, the US Food and Drug Administration (FDA) accepted Merck's Biologics License Application and granted priority review for the vaccine. In October 2019, the European Medicines Agency (EMA) recommended granting conditional marketing authorization for the rVSV-ZEBOV-GP vaccine. In November 2019,
6864-766: The volunteers as expected from vaccination. The Phase II trial enrolled 612 adult volunteers and commenced in July 2015, in the United Kingdom and France. A second Phase II trial, involving 1,200 volunteers, was initiated in Africa with the first trial commenced in Sierra Leone in October 2015. In September 2019, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an accelerated assessment to Janssen for Ad26.ZEBOV and MVA-BN-Filo, and in November 2019, Janssen submitted
6952-803: The workforce is split between Kirtland Air Force Base and the White Sands Missile Range in New Mexico , and the Nevada National Security Site (formerly the Nevada Test Site), where they test and support the U.S. military's nuclear mission. The remaining 15% of the workforce is stationed in Germany , Kazakhstan , Azerbaijan , Uzbekistan , Georgia , Ukraine , Armenia , Kenya , South Korea , Japan , and Singapore . DTRA also has liaisons with
7040-403: Was a randomized cluster (ring) vaccination study in which 3,537 contacts, and contacts of contacts, of individuals with laboratory-confirmed Ebola virus disease (EVD) received either "immediate" or 21-day "delayed" vaccination. This design was intended to capture a social network of individuals and locations that might include dwellings or workplaces where a patient spent time while symptomatic, or
7128-556: Was changed again in 2017 when responsibility was moved to U.S. Special Operations Command (USSOCOM). In 2012, the Standing Joint Force Headquarters for Elimination (SJFHQ-E) was relocated to the DTRA/SCC-WMD headquarters at Fort Belvoir. This centralized the DoD's Combating Weapons of Mass Destruction operations, a move recommended in the 2010 Quadrennial Defense Review . On 30 September 2016,
7216-604: Was designed to deal with any U.S. troops exposed to or infected with Ebola while serving in Operation United Assistance , but it is for transporting anyone exposed to or infected with any highly contagious disease. It can hold eight patients lying down, 12 sitting, or a combination of the two. DTRA worked with the Air Force Life Cycle Management Center (AFLCMC) and United States Transportation Command (USTRANSCOM) on
7304-496: Was developed by Johnson & Johnson at its Janssen Pharmaceutical company. It was approved for medical use in the European Union in July 2020. The regimen consists of two vaccine components (first vaccine as prime, followed by a second vaccine as boost ) – the first based on AdVac technology from Crucell Holland B.V. (which is part of Janssen), the second based on the MVA-BN technology from Bavarian Nordic . The Ad26.ZEBOV
7392-582: Was highly immunogenic at all dose levels. On 5 November 2014, the Houston Chronicle reported that a research team at the University of Texas-Austin was developing a nasal spray Ebola vaccine, which the team had been working on for seven years. The team reported in 2014, that in the nonhuman primate studies it conducted, the vaccine had more efficacy when delivered via nasal spray than by injection. As of November 2014 , further development by
7480-795: Was officially established on 1 October 1998, as a result of the 1997 Defense Reform Initiative by consolidating several DoD organizations, including the Defense Special Weapons Agency (successor to the Defense Nuclear Agency) and the On-Site Inspection Agency. The Defense Technology Security Administration and the Nunn–Lugar Cooperative Threat Reduction program office in the Office of the Secretary of Defense were also incorporated into
7568-644: Was reduced to zero on June 28, 2018. The outbreak completed the required 42-day cycle on July 24. On August 1, 2018, an EVD outbreak was declared in North Kivu DRC. After six months the current totals stand at 735 total cases and 371 deaths; violence in the region has helped the spread of the virus. Preliminary results show ring vaccination with the vaccine has been highly effective at reducing Ebola transmission. Ebola vaccine Ebola vaccines are vaccines either approved or in development to prevent Ebola . As of 2022, there are only vaccines against
7656-414: Was supported by a study conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older. The study was a randomized cluster (ring) vaccination study in which 3,537 contacts, and contacts of contacts, of individuals with laboratory-confirmed Ebola virus disease (EVD) received either "immediate" or 21-day "delayed" vaccination with Ervebo. This noteworthy design was intended to capture
7744-437: Was widely reported in the media that vaccine was safe and appeared to be nearly 100% effective, but the vaccine remained unavailable for commercial use as of December 2016. In April 2017, scientists from the U.S. National Academy of Medicine (NAM) published a review of the response to the Ebola outbreak that included a discussion of how clinical trial candidates were selected, how trials were designed and conducted, and reviewed
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