COVID-19 vaccine development became one of the most urgent scientific priorities in modern history when the pandemic emerged, demanding unprecedented collaboration between pharmaceutical companies, public health organizations, and clinical research networks. The partnership between Merck and IAVI to develop an investigational vaccine against SARS-CoV-2 is a clear example of how that collaboration took shape during the earliest and most critical phase of the global response.<\/p>\n
At FOMAT, vaccine development and infectious disease research have been central to our work since the early days of the pandemic. As a clinical research organization that conducted COVID-19 trials directly in the communities we serve, we understand firsthand how critical industry and public health partnerships are to accelerating the development of safe and effective treatments. Collaborations like the one between Merck and IAVI represent exactly the kind of innovation that brings new therapies to the patients who need them most.<\/p>\n
Merck and IAVI announced a collaboration to develop an investigational vaccine against SARS-CoV-2 with the goal of preventing COVID-19. The vaccine candidate was designed to use the recombinant vesicular stomatitis virus technology, known as rVSV, which served as the basis for Merck’s Ervebo vaccine against Ebola Zaire virus. Ervebo was the first Ebola vaccine to receive approval for use in humans, establishing the rVSV platform as a proven foundation for tackling serious viral threats.<\/p>\n
To support the collaboration, Merck signed an agreement with the Biomedical Advanced Research and Development Authority, known as BARDA, which is part of the US Department of Health and Human Services, to provide funding for the development program.<\/p>\n
The rVSV platform used in this collaboration has a meaningful track record. Its application in the Ervebo Ebola vaccine demonstrated that the technology could be deployed safely and effectively in humans under urgent conditions, including during active outbreak responses in sub-Saharan Africa. Applying this same platform to SARS-CoV-2 offered a credible and potentially accelerated pathway to a viable COVID-19 vaccine candidate.<\/p>\n
The vaccine candidate evaluated in this collaboration was designed and engineered by IAVI scientists and was in preclinical development at the time of the announcement, with clinical study plans set for later that year. IAVI’s design and development laboratory in Brooklyn, New York served as the primary site for development work, which was part of a broader IAVI initiative to develop rVSV vaccines for multiple infectious diseases including HIV, Lassa fever, Marburg, and Ebola Sudan.<\/p>\n
Under the terms of the collaboration, Merck took responsibility for leading regulatory filings globally, while both organizations committed to working together to develop the vaccine and ensure that, if approved, it would be made accessible and affordable to populations in need.<\/p>\n
COVID-19 vaccine development at the speed required by the pandemic was only possible because of collaborative models that combined the scientific expertise of research institutions with the regulatory, manufacturing, and distribution capabilities of established pharmaceutical companies. IAVI brought deep expertise in rVSV platform design and a mission focused specifically on developing vaccines for diseases that disproportionately affect low and middle income countries. Merck brought the scale, regulatory experience, and manufacturing infrastructure needed to move a candidate from preclinical development toward global deployment.<\/p>\n
According to the Mayo Clinic<\/a>, COVID-19 vaccines work by training the immune system to recognize and respond to the virus, and the development of multiple vaccine platforms during the pandemic expanded the options available to address different population needs and supply constraints.<\/p>\n This kind of partnership model, where complementary strengths are combined rather than duplicated, is one of the defining features of how COVID-19 vaccine development succeeded at a pace that would have seemed impossible under traditional timelines.<\/p>\n FOMAT’s participation in COVID-19 clinical trials during the pandemic reflects the organization’s commitment to being a responsive and capable research partner when public health needs are most urgent. By conducting trials within established community based physician practices, FOMAT was able to recruit diverse patient populations quickly and maintain the trust relationships that are essential for effective enrollment in a crisis environment.<\/p>\n Infectious disease remains an active area of clinical research within FOMAT’s network. Our infectious disease and vaccine clinical trial capabilities<\/a> support sponsors and CROs conducting studies in this therapeutic area, with access to a diverse national patient population and experienced investigators across multiple sites.<\/p>\n For sponsors evaluating research partners for vaccine and infectious disease programs, FOMAT’s patient recruitment excellence<\/a> and Phase I through Phase IV clinical research capabilities<\/a> provide the infrastructure needed to execute high quality studies efficiently and with the demographic diversity that regulatory agencies increasingly require.<\/p>\n COVID-19 vaccine development demonstrated what is possible when scientific collaboration, public health urgency, and well-executed clinical research align. The lessons learned from that experience continue to shape how FOMAT and its partners approach infectious disease research today.<\/p>\n","protected":false},"excerpt":{"rendered":" El desarrollo de la vacuna contra la COVID-19 se convirti\u00f3 en una de las prioridades cient\u00edficas m\u00e1s urgentes de la historia moderna cuando surgi\u00f3 la pandemia, lo que exigi\u00f3 una colaboraci\u00f3n sin precedentes entre las empresas farmac\u00e9uticas, las organizaciones de salud p\u00fablica y las redes de investigaci\u00f3n cl\u00ednica. La alianza entre Merck e IAVI para desarrollar una vacuna experimental\u2026<\/p>","protected":false},"author":3,"featured_media":87525,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[968],"tags":[931,932,1213,937],"class_list":["post-14298","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs-updates","tag-covid","tag-covid-19","tag-covid-19-trials","tag-covid-19-vaccine"],"acf":[],"_links":{"self":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts\/14298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/comments?post=14298"}],"version-history":[{"count":0,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts\/14298\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/media\/87525"}],"wp:attachment":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/media?parent=14298"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/categories?post=14298"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/tags?post=14298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}FOMAT’s role in infectious disease and vaccine clinical research<\/strong><\/h2>\n