CEPI – Coalition for Epidemic Preparedness Innovations [to 10 June 2017]
Newsletter 9 June 2017
Address from CEO
It appears that the recent outbreak of Ebola in the Democratic Republic of Congo has been brought under control. Merck’s investigational rVSV ZEBOV vaccine was approved for use under an Expanded Access Protocol by the national regulatory and ethical authorities in the DRC, but the outbreak had already subsided by the time these reviews were completed and no individuals have been vaccinated. It is possible, of course, that new cases could yet emerge, but so far so good.
I have received a number of calls since the outbreak began from people asking what, if any, role CEPI played in the response. Our role in the response to this outbreak was limited: we offered support, if needed, to WHO, and WHO kept us apprised of developments. But what role should CEPI play, especially as its capabilities evolve and the organization grows?
For the vaccines in its portfolio, CEPI will play a critical role in ensuring the early engagement of regulatory authorities, public health officials, and clinical scientists in countries at risk for the diseases targeted. Early engagement will facilitate the review of clinical trial protocols before outbreaks occur by institutional review board and ethics panels and thereby facilitate more rapid responses.
CEPI will also need to build strong partnerships and coordinate its efforts with agencies that have strong logistical capabilities and the ability to project medical personnel and support wherever and whenever needed. Médecins Sans Frontières is such an organization and its representatives have contributed substantially to CEPI’s understanding of the problem it is tackling and to the development of CEPI’s goals and policies. CEPI needs to build more such relationships.
We are also in the process of developing an investment strategy and financing mechanisms that will allow CEPI to respond rapidly to new threats. Mobilizing resources – particularly financial resources – quickly in a crisis is a great challenge. The Obama Administration, for example, requested a supplemental appropriation to address the Zika epidemic in February 2016 but the U.S. Congress did not provide such funding until the end of September. It is critical that CEPI be in a position to move much more rapidly if the situation demands.
Finally, CEPI has an important advocacy role and will be vocal in supporting the importance of preparedness for infectious disease outbreaks. It is all too easy for governments to neglect preparedness to address more immediate concerns. CEPI has a right and duty to speak on behalf of its coalition members in support of preparedness as a critical priority.
As I mentioned in my last note, I have asked CEPI staff to accelerate the development of our emergency response plans, which will take account of all the steps required to deliver vaccine rapidly in an emergency. This is a critical initiative for CEPI and I will keep you updated as our plans evolve.
Richard Hatchett, CEPI CEO
IAVI – International AIDS Vaccine Initiative [to 10 June 2017]
June 5, 2017
New Studies Improve Candidate Vaccine Design for HIV Subtypes Most Common in India and Africa
IAVI Scientists Demonstrate How to Produce a Variety of HIV Surface Protein Variants
Two papers published recently in the journal Immunity provide important information to inform HIV vaccine design. Using cutting-edge tools, scientists with the International AIDS Vaccine Initiative’s Neutralizing Antibody Center (IAVI NAC) at The Scripps Research Institute describe the first successful attempt at obtaining a high-resolution snapshot of a subtype C outer envelope or protein “spike” that decorates the surface of the virus. Until now, researchers have only been able to do so for subtypes A, B, and G. In the second study, researchers isolate and analyze neutralizing antibodies that are generated following vaccination of non-human primates (monkeys) with these vaccine candidates, which can penetrate these well-shielded spikes.
“Together the two studies show how structure-based immunogen design can advance vaccine development for HIV, and potentially other infectious diseases,” said Richard Wyatt, Director of Viral Immunology at the IAVI NAC. “Through enhanced understanding of subtype C’s structural complexities, we understand how antibodies can penetrate HIV’s dense protective armor – a camouflaging sugar shield – to target and latch onto a surface region called V2 that possesses some conserved sites.” Targeting of V2 also was seen in human volunteers in the RV144 – the Thai trial – the only HIV vaccine clinical trial to date to show any effectiveness.
Seeking a more effective vaccine, IAVI’s scientists generated a stabilized version of the envelope protein from a subtype C virus isolated previously from an HIV-infected Indian individual and generated crystals that permitted the determination of its atomic structure. They arranged these envelope spikes on the outside of nanoparticles, and injected the spiked nanoparticles into monkeys. Subsequent analysis showed that the vaccinated monkeys mounted immune defenses, including B-cell responses and HIV antibodies capable of blocking this subtype C HIV strain virus. The monkeys’ immune response is one indication that an HIV vaccine may be developed from this initial immunogen design approach, perhaps using many spikes derived from multiple strains to accommodate viral diversity.
Wyatt’s findings are important for several reasons. Subtype C HIV strains are responsible for the majority of HIV-1 infections worldwide and the findings presented in these two studies define a roadmap to produce vaccines for subtype C HIV viral variants. Also, the identification of which regions are immunogenic on these envelope glycoprotein immunogens, that is which elements stimulate neutralizing antibodies, inform future vaccine re-design efforts.
These findings further inform future clinical trials toward a vaccine that can prevent infection with multiple strains of HIV – otherwise known as a “broadly effective” vaccine.
NIH [to 10 June 2017]
June 5, 2017
NIAID-Sponsored Trial of Experimental Chikungunya Vaccine Begins
A clinical trial of an experimental vaccine to prevent infection with chikungunya virus is now enrolling healthy adult volunteers at three sites in the United States. The Phase 1/2 trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is being conducted at several NIAID-funded Vaccine and Treatment Evaluation Units. The candidate vaccine, MV-CHIKV, was developed by Themis Bioscience of Vienna, Austria.
Although chikungunya is rarely fatal, the mosquito-transmitted virus causes an intense inflammatory reaction resulting in severe joint pain, fever, rash and muscle pain. While most symptoms usually resolve in days, the joint inflammation can linger.
“Chikungunya virus can cause debilitating joint pain that can last for months or even longer,” said NIAID Director Anthony S. Fauci, M.D. “A vaccine to prevent infection with this virus would be of considerable benefit to people living in the more than 60 countries where chikungunya transmission has occurred, as well as travelers to those countries.”…
FDA [to 10 June 2017]
What’s New for Biologics
High-dose influenza vaccine appears better than standard-dose vaccines in preventing deaths from A(H3N2) influenza among older adults
High-dose influenza vaccine was more effective at preventing post-influenza deaths among elderly individuals during the 2012-2013 influenza season than standard-dose vaccines– when the A(H3N2) influenza viruses were broadly circulating– according to a study done by researchers at the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.
Specifically, people who received the high-dose influenza vaccine during the 2012-2013 influenza season were 36.4% less likely to die in the 30 days following hospitalization or an emergency department visit that included an influenza diagnosis compared to the standard-dose vaccine. During the following season (2013-2014), when H1N1 viruses dominated and the standard-dose vaccine had better effectiveness than the previous season, the high-dose vaccine was not significantly better at preventing deaths among the Medicare patients studied.
The findings suggest that the high-dose influenza vaccine offers greater benefit to older adults than do standard-dose vaccines when A(H3N2) influenza viruses are widely circulating…
IVI [to 10 June 2017]
University of Siena, Incheon National University and the International Vaccine Institute (IVI) Launch New Joint Executive Master’s in Biotechnology & Pharmaceutical Clinical Development
Incheon, Korea: On June 8th, 2017, Incheon National University hosted a kickoff event to announce a new International partnership with the Institute for Global Health, from University of Siena, Italy. Both institutions, with support from IVI, the International Vaccine Institute based in Seoul, launched a new and unique Executive Master Program in Public Health, Biotechnology and Pharmaceutical Clinical Development. Successful graduates will receive a joint master degree from the Medical Faculty of University of Siena, one of the oldest and most prestigious universities in Europe, and the Incheon National University, Korea.
The program is an extension of the University of Siena’s current Executive Master in Vaccinology and Pharmaceutical Clinical Development, a successful and much appraised course intended for public health and biotechnology industry professionals. Whilst the Master’s Program in Siena focuses exclusively on vaccines, this new joint master broadens the scope including the pharmaceutical development of small molecules and biologicals beyond vaccines…
Fondation Merieux [to 10 June 2017]
Mission: Contribute to global health by strengthening local capacities of developing countries to reduce the impact of infectious diseases on vulnerable populations.
8 June 2017, Paris (France)
Serge Eholié and Xavier Anglaret Winners of the 2017 Christophe Mérieux Prize: Rewarding Infectious Disease Research in Côte d’Ivoire
The 2017 Christophe Mérieux prize has been awarded to Serge Eholié and Xavier Anglaret of the Centre de recherche sur les maladies infectieuses et pathologies associées* in Abidjan (Côte d’Ivoire).
Serge Eholié and Xavier Anglaret together manage a team that was founded in 1994 and is made up of highly respected Ivorian and French researchers. The team has two main roles: conducting infectious disease research to improve the health of the population and training young scientists in medical research. These multidisciplinary studies combine clinical medicine, biology and medical sciences with international research organizations.
Over its 23 years of activity, the team has expanded and today carries out studies in 15 countries, 11 of which are in Africa. Its research programs now include all types of infectious disease with epidemic potential, including Ebola virus disease. Thanks to its clinical research experience, this team was one of the rare teams in the world able to mobilize rapidly during the Ebola virus epidemic in 2014 to carry out therapeutic trials in Guinea…
PATH [to 10 June 2017]
Press release | June 07, 2017
New WHO Designation for Oxygen Could Save Thousands of Lives Globally
Additional listing for oxygen on the Model List of Essential Medicines part of broader effort by PATH and other organizations to improve global health by making oxygen more accessible
Announcement | June 06, 2017
PATH’s contribution to global disease prevention recognized by US National Vaccine Program Office 2017 UpShot Award
Global Fund [to 10 June 2017]
Coca-Cola’s “Project Last Mile” Expands to Liberia and Swaziland Strengthening Health Systems across Africa
08 June 2017
Today at the European Development Days, The Coca-Cola Company and its Foundations, in partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria, the U.S. Agency for International Development and the Bill & Melinda Gates Foundation, announced the latest expansion of “Project Last Mile” with innovative programs to strengthen local health systems in Liberia and Swaziland. Launched in 2010 to transform the delivery of medical supplies in Tanzania, Project Last Mile has since worked with Ministries of Health in Ghana, Mozambique, Nigeria and South Africa to improve the availability of essential medicines.
Remembering Babatunde Osotimehin
06 June 2017
The Global Fund expressed its profound sadness at the news that Babatunde Osotimehin, Executive Director of UNFPA, the United Nations Population Fund, passed away. He was 68 years old.
UNAIDS [to 10 June 2017]
Selected Press Releases & Updates
Press Release – 5 June 2017
UNAIDS gala returns to Basel in June to raise awareness and funds to support efforts to end AIDS by 2030
To be hosted by Princess Eugenie of York, Caroline Rupert and Ndaba Mandela.
Wellcome Trust [to 10 June 2017]
Explainer / Published: 5 June 2017
EC report: testing on non-human primates falling but still needed
A European Commission report on the use of non-human primates in research says there has been sustained scientific progress and a reduction in primate use and suffering, but still more can be done.