Coalition for Epidemic Preparedness Innovations

Valneva with Instituto Butantan is expediting access to chikungunya vaccines in Brazil and the region. Credit: © 2025 Valneva SE. All rights reserved. Valneva has received marketing authorisation from the Brazilian Health Regulatory Agency (ANVISA) for its single-dose chikungunya vaccine, Ixchiq, for individuals aged 18 years and above. This is the first approval of a chikungunya vaccine in a country where the condition is endemic. Chikungunya is a viral disease spread through the bites of Aedes mosquitoes, which causes fever, severe joint pain, headaches, muscle pain and rash. The initiative is backed by the Coalition for Epidemic Preparedness Innovations (CEPI), joint funding from the European Union and Brazil’s Instituto Butantan to ensure wider access in low and middle-income countries (LMICs). Ixchiq is also approved in the European Union for preventing the condition in those aged 12 years and above, and in individuals aged 18 years and over in the UK, Canada and the US. Valneva has filed label extension applications for adolescents in these regions. The authorisation in Brazil paves the way for the commencement of clinical studies, including CEPI-funded Phase IV studies to support US Food and Drug Administration (FDA) and European Commission approvals of the vaccine. The Brazilian regulator is also reviewing another chikungunya vaccine candidate, VLA1555. Once approved, Instituto Butantan will manufacture and distribute it locally along with the company. Approval is expected by mid-2025. The institute aims to offer an affordable vaccine for the Latin American region and certain LMICs. Instituto Butantan and the company are collaborating to expedite access to chikungunya vaccines in Brazil and the region. With CEPI and the EU’s Horizon programme support, the company is also broadening vaccine access in LMICs. CEPI CEO Dr Richard Hatchett stated: “ANVISA’s marketing authorisation of the vaccine offers new hope in the fight against the debilitating disease and allows us to make headway in our goal to protect the tens of thousands in the country who suffer from chikungunya each year.” A new collaboration with the Serum Institute of India, announced in December 2024, will facilitate the vaccine supply in Asia. The company is carrying out a Phase II trial in paediatric patients aged one to 11 years in Honduras and the Dominican Republic. Positive outcomes were announced in January 2025. The company also plans to assess the vaccine in pregnant women in chikungunya-affected nations such as Brazil. In August 2024, the company and LimmaTech Biologics entered a strategic collaboration to advance the development of the Shigella4V vaccine.

Like malaria, there are concerns that Rift Valley fever rates could increase due to it being a climate-sensitive disease. Image credit: Shutterstock/mycteria. South African biotech Afrigen Biologics has secured a $6.2m grant from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop the first mRNA-based vaccine against Rift Valley fever. The funding will see Afrigen’s researchers work with the International Vaccine Institute (IVI) to advance the mRNA candidate through preclinical testing and into a Phase I clinical trial in humans. The trial will either be conducted in South Africa or another country affected by an outbreak of the mosquito-borne disease. Rift Valley fever was first identified more than 90 years ago in Kenya. The disease occurs in humans after contact with infected animals, meaning pastoral farmers are commonly affected due to frequent interactions with livestock, though bites from infected mosquitoes can also transmit the virus. Whilst there are vaccines approved for animal use, none are yet marketed for human use. Around 1%-2% of infections are haemorrhagic, which can cause blindness, convulsions, encephalitis and bleeding. This more severe form of the disease has mortality rates in humans of around 50%. The World Health Organization (WHO) has reported outbreaks in Egypt, Kenya, Somalia and Tanzania in the 20th century, however, Rift Valley fever cases occurred outside Africa for the first time in September 2000, following livestock trade to the Middle East. Similar to malaria, there are concerns that Rift Valley fever rates could increase due to it being a climate-sensitive disease. CEPI stated the need for a new vaccine is due to the risk of the disease spreading to new areas or increasing in frequency or size due to changing weather events. WHO made Afrigen Biologics its mRNA Hub to scale mRNA vaccine development and production in low-income and middle-income countries. These regions are more adversely affected by infectious disease outbreaks, especially from mosquito-borne viruses. CEPI’s CEO Dr Richard Hatchett said: “A safe and effective Rift Valley fever mRNA vaccine made in Africa, for Africa, raises the bar in our response to future Rift Valley fever outbreaks, and paves the way to make rapid response mRNA vaccines against similar viruses that could emerge on the continent or in other low- and middle-income countries.” Although Afrigen’s candidate is the first mRNA-based vaccine for Rift Valley fever funded by CEPI, the organisation has previously funded further research. This includes a candidate developed at the University of Oxford, which will be evaluated in a Phase II clinical trial in Kenya, with CEPI providing $3.7m in funding for the study. The funding for Rift Valley fever comes in the same week as Tanzania confirmed an outbreak of Marburg virus , another haemorrhagic illness for which there are also no approved vaccines.

CEPI grant aims to build on evidence of Micron Biomedical’s needle-free delivery of vaccines to bring CastleVax’s novel rapid-response platform to the clinicOSLO, Norway and ATLANTA, Jan. 08, 2025 (GLOBE NEWSWIRE) -- The Coalition for Epidemic Preparedness Innovations (CEPI) is awarding $3.7 million in new funding to Micron Biomedical to advance research into an innovative technology that could overcome critical vaccine access challenges with needle-free administration. The grant will allow researchers to build on learnings from the COVID-19 pandemic and advance technology designed to simplify and accelerate distribution of life-saving vaccines and prepare for a more efficient and effective global response to future disease outbreaks. The technology, developed by Atlanta-based life sciences company Micron Biomedical, uses a small and thermostable dissolvable microarray “button” that is applied to the skin and, when pushed, painlessly delivers a vaccine or therapeutic directly into the uppermost skin layers. Drug delivery is complete within moments and the button is removed from the skin and safely discarded. The button-like technology has been recognized for its potential to address vaccine immunization barriers and drive forward vaccine coverage, especially in hard-to-reach settings1. It is anticipated to help to overcome common vaccine refrigeration requirements during storage and transportation and opens the door to vaccines that can be mailed to people’s homes and self-administered as easily as applying and removing a sticker to their wrist to address challenges with clinician shortages and needle phobia. “Novel viral threats unfortunately have an advantage over susceptible populations today, in part because conventional vaccines take too long to develop, are too hard to distribute and require too many resources to administer. Micron Biomedical’s goal is to change that by overcoming the most pressing barriers to vaccine and therapeutic access,” said Steven Damon, CEO of Micron Biomedical. “We are honored that CEPI has recognized Micron’s unique technology, and we are grateful to CEPI for their support of next-generation vaccine development.” The button-like technology has already been shown to induce seroprotection against seasonal flu and measles rubella in clinical trials published in The Lancet. Micron safely immunized infants as young as nine months old against measles and rubella, inducing immune responses similar to those generated by traditional injection. A separate clinical trial, also published in The Lancet, studied Micron’s technology combined with a trivalent seasonal flu vaccine both self-administered and administered by a clinician. The new CEPI award will now be used to study Micron’s microarray technology in combination with a Next-Generation vaccine platform technology developed by CastleVax that can be quickly adapted to protect against different pathogens in response to novel viral threats. This is the first time that Micron’s technology will be studied with a rapid-response vaccine platform. Using COVID-19 as a target pathogen, the research will compare how a vaccine administered using Micron’s technology performs in stability and preclinical studies as compared to administering the vaccine via muscular injection or nasal inhalation. Compared to conventional vaccine injections administered via the muscle, delivering the vaccine intradermally (into layers of the skin) is thought to enhance the immune response2. Once appropriate scientific milestones are met, researchers plan to initiate the first-ever study of the vaccine platform delivered to humans, without needles, as part of a Phase1 study. “Micron Biomedical’s button-like technology is a very promising innovation in vaccine delivery and could pave the way for quick, easy and equitable vaccination when responding to future infectious disease outbreaks,” says Dr Raafat Fahim, CEPI’s Executive Director of Vaccine Manufacturing and Supply Chain (Acting). “By combining their innovation with a rapid response vaccine platform, we are developing a technology that could be a gamechanger through protecting populations against epidemic or pandemic threats even in the most remote regions. This project adds one of the most advanced vaccine patch developers to the CEPI portfolio, as well as CastleVax’s new rapid response platform.” A commitment to equitable accessCEPI and Micron Biomedical are committed to enabling equitable access to the outputs of their partnership, in line with CEPI’s Equitable Access Policy. Project results, including related data, will be published open access for the benefit of the global scientific community. If the research is successful, CEPI also holds the right to fund follow-up projects with equitable access commitments. This could include investigating the potential of the vaccine patch to deliver other vaccine candidates prioritised by CEPI for use against existing and novel threats. Notes to Editors CastleVax’s rapid-response technology is based on Newcastle disease virus (NDV), a pathogen in the avian paramyxovirus family, that is harmless in humans. To date, their platform has been engineered to help create vaccines targeting COVID-19 variants and other viral pathogens, administered either inhaling the vaccine into the lungs or sprayed into the nose (the intranasal route) or injection into the muscle (intramuscular route).CastleVax’s COVID-19 vaccine has already been licensed for emergency use through administration via injection into the muscle in some countries (Mexico and Thailand). Phase IIb studies are also underway testing its performance when administered through the intranasal route About CEPI CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. About Micron BiomedicalMicron Biomedical is the leader in dissolvable microarray-based, drug and vaccine administration technology. Micron Biomedical is a clinical-stage life science company on a rapid path to commercializing its proprietary dissolvable, microarray technology. Micron’s technology is designed to improve access and achieve better health outcomes globally through injection-free, painless, and simple and/or self-administration of drugs and vaccines, and by eliminating or reducing the need for cold chain transport and storage, enhancing safety and efficacy, and improving patient compliance. Micron partners with and/or receives funding from private and public pharmaceutical and biotech companies, the Bill & Melinda Gates Foundation, the Centers for Disease Control and Prevention (CDC), PATH and the Georgia Research Alliance. For more information visit www.micronbiomedical.com Press Contacts: Micron Biomedical:CEPI:Shira DerasmoCEPI Communications TeamEmail: pr@micronbiomedical.comEmail: press@cepi.netPhone: +1-917-280-2497Phone: +44 7387 055214 _____________________ 1 Identified by The Vaccine Innovation Prioritisation Strategy (VIPS), a collaboration between Gavi, World Health Organization, Bill & Melinda Gates Foundation, UNICEF and PATH.2 https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC7564253/