#AseBioInterview | This has been the development process of the first vaccine against Epizootic Hemorrhagic Disease by the Zendal group

The biotechnology group Zendal has launched the first vaccine to prevent the virus of Epizootic Hemorrhagic Disease, serotype 8, onto the market. This step comes after receiving temporary authorization for use (granted to CZ Vaccines of the Zendal group) from the Spanish Agency of Medicines and Medical Devices (AEMPS, by its initials in Spanish), allowing its use in cattle.

Epizootic Hemorrhagic Disease (EHD) is a non-contagious infectious viral disease transmitted by vectors (Culicoides spp.), affecting domestic and wild ruminants. According to information collected by the Ministry of Agriculture, Fisheries, and Food, no cases had been detected in Europe until November 10, 2022, in Italy. Barely a week later, the first cases were identified in Spain. This ministry has classified the situation in Spain regarding this disease as a "health emergency."

In recent months, the Zendal group has been working intensively to develop this vaccine aimed at protecting our country's livestock. To learn more about how this process has been developed and the implications this vaccine may have, we interviewed Beatriz Díaz Lorenzo, Communications & Corporate Brand Director of the Zendal group.

AseBio. What is Epizootic Hemorrhagic Disease? What kinds of animals does it affect?

Beatriz Díaz. It is a non-contagious infectious viral disease transmitted by vectors (Culicoides spp.), affecting domestic and wild ruminants. In cattle, while it usually causes moderate and self-limiting clinical symptoms, in some cases it can lead to more severe conditions, potentially causing sequelae and, to a lesser extent, death.

AseBio. The Ministry of Agriculture, Fisheries, and Food has classified the situation of Epizootic Hemorrhagic Disease in Spain as a "health emergency." Why?

Beatriz Díaz. Over the last decade, significant changes have occurred both in the disease pattern, with increasing and alarming severity in cattle, and in its geographical distribution, with outbreaks appearing in the Mediterranean basin in previously disease-free areas. Currently, the outbreak of EHDV serotype 8 is generating great alarm due to its epidemic potential and the absence of a vaccine to date. The goal was to develop an inactivated vaccine against Epizootic Hemorrhagic Disease to address a situation that is causing great concern in the livestock sector.

AseBio. The Zendal group has launched the first vaccine to prevent the virus of Epizootic Hemorrhagic Disease. How was the development process?

Beatriz Díaz. The technical and scientific team at Zendal has been working intensively over the past months to develop a vaccine that could prevent this disease affecting our country's livestock. We have achieved this inactivated virus vaccine thanks to the responsiveness and collaboration of AEMPS, the Ministry of Agriculture, and the reference laboratory in Algete.

AseBio. What have been the results of the vaccine in terms of disease prevention?

Beatriz Díaz. We have obtained temporary authorization for the use of this inactivated virus vaccine, which will be administered subcutaneously in two doses with a three-week interval in cattle.

AseBio. This vaccine specifically targets serotype 8. Why this serotype? How many serotypes have been identified?

Beatriz Díaz. EHDV serotype 8 was first diagnosed in southwestern Spain in November 2022. Subsequently, the disease spread throughout the national territory, excluding the island territories of the Balearic and Canary Islands. To date, it is the only serotype present in Europe.

AseBio. The temporary authorization for the use of this vaccine has been granted by AEMPS, whose collaboration has been indispensable. How have they collaborated?

Beatriz Díaz. AEMPS has been responsive to the concerns and needs of livestock and veterinarians, expediting the vaccine's authorization as much as possible without compromising the essential requirements to ensure its quality, safety, and efficacy. The Central Veterinary Laboratory in Algete, part of MAPA, has also been consistently cooperative.

AseBio. When will the vaccine start being used?

Beatriz Díaz. We are prioritizing the production of the vaccine so that it will be available on the market this summer.

AseBio. The animal health area of the Zendal group has significant experience in developing vaccines for animal health. What other milestones have you achieved?

Beatriz Díaz. Our animal health area has over 30 years of experience in developing and manufacturing vaccines for animal health, with notable achievements in our portfolio such as vaccines for Paratuberculosis in cattle, sheep, and goats; vaccines against Brucellosis in ruminants; and bacterial vaccines against E. coli in swine. These projects are complemented by the Bluevac range of vaccines against another viral disease—Bluetongue, targeting various serotypes of the virus. Like the new vaccine against EHD, we developed Bluevac in record time, supplying over 100 million doses of Bluetongue vaccine in Europe in 2008.

AseBio. What other projects are you working on?

Beatriz Díaz. In the animal health area of the Zendal group, we have several ongoing projects for medicines for both production and companion animals.

In the human health area, among other projects, we are continuing to advance our human tuberculosis vaccine. MTBVAC is a scientifically pioneering vaccine constructed through genetic engineering, thanks to the talent and scientific initiative of Professor Carlos Martín from the University of Zaragoza, and developed and manufactured by Biofabri, part of the Zendal group.

This is a live attenuated vaccine and, due to its high immunogenic capacity, does not require an adjuvant. It is currently being studied in two parallel indications: neonates and children, as well as adolescents and adults. It is in phase 3 clinical trials in infants (South Africa) and phase 2 clinical trials in adults and adolescents in India.