The SINOVAC inactivated hepatitis A vaccine, Haliflex ®, was approved in Egypt

SINOVAC has announced that its inactivated hepatitis A vaccine, Halifrol ®, has been approved by the Egyptian Drug Authority (EDA) for hepatitis A prophylaxis in children and adults.

Up to now, Halife ® has been approved in 24 countries around the world, exported to more than 30 countries and used more than 100 million times. As the only hepatitis A vaccine in China that has been pre-certified by the World Health Organization, the approval of Halifu ® will further meet the local demand for high-quality vaccine products in Egypt, and better help local hepatitis A prevention and control.

Hepatitis A is a common infectious disease worldwide. The pathogen hepatitis A virus is mainly transmitted through fecal-oral transmission. Once ingested food or drink contaminated with the virus, it may cause morbidity and harm to health. With the popularization and use of hepatitis A vaccine, the incidence of hepatitis A has decreased, but there are still some regions and countries with high prevalence of hepatitis A, and there are also local outbreaks of hepatitis A in medium-low prevalence areas.

Figures show that about 8-10 million people in Egypt have been infected with viral hepatitis. Between 2014 and 2017, 93.4% of the cases in Egypt were Acute viral hepatitis (AVH). Although the number of cases of hepatitis A infection decreased from 7806 to 818 in Egypt during this period, the proportion of hepatitis A to AVH increased to 96%, and the majority (81.8%) of hepatitis infections occurred in persons under 16 years of age.

Hepatitis A vaccine is the most effective and economical means to improve the specific immunity of the population, establish an effective immune barrier, and prevent and control hepatitis A.

SINOVAC hepatitis A vaccine, Haliflex ®, was marketed in China in 2002 with the approval of drug registration, and was precertified by the World Health Organization in 2017. It is the only domestic hepatitis A vaccine that has been precertified by the World Health Organization. From the published data:

Haliflex ® has good safety and low incidence of adverse reactions. It can produce an immune response one week after immunization and is effective quickly. Serum protection remained 100% after 11 years of two doses of Halifolium ®, and the model estimated that Halifolium ® provided protection for up to 30 years.

In the WHO position Paper on hepatitis A vaccine (2022 edition), countries are recommended to vaccinate people aged 12 months or older in their national immunization programmes based on their hepatitis A epidemic, changes in prevalence, cost-effectiveness and other factors. At present, dozens of countries and regions around the world have included hepatitis A vaccine in the immunization program.

Over the past 20 years, there has been abundant clinical evidence of safety and immunogenicity of Halife ®, and 44 clinical trials and studies have been carried out successively since its launch. A total of 67 papers have been published in both Chinese and English, covering such contents as antibody response speed, immunogenicity comparison with imported inactivated/attenuated live vaccines, effect of exchange vaccination, immune persistence, enhanced immune effect, emergency/mass vaccination, safety, etc. In addition, SINOVAC is conducting phase III clinical trials of Halifol ® in collaboration with institutions in South Korea and India to provide protection to more children.

SINOVAC is in Egypt

Egypt is one of SINOVAC's important international markets. In April 2021, SINOVAC's inactivated vaccine Kellifol ® was approved for emergency use in Egypt. In the same month, SINOVAC signed an agreement with VACSERA, Egypt's state-owned vaccine manufacturer, to produce COVID-19 vaccines in Egypt, making Egypt the first country in Africa to localize the production of Chinese vaccines, effectively filling the local vaccine gap and helping people in Egypt and the African continent have access to high-quality and affordable vaccine products.

In September 2022, SINOVAC automated vaccine cold storage was completed in Egypt. The automated vaccine cold storage is the largest vaccine storage center in Egypt and even Africa, which can greatly improve the cold chain storage and transportation capacity of vaccines in Egypt and improve the vaccine supply chain in Africa. On the same day, the Chinese government provided 10 million doses of Kellifr ® to Egyptian women, children and adolescents through the African First Ladies Development Association, becoming the first batch of vaccines to be stored and shipped after the completion of the cold storage.

Chinese State Councilor Wang Yi said at the "Cloud Witness" ceremony of the China-Egypt COVID-19 vaccine production project, which achieved 1 million doses, that the solidarity between the two countries in the fight against COVID-19 after the outbreak has become a new highlight in bilateral relations.