CanSinoBIO's Convidecia Approved as Heterologous Booster in Malaysia and Indonesia

TIANJIN, China, March 22, 2022 /PRNewswire/ -- CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convidecia) has been approved by the Ministry of Health Malaysia ("MOH Malaysia") and the Indonesian National Agency of Drug and Food Control ("BPOM") as a heterologous booster.

The MOH Malaysia recommends using Convidecia as a heterologous booster for individuals aged 18 and above who have been administered two doses of inactivated COVID-19 vaccine at least three months prior. The approval was made as the Malaysian authorities continued to achieve high booster vaccination rates – especially among vulnerable groups such as the elderly and the immunocompromised – in the fight against the Omicron variant.

The BPOM recommends that adults who have received inactivated COVID-19 vaccines opt for either Convidecia or an mRNA vaccine as a booster.

In Malaysia, CanSinoBIO partnered with Solution Biologics Sdn Bhd ("SOLBIO") to carry out local formulation and distribution processes. The local fill-and-finish facility established by CanSinoBIO and SOLBIO received the Good Manufacturing Practices ("GMP") certification from the National Pharmaceutical Regulatory Agency ("NPRA") in February 2022. In Indonesia, Convidecia received emergency use authorization from the BPOM in September 2021.

In addition to Malaysia and Indonesia, Convidecia has been approved for use as a heterologous booster in China and Argentina in national vaccination programs in February 2022 and November 2021, respectively. It is also the first and only adenovirus-vectored vaccine to be included in the heterologous vaccination program in China.

Heterologous booster vaccination refers to the use of vaccine boosters from different technology platforms from the prime vaccines, which could improve the overall immune response and enhance protection against other variants. Recent studies[1] showed that using Convidecia as a heterologous booster, either through intramuscular injection or inhalation, generated greater neutralizing antibody responses than those induced by the homologous inactivated vaccine booster or heterologous recombinant protein vaccine booster.

According to a recent study by the Jiangsu Provincial Center for Disease Control and Prevention, for individuals who had been administered with two-dose inactivated vaccines, receiving a single dose of Convidecia as a heterologous booster could induce neutralizing antibody levels 5 times higher than a homologous booster of the inactivated vaccine. Administering Convidecia as a booster can also elicit a strong CD8+T cell response, which plays an important role in killing virus-infected cells, without any serious adverse events reported.

Another clinical trial conducted by China's CAS Key Laboratory of Pathogenic Microbiology and Immunology alongside other leading research teams in China, found that those who had used Convidecia as a heterologous booster 4 – 8 months after the administration of two doses of inactivated vaccines can generate neutralizing antibody levels against the Omicron variant 6 times that of those given a homologous inactivated vaccine booster.

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