CanSinoBIO's Convidecia™ Approved as Heterologous Booster in Malaysia and Indonesia
TIANJIN,China,March 22,2022 --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.
About CanSinoBIO
Incorporated in 2009,CanSinoBIO (SSE: 688185,HKEX: 06185) commits to research,production and commercialization of innovative vaccines for China and global public health security. It possesses five integrated platform technologies including viral vector-based technology,synthetic vaccine technology,protein structure design and recombinant technology,mRNA technology,as well as formulation and delivery technology. As of today,it has established a robust pipeline of 17 vaccines preventing 12 diseases,including the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) conditionally approved in 2021,the Group A and Group C Meningococcal Conjugate Vaccine (CRM197) and the Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) approved in the same year. Additional information can be found online at www.cansinotech.com
[1] Source: https://www.medrxiv.org/content/10.1101/2022.03.08.22271816v1
