CanSinoBio Convidecia™ COVID-19 Vaccine

CanSinoBio Biologics Inc. Convidecia™ (Ad5-nCoV) is a novel recombinant viral vector vaccine for COVID-19 produced in China. The single-dose vaccine was developed on CanSinoBIO's adenovirus-based viral vector vaccine technology platform and the Beijing Institute of Biotechnology. Convidecia is a genetically engineered vaccine with the replication-defective adenovirus type 5 vector to express the SARS-CoV-2 coronavirus spike protein. In addition, the Company used protein structure design technology to design pneumococcal protein antigens. And it has developed a proprietary cell line for viral vector production. It uses a weakened common cold virus (adenovirus, which infects human cells readily but is incapable of causing disease) to deliver genetic material that codes for the SARS-CoV-2 spike protein to the cells. These cells then produce the spike protein and travel to the lymph nodes, where the immune system creates antibodies that will recognize that spike protein and fight off the coronavirus.

In early 2020, a joint team of the Institute of Biotechnology, the Academy of Military Medical Sciences, and CanSino Biologics began developing the AD5-nCOV vaccine candidate. According to China Daily, the team registered the experimental COVID-19 vaccine for a phase I clinical trial in China on March 23, 2020. On May 22, 2020, the Ad5 vectored COVID-19 vaccine was reported in a study to be tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid, specific T-cell responses were noted from day 14 post-vaccination. According to the National Intellectual Property Administration, on August 11, 2020, China granted its first COVID-19 vaccine patent. The patent was submitted for application on March 18, 2020.

The Lancet published an analysis of a phase 3 study on December 23, 2021, that showed a single dose of Convidecia is efficacious and safe, with an efficacy of 96% in preventing severe COVID-19 disease and an overall efficacy of 63.7% 14 days post-vaccination for healthy adults aged 18 and above, without any reported vaccine-related serious adverse events. In addition, against severe infection with the virus, the vaccine's effectiveness increased to 91.7% effective. The Company announced on January 11, 2022, a phase 1/2 study published on January 4, 2022, showed that boosting the inactivated vaccine with the Inhalation Convidecia™stimulates a strong mucosal immune response. In addition, the level of RBD-specific IgA-binding antibody was detected in the subjects' serum 14 days after vaccination.

CanSinoBio announced on March 13, 2022, a non-peer-reviewed phase 4 study's results showed that administering Convidecia as a heterologous booster can induce a stronger immune response than the recombinant protein and inactivated vaccines, stimulating greater humoral and cellular immune responses regardless of the delivery route. Additionally, the inhaled version of Convidecia provided a more effective and efficient alternative for the booster vaccination program. It can also induce mucosal immunity to achieve triple protection with just one-fifth of the dosage of an injectable version of Convidecia.

On May 19, 2022, the World Health Organization (WHO) issued an emergency use listing (EUL) for Convidecia and published   Interim recommendations for the use of the Cansino Ad5-nCoV-S vaccine (Convidecia®) against COVID-19. On June 10, 2022, the WHO published The CanSino Biologics Ad5-nCoV-S COVID-19 vaccine: What you need to know. On May 30, 2022, The Lancet published a study that found that a heterologous booster vaccine with an orally administered aerosolized Ad5-nCoV is safe and highly immunogenic in adults who have previously received two doses of CoronaVac as the primary series vaccination. As of December 2023, Convidecia is one of the 12 COVID-19 vaccines granted an EUL by the WHO.

Convidecia (Ad5-nCoV) Drugbank Accession Number: DB15655. Ad5-nCoV clinical trial listing.

Tianjin, China-based CanSino Biologics Inc. is an innovative biopharmaceutical company (SHSE: 688185, HKEX: 06185) established in 2009 and dedicated to exploring the best solutions to preventing diseases through cutting-edge research & development, advanced manufacturing, and commercialization of innovative vaccine products for human use worldwide. Inclusive of the COVID-19 vaccine, they are developing several vaccines, including 13 for infectious diseases. In addition, CanSinoBio announced its new brand identity on April 24, 2022, which is intended to represent the Company's continuous dedication to life sciences research and its commitment to protecting the global population with innovative, high-quality, and accessible vaccines and empowering people to lead a healthy and better life.

Headquarters: 401-420, 4th Floor, Biomedical Park, 185 South Avenue, TEDA West District, Tianjin, PRC.

Convidecia Air™ Inhaled Vaccine

Convidecia Air provides a non-invasive option using a nebulizer to change liquid into an aerosol inhalation through the mouth. Convidecia Air is needle-free and can effectively induce comprehensive immune protection in response to SARS-CoV-2 after just one breath. This route mimics the natural infection pathway of the respiratory virus COVID-19 and may create additional benefits by generating mucosal immunity. Compared to intramuscular vaccines, which usually require low-temperature storage and trained health personnel to administer them, inhalable vaccines can be administered through disposable devices, with minimal storage requirements for mass vaccination.

Convidecia Air™ was approved by China's medical products regulator as a booster dose on September 4, 2022. The city of Shanghai started administering the inhalable COVID-19 vaccine on October 26, 2022. Reuters reported on November 10, 2022, that Convidecia Air was available in Tianjin City and Shanghai, and 13 cities introduced the vaccine as a booster. China Central Television reported on November 18, 2022, that Chinese health authorities approved Convidecia Air as an emergency-use booster. On December 27, 2022, CanSino Biologics Inc. announced that the first Convidecia Air™ arrived in Morocco. With this shipment, Morocco became the first overseas country to offer Convidecia Air as booster doses. On March 1, 2023, CanSino Biologics announced that Indonesia Badan Pengawas Obat dan Makanan granted the Company Emergency Use Approval for its Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation Convidecia Air® as a heterologous booster. On December 9, 2021, Aerogen® (Galway, Ireland) and CanSinoBIO announced a development and commercial supply partnership for the inhaled delivery of CanSinoBIO's Convidecia Air utilizing Aerogen's proprietary vibrating mesh aerosol drug delivery technology.

CanSinoBio mRNA Vaccine (CS-2034)

CanSino Biologics Inc. announced on April 4, 2022, pre-clinical trial results showed that CanSinoBIO's COVID-19 mRNA vaccine-induced high-titer neutralizing antibody levels against multiple SARS-CoV-2 variants of concern (VoC), including the Omicron variant. Additionally, results showed that the CanSinoBio mRNA vaccine could induce neutralizing antibodies with greater cross-reactivity against global VOCs and provide stronger protection against infections caused by the circulating variants than the original strain-based COVID-19 vaccines. The latest results announced on April 10, 2023, show that during the epidemic of Omicron BA.5.2 and BF.7 mutant strains, CanSino Biologics mRNA COVID-19 vaccine showed good safety and immunogenicity, and the incidence and severity of adverse reactions were lower than those currently on the market For the mRNA vaccine, the antibody level against the currently popular Omicron BA.5 variant strain can reach its peak seven days after vaccination, which is 29 times the homologous enhancement of the inactivated vaccine.

CanSino Convidecia Dosage

The WHO's SAGE recommends using the vaccine as a single (0.5ml) dose in all age groups 18 and above.

CanSino Convidecia Storage

Convidecia can be stored and transported between 2°C and 8°C, making it more accessible, especially to underserved public health regions.

CanSino Availability

As of April 2023, CanSino vaccines were available in about ten countries and as a heterologous booster.

CanSino Convidecia Price

TV media reported that the Pakistan-based Dr. Zeeshan Bin Ishtiaque confirmed that they had started inoculations with Convidecia, whose maximum retail price was Rs4,250 (US $58).

CanSino Convidecia News 2020 - 2023

April 7, 2023 - Ad5-nCoV vaccination can clear the virus carried by long-term asymptomatic infection.

April 4, 2023 - The Company announced: "The probability of people being infected with XBB after being infected with BA.5 is still high, and vaccine intervention still needs to be considered to maintain the population's high immunity to new crown infection."

November 22, 2022 - Local media reported the inhaled vaccine was offered in Beijing.

October 25, 2022 - CanSino Biologics Inc. announced that its Recombinant COVID-19 Vaccine for Inhalation (Convidecia Air™) had been approved by the Joint Prevention and Control Mechanism of the State Council of China for inclusion in Shanghai's booster vaccination program starting from October 26, 2022, marking the start of the rollout of the world's first inhaled COVID-19 vaccine.

July 28, 2022 - A non-peer-reviewed study - Antibody Persistence and Safety through 6 Months after Heterologous Orally Aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously. Conclusions: These data suggested that heterologous aerosolized Ad5-nCoV following two-dose CoronaVac priming was safe and persistently more immunogenic than three-dose CoronaVac, although immune responses waned over time.

May 19, 2022 - The WHO added the CanSino Biologics vaccine to its portfolio of vaccines validated for preventing COVID-19.

March 13, 2022 - CanSino Biologics Inc. announced results from an academic paper on the efficacy of a Convidecia single dose heterologous booster against the Omicron virus variant generated greater neutralizing antibody responses than those induced by the homologous inactivated vaccine booster or heterologous recombinant protein vaccine booster.

February 8, 2022 - A non-peer-reviewed study compared primary outcomes in 260 hospitalized vaccinated vs. 507. unvaccinated adults with COVID-19 (mid-2021). The vaccinated group was much older, required less critical care, had lower hospital mortality (adjusted by age), and had shorter hospitalization than the unvaccinated. Benefits were most pronounced in those older than 59 years.

January 11, 2022 - CanSino Biologics Inc. announced that Preprints with The Lancet published a clinical study on the safety and immunogenicity of CanSinoBIO's Recombinant COVID-19 Vaccine（Adenovirus Type 5 Vector）for Inhalation Convidecia™as a heterologous booster. The results of a phase 1/2 study indicated a heterologous booster with one dose of the Inhalation Convidecia™ for adults aged 18 years and above who have received two doses of inactivated COVID-19 vaccine can induce a higher level of neutralizing antibodies than those with a homogeneous booster of inactivated vaccine.

December 24, 2021 - CanSino Biologics Inc. announced that the journal The Lancet published its Phase III clinical trial results on the safety and efficacy of its Convidecia™ vaccine. The publication of the analysis showed that a single dose of Convidecia is efficacious and safe, with an efficacy of 96% in preventing severe COVID-19 disease and displayed an overall efficacy of 63.7% 14 days post-vaccination for healthy adults aged 18 and above, without any reported vaccine-related serious adverse events.

September 21, 2021 - Malaysia media reported SGB's statement indicating data from a recent Chinese clinical study showed that a booster shot with the Convidecia vaccine, following a two-dose inactivated vaccine, is effective in producing an immune response to the Covid-19 virus. "The study by the Jiangsu Centre of Disease Control revealed that the Convidecia booster shot demonstrated an increase of at least 78-fold in average neutralizing antibody levels, compared to a booster shot with the same inactivated vaccine showing a 15.2-fold increase in antibody levels," it said.

July 26, 2021 - The Lancet published a study: Safety, tolerability, and immunogenicity of an aerosolized adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomized phase 1 clinical trial. Interpretation - Aerosolised Ad5-nCoV is well tolerated, and two doses of aerosolized Ad5-nCoV elicited neutralizing antibody responses, similar to one dose of intramuscular injection. An aerosolized booster vaccination 28 days after the first intramuscular injection induced strong IgG and neutralizing antibody responses. The efficacy and cost-effectiveness of aerosol vaccination should be evaluated in future studies.

March 22, 2021 - The National Medical Products Administration of China approved CanSinoBIO's clinical trial application for an inhaled COVID-19 vaccine.

February 28, 2021 - China's single-dose COVID-19 vaccine began its rollout.

February 25, 2021 - CanSino Biologics Inc. announced that the National Medical Products Administration of China had granted conditional marketing authorization for its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convidecia™), making it the first of its kind authorized in China.

February 13, 2021 - Pakistan's Drug Regulatory Authority approved the emergency use of Convidicea (Ad5-nCoV) on the recommendations of an expert committee. Pakistan is the second country, following Mexico, to approve the vaccine.

November 7, 2020 - CanSinoBIO announced it had initiated the Phase III clinical trial for a recombinant COVID-19 vaccine (Ad5-nCoV) developed in Mexico. The Mexican authority approved the study in October 2020.

July 20, 2020 - The Lancet published 'Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomized, double-blind, placebo-controlled, phase 2 trial. The Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles is safe and induces significant immune responses in most recipients after a single immunization.

June 25, 2020 - China's Central Military Commission approved the use of the vaccine by the military for 1-year.

May 22, 2020 - The first human trial of a COVID-19 vaccine finds it is safe and induces a rapid immune response.

March 17, 2020 - CanSinoBIO's Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China.

CanSino Convidicea Vaccine Clinical Trials

CanSino Convidicea vaccine continues to be tested in several clinical trials.

CanSinoBIO approved its clinical trial application for Convidecia Air™ in March 2021. Studies published in The Lancet indicated that Convidecia Air™ could induce strong humoral, cellular, and mucosal immunity to achieve triple protection and effectively contain the infection and spread of the virus. 

On July 26, 2022, a study - Safety, tolerability, and immunogenicity of an aerosolized adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomized phase 1 clinical trial - Interpretation: Aerosolised Ad5-nCoV is well tolerated, and two doses of aerosolized Ad5-nCoV elicited neutralizing antibody responses, similar to one dose of intramuscular injection. An aerosolized booster vaccination 28 days after the first intramuscular injection induced strong IgG and neutralizing antibody responses. The efficacy and cost-effectiveness of aerosol vaccination should be evaluated in future studies.

On January 4, 2022, a phase 1/2 study found that a heterologous boost immunization with an aerosolized Ad5-nCoV is safe and highly immunogenic in adults receiving two-dose inactivated COVID-19 vaccine CoronaVac as the primary series vaccination.

A study published results in May 2022 Findings Between Sept 14 and 16, 2021, 420 participants were enrolled: 140 (33%) participants per group. Adverse reactions were reported by 26 (19%) participants in the low dlow-dosep and 33 (24%) in the high-dose group within 14 days after the booster vaccination, significantly less than the 54 (39%) participants in the CoronaVac group (p<0·0001). The low-dose group had a serum NAb GMT of 744·4 (95% CI 520·1–1065·6), and the high-dose group had a GMT of 714·1 (479·4–1063·7) 14 days after booster dose, significantly higher than the GMT in the CoronaVac group (78·5 [60·5–101·7]; p<0·0001).