Convidicea Vaccine (Ad5-nCoV) Description
Convidicea (Ad5-nCoV) is a novel recombinant viral vector vaccine for COVID-19 in China. The single-dose vaccine is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform.
The CanSino Biologics Convidicea is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express the SARS-CoV-2 coronavirus spike protein.
'We have used protein structure design technology to design pneumococcal protein antigens. We have also developed novel recombinant strains to produce a new generation pertussis vaccine. We also developed a proprietary cell line to be used for viral vector production,' says the company.
The new Ad5 vectored COVID-19 vaccine evaluated in the phase 1 trial is the first to be tested in humans. 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.
On February 25, 2021, the company announced the interim analysis data of the phase III clinical trial of Convidecia shows that the vaccine candidate has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination and 68.83% at preventing all symptomatic COVID-19 disease 14 days after single-dose vaccination.
And, Ad5-nCoV has an efficacy of 90.07% at preventing severe disease 28 days after single-dose vaccination and 95.47% at preventing severe disease 14 days after single-dose vaccination. The data is based on interim results from Phase-3 clinical trials enrolling more than 4,000 participants in Pakistan, Mexico, Russia, Chile, and Argentina, according to CanSino.
Convidecia is similar to other viral vector vaccines produced by AstraZeneca (AZD1222), Sputnick V (Gam-COVID-Vac), and Ad26.COV2.S.
CanSino Biologics Inc. (SHSE: 688185, HKEX: 06185) Convidicea (Ad5-nCoV) Drugbank Accession Number: DB15655.
Convidicea Vaccine (Ad5-nCoV) History
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 the Phase I trial in China on March 23, 2020.
On April 15, 2020, China began the second phase of clinical trials for a COVID-19 vaccine with 500 volunteer participants recruited from Wuhan. It was the first Phase 2 human test for a COVID-19 vaccine, reported Xinhua News.
On May 16, 2020, Health Canada approved human clinical trials for a possible coronavirus vaccine.
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. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.
On June 29, 2020, media sources reported China's military had received the 'green-light' to use a COVID-19 vaccine candidate developed by its research unit and CanSino Biologics. After clinical trials proved, it was safe and somewhat efficient.'
On July 20, 2020, a study published in The Lancet reported the Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles are safe and induced significant immune responses in the majority of recipients after a single immunization during a phase 2 study. The primary endpoints for immunogenicity were the geometric mean titers of specific ELISA antibody responses to the receptor-binding domain and neutralizing antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses.
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.
SCMP reported on September 2, 2020, “The company is currently driving the international multi-center phase three clinical trial for Ad5-nCoV and plans to conduct the clinical trial for Ad5-nCoV in several countries,” it said in the statement. In addition, it plans to recruit 40,000 volunteers in countries including Russia, Saudi Arabia, Pakistan, and Mexico.
On September 21, 2020, Petrovax announced it would produce more than 4 million vaccine doses per month in 2020 at its Moscow Region facilities. Vaccine production can be increased to 10 million doses per month in 2021 due to the planned production capacity expansion. Petrovax will have exclusive rights to supply it in Russia and the CIS countries as a Russian vaccine manufacturer.
Dr. Xuefeng Yu, Chairman and CEO of CanSinoBIO, stated in a press release issued on November 7, 2020: “Launching the clinical study of Ad5-nCoV in Mexico, represents another milestone of CanSinoBIO. We are delighted to collaborate with EPIC and the authorities that make this initial clinical study possible in Mexico. Hopefully, we could see the outcome of the study very soon and contributes to the pandemic fight in Mexico.”
Production capacity for the Convidicea (Ad5-nCov) could reach 500 million doses in 2021.
Tianjin China-based CanSino Biologics Inc. is an innovative biopharmaceutical company 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. CanSino Biologics was established in Tianjin, China, in 2009. Inclusive of the COVID-19 vaccine, they are developing several vaccines, including 13 for infectious diseases.
Convidicea Vaccine (Ad5-nCoV) Indication
The Ad5-nCoV vaccine is indicated to prevent COVID-19 disease caused by SARS-CoV-2 coronavirus.
Convidicea Vaccine (Ad5-nCoV) Dosage
The phase 3 clinical study did a dose-escalation, single-center, open-label, non-randomized, phase 1 trial Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 1010, 1 × 1011, and 1·5 × 1011 viral particles) to receive a single intramuscular injection of vaccine.
Convidecia™ can be stored and transported between 2°C and 8°C, making it more accessible, especially to underserved public health regions.
On September 17, 2020, CanSino began a Phase I trial in China with 144 adults to determine the safety and immunogenicity of the vaccine to be administered as a nasal spray.
Convidicea Vaccine Price
TV media reported Pakistan-based Medical Director of Shifa International Hospital, Dr. Zeeshan Bin Ishtiaque confirmed that they had started inoculations with Convidecia, whose maximum retail price was Rs4,250 (the US $58).
Convidicea Vaccine (Ad5-nCoV) News
September 9, 2021 - Local media reported Solution Biologics had secured a contract from the Malaysian government to supply some 3.5 million doses of the single-dose COVID-19 vaccine developed by CanSino comprising half a million doses of finished product from its plant in Tianjin, China, and the remainder delivered in bulk to be filled and finished in Malaysia. In addition, approval has been given by the National Pharmaceutical Regulatory Agency for the Convidecia Recombinant Novel Coronavirus Vaccine.
September 8, 2021 - The Indonesian Drug and Food Monitoring Agency authorized the emergency use of the US-made Janssen and China-manufactured Convidecia COVID-19 vaccines in Indonesia.
August 30, 2021 - CanSino vaccines will step up vaccination in six states that have yet to vaccinate 50% of the adult Malaysian population.
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 at 28 days after first intramuscular injection induced strong IgG and neutralizing antibody responses. The efficacy and cost-effectiveness of aerosol vaccination should be evaluated in future studies.
June 28, 2021 - The Collegiate Board of the National Health Surveillance Agency in Brazil decided unanimously to close the process that dealt with the temporary authorization of emergency use, on an experimental basis, of the Convidecia vaccine (Ad5-nCoV Vaccine CanSino).
May 24, 2021 - CanSino Biologics Inc. announced that its Convidecia™ had been granted a Good Manufacturing Practice certificate by the Hungarian National Institute of Pharmacy and Nutrition.
May 21, 2021 - CanSino Biologics Inc. announced that its Recombinant Novel Coronavirus Vaccine, Convidecia, issued a Good Manufacturing Practice certificate by the Hungarian National Institute of Pharmacy and Nutrition.
May 7, 2021 - Local media reported Pakistan's Federal Planning Minister Asad Umar stated the Cansino vaccine would be available by the end of May 2021.
April 27, 2021 - CanSino Biologics is expected to increase the annual production capacity of its single-dose, recombinant adenovirus vector COVID-19 vaccine to 200 to 300 million doses after its third plant comes into full operation.
April 14, 2021 - A financial filing to the Hong Kong stock exchange said no serious adverse events related to blood clots had been reported among the almost 1 million doses of its Covid-19 vaccine that had been administered to date.
April 8, 2021 - CanSino Biologics Inc. announced that the Instituto de Salud Pública de Chile granted emergency use authorization for its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", Convidecia™). This marks the first approval of Convidecia in South America and the first single-dose COVID-19 vaccine approved for emergency use in Chile.
April 2, 2021 - Solution Biologics Sdn Bhd has entered into a supply agreement with the Malaysian government to supply 3.5 million doses of the Convidicea recombinant novel coronavirus vaccine.
March 22, 2021 - CanSinoBIO Biologics Inc. announced that the Hungarian National Institute of Pharmacy and Nutrition granted emergency use authorization for its Recombinant Novel Coronavirus Vaccine Convidecia™. The approval is based on the vaccine's interim results for Phase III clinical trial and marks the first approval of Convidecia™ in a European Union member state. Globally, Convidecia received authorization for emergency use by the Federal Commission for Protection against Sanitary Risks of Mexico and the Drug Regulatory Authority of Pakistan for adults aged 18 and above in February 2021.
March 22, 2021 - The National Medical Products Administration of China approved CanSinoBIO's clinical trial application for an inhaled version of the COVID-19 vaccine. The safety and efficacy of the inhaled vaccine remain "subject to confirmation," the firm said.
February 28, 2021 - China's single-dose COVID-19 vaccine began its roll-out.
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 24, 2021 - CanSino Biologics Inc. announced today that it had filed an application with National Medical Products Administration (NMPA) for conditional marketing authorization of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (“Ad5-nCoV”, trade name: Convidecia™). The NMPA has accepted the application.
February 13, 2021 - Pakistan's Drug Regulatory Authority approved the emergency use of Convidicea (Ad5-nCoV) on the recommendations of an experts committee. Pakistan is the second country after Mexico to approve the vaccine.
February 8, 2021 - Social Media reported CanSino Biologics Inc’s Convidicea COVID-19 vaccine candidate presented 65.7% efficacy in preventing symptomatic cases and a 90.98% success rate in stopping the severe disease an interim analysis of global trials conducted in Pakistan.
February 4, 2021 - CanSino, the vaccine being tested in southern Chile, is almost ready for international authorization. More than 3,500 volunteers have been inoculated with the experimental vaccine, waiting for volunteers' enrollment to conclude at the end of March. For analysis of the trials, the plan was to wait for 150 cases of Covid to be found in the world within a year, but the figure was reached earlier than previously thought. If the vaccine is approved in Chile, it will be the central laboratory in Canada that will finally decide whether it is marketable or not.
December 15, 2020 - CanSino, the Chinese vaccine nobody talks about, begins testing in southern Chile this Wednesday. In Chile, in addition to Sinovac, which has more than one hundred vaccinated volunteers in the country, CanSino Biologics began its tests in Santiago two weeks ago and began its tests this Wednesday in the south, in conjunction with the Universidad de la Frontera (UFRO), seeking to enroll people from Talcahuano, Valdivia, Osorno, Temuco, and Puerto Montt. The vaccine, developed by CanSino, the Beijing Institute of Biotechnology, and the Academy of Military Medical Sciences, is a viral vector vaccine similar to Gamaleya's AstraZeneca and Gam-COVID-Vac developed in Russia.
December 6, 2020 - The Health Ministry has allowed Russia's participation in the massive international multi-center randomized placebo-controlled third phase of clinical trials of the candidate coronavirus vaccine's efficacy and immunogenicity Ad5-nCov made by CanSino Biologics. The international trials are conducted in partnership with Petrovax," the company said.
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. The trial aims to recruit a total number of 15,000 subjects to demonstrate the candidate's efficacy further. Previously, CanSinoBIO signed an advance purchase agreement with Mexico’s government to supply 35 million doses of the COVID-19 vaccine candidate. Dr. Xuefeng Yu, CEO of CanSinoBIO, stated, “Launching the clinical study of Ad5-nCoV in Mexico, represents another milestone of CanSinoBIO. We are delighted to collaborate with EPIC and the authorities that make this initial clinical study possible in Mexico. Hopefully, we could see the outcome of the study very soon and contributes to the pandemic fight in Mexico.”
October 15, 2020 - CanSino Biologics Inc. announced that it had signed an advance purchase agreement with the Mexican government, which aims to provide Mexico with 35 million doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV"). According to the agreement, CanSinoBIO will supply 35 million doses of the COVID-19 vaccine to Mexico from 2020 to 2021.
October 2, 2020 - SOLBIO has signed a deal with China-based CanSino Biologics to distribute the Ad5-nCoV vaccine candidate targeting COVID-19 in Malaysia.
September 21, 2020 - The Petrovax company, CanSino Biologics Inc. The contract research organization OCT Clinical has launched its first volunteers at Moscow medical centers. According to clinical regulations, study participants will be under direct supervision for the first 28 days after vaccination. After that, they will have to undergo four interim face-to-face examinations at treatment centers.
September 10, 2020 - China media reported CanSino's Chief Scientific Officer Zhu Tao stressed the safety of a recombinant adenovirus vector vaccine the company developed after a trial on another vaccine using a similar mechanism was suspended AstraZeneca and Oxford University after a volunteer became ill during the trial. One difference is that Ad5-nCoV uses an adenovirus that exists in human bodies, while the AstraZeneca vaccine candidate uses chimpanzee adenovirus. No severe adverse effects from Ad5-nCoV have been discovered so far, Zhu noted.
September 2, 2020 - CanSino Biologics announced that it had initiated phase 3 clinical trials for its Ad5-nCoV vaccine candidate in Russia after receiving approval from Moscow's health ministry.
August 27, 2020 - The National Research Council of Canada announced a COVID-19 vaccine-development partnership between China’s CanSino Biologics and Dalhousie University in Nova Scotia had been abandoned.
August 17, 2020 - Russia’s Petrovax has started a late-stage clinical trial of a COVID-19 candidate vaccine from CanSino Biologics. Inc.
August 9, 2020 - Saudi Arabia announced that it would begin a Phase 3 clinical trial on around 5,000 people.
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 induced significant immune responses in the majority of recipients after a single immunization.
July 11, 2020 - Chinese vaccine developer CanSino Biologics announced its talks with Russia, Brazil, Chile, and Saudi Arabia to launch a Phase III trial of its experimental COVID-19 vaccine.
June 29, 2020 - China's military has received permission to use a COVID-19 vaccine candidate, Ad5-nCoV, developed by its research unit and CanSino Biologics after clinical trials proved it was safe and somewhat efficient.
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. "These results represent an important milestone. The trial demonstrates that a single dose of the new adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine produces virus-specific antibodies and T cells in 14 days, making it a potential candidate for further investigation", says Professor Wei Chen from the Beijing Institute of Biotechnology in Beijing, China.
On May 16, 2020, Health Canada approved human clinical trials for a possible coronavirus vaccine. Prime Minister Justin Trudeau says the first Canadian clinical trials will be conducted out of the Canadian Centre for Vaccinology at Dalhousie University.
May 12, 2020 - The National Research Council of Canada announced a collaboration with CanSino Biologics Inc. to advance bioprocessing and clinical development in Canada of a candidate vaccine against COVID-19 disease, which is caused by SARS-CoV-2 coronavirus.
April 9, 2020 - CanSino Biologics Inc. Chairman Xuefeng Yu filed a public statement which says 'Based on the preliminary safety data of phase I clinical trial for the Recombinant Novel Coronavirus Disease Vaccine (Adenovirus Type 5 Vector) (the “Ad5-nCoV”), the Company and the Institute of Biotechnology, Academy of Military Medical Sciences plan to initiate phase II clinical trial for Ad5-nCoV in China.
March 17, 2020 - CanSinoBIO’s Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China. “Thanks to our collaborators and our diligent team, who worked almost around the clock since late January to develop this vaccine candidate with sound scientific data to support IND filing,” said Xuefeng Yu, Chairman and CEO of CanSinoBIO, “Having committed to providing unconditional support to fight against the global pandemic, CanSinoBIO is determined to launch our vaccine product candidate as soon as possible with no compromise on quality and safety.”
Convidicea Vaccine Clinical Trials
Convidicea vaccine candidate continues to be tested in several clinical trials. In addition, a Phase 4 clinical trial was announced on May 19, 2021.