Convidecia

Last updated
AD5-nCOV
Convidecia logo.png
Convidecia vial.jpg
A vial of Convidecia vaccine
Vaccine description
Target SARS-CoV-2
Vaccine type Viral vector
Clinical data
Trade names Convidecia
Other namesPakVac
Routes of
administration
Intramuscular, Intranasal
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank

AD5-nCOV, trade-named Convidecia, is a single-dose [1] viral vector vaccine for COVID-19 developed by CanSino Biologics. It conducted its Phase III trials in Argentina, [2] Chile, [3] Mexico, [4] Pakistan, [5] Russia, [6] and Saudi Arabia [7] with 40,000 participants.

Contents

In February 2021, global data from Phase III trials and 101 COVID cases showed that the vaccine had a 65.7% efficacy in preventing moderate symptoms of COVID-19, and 91% efficacy in preventing severe disease. [8] It has similar efficacy to the Janssen vaccine, another one-shot adenovirus vector vaccine with 66% efficacy in a global trial. [9] [1] Convidecia is similar to other viral vector vaccines like AZD1222, Gam-COVID-Vac, and Ad26.COV2.S. [10] Its single-dose regimen and normal refrigerator storage requirement (2° to 8 °C) could make it a favorable vaccine option for many countries. [9] It is currently under evaluation for emergency use listing by the WHO. [11]

A Phase I study published in The Lancet showed two doses of a nasal-spray version of Convidecia resulted in neutralising antibody responses similar to the existing one-dose injection. [12]

Convidecia and the Pakistani version called Pakvac are approved for use by some countries in Asia, [13] [14] [15] Europe, [16] [17] and Latin America. [18] [19] [20] Production capacity for Ad5-NCov should reach 500 million doses in 2021. Manufacturing will take place in China, [21] with filling and finishing of the vaccine additionally also taking place in Malaysia, [15] Mexico, [22] and Pakistan. [23]

Efficacy

In February 2021, data released from an interim analysis of Phase III trials with 30,000 participants and 101 COVID cases showed that globally, the vaccine had an efficacy of 65.7% at preventing moderate cases of COVID-19 and 90.98% efficacy at preventing severe cases. In the Pakistan trial subset, the vaccine had an efficacy of 74.8% at preventing symptomatic cases, and 100% for preventing severe disease. [8]

While the efficacy rates were lower than the Pfizer–BioNTech and Moderna vaccines, its single-dose regimen and normal refrigerator storage requirement (2 to 8 °C) could make it a favorable option for many countries. It has similar efficacy to the Janssen vaccine, another one-shot adenovirus vaccine found to be 66% effective in a global trial. [9] [1]

Pharmacology

Convidecia is a viral vector vaccine similar to AstraZeneca's AZD1222 and Gamaleya's Gam-COVID-Vac. [10]

Manufacturing

Ad5-nCOV can be stored in less extreme cold conditions compared to mRNA vaccines. [24] [9]

In February, Chen Wei who lead the development of the vaccine, said annual production capacity for Ad5-NCov could reach 500 million doses in 2021. [21]

In February, Mexico received the first batch of active ingredients for Convidecia, which is being filled and finished in Querétaro by Drugmex. [22]

In Malaysia, filling and finishing of the vaccine for distribution would be completed by Solution Biologics. [15]

In May, Pakistan began filling and finishing 3 million doses a month at the National Institute of Health, which would be branded as PakVac for domestic distribution. [25]

If the vaccine is approved in Russia, Petrovax said it has the ability to fill and finish 4 million doses per month to start with, eventually reaching a target of 10 million doses a month in 2021. [26] The company eventually hopes to build a plant within 3 years to manufacture Convidecia in Russia. [27]

History

Clinical trials

Phase I-II

In early 2020, Chen Wei led a joint team of the Institute of Biotechnology, the Academy of Military Medical Sciences and CanSino Biologics to develop AD5-nCOV. According to the Chinese state media, the team registered an experimental COVID-19 vaccine for Phase I trial in China on 17 March 2020 to test its safety. The trial was conducted on 108 healthy adults aged 18 to 60 in two medical facilities in Wuhan, Hubei province. [28]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials. [29] The Phase II trial results were published in the peer-reviewed journal The Lancet in August 2020, and noted neutralizing antibody and T cell responses based on statistical analyses of data involving 508 eligible participants. [30] In September, Zeng Guang, chief scientist of the Chinese Center for Disease Control and Prevention said the amount of COVID-19 antibodies in subjects from the Phase I trials remained high six months after the first shot. Zeng said the high levels of antibodies suggested the shots may provide immunity for an extended period of time, although Phase III results were still required. [31] On September 24, CanSino began Phase IIb trials on 481 participants to evaluate the safety and immunogenicity of Ad5-nCoV for children ages 6–17 and elderly individuals ages 56 and above. [32]

In August, China's National Intellectual Property Administration issued the country's first COVID-19 vaccine patent to CanSino. [33]

On 16 May 2020, Canadian Prime Minister Justin Trudeau announced Health Canada had approved Phase II trials to be conducted by the Canadian Center for Vaccinology (CCfV) on the COVID-19 vaccine produced by CanSino. Scott Halperin, director of the CCfV said the vaccine would not be the only one going into clinical trials in Canada, and any potential vaccine would not be publicly available until after Phase 3 is complete. [34] [35] If the vaccine trials were successful, then the National Research Council would work with CanSino to produce and distribute the vaccine in Canada. [35] In August 2020, the National Research Council disclosed the vaccine had not been approved by Chinese customs to ship to Canada, after which the collaboration between CanSino and the Canadian Center for Vaccinology was abandoned. [36]

Nasal Spray Trials

In September 2020, CanSino began a Phase I trial in China with 144 adults to determine safety and immunogenicity when administered as a nasal spray, in contrast to COVID-19 vaccines which require intramuscular injection. [37] On June 3, 2021, expansion of clinical trials was approved by the NMPA and the nasal spray applied for Emergency Use Listing. [38]

In July 2021, results published in The Lancet showed two doses of the nasal spray resulted in neutralising antibody responses similar to the existing one-dose injection and recommended the efficacy and cost-effectiveness of the nasal vaccine to be evaluated in Phase II/III studies. [12]

Phase III

In August 2020, Saudi Arabia confirmed it would begin Phase III trials on 5,000 people for Ad5-nCoV in the cities of Riyadh, Dammam, and Mecca. [7]

In October 2020, Mexico began Phase III trials on 15,000 volunteers. [39] [4]

In September 2020, Russia began Phase III trials on 500 volunteers, [40] which Petrovax later received approval from the government to expand to 8,000 more volunteers. [41] [6]

In September 2020, Pakistan began Phase III trials on 40,000 volunteers as part of a global multi-center study. [5] As of December, about 13,000 volunteers have participated in trials of Ad5-nCoV. [24]

In November 2020, Chile began Phase III trials on 5,200 volunteers to be managed by University of La Frontera. [42] [3]

In December 2020, Argentina's Fundación Huésped began Phase III trials in 11 health centers in the metropolitan area of Buenos Aires and Mar del Plata. [2]

Combination trials

In April 2021, a new trial was registered in Jiangsu involving one dose of Convidecia followed by a dose of ZF2001 28 or 56 days later using different technologies as a way to further boost efficacy. [43]

In July, 2021, Cansino said it would begin combination trials with a dose of Sputnik V followed by a dose of Convidecia. This would address a supply shortage of Sputnik V, which has had difficulties in supplying the second dose in sufficient quantities compared to the first dose. [44]

Authorizations

  Full authorization
  Emergency authorization
  Eligible COVAX recipient (ongoing assessment) [45]

On 25 June 2020, China approved the vaccine for limited use by the military. [46] In February 2021, China approved the vaccine for general use. [13]

In February 2021, Mexico approved the vaccine for emergency use. [47]

In February 2021, Pakistan approved the vaccine for emergency use. [48]

In March, Hungary approved the vaccine for emergency use. [16]

In March, Moldova authorized use of the vaccine. [17]

On 15 June 2021, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued conditional registration for emergency use of the vaccine. [49]

On 7 September 2021, National Agency of Drug and Food Control (BPOM) has issued emergency use authorization in Indonesia. [50]

Economics

Americas

In December 2020, Mexico's Foreign Minister Marcelo Ebrard signed an agreement for 35 million doses. [51] Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February. [18]

In June 2021, Argentina approved emergency use of the vaccine and ordered 5.4 million doses. [19]

In October 2021, Brazil's Bionn SA signed a deal to distribute the vaccine in Brazil, which included producing the vaccine domestically. [52]

In March, Chile signed a deal for 1.8 million doses for delivery between May and June, [53] for which emergency use approval was granted in April. [20]

In June, Ecuador approved emergency use and ordered 6 million doses for delivery between June and August 2021. [54]

Asia

In October 2020, Indonesia reached an agreement with CanSino to deliver 100,000 doses in November 2020, with the expectation that an additional 15 to 20 million doses would be delivered in 2021. [55]

In February 2021, Malaysia's Solution Biologics agreed to supply 3.5 million Convidecia doses to the government. [56] The doses would be delivered starting in April with 500,000 complete doses, with the rest in bulk to be finished by Solution Biologics. [15]

In February 2021, Pakistan purchased 20 million doses of the vaccine [14] of which the first 3 million doses are to arrive in May. [14]

In June 2021, Malaysia's coordinating minister for COVID-19 Immunisation Khairy Jamaluddin confirmed refugee communities in Malaysia would receive the vaccine; with the first shipment due to arrive in late July. [57] By 19 September 2021, more than 70,000 people in Malaysia had received the Convidecia vaccine. The COVID-19 Immunisation Task Force has prioritised the single-dose vaccine for communities living in remote areas including the Orang Asli as well as the homeless and undocumented individuals. Priority states for the CanSino vaccine include Sabah, Johor, Kedah, Kelantan, Perak, Sabah and Terengganu. [58]

Related Research Articles

Sinovac Biotech Ltd. is a Chinese biopharmaceutical company that focuses on the research, development, manufacture, and commercialization of vaccines that protect against human infectious diseases. The company is based in Haidian District, Beijing in China. The company is listed on the NASDAQ but the exchange halted Sinovac's trading in February 2019 due to a proxy fight. The company has faced bribery probes in China.

Sinopharm (company) Chinese state-owned enterprise

China National Pharmaceutical Group Corporation (CNPGC), commonly referred to as Sinopharm, is a Chinese state-owned enterprise. The corporation was the indirect major shareholder of publicly traded companies Sinopharm Group, China Traditional Chinese Medicine, Shanghai Shyndec Pharmaceutical, and Beijing Tiantan Biological Products.

Academy of Military Medical Sciences

The Academy of Military Medical Sciences (AMMS) of the PLA Academy of Military Science is a Chinese military medical research institute. It was established in Shanghai in 1951. It has been based in Beijing since 1958.

Chen Wei is a Chinese epidemiologist and virologist specializing in biodefense, currently researcher and doctoral adviser at the Academy of Military Medical Sciences, and an Academician of the Chinese Academy of Engineering (CAE). In September 2021, The Globe and Mail reported that Chen is also a major general in China's People's Liberation Army.

COVID-19 vaccine Vaccine designed to provide acquired immunity against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID‑19). Prior to the COVID‑19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. On 10 January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by 19 March, the global pharmaceutical industry announced a major commitment to address COVID-19. The COVID‑19 vaccines are widely credited for their role in reducing the spread, severity, and death caused by COVID-19.

CanSino Biologics Chinese vaccine company

CanSino Biologics, often abbreviated as CanSinoBIO, is a Chinese vaccine company.

Oxford–AstraZeneca COVID-19 vaccine Viral vector vaccine for prevention of COVID-19 by Oxford University and AstraZeneca

The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222, and sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for prevention of COVID-19. Developed in the United Kingdom by the Oxford University and British-Swedish company AstraZeneca, using as a vector the modified chimpanzee adenovirus ChAdOx1. The vaccine is given by intramuscular injection. Studies carried out in 2020 showed that the efficacy of the vaccine is 76.0% at preventing symptomatic COVID-19 beginning at 22 days following the first dose, and 81.3% after the second dose. A study in Scotland found that, for symptomatic COVID-19 infection after the second dose, the vaccine is 81% effective against the Alpha variant, and 61% against the Delta variant.

Sputnik V COVID-19 vaccine Vaccine against COVID-19

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Vaccine diplomacy Use of vaccines

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CoronaVac Vaccine against COVID-19

CoronaVac, also known as the Sinovac COVID-19 vaccine, is an inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech. It was Phase III clinical trialled in Brazil, Chile, Indonesia, the Philippines, and Turkey and relies on traditional technology similar to other inactivated-virus COVID-19 vaccines, such as BBIBP-CorV, another Chinese vaccine, and Covaxin, an Indian vaccine. CoronaVac does not need to be frozen and both the final product and the raw material for formulating CoronaVac can be transported refrigerated at 2–8 °C (36–46 °F), temperatures at which flu vaccines are kept.

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Sinopharm BIBP COVID-19 vaccine Vaccine against COVID-19

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Janssen COVID-19 vaccine Vaccine against COVID-19

The Janssen COVID-19 vaccine or Johnson & Johnson COVID-19 vaccine is a COVID-19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, subsidiary of American company Johnson & Johnson.

Sinopharm WIBP COVID-19 vaccine Vaccine against COVID-19

The Sinopharm WIBP COVID-19 vaccine, also known as WIBP-CorV, is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. Peer-reviewed results show WIBP-CorV 72.8% effective against symptomatic cases and 100% against severe cases. The other inactivated virus COVID-19 vaccine developed by Sinopharm is BBIBP-CorV which is comparably more successful. 1 billion doses are expected to be produced per year.

Viral vector vaccine Type of vaccine

A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material coding for a desired antigen into the recipient's host cells. As of April 2021, six viral vector vaccines have been authorized for use in humans in at least one country: four COVID-19 vaccines and two Ebola vaccines.

Walvax COVID-19 vaccine Vaccine candidate against COVID-19

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COVID-19 vaccine clinical research

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Further reading