Convidicea (Ad5-nCoV)

Convidicea (Ad5-nCoV)

Recombinant vaccine (adenovirus type 5 vector)

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

CanSino Biologics, china

see https://covid19.trackvaccines.org/vaccines/2/

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.

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 Johnson & Johnson’s Ad26.COV2.S, 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]

Convidecia is approved for use by some countries in Asia,^[11][12][13] Europe,^[14][15] and Latin America.^[16][17][18] Production capacity for Ad5-NCov should reach 500 million doses in 2021. Manufacturing will take place in China,^[19] Malaysia,^[13] Mexico,^[20] and Pakistan.^[21]

Ad5-nCoV is a recombinant adenovirus type-5 vector (Ad5) vaccine currently being investigated for prophylaxis against SARS-CoV-2.^1,2 It is being developed by CanSino Biologics Inc., in partnership with the Beijing Institute of Biotechnology, who in March 2020 announced the approval of a phase I clinical trial (ChiCTR2000030906)¹ with an expected completion in December 2020. The study will evaluate antibody response in healthy patients between the ages of 18 and 60 who will receive one of three study doses, with follow-up taking place at weeks 2 and 4 and months 3 and 6 post-vaccination.²

1. Chinese Clinical Trial Register: A phase I clinical trial for recombinant novel coronavirus (2019-COV) vaccine (adenoviral vector) [Link]
2. Antibody Society: COVID-19 Archives [Link]

Technology

Convidecia is a viral vector vaccine similar to AstraZeneca‘s AZD1222 and Gamaleya‘s Gam-COVID-Vac.^[10] Ad5-nCOV can be stored in less extreme cold conditions compared to mRNA vaccines.^[22][9]

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 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 Johnson & Johnson’s Ad26.COV2.S, another one-shot adenovirus vaccine found to be 66% effective in a global trial.^[9][1]

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.^[23]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials.^[24] 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.^[25] 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.^[26] 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.^[27]

In August, China’s National Intellectual Property Administration issued the country’s first COVID-19 vaccine patent to CanSino.^[28]

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.^[29][30] If the vaccine trials were successful, then the National Research Council would work with CanSino to produce and distribute the vaccine in Canada.^[30] 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.^[31]

Nasal spray trials

In September, 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, in contrast with most COVID-19 vaccine candidates which require intramuscular injection.^[32] On June 3, 2021, Chen Wei announced the expansion of clinical trials was approved by the NMPA, in the meantime, they are applying for Emergency Use Listing for the nasal spray.^[33]

Phase III

In August, 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, Mexico began Phase III trials on 15,000 volunteers.^[34][4]

In September, Russia began Phase III trials on 500 volunteers,^[35] which Petrovax later received approval from the government to expand to 8,000 more volunteers.^[36][6]

In September, 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.^[22]

In November, Chile began Phase III trials on 5,200 volunteers to be managed by University of La Frontera.^[37][3]

In December, 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.^[38]

Manufacturing

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.^[19]

In February, Mexico received the first batch of active ingredients for Convidecia, which is being packaged in Querétaro by Drugmex.^[20]

In Malaysia, final filling and packaging of the vaccine for distribution would be completed by Solution Biologics.^[13]

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.^[39]

If the vaccine is approved in Russia, Petrovax said it would produce 10 million doses per month in 2021.^[40]

Marketing and deployment

See also: List of COVID-19 vaccine authorizations § Convidecia

Asia

On 25 June 2020, China approved the vaccine for limited use by the military.^[42] In February 2021, China approved the vaccine for general use.^[11]

In February, Malaysia‘s Solution Biologics agreed to supply 3.5 million doses to the government.^[43] The doses would be delivered starting in April with 500,000 complete doses, with the rest in bulk to be finished by Solution Biologics.^[13]

In October, 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.^[44]

In February, Pakistan approved the vaccine for emergency use.^[45] The country purchased 20 million doses of the vaccine^[12] of which the first 3 million doses are to arrive in May.^[12]

Europe

In March, Hungary granted emergency use approval for the vaccine.^[14]

In March, Moldova authorized use of the vaccine.^[46]

North America

In December 2020, Mexico‘s Foreign Minister Marcelo Ebrard signed an agreement for 35 million doses.^[47] In February, Mexico approved the vaccine for emergency use.^[48] Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February.^[16]

South America

In June, Argentina approved emergency use of the vaccine and ordered 5.4 million doses.^[17]

In June, Brazil announced plans to purchase 60 million doses.^[49] In May, Brazil began reviewing the vaccine for emergency use.^[50]

In March, Chile signed a deal for 1.8 million doses for delivery between May and June,^[51] for which emergency use approval was granted in April.^[18]

In June, Ecuador approved emergency use and ordered 6 million doses for delivery between June and August 2021.^[52]

References

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Further reading

• Zhu FC, Li YH, Guan XH, Hou LH, Wang WJ, Li JX, et al. (June 2020). “Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial”. Lancet. 395 (10240): 1845–1854. doi:10.1016/S0140-6736(20)31208-3. PMC 7255193. PMID 32450106.

External links

Scholia has a profile for Ad5-nCoV (Q96695265).

/////////Convidicea, Ad5-nCoV, Recombinant vaccine, adenovirus type 5 vector, CanSino Biologics, china, SARS-CoV-2, corona virus, vaccine, covid 19

Convidecia

Convidecia is a viral vector vaccine^[478] produced by the Chinese company CanSino Biologics and the Beijing Institute of Biotechnology of the Academy of Military Medical Sciences.Full (1)

1. China^[479]

Emergency (8)

1. Argentina^[480]
2. Chile^[481]
3. Ecuador^[482]
4. Hungary^[483][272]
5. Malaysia^[484]
6. Mexico^[436]
7. Moldova^[229]
8. Pakistan^[485]

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