Sinopharm WIBP COVID-19 vaccine

Sinopharm WIBP COVID-19 vaccine
Vaccine description
Target	SARS-CoV-2
Vaccine type	Inactivated
Clinical data
Other names	Zhongkangkewei (Chinese: 众康可维)
Routes of; administration	Intramuscular
ATC code	None;
Legal status
Legal status	Full and emergency authorizations; Full list of Sinopharm WIBP authorizations
Identifiers
DrugBank	DB15862;

The Sinopharm WIBP COVID-19 vaccine, also known as WIBP-CorV,[1][2] is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. Peer-reviewed results show that the vaccine is 72.8% effective against symptomatic cases and 100% against severe cases (26 cases in vaccinated group vs. 95 cases in placebo group).[3] The other inactivated virus COVID-19 vaccine developed by Sinopharm is the BIBP vaccine (BBIBP-CorV) which is comparably more successful. 1 billion doses are expected to be produced per year.

Medical uses

The vaccine is given by intramuscular injection. The administered is 2 doses in 3 weeks.[4][5][6]

Efficacy

In May 2021, peer-reviewed results published in JAMA of Phase III trials in United Arab Emirates and Bahrain showed that the vaccine is 72.8% effective against symptomatic cases and 100% against severe cases (26 cases in vaccinated group vs. 95 cases in placebo group). 12,743 people received the vaccine and 12,737 people received the placebo in these trials.[3]

Manufacturing

In June 2021, a new factory started production with the capacity to manufacture 1 billion doses annually.[7]

History

In April 2020, China approved clinical trials for a candidate COVID-19 vaccine developed by Sinopharm's Beijing Institute of Biological Products (BIBP)[8] and the Wuhan Institute of Biological Products (WIBP).[9] Both vaccines are chemically-inactivated whole virus vaccines for COVID-19.

On August 13, 2020, the Wuhan Institute of Biological Products published interim results of its Phase I (96 adults) and Phase II (224 adults) clinical studies. The report noted the vaccine had a low rate of adverse reactions and demonstrated immunogenicity, but longer-term assessment of safety and efficacy would require Phase III trials.[9]

Clinical trials

In March 2021, Cayetano Heredia University running the BIBP and WIBP trials in Peru announced they were seeking to suspend and unblind participants in the WIBP trials for lower efficacy and offer the participants the BIBP vaccine instead, which was showing efficacy.[10]

Authorizations

On February 25, 2021, China approved the vaccine for general use.[11]

According to The New York Times, the vaccine is only approved for limited use in United Arab Emirates.[12]

On August 19, 2021, the Philippines approved the vaccine for emergency use authorization.[13]

References

Evidence Assessment: Sinopharm/BBIBP COVID-19 vaccine (PDF) (Presentation). World Health Organization. 29 April 2021. Retrieved 10 July 2021. Evaluated BBIBP-CorV & WIBP-CorV
Hassine, Ikbel Hadj (2021). "Covid-19 vaccines and variants of concern: A review". Reviews in Medical Virology. 32 (4): e2313. doi:10.1002/rmv.2313. ISSN 1099-1654. PMC 8646685. PMID 34755408. S2CID 243939603.
Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, et al. (July 2021). "Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial". JAMA. 326 (1): 35–45. doi:10.1001/jama.2021.8565. PMC 8156175. PMID 34037666.
China National Biotec Group Company Limited (29 October 2020). G42 Healthcare company, Abu Dhabi Health Services Company, Wuhan Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd. "Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above". ClinicalTrials.gov.
Universidad Peruana Cayetano Heredia (3 November 2020). National University of San Marcos, Peru. "Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru (Covid-Peru)". ClinicalTrials.gov. NCT04612972.
"Two Chinese-developed COVID-19 vaccines under review". National Medical Products Administration. 25 February 2021. Retrieved 11 April 2021.
"Sinopharm's Wuhan affiliate boosts COVID-19 shot annual capacity to 1 billion doses". CNA. Retrieved 2021-06-08.
Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. (October 2020). "Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial". The Lancet. Infectious Diseases. 21 (1): 39–51. doi:10.1016/s1473-3099(20)30831-8. PMC 7561304. PMID 33069281.
Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, et al. (September 2020). "Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials". JAMA. 324 (10): 951–960. doi:10.1001/jama.2020.15543. PMC 7426884. PMID 32789505.
"COMUNICADO A LA OPINIÓN PÚBLICA". Universidad Peruana Cayetano Heredia. March 9, 2021.{{cite web}}: CS1 maint: url-status (link)
Reuters Staff (2021-02-25). "China approves two more domestic COVID-19 vaccines for public use". Reuters. Retrieved 2021-03-30.
Zimmer C, Corum J, Wee SL (10 June 2020). "Coronavirus Vaccine Tracker". The New York Times. ISSN 0362-4331. Retrieved 2021-03-30.
De Vera, Analou (August 25, 2021). "FDA grants EUA to COVID-19 vaccine Sinopharm manufactured by Wuhan affiliate". Manila Bulletin.

External links

This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.

[who-bibp-evidence-1] Evidence Assessment: Sinopharm/BBIBP COVID-19 vaccine (PDF) (Presentation). World Health Organization. 29 April 2021. Retrieved 10 July 2021. Evaluated BBIBP-CorV & WIBP-CorV

[2] Hassine, Ikbel Hadj (2021). "Covid-19 vaccines and variants of concern: A review". Reviews in Medical Virology. 32 (4): e2313. doi:10.1002/rmv.2313. ISSN 1099-1654. PMC 8646685. PMID 34755408. S2CID 243939603.

[jama.2021.85652-3] Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, et al. (July 2021). "Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial". JAMA. 326 (1): 35–45. doi:10.1001/jama.2021.8565. PMC 8156175. PMID 34037666.

[NCT04510207-4] China National Biotec Group Company Limited (29 October 2020). G42 Healthcare company, Abu Dhabi Health Services Company, Wuhan Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd. "Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above". ClinicalTrials.gov.

[NCT04612972-5] Universidad Peruana Cayetano Heredia (3 November 2020). National University of San Marcos, Peru. "Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru (Covid-Peru)". ClinicalTrials.gov. NCT04612972.

[wibp-efficacy-doses-6] "Two Chinese-developed COVID-19 vaccines under review". National Medical Products Administration. 25 February 2021. Retrieved 11 April 2021.

[7] "Sinopharm's Wuhan affiliate boosts COVID-19 shot annual capacity to 1 billion doses". CNA. Retrieved 2021-06-08.

[:0-8] Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. (October 2020). "Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial". The Lancet. Infectious Diseases. 21 (1): 39–51. doi:10.1016/s1473-3099(20)30831-8. PMC 7561304. PMID 33069281.

[:1-9] Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, et al. (September 2020). "Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials". JAMA. 324 (10): 951–960. doi:10.1001/jama.2020.15543. PMC 7426884. PMID 32789505.

[10] "COMUNICADO A LA OPINIÓN PÚBLICA". Universidad Peruana Cayetano Heredia. March 9, 2021.{{cite web}}: CS1 maint: url-status (link)

[11] Reuters Staff (2021-02-25). "China approves two more domestic COVID-19 vaccines for public use". Reuters. Retrieved 2021-03-30.

[12] Zimmer C, Corum J, Wee SL (10 June 2020). "Coronavirus Vaccine Tracker". The New York Times. ISSN 0362-4331. Retrieved 2021-03-30.

[13] De Vera, Analou (August 25, 2021). "FDA grants EUA to COVID-19 vaccine Sinopharm manufactured by Wuhan affiliate". Manila Bulletin.

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