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BBIBP-CorV

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BBIBP-CorV
Sinopharm COVID-19 vaccine (2021) K (cropped).jpeg
A vial of the BBIBP-CorV COVID‑19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Routes of
administration		Intramuscular
ATC code
  • None
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Legal status
Identifiers
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BBIBP-CorV, also known as the Sinopharm COVID-19 vaccine,[1] is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. In late December 2020, it was in Phase III trials in Argentina, Bahrain, Egypt, Morocco, Pakistan, Peru, and the United Arab Emirates (UAE) with over 60,000 participants.[2] BBIBP-CorV shares similar technology with CoronaVac and BBV152, other inactivated virus vaccines for COVID-19.[3][4]

On December 9, the UAE announced interim results from Phase III trials showing BBIBP-CorV had a 86% efficacy against COVID-19 infection.[5] In late December, Sinopharm announced that its internal analysis indicated a 79% efficacy.[6] While mRNA vaccines like the Pfizer–BioNTech COVID-19 vaccine and mRNA-1273 showed higher efficacy of over 90%, those present distribution challenges for some nations as they require deep-freeze facilities and trucks. BIBP-CorV could be transported and stored at normal refrigerated temperatures.[7]

BBIBP-CorV is being used in vaccination campaigns by certain countries in Asia,[8][9][10] Africa,[11][12][13] South America,[14][15][16] and Europe.[17][18][19] Sinopharm expects to produce one billion doses of BBIBP-CorV in 2021.[20] On March 26, Sinopharm said more than 80 million doses had been administered.[21]

No detailed efficacy data of the vaccine has been published in peer-review journals.

A vaccination certificate of BBIBP-CorV (Beijing Institute of Biological Products, Sinopharm).

Technology

As an inactivated vaccine like CoronaVac and BBV152, BBIBP-CorV uses a more traditional technology that is similar to the inactivated polio vaccine. Initially, a sample of SARS-CoV-2 from China capable of rapid multiplication was used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone, which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with an aluminium-based adjuvant.[22]

Clinical research

Main article: COVID-19 vaccine

Phases I and II

In April 2020, China approved clinical trials for a candidate COVID-19 vaccine developed by Sinopharm's Beijing Institute of Biological Products (BBIBP-CorV)[23] and the Wuhan Institute of Biological Products (WIBP-CorV).[24] Both vaccines are chemically-inactivated whole virus vaccines for COVID-19.

On October 15, the Beijing Institute of Biological Products published results of its Phase I (192 adults) and Phase II (448 adults) clinical studies for the BBIBP-CorV vaccine, showing BBIBP-CorV to be safe and well-tolerated at all tested doses in two age groups. Antibodies were elicited against SARS-CoV-2 in all vaccine recipients on day 42. These trials included individuals older than 60.[23]

BIBP-CorV may have characteristics favorable for vaccinating people in the developing world. While mRNA vaccines, such as the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine showed higher efficacy of +90%, mRNA vaccines present distribution challenges for some nations, as some may require deep-freeze facilities and trucks. By contrast, BIBP-CorV can be transported and stored at normal refrigeration temperatures.[25] While Pfizer and Moderna are among developers relying on novel mRNA technology, manufacturers have decades of experience with the inactivated virus technology Sinopharm is using.[25]

Phase III

Africa and Asia

On July 16, Sinopharm began conducting a Phase III vaccine trial of 31,000 volunteers in the UAE in collaboration with G42 Healthcare, an Abu Dhabi-based company.[26] By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks.[27] On December 9, UAE's Ministry of Health and Prevention announced the official registration of BBICP-CorV, after an interim analysis of the Phase III trial showed BBIBP-CorV to have a 86% efficacy against COVID-19 infection.[28] The vaccine was 100% effectiveness in preventing moderate and severe cases of the disease.[29]

In April 2021, a study conducted by Abu Dhabi Public Health Centre in UAE found the vaccine was 93% effective in preventing hospitalization and 95% effective against admission to intensive care. The study found no deaths related to Covid-19 in patients who had received both doses. It was unknown when the study was conducted or how many people were included in the research.[30]

On September 2, Sinopharm began Phase III trial in Casablanca and Rabat on 600 people.[31][32] In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.[33]

In August 2020, Sinopharm began Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers.[34][35] In a November update, 7,700 people had volunteered in the trials.[36] Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.[37][38]

In Pakistan, Sinopharm worked with the University of Karachi on a trial with 3,000 volunteers.[39]

South America

On September 10, Sinopharm began a Phase III trial in Peru with the long-term goal of vaccinating a total of 6,000 people between the ages of 18 and 75.[40] In October, the trials were expanded to include an additional 6,000 volunteers.[41] On January 26, a volunteer in the placebo group of the vaccine trials had died.[42]

On September 16, Argentina began a Phase III trial with 3,000 volunteers.[43]

COVID-19 variants

In February, lab studies of twelve serum samples taken from recipients of BBBP-CorV and ZF2001 retained neutralizing activity against 501.V2 variant although with weaker activity than against the original virus.[44] For BBIBP-CorV, geometric mean titers declined by 1.6-fold, from 110.9 to 70.9, which was less than antisera from mRNA vaccine recipients with a 6-folds decrease.[45] Preliminary clinical data from Novavax and Johnson & Johnson also showed they were less effective in preventing COVID-19 in South Africa, where the new variant is widespread.[44]

Manufacturing

Sinopharm's Chairman Yang Xioyun has said the company could produce one billion doses in 2021.[20]

In March 2021, Sinopharm and Abu Dhabi G42 announced plans to produce up to 200 million doses annually in the UAE at a new plant to become operational in 2021. The UAE manufactured vaccine will be named Hayat-Vax.[46]

In December, Egypt announced an agreement between Sinopharm and Egypt's VACSERA for the vaccine to be manufactured locally.[47]

In March, Serbia announced plans to produce 24 million doses of BBIBP-CorV annually starting in October. The production volume would be sufficient to meet the needs of Serbia and all of its neighbors, according to deputy Prime Minister Branislav Nedimović.[48]

In March, Belarus was looking to produce BBIBP-CorV locally.[19]

In April, Bangladesh approved local production of BBIBP-CorV.[49]

Marketing and Distribution

  Full authorization
  Emergency authorization
  Eligible COVAX recipient (ongoing assessment)[50]
See also: List of COVID-19 vaccine authorizations § Sinopharm-BBIBP

On March 26, 2021 Sinopharm said more than 80 million doses had been administered so far out of 100 million doses supplied around the world.[21]

Asia

In February, Afghanistan was pledged 400,000 doses by China.[51]

In November 3, 2020 Bahrain granted emergency use authorization for frontline workers.[36] In December, Bahrain approved the vaccine, citing Phase III trials which showed an 86% efficacy rate.[52]

In February, Brunei received the first batch of the vaccine donated by China,[53] which has been approved for emergency use.[54]

In January, Cambodia said China would provide a million doses.[55] Cambodia granted emergency use authorization on February 4[56] and started the vaccination campaign on February 10 with the first 600,000 doses.[57]

In China, Sinopharm obtained an EUA in July.[58] On December 30, China's National Medical Products Administration approved BBIBP-CorV for general use.[8] In February, Macau received the first 100,000 doses of 400,000 doses.[59]

In April, Indonesia approved emergency use. Indonesia is looking to procure 15 million doses OF which 482,000 doses arrived on April 30.[60] The vaccine will be used for a vaccination scheme known as "Gotong Royong", where companies or legal entities can arrange the free Covid-19 vaccine rollout for their employees.[61]

In February, Iran approved emergency use[62] and received 650,000 doses by April 15.[63]

In January, Iraq approved emergency use[64] and signed agreements for 2 million doses. The first doses arrived on March 2.[65]

In January, Jordan approved emergency use[66] and began vaccinations on January 13.[67]

In April, Kazakhstan approved emergency use of the vaccine,[68] for which it had ordered 1 million doses.[69]

In March, Kyrgyzstan received a donation of 150,000 doses[70] and began vaccinations on March 29.[71]

In January, Laos began vaccinating healthcare workers in Vientiane [72] and received another 300,000 doses in early February.[73]

In April, Lebanon received a donation of 90,000 doses[74] after granting emergency use authorization on March 2.[75]

In March, Maldives granted emergency approval for use.[76] 100,000 doses were received on March 25 out of a total of 200,000 donated doses.[77]

In February, Mongolia received a donation of 300,000 doses.[78] On March 10, Governor of Ulaanbaatar D. Sumiyabazar and Deputy Prime Minister S. Amarsaikhan received the first doses.[79]

In February, Nepal approved the vaccine for emergency use,[80] and a donation of 800,000 doses arrived on March 29.[81]

In January, Pakistan approved the vaccine for emergency use[82] and began a vaccination campaign on February 2.[10] By April, it had purchased 5.5 million doses.[83]

In March, Palestine received 100,000 doses donated by China.[84]

In April, Philippines president Rodrigo Duterte received the vaccine after the food and drug regulator approved compassionate use of 10,000 doses for his security team. Emergency use approval was still pending.[85]

In April, Syria received 150,000 dose donated by China.[86]

In March, Sri Lanka approved the vaccine for emergency use,[87] and received the first batch of 600,000 donated doses on March 31.[88]

On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following interim Phase III trials.[26] In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis.[28] In March, a small number of people who have reduced immunity against diseases, chronic illnesses, or belong to high-risk groups have been given a 3rd booster shot.[89]

On 29 April 2021, Bangladesh regulatory body approved emergency use of the vaccine.[90][91]

Africa

In February, Algeria received a donation of 200,000 doses.[92]

In March, Angola received a donation of 200,000 doses.[93]

In April, Cameroon took delivery of 200,000 doses.[94]

In January, Egypt approved use of the vaccine[95] and had purchased 20 million doses, of which 1.5 million had arrived by April.[96] President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.[11]

In March, Ethiopia received a donation of 300,000 doses.[97]

In February, Equatorial Guinea received a donation of 100,000 doses which arrived on February 10. The country began vaccinations on February 15.[98]

In March, Gabon received a donation of 100,000 doses which was the second vaccine approved for use in the country.[99]

Morocco has ordered 40 million doses, of which 2.5 million had arrived in March, with another 10 million arriving in April and May.[100] Morocco had granted emergency use approval on January 23.[101]

In March, Mauritania received a donation of 50,000 doses[102] and started its vaccination campaign on March 26.[103]

In April, Mauritius received 100,000 doses and ordered an additional 500,000 doses.[104]

In February, Mozambique received a donation of 200,000 doses[105] and planned to start vaccinations on March 8.[106]

In March, Namibia received a donation of 100,000 doses and announced the start of vaccinations in the Khomas and Erongo regions.[107]

In March, Niger received a donation of 400,000 doses with vaccinations to begin on March 27.[108]

In February, Senegal received 200,000 doses[109] and began vaccinating health workers on February 22.[110]

In February, Sierra Leone received a donation of 200,000 doses.[111] It was approved for emergency use and vaccinations began on March 15.[112]

In January, Seychelles began administering vaccinations with 50,000 doses it had received as a gift from the UAE.[113][114]

In April, Somalia received a donation of 200,000 doses[115] and started vaccinations with the vaccine on April 14.[116][117]

In April, South Africa announced it would order 10 million doses of the vaccine.[118]

In March, Sudan received a donation of 250,000 doses.[119][120]

In March, Republic of the Congo received 100,000 doses with vaccinations prioritizing the medically vulnerable and those over 50.[121]

In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China,[122] and started vaccinations on February 18.[13] Zimbabwe purchased an additional 1.2 million doses.[123]

North America

In April, Barbados announced it would receive 30,000 doses of BBIBP-CorV, according to Prime Minister Mia Mottley.[124]

In February, the Dominican Republic ordered 768,000 doses of BBIBP-CorV.[125]

In March, Dominica received 20,000 doses of BBIBP-CorV which it began using in its vaccination campaign on March 4.[126]

In March, Mexico announced it would order 12 million doses of BBIBP-CorV pending approval by its health regulator.[127]

South America

In February, Argentina authorized emergency use of BBIBP-CorV[128] ahead of the arrival of 904,000 doses on February 26.[129] Eligibility was expanded to include people older than 60 on March 25.[14]

In February, Bolivia purchased 400,000 doses on top of 100,000 doses donated by China,[130] and started its vaccination campaign on February 26.[16]

In March, Guyana received a donation of 20,000 doses of BBIBP-CorV.[131] Vaccinations were to start on March 7.[132]

In January, Peru purchased 38 million doses of BBIBP-CorV.[133] Peru granted emergency approval on January 27[134] and started vaccinations on February 9.[15]

In March, Venezuela granted approval for the vaccine[135] and the first 500,000 doses arrived on March 2.[136]

Europe

In February, Belarus received a donation of 100,000 doses[137] and began using the vaccine on March 15.[19]

In April, Georgia received 100,000 doses for which vaccinations would begin after it receives the WHO authorization.[138]

In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses.[139] The first 550,000 doses arrived in Budapest on February 16[140] and vaccinations started on February 24.[18] Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28.[141]

In March, Moldova received 2,000 doses donated by the UAE[142] which will be used to vaccinate doctors starting on March 22.[143]

On March 3, Montenegro received a donation of 30,000 doses of BBIBP-CorV.[144]

In April, North Macedonia received the first 200,000 of 800,000 doses which arrived by truck from Serbia. The vaccination program would begin on May 4.[145]

On January 19, Serbia started vaccinations with BBIBP-CorV and was the first country in Europe to approve the vaccine. By April, Serbia has received 2.5 million doses. In March, Serbia's had signed an agreement for an additional 2 million doses.[146]

Oceania

In April, Solomon Islands receive a donation of 50,000 doses.[147]

Controversies

Lack of public data

Unlike Moderna's MRNA-1273, Oxford-AstraZeneca's AZD1222, and Johnson & Johnson's Ad26.COV2.S, there is little public information about the Chinese vaccine's safety or efficacy.[148] The UAE said it had reviewed Sinopharm's interim data analysis which showed the vaccine was 100% effective to prevent moderate and severe instances of COVID-19, but did not say whether it had independently analyzed the case data in its review. It was unclear how Sinopharm drew conclusions, since the UAE announcement of the approval for BBIBP-CorV noticeably lacked details such as the number of COVID-19 cases in the placebo or active group or the volunteers ages.[149]

As of December 30, 2020, no detailed efficacy data of the vaccine has been released to the public. A Sinopharm executive said detailed data would be released later and published in scientific journals in China and internationally.[8]

Sinopharm president Wu Yonglin said the trial results exceeded the WHO's requirements, but a director at a large pharmaceutical company in Shanghai expressed skepticism over the trials and the expectation that drug regulators in Bahrain and the UAE would not hold the same standard as the U.S. Food and Drug Administration.[150]

Unauthorized use in Asia

On December 30, Philippine Defense Secretary Delfin Lorenzana said in an interview that at least one minister and president Rodrigo Duterte's bodyguards were provided BBIBP-CorV which were "smuggled" but that he felt what happened was "justified". Brigadier General Jesus Durante, head of the Presidential Security Guard (PSG), said he felt compelled and "took the risk" to have some of his men vaccinated because they provide close-in security to Duterte, who at 75 is highly vulnerable to COVID-19.[151] In April, president Rodrigo Duterte received the vaccine after the food and drug regulator approved compassionate use of 10,000 doses for his security team.[85]

On January 1, Mainichi Shimbun reported that 18 wealthy people, including several owners of leading Japanese companies, have been vaccinated with the vaccine since November 2020. The vaccines were brought in by a Chinese consultant close to a senior member of the Communist Party of China.[152]

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External links

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