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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
Legal status
Legal status
Identifiers
CAS Number
  • 2503126-65-4
DrugBank

BBIBP-CorV, also known as the Sinopharm COVID-19 vaccine,[1] is one of two inactivated virus COVID-19 vaccines developed by Sinopharm's Beijing Institute of Biological Products. It completed 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 Covaxin, other inactivated virus vaccines for COVID-19.[3] Its product name is SARS-CoV-2 Vaccine (Vero Cell),[4][5][6] not to be confused with the similar product name of CoronaVac.[7][8]

Peer-reviewed results published in JAMA of Phase III trials in United Arab Emirates and Bahrain showed BBIBP-CorV 78.1% effective against symptomatic cases and 100% against severe cases (21 cases in vaccinated group vs. 95 cases in placebo group).[9] In December 2020, the UAE previously announced interim results showing 86% efficacy.[10]

While mRNA vaccines like the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine 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.[11]

BBIBP-CorV is being used in vaccination campaigns by certain countries in Asia,[12][13][14] Africa,[15][16][17] South America,[18][19][20] and Europe.[21][22][23] Sinopharm expects to produce one billion doses of BBIBP-CorV in 2021.[24] By May, Sinopharm had supplied 200 million doses.[25]

On 7 May 2021, the World Health Organization approved the vaccine for use in COVAX.[26][27]

The other inactivated virus vaccine developed by Sinopharm is WIBP-CorV.

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

Technology

As an inactivated vaccine like CoronaVac and Covaxin, 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.[3]

Efficacy

In May 2021, peer-reviewed results published in JAMA of Phase III trials in United Arab Emirates and Bahrain showed BBIBP-CorV 78.1% effective against symptomatic cases and 100% against severe cases (21 cases in vaccinated group vs. 95 cases in the placebo group). 12,726 people received the vaccine and 12,737 people received the placebo in these trials.[9] These results were previously published with the WHO in April.[28]

Real-world test-negative analysis in Bahrain (based on 14 days post 2nd dose) indicated a vaccine effectiveness of 90% for adults aged 18–59, and 91% for those 60 year old or older.[28] Due to low participation in studies, WHO experts expressed very low confidence in the safety of BBIBP-CorV for people with comorbidities, pregnant women and the elderly, while being confident in its overall efficacy.[29]

Back in December 2020, UAE's Ministry of Health and Prevention announced the official registration of BBICP-CorV after an interim analysis of Phase III results showed BBIBP-CorV to have a 86% efficacy against COVID-19 infection.[30] In April 2021, a study conducted by the Abu Dhabi Public Health Centre 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.[31]

SARS-CoV-2 variants

In February, lab studies of twelve serum samples taken from recipients of BBBP-CorV and ZF2001 retained neutralizing activity against the Beta variant although with weaker activity than against the original virus.[32] 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.[33] 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.[32]

Clinical research

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)[34] and the Wuhan Institute of Biological Products (WIBP-CorV).[35] 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.[34]

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.[36] 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.[36]

Phase III

Africa and Asia

On July, Sinopharm began trials with 31,000 volunteers in the UAE in collaboration with G42 Healthcare, an Abu Dhabi-based company.[37] In June, Sinopharm began Phase III trials for children and adolescents aged 3–17 with 1,800 volunteers.[38]

On September, Sinopharm began trials in Casablanca and Rabat on 600 people.[39][40] In September, Egypt started trials with 6,000 people.[41]

In August, Sinopharm began trials in Bahrain with 6,000 people,[42] later increased to 7,700 people.[43] Also in August, Jordan began trials with 500 people.[44][45]

In Pakistan, University of Karachi conducted a trial with 3,000 volunteers.[46]

South America

In September, Peru began trails with 6,000 people[47] which later expanded to 12,000 people.[48] On January 26, a volunteer in the placebo group of the trials had died.[49]

In September, Argentina began trials with 3,000 people.[50]

Manufacturing

Sinopharm's Chairman Yang Xioyun has said the company could produce one billion doses in 2021.[24]

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.[51]

In December, Egypt announced an agreement between Sinopharm and Egypt's VACSERA for the vaccine to be manufactured locally.[52]

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.[53]

In March, Belarus was looking to produce BBIBP-CorV locally.[23]

In April, Bangladesh approved local production of BBIBP-CorV.[54]

Marketing and Distribution

  Full authorization
  Emergency authorization
  Eligible COVAX recipient[55]

By May, Sinopharm had supplied 200 million doses across all countries.[25] On 7 May 2021, the World Health Organization added the vaccine to the list of vaccines authorized for emergency use for COVID-19 Vaccines Global Access (COVAX).[26][27]

Asia

In February, Afghanistan was pledged 400,000 doses by China.[56]

In November 3, 2020 Bahrain granted emergency use authorization for frontline workers.[43] In December, Bahrain approved the vaccine.[57]

In April, Bangladesh approved emergency use[58] and received 500,000 doses in May.[59] The country may purchase 40 to 50 million doses.[60]

In February, Brunei received the first batch of the vaccine donated by China,[61] which has been approved for emergency use.[62]

In February, Cambodia granted emergency use authorization[63] and started the vaccination campaign on February 10.[64] By May the country had received 1.7 million doses.[65]

In China, Sinopharm obtained an EUA in July.[66] On December 30, China's National Medical Products Administration approved BBIBP-CorV for general use.[12] In February, Macau received the first 100,000 doses of 400,000 doses.[67]

The instruction manual of BBIBP-CorV in Chinese

In April, Indonesia approved emergency use. Indonesia is looking to procure 15 million doses of which 482,000 doses arrived on April 30.[68] 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.[69]

In February, Iran approved emergency use[70] and received 650,000 doses by April 15.[71]

In January, Iraq approved emergency use[72] and signed agreements for 2 million doses. The first doses arrived on March 2.[73]

In January, Jordan approved emergency use[74] and began vaccinations on January 13.[75]

In April, Kazakhstan approved emergency use of the vaccine,[76] for which it had ordered 1 million doses.[77]

In March, Kyrgyzstan received a donation of 150,000 doses[78] and began vaccinations on March 29.[79]

In January, Laos began vaccinating healthcare workers in Vientiane[80] and received another 300,000 doses in early February.[81]

In April, Lebanon received a donation of 90,000 doses[82] after granting emergency use authorization on March 2.[83]

In March, Maldives granted emergency approval for use.[84] 100,000 doses were received on March 25 out of a total of 200,000 donated doses.[85]

By May, Mongolia had received 4 million doses.[86] On March 10, Governor of Ulaanbaatar D. Sumiyabazar and Deputy Prime Minister S. Amarsaikhan received the first doses.[87]

In February, Nepal approved the vaccine for emergency use,[88] and a donation of 800,000 doses arrived on March 29.[89]

In January, Pakistan approved the vaccine for emergency use[90] and began a vaccination campaign on February 2.[14] By April, it had purchased 5.5 million doses.[91]

In March, Palestine received 100,000 doses donated by China.[92]

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.[93] In June, Philippines approved the vaccine for emergency use.[94]

In April, Syria received 150,000 dose donated by China.[95]

In March, Sri Lanka approved emergency use.[96] The country ordered 14 million doses on top of 1.1 million doses previously donated.[97]

In April, Turkmenistan began vaccinating school teachers and medical personnel with the Sinopharm vaccine.[98]

On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following interim Phase III trials.[37] In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis.[30] 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 third booster dose.[99] In May, due to concerns about effectiveness, Bahrain planned to give a third booster dose to some groups at risk, and the United Arab Emirates extended its third booster dose to anyone who had received the second dose more than six months ago.[100]

Africa

In February, Algeria received a donation of 200,000 doses.[101]

In March, Angola received a donation of 200,000 doses.[102]

In April, Cameroon took delivery of 200,000 doses.[103]

In January, Egypt approved use of the vaccine[104] and had purchased 20 million doses, of which 1.5 million had arrived by April.[105] President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.[15]

In March, Ethiopia received a donation of 300,000 doses.[106]

In February, Equatorial Guinea received a donation of 100,000 doses which arrived on February 10. The country began vaccinations on February 15.[107]

In March, Gabon received a donation of 100,000 doses which was the second vaccine approved for use in the country.[108]

In May, Kenya announced plans to buy the vaccine.[109]

Morocco has ordered 40.5 million doses, of which 8.5 million had been delivered by May.[110] Morocco had granted emergency use approval on January 23.[111]

In March, Mauritania received a donation of 50,000 doses[112] and started its vaccination campaign on March 26.[113]

In April, Mauritius received 100,000 doses and ordered an additional 500,000 doses.[114]

In February, Mozambique received a donation of 200,000 doses[115] and planned to start vaccinations on March 8.[116]

In March, Namibia received a donation of 100,000 doses and announced the start of vaccinations in the Khomas and Erongo regions.[117]

In March, Niger received a donation of 400,000 doses with vaccinations to begin on March 27.[118]

In February, Senegal received 200,000 doses[119] and began vaccinating health workers on February 22.[120]

In February, Sierra Leone received a donation of 200,000 doses.[121] It was approved for emergency use and vaccinations began on March 15.[122]

In January, Seychelles began administering vaccinations with 50,000 doses it had received as a gift from the UAE.[123][124] The Seychelles, where the vaccine makes up around 60% of doses administered, saw a surge in cases in early May 2021. Some experts believe this uptick raises questions about the vaccine's effectiveness to reach herd immunity.[27]

In April, Somalia received a donation of 200,000 doses[125] and started vaccinations with the vaccine on April 14.[126][127]

In April, South Africa announced it would order 10 million doses of the vaccine.[128]

In March, Sudan received a donation of 250,000 doses.[129][130]

In March, Republic of the Congo received 100,000 doses with vaccinations prioritizing the medically vulnerable and those over 50.[131]

In May, Zambia approved use of the vaccine.[132]

In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China,[133] and started vaccinations on February 18.[17] Zimbabwe purchased an additional 1.2 million doses.[134]

Europe

In February, Belarus received a donation of 100,000 doses[135] and began using the vaccine on March 15.[23]

In April, Georgia received 100,000 doses with which the country began vaccinations on May 4.[136]

In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses.[137] Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28.[138] 5.2 million doses were delivered to Hungary by May, fulfilling the contract.[139]

In March, Moldova received 2,000 doses donated by the UAE[140] which will be used to vaccinate doctors starting on March 22.[141]

In May, Montenegro received 200,000 doses, which was used to launch the vaccination campaign starting May 4.[142]

In April, North Macedonia received the first 200,000 of 800,000 doses which arrived from Serbia[143] which was used in the vaccination campaign starting May 4.[144]

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 had signed an agreement for an additional 2 million doses.[145]

North America

In February, the Dominican Republic ordered 768,000 doses of BBIBP-CorV.[146]

In March, Dominica received 20,000 doses of BBIBP-CorV which it began using in its vaccination campaign on March 4.[147]

In March, Mexico announced it would order 12 million doses of BBIBP-CorV pending approval by its health regulator.[148]

In March, Trinidad and Tobago announced it would receive 100,000 doses of BBIBP-CorV, once approved by the WHO. The first delivery was expected to arrive on May 18.[149]

In April, Barbados announced it would receive 30,000 doses of BBIBP-CorV, according to Prime Minister Mia Mottley.[150]

Oceania

In April, Solomon Islands receive a donation of 50,000 doses.[151]

In May, Papua New Guinea approved use of 200,000 donated doses.[152]

South America

In February, Argentina authorized emergency use of BBIBP-CorV.[153] Eligibility was expanded to include people older than 60 on March 25.[18] By June 4 million doses had arrived and 6 million more were ordered.[154]

In February, Bolivia purchased 400,000 doses on top of 100,000 doses donated by China,[155] and started its vaccination campaign on February 26.[20] One million more doses were set to arrive in May.[156]

In March, Guyana received a donation of 20,000 doses[157] and later purchased another 100,000 doses. Vaccinations started with elderly and healthcare workers.[158]

In January, Peru purchased 38 million doses of BBIBP-CorV.[159] Peru granted emergency approval on January 27[160] and started vaccinations on February 9.[19]

In March, Venezuela granted approval for the vaccine[161] and the first 500,000 doses arrived on March 2.[162]

Controversies

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.[163] 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.[93] In June, the vaccine was approved for emergency use.[94]

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