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BBIBP-CorV, also known as the Sinopharm COVID-19 vaccine, 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. BBIBP-CorV shares similar technology with CoronaVac and Covaxin, other inactivated virus vaccines for COVID-19. Its product name is SARS-CoV-2 Vaccine (Vero Cell), not to be confused with the similar product name of CoronaVac.
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). In December 2020, the UAE previously announced interim results showing 86% efficacy.
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.
BBIBP-CorV is being used in vaccination campaigns by certain countries in Asia, Africa, South America, and Europe. Sinopharm expects to produce one billion doses of BBIBP-CorV in 2021. By May, Sinopharm had supplied 200 million doses.
The other inactivated virus vaccine developed by Sinopharm is WIBP-CorV.
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.
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. These results were previously published with the WHO in April.
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. 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.
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. 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.
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. 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. 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.
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) and the Wuhan Institute of Biological Products (WIBP-CorV). 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.
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. 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.
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. In June, Sinopharm began Phase III trials for children and adolescents aged 3–17 with 1,800 volunteers.
Sinopharm's Chairman Yang Xioyun has said the company could produce one billion doses in 2021.
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.
In December, Egypt announced an agreement between Sinopharm and Egypt's VACSERA for the vaccine to be manufactured locally.
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.
In March, Belarus was looking to produce BBIBP-CorV locally.
In April, Bangladesh approved local production of BBIBP-CorV.
Marketing and Distribution
By May, Sinopharm had supplied 200 million doses across all countries. 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).
In China, Sinopharm obtained an EUA in July. On December 30, China's National Medical Products Administration approved BBIBP-CorV for general use. In February, Macau received the first 100,000 doses of 400,000 doses.
In April, Indonesia approved emergency use. Indonesia is looking to procure 15 million doses of which 482,000 doses arrived on April 30. 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.
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. In June, Philippines approved the vaccine for emergency use.
On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following interim Phase III trials. In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis. 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. 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.
In January, Egypt approved use of the vaccine and had purchased 20 million doses, of which 1.5 million had arrived by April. President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.
In January, Seychelles began administering vaccinations with 50,000 doses it had received as a gift from the UAE. 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.
In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses. Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28. 5.2 million doses were delivered to Hungary by May, fulfilling the contract.
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.
In February, Argentina authorized emergency use of BBIBP-CorV. Eligibility was expanded to include people older than 60 on March 25. By June 4 million doses had arrived and 6 million more were ordered.
In February, Bolivia purchased 400,000 doses on top of 100,000 doses donated by China, and started its vaccination campaign on February 26. One million more doses were set to arrive in May.
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. 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. In June, the vaccine was approved for emergency use.
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The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell).
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|Scholia has a profile for BBIBP-CorV (Q97154230).|