Vaccine against COVID-19
Sinopharm BBIBP-CorV, also known as the Sinopharm COVID-19 vaccine, is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. The other inactivated virus COVID-19 vaccine developed by Sinopharm is WIBP-CorV which is comparably less successful. 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. BBIBP-CorV shares similar technology with CoronaVac and BBV152, other inactivated virus vaccines for COVID-19.
On December 9, the UAE announced interim results from Phase III trials showing BBIBP-CorV had a 86% efficacy against COVID-19 infection. In late December, Sinopharm announced that its internal analysis indicated a 79% efficacy. 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.
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. On March 26, Sinopharm said more than 80 million doses had been administered.
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.
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 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. By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks. 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. The vaccine was 100% effectiveness in preventing moderate and severe cases of the disease.
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.
On September 2, Sinopharm began Phase III trial in Casablanca and Rabat on 600 people. In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.
In August 2020, Sinopharm began Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers. In a November update, 7,700 people had volunteered in the trials. Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.
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. In October, the trials were expanded to include an additional 6,000 volunteers. On January 26, a volunteer in the placebo group of the vaccine trials had died.
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. 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.
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
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.
In January, Cambodia said China would provide a million doses. Cambodia granted emergency use authorization on February 4 and started the vaccination campaign on February 10 with the first 600,000 doses.
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. Emergency use approval was still pending.
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 3rd booster shot.
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 percent of doses administered, saw a surge in cases in early May 2021. Some experts believe this uptick raises questions about the vaccine’s effectiveness for reaching herd immunity.
In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses. The first 550,000 doses arrived in Budapest on February 16 and vaccinations started on February 24. Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28.
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.
This section needs to be updated.May 2021)(
Lack of public data
Parts of this article (those related to Lack of public data) need to be updated.May 2021)(
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.[obsolete source] 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.
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.
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.
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.
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