BBIBP-CorV, also known as the Sinopharm COVID-19 vaccine, 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.
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.
No detailed efficacy data of the vaccine has been published in peer-review journals.
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 had a 99% sero-conversion rate of neutralizing antibodies and 100% effectiveness in preventing moderate and severe cases of the disease.
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 Chariman 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.
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.
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 November 3, 2020 Bahrain granted emergency use authorization for frontline workers. In December, Bahrain approved Sinopharm's vaccine, citing data from Phase III clinical trials that showed an 86% efficacy rate.
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.
On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following successful 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, have chronic illnesses, or belong to high-risk groups have been given a 3rd booster shot.
Morocco has ordered 40 million doses, of which 2.5 million had arrived in March, with another 10 million arriving in April and May. Morocco first granted emergency use approval on January 23.
In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China, and started vaccinations on February 18. Zimbabwe later purchased an additional 1.2 million doses.
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.
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. 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.
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.
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. Ingming Aberia, an author at The Manila Times commented that FDA director-general Enrique Domingo had reason to believe Sinopharm may cause harm to the consuming public given that no COVID-19 vaccine license was issued, but out of "self-preservation", he would not initiate charges against PSG.
On January 1, Mainichi Shimbun reported that 18 wealthy people, including several owners of leading Japanese companies, have been vaccinated with Sinopharm vaccines 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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