![]() A vial of the BBIBP-CorV COVID‑19 vaccine | |
Vaccine description | |
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Target | SARS-CoV-2 |
Type | Killed/Inactivated |
Clinical data | |
Routes of administration | Intramuscular |
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Part of a series on the |
COVID-19 pandemic |
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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]
On December 9, the UAE announced interim results from Phase III trials showing BBIBP-CorV had a 86% efficacy against COVID-19 infection.[3] In late December, Sinopharm announced that its internal analysis indicated a 79% efficacy.[4] While mRNA vaccines like the Pfizer–BioNTech COVID-19 vaccine and mRNA-1273 showed higher efficacy of +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.[5]
BBIBP-CorV shares similar more traditional technology with CoronaVac and BBV152, other inactivated virus vaccines for COVID-19 being developed in Phase III trials.[6][7]
BBIBP-CorV was being used in vaccination campaigns by certain countries in Asia,[8][9][10] Africa,[11][12][13] South America,[14][15] and Europe.[16][17] Sinopharm expects to produce one billion doses of BBIBP-CorV in 2021.[18] By February 21, Sinopharm said more than 43 million doses of the vaccine had been administered in total.[19]
Lack of public data related to BBIBP-CorV could limit Sinopharm from distributing the vaccine within China and across a variety of other countries.[20][21]
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[22] and the Wuhan Institute of Biological Products.[23] 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.[22]
On August 13, the Wuhan Institute of Biological Products published interim results of its Phase I (96 adults) and Phase II (224 adults) clinical studies. The report noted the inactivated COVID-19 vaccine had a low rate of adverse reactions and demonstrated immunogenicity, but longer-term assessment of safety and efficacy would require Phase III trials.[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 mRNA-1273 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.[24] 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.[24]
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.[25] By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks.[26] 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.[27] The vaccine had a 99% sero-conversion rate of neutralizing antibodies and 100% effectiveness in preventing moderate and severe cases of the disease.[28]
On September 2, Sinopharm began a Phase III trial in Casablanca and Rabat on 600 people.[29][30] In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.[31]
In August 2020, Sinopharm began a Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers.[32][33] In a November update, 7,700 people had volunteered in the Phase III trial.[34] Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.[35][36]
In Pakistan, Sinopharm began working with the University of Karachi on a vaccine trial with 3,000 volunteers.[37]
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.[38] In October, Phase III trials were expanded to include an additional 6,000 volunteers.[39] On January 26, a volunteer in the placebo group of the vaccine trials had died.[40]
On September 16, Argentina began a Phase III trial on 3,000 volunteers through Elea Phoenix Laboratory.[41]
Manufacturing
Sinopharm's Chariman Yang Xioyun has said the company could produce one billion doses in 2021.[18]
In October, Dubai's G42 Healthcare reached manufacturing agreements with Sinopharm to provide UAE and other regional states with BBIBP-CorV, with the UAE producing 75 to 100 million doses in 2021.[42]
In December, Egypt announced an agreement between Sinopharm and Egyptian Holding Company for Biological Products & Vaccines (VACSERA) for the vaccine to be manufactured locally,[43] which would also be exported to other African countries.[44]
In December, AP reported Morocco's initial vaccines will come from China, but that the country also plans to produce BBIBP-CorV locally.[45]
Marketing and Distribution
On February 21, 2021 Sinopharm said more than 43 million doses of BBIBP-CorV had been administered so far, including more than 34 million administered in China and the rest internationally.[19]
Asia
In February, Afghanistan was pledged 400,000 doses of BBIBP-CorV by China.[46]
In November 3, 2020 Bahrain granted emergency use authorization of BBIBP-CorV for frontline workers. Several ministers received the vaccine, including Salman, Crown Prince of Bahrain.[34] In December, Bahrain's National Health Regulatory Authority approved Sinopharm's vaccine, citing data from Phase III clinical trials that showed an 86% efficacy rate.[47]
In February, Brunei received the first batch of Sinopharm vaccines donated by China.[48]
In January, Cambodia said China would provide a million doses.[49] Cambodia's Health Ministry granted emergency use authorization on February 4[50] and started the vaccination campaign on February 10 with the first batch of 600,000 doses.[51]
In China, Sinopharm obtained an EUA in July.[52] In October, it began offering the vaccine for free to students going abroad for higher studies.[53] On December 30, China's National Medical Products Administration approved BBIBP-CorV for general use.[54][8] In February, Macau received the first 100,000 doses of 400,000 doses.[55]
In October, Indonesia reached an agreement with Sinopharm to deliver 15 million dual-dose vaccines in 2020.[56]
In February, Iran approved emergency use of BBIBP-CorV,[57] and received the first batch of 250,000 doses on February 28.[58]
In January, Iraq approved BBIBP-CorV for emergency use[59] and has signed agreements for 2 million doses. The first 50,000 doses arrived on March 2.[60]
In January, Jordan approved BBIBP-CorV for emergency use[61] and started its vaccination campaign on January 13.[62]
In January, Laos began vaccinating medical workers at hospitals in Vientiane with BBIBP-CorV[63] and received another 300,000 doses in early February.[64]
In March, Lebanon received a donation of 50,000 doses at its request,[65] for which it granted emergency use authorization on March 2.[66]
In February, Mongolia received 300,000 doses donated by China.[67]
In February, Nepal granted emergency approval for BBIBP-CorV, paving the way to bring 500,000 doses into the country under grant assistance.[68]
In December, Pakistan's purchased 1.2 million doses ,[69] which was approved for emergency use on January 18,[70] and began a vaccination campaign on February 2.[10]
In January, Sri Lanka said it would receive 300,000 doses of donated by China arriving in February.[71]
On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following successful interim Phase III trials.[25] In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis.[27]
Africa
In February, Algeria received a donation of 200,000 doses of BBIBP-CorV.[72]
Egypt plans to buy 40 million doses of Sinpharm's vaccine[73] which was approved for regulatory use on January 3.[73] President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.[11]
Morocco placed orders for 41 million vaccine doses from Sinopharm and 25 million from AstraZeneca, for a total of 66 million doses.[74] Morocco granted emergency use approval for BBIBP-CorV on January 23,[75] and the first 500,000 doses arrived on January 27.[12]
In February, Mozambique received a donation of 200,000 doses of BBIBP-CorV[76] and planned to start vaccinations on March 8.[77]
In February, Namibia received a donation of 100,000 doses of BBIBP-CorV.[78]
In February, Senegal received 200,000 doses in Dakar[79] and began vaccinating health workers on February 22.[80]
In February, Sierra Leone received a donation of 200,000 doses of BBIBP-CorV.[81]
In January, Seychelles said it would begin administering vaccinations on January 10 with 50,000 doses it had received as a gift from the UAE.[82]
In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China,[83] and started its vaccination campaign on February 18.[13] On February 24 Zimbabwe purchased an additional 1.2 million doses at preferential prices.[84]
North America
In February, the Dominican Republic ordered 768,000 doses of BBIBP-CorV.[85]
In March, Dominica received 20,000 doses of BBIBP-CorV which it began using in its vaccination campaign on March 4.[86]
South America
In February, Argentina authorized emergency use of BBIBP-CorV[87] ahead of the arrival of 904,000 doses on February 26.[88]
In February, Bolivia purchased 400,000 doses on top of 100,000 doses donated by China,[89] and started its vaccination campaign on February 26.[15]
In March, Guyana received a donation of 20,000 doses of BBIBP-CorV.[90] Vaccinations were to start on March 7.[91]
In January, Peru purchased 38 million doses of BBIBP-CorV.[92] Peru granted emergency approval for BBIBP-CorV on January 27[93] and started vaccinations on February 9 with the first 300,000 doses.[14]
In March, Venezuela granted approval for BBIBP-CorV to be used in the country.[94] The first 500,000 doses arrived on March 2.[95]
Europe
In January, Serbia received one million doses, making it the first country in Europe to receive BBIBP-CorV.[96] On January 19, Serbia approved the vaccine and Health Minister Zlatibor Lončar became the first person to receive a shot.[16]
In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses.[97] The first 550,000 doses arrived in Budapest on February 16[98] and vaccinations started on February 24.[17] Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28.[99]
In February, North Macedonia signed an agreement for 200,000 doses of BBIBP-CorV, with which they hoped to launch their vaccination program later that month.[100]
In February, Belarus received a donation of 100,000 doses of BBIBP-CorV.[101]
In March 3, Montenegro received a donation of 30,000 doses of BBIBP-CorV.[102]
Controversies
Lack of public data and trust
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.[103] 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.[104] Zhengming Chen, a University of Oxford epidemiologist, said, "It's difficult to tell how well the vaccine works. I hope it is real."[21]
The lack of public data could limit Sinopharm from sending the vaccine to a variety of other countries, as confidence in BBIBP-CorV's safety and efficacy will be crucial to its successful rollout internationally. Chen said that to convince other countries to follow suit requires solid scientific evidence and robust data that are open to scrutiny.[21] As of December 30, 2020, no detailed efficacy data of the vaccine has been released to the public. Jin said while China's recent approval could boost BBIBP-CorV's credibility, more data is needed if it is to take a share in the global market. 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.[20]
In January 2021, the government of the Philippines acknowledged the public's hesitation over safety concerns about COVID-19 vaccines and commented on a foreign news report about BBIBP-CorV, which listed 73 side effects, including loss of vision and taste as well as blood pressure increase. The government said the FDA would carefully review all documents, including the report on the 73 adverse reactions, should Sinopharm apply for clinical trial or emergency use.[105]
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.[106] 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.[107]
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 Chinese Communist Party.[108] The Chinese embassy in Japan later expressed its dissatisfaction at the unverified claims by Japanese news media.[109]
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- ^ Dancel R. "Philippine officials under fire from critics, health authorities for unsanctioned Covid-19 vaccinations". The Straits Times.
- ^ Aberia, Ingming (6 January 2021). "Did Sinopharm forget that Duque exists?". The Manila Times. Retrieved 9 January 2021.
- ^ "水面下で出回る中国ワクチン 富裕層から永田町へ? 狙われる日本市場". Mainichi Daily News (in Japanese). 2020-12-31. Retrieved 2021-01-02.
- ^ Elmer, Keegan (January 3, 2021). "Beijing responds to claims Japanese were given unapproved Sinopharm jabs". South China Morning Post. Retrieved January 9, 2021.
External links
- "How the Sinopharm Covid-19 Vaccine Works". The New York Times.