BBIBP-CorV

BBIBP-CorV
البيانات السريرية
Routes of
administration
Intramuscular
ATC code
الوضع القانوني
الوضع القانوني
المعرفات
DrugBank
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ECHA InfoCard{{#property:P2566}}

BBIBP-CorV is one of two inactivated virus COVID-19 vaccines being developed by Sinopharm. As of December 2020, it is in Phase III trials in Argentina, Bahrain, Egypt, Morocco, Pakistan, Peru, and the United Arab Emirates (UAE) with over 60,000 participants.[1] By November 2020, nearly one million people had taken the vaccine through China's emergency use program.[1] By December 2020, almost 100,000 people in the UAE had also received the vaccine as part of a voluntary program.[2]

On 30 December 2020, Sinopharm announced the vaccine's efficacy was 79.34%, which was lower than the 86% announced by the United Arab Emirates on December 9. The UAE had based its results on an interim analysis of Phase III trials conducted from July.[3] Both Bahrain and UAE have approved the vaccine for use.[4][5] The UAE will provide BBIBP-CorV for free to all citizens and residents.[6]

BBIBP-CorV uses a similar, more traditional technology as in CoronaVac and BBV152, other inactivated virus vaccines for COVID-19 being developed in Phase III trials.[7][8] Such a technology has been successfully applied in many well known vaccines such as the rabies vaccine.[8] but the lack of public data related to BBIBP-CorV could limit Sinopharm from distributing the vaccine within China and across a variety of other countries.[9][10]

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الأبحاث السريرية


المرحلة الأولى والثانية

In April 2020, China approved clinical trials for a candidate COVID-19 vaccine developed by Sinopharm's Beijing Institute of Biological Products[11] and the Wuhan Institute of Biological Products.[12] 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.[11]

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.[12]

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.[13] 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.[13]

المرحلة الثالثة

آسيا وأفريقيا

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.[14] By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks.[15] 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.[4] The vaccine had a 99% sero-conversion rate of neutralizing antibodies and 100% effectiveness in preventing moderate and severe cases of the disease.[16]

On September 2, Sinopharm began a Phase III trial in Casablanca and Rabat on 600 people.[17][18] In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.[19]

In August 2020, Sinopharm began a Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers.[20][21] In a November update, 7,700 people had volunteered in the Phase III trial.[22] Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.[23][24]

In Pakistan, Sinopharm began working with the University of Karachi on a vaccine trial with 3,000 volunteers,[25] which if successful would allow the country to receive enough doses early in distribution to vaccinate one-fifth of its population.[26]

أمريكا الجنوبية

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.[27] In October, Phase III trials were expanded to include an additional 6,000 volunteers.[28] On January 26, a volunteer who received a placebo in the vaccine trials died of COVID.[29]

On September 16, Argentina began a Phase III trial on 3,000 volunteers through Elea Phoenix Laboratory.[30]


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التصنيع

A Sinopharm facility in Beijing will be able to produce 120 million doses per year while another facility in Wuhan will be able to produce 100 million doses per year.[31] In an October update, Sinopharm said it may have the capacity to produce more than 1 billion doses in 2021.[32]

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.[33]

In December, Egypt announced an agreement between Sinopharm and Egyptian Holding Company for Biological Products & Vaccines (VACSERA) for the vaccine to be manufactured locally,[34] which would also be exported to African countries after being produced.[35]

In December, the AP reported Morocco's initial vaccine doses will come from China, but that the country also plans to produce BBIBP-CorV locally.[36]

التصريح باستخدام الطواريء

الصين

Sinopharm obtained an EUA for one of its COVID-19 vaccine candidates in July. In June, prior to the emergency use program, employees at state firms travelling overseas were allowed to take one of the two vaccines being developed by Sinopharm.[37] In October, it began offering the vaccine for free to Chinese students going abroad for higher studies.[38] In October, Zhejiang, a province with a population of 58.5 million near Shanghai, announced high-risk residents could receive vaccinations starting late November.[39]

البحرين

On November 3, Bahrain granted emergency use authorization (EUA) for the use of Sinopharm's COVID-19 vaccine for frontline workers, according to state news agency BNA. Several ministers and senior officials have received the vaccine in Bahrain, including Salman, Crown Prince of Bahrain.[22]

الإمارات

On 14 September 2020, the UAE approved Sinopharm's COVID-19 vaccine for front-line workers following successful interim Phase III trials. "The results of studies during the final stages of the Phase III trial showed that the vaccine is effective and resulted in a strong response, and the generation of antibodies to the virus." said Minister of Health Abdulrahman Al Owais.[14]

On 3 November 2020, Prime Minister of the UAE and ruler of Dubai Mohammed bin Rashid al-Maktoum received the COVID-19 vaccine.[22]

التسويق والانتشار

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آسيا

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 and saying Bahrain had participated in those trials.[5]

In January, Cambodia Prime Minister Hun Sen said China would provide a million doses of BBIBP-CorV to vaccinate 500,000 people.[40] The Health Ministry granted emergency use authorization on February 4.[41]

In November, China received Sinopharm's regulatory application to launch its vaccine to the general market.[42] On December 30, Sinopharm received conditional approval from the National Medical Products Administration, becoming the first COVID-19 vaccine approved for general use in China.[43][44]

In October, Indonesia reached an agreement with Sinopharm to deliver 15 million dual-dose vaccines in 2020.[45]

In January, Iraq approved of BBIBP-CorV for emergency use.[46]

In January, Jordan approved of BBIBP-CorV for emergency use after previously approving the Pfizer–BioNTech COVID-19 vaccine. Prime Minister Bisher Al-Khasawneh and several other members of the government received the vaccine candidate during its Phase III testing. Jordan started its vaccination campaign on January 13.[47]

In January, Laos began vaccinations on medical workers at hospitals in Vientiane with BBIBP-CorV. Laos expects to vaccinate 1.5 million people in 2021 with doses from Sinopharm, Russia, and COVAX.[48]

In December, Pakistan's announced it would purchase 1.2 million doses of BBIBP-CorV which would be provided free to frontline workers in the first quarter of 2021.[49] Pakistan approved the vaccine for emergency use on January 18,[50] and began its vaccination campaign with BBIBP-Corv on February 2.[51]

In January, Sri Lanka media announced the country would receive a donation 300,000 doses of BBIBP-CorV from China arriving in February.[52]

In December, the United Arab Emirates officially registered BBIBP-CorV after it reviewed the results of the interim analysis.[4] On December 14, Abu Dhabi, began widespread inoculation with BBIBP-CorV on a voluntary basis.[53][54] Some UAE residents were reluctant to take the vaccine.[6] By January 18, more than 1.8 million people in the UAE had received BBIBP-CorV, which is available for free to all citizens and residents.[55]

أفريقيا

Egypt plans to buy 40 million doses of Sinpharm's vaccine.[56] On January 3, Egypt granted regulatory approval for use of BBIBP-CorV.[56] President Abdel Fattah el-Sisi announced the commencement of vaccination in Egypt to be due in 24 January, with health officials being prioritized.[57]

Morocco placed orders for 41 million vaccine doses from Sinopharm and 25 million from AstraZeneca, for a total of 66 million doses.[58] Morocco granted emergency use approval for BBIBP-CorV on January 23,[59] and the first 500,000 doses arrived in Morocco on January 27.[60]

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. Health Minister Peggy Vidot said political leaders will be first vaccinated, then health workers.[61]

In February, Zimbabwe's president Emmerson Mnangagwa announced the country would received 200,000 doses of BBIBP-CorV from China.[62]

أمريكا الجنوبية

In January, Peru's President Francisco Sagasti said the country will receive delivery of one million doses of BBIBP-CorV in January as part of a larger agreement to purchase 38 million doses of BBIBP-CorV.[63] Peru granted emergency approval for BBIBP-CorV on January 27.[64]

أوروپا

In January, Hungary became the European Union's first member state to approve BBIBP-CorV, signing a deal for 5 million doses to enable Hungary to inoculate 2.5 million people, about a quarter of its population. Prime Minister Viktor Orbán said the government had been monitoring the outcome of mass vaccinations using BBIBP-CorV in Serbia.[65]

In January, Montenegro agreed to delivery of doses of BBIBP-Corv by the end of January, according to the Health Ministry.[66]

In January, North Macedonia's Health Minister Venko Filipce said the country was in talks to buy doses of BBIBP-Corv.[67]

In January, Serbia received one million doses of BBIBP-CorV, making it the first European country to receive BBIBP-CorV.[68] On January 19, Serbia approved the vaccine and Health Minister Zlatibor Lončar became the first person to receive the vaccine.[69]

جدل

افتقاد البيانات العامة والثقة

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.[53] 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.[70] Zhengming Chen, a University of Oxford epidemiologist, said, "It's difficult to tell how well the vaccine works. I hope it is real."[10]

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.[10] 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.[44]

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. Some people, including health professionals in China, intended to be cautious about the vaccine. A doctor at a leading hospital in Shandong said, "I am not going to get the vaccine over safety concerns", adding "It is still in clinical trials."[9]

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.[71]

الاستخدام الغير مصرح به في آسيا

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.[72] 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.[73]

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.[74] The Chinese embassy in Japan later expressed its dissatisfaction at the unverified claims by Japanese news media.[75]

انظر أيضاً

المصادر

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وصلات خارجية