BBIBP-CorV

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BBIBP-CorV
Vaccine description
Target diseaseCOVID-19
Clinical data
Routes of
administration		Intramuscular injection
Legal status
Legal status
Identifiers
DrugBank
Part of a series on the
COVID-19 pandemic
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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 across a variety of other countries.[9]

Clinical research[edit]

Main article: COVID-19 vaccine

Phases I and II[edit]

In April 2020, China approved clinical trials for a candidate COVID-19 vaccine developed by Sinopharm's Beijing Institute of Biological Products[10] and the Wuhan Institute of Biological Products.[11] 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.[10]

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.[11]

BIBP-CorV may have characteristics favorable for vaccinating people in the developing world. While mRNA vaccines, such as tozinameran and mRNA-1273 showed higher efficacy of +90%, mRNA vaccines present distribution challenges for some nations, as they require deep-freeze facilities and trucks. By contrast, BIBP-CorV can be transported and stored at normal refrigeration temperatures.[12] 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.[12]

Phase III[edit]

Asia[edit]

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 AI and cloud computing company.[13] By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks.[14] 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.[15]

On September 2, Sinopharm began a Phase III trial in Casablanca and Rabat on 600 people.[16][17] In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.[18]

In August 2020, Sinopharm began a Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers.[19][20] In a November update, 7,700 people had volunteered in a Phase III trial and had received a second dose.[21] Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.[22][23]

In Pakistan, Sinopharm began working with the University of Karachi on a vaccine trial with 3,000 volunteers,[24] which if successful would allow the country to receive enough doses early in distribution to vaccinate one-fifth of its population.[25]

South America[edit]

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.[26] In October, researchers announced that the Phase III trial would be expanded to include an additional 6,000 volunteers.[27] On December 12, Peru suspended trials for Sinopharm's vaccine as a safety measure after a volunteer experienced decreased strength in his legs before resuming them on December 16.[28]

On September 16, Argentina began a Phase III trial on 3,000 volunteers through Elea Phoenix Laboratory.[29]

Manufacturing[edit]

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.[30] In an October update, Sinopharm said it may have the capacity to produce more than 1 billion doses in 2021.[31]

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.[32]

In December, Egypt announced an agreement between Sinopharm and Egyptian Holding Company for Biological Products & Vaccines (VACSERA) for the vaccine to be manufactured locally,[33] which would also be exported to African countries after being produced.[34]

In December, AP reported Morocco's initial vaccine doses will come from China, but that the country also plans to produce BBIBP-CorV locally.[35]

Emergency use authorization[edit]

China[edit]

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.[36] In October, it began offering the vaccine for free to Chinese students going abroad for higher studies.[37] In October, Zhejiang, a province with a population of 58.5 million near Shanghai, announced high-risk residents could receive vaccinations starting late November.[38]

Bahrain[edit]

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.[21]

UAE[edit]

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.[13]

On 3 November 2020, Prime Minister of the UAE and ruler of Dubai Mohammed bin Rashid al-Maktoum received the COVID-19 vaccine.[21]

By December 2020, CNN reported that almost 100,000 people in the UAE had received the vaccine as part of a voluntary program.[2]

Market and deployment[edit]

Bahrain[edit]

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]

China[edit]

In November, Sinopharm filed for regulatory approve in China to launch its vaccine to the general market. The application likely includes data from the company's Phase III human testing conducted in the Middle East and South America.[39] 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.[40][41]

Egypt[edit]

Egypt plans to buy 40 million doses of Sinpharm's vaccine.[42] On December 10, the first 50,000 doses of BBIBP-CorV arrived at Cairo International Airport as a gift from the UAE, according to Minister of Health Hala Zayed. Medical staff working in isolation hospitals and patients with kidney, heart, and other chronic diseases were to receive priority access to the vaccine.[43] On January 3, Egypt granted regulatory approval for use of BBIBP-CorV, with the vaccination campaign expected to get under way in January.[42]

Indonesia[edit]

In October, Indonesia reached an agreement with Sinopharm to deliver 15 million dual-dose vaccines in 2020.[44] On November 13, Indonesia's President Joko Widodo said the country would start a mass vaccination campaign in December. Sinopharm's vaccine as well as CoronaVac will be used in the early stages of the campaign. In 2020–21, the companies will provide 18 million vaccines, including 15 million that will be manufactured by state-owned Bio Farma.[45]

Morocco[edit]

In November, Mohammed VI of Morocco ordered a massive vaccination campaign to start in mid-December. Front-line staff, including healthcare workers, public authorities, security forces, and national education employees, would get priority access besides the elderly and people vulnerable to the virus.[46] Morocco is scheduling 10 flights throughout December to bring 10 million doses of the vaccine, enough to initially vaccinate 5 million people in the first stage.[47] Morocco's Health Minister Khalid Ait Taleb announced that the country would receive 10 million doses of Sinopharm's vaccine starting in December.[46] It is part of a broader program to acquire 65 million doses from Sinopharm and AstraZeneca, as the country aims to immunize 80% of its adult population.[35]

Pakistan[edit]

In December, Pakistan's Ministry of Science and Technology 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.[48]

Serbia[edit]

In December, Prime Minister Ana Brnabić said shipments of BBIBP-CorV and Gam-COVID-Vac were expected to arrive soon, but didn't give a specific date. She said President Aleksandar Vučić would most likely get BBIBP-CorV, as “we agreed that the two us take shots from different producers.” Brnabic received Serbia's first COVID-19 vaccine Tozinameran, kicking off the mass inoculation drive in the country.[49]

UAE[edit]

BBIBP-CorV was officially registered on December 9 after the UAE reviewed the results of the interim analysis.[4] On December 14, Abu Dhabi, began widespread inoculation with BBIBP-CorV on a voluntary basis via the Abu Dhabi Health Services clinics.[50][51] The UAE will provide BBIBP-CorV for free to all citizens and residents.[6]

Controversies[edit]

Lack of public data and trust[edit]

Unlike MRNA-1273, AZD1222, and Ad26.COV2.S, there is little public information about the Chinese vaccine's safety or efficacy.[50] 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.[52] Zhengming Chen, a University of Oxford epidemiologist, said, "It's difficult to tell how well the vaccine works. I hope it is real."[9] The Financial Times reported that some UAE residents were reluctant to take the vaccine.[6]

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. Jin Dong-Yan, a virologist at the University of Hong Kong, was concerned that countries might have to decide whether to accept the vaccine without independent analysis or not to use it at all.[9]

As of December 30, 2020, no detailed efficacy data of the vaccine had been released to the public. Dong-Yan 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.[41]

Unauthorized use in Asia[edit]

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, 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.[53]

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.[54]

See also[edit]

References[edit]

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