BBIBP-CorV

candidate vaccine against COVID-19

Encyclopedia from Wikipedia, the free encyclopedia


BBIBP-CorV
Sinopharm COVID-19 vaccine (2021) K (cropped).jpeg
Vaccine description
Target diseaseCOVID-19
TypeKilled/Inactivated
Clinical data
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank

BBIBP-CorV 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.[1]

On December 9, the UAE announced interim results from Phase III trials showing BBIBP-CorV had a 86% efficacy against COVID-19 infection.[2] In late December, Sinopharm announced that its internal analysis indicated a 79% efficacy.[3] 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.[4]

BBIBP-CorV shares similar more traditional technology with CoronaVac and BBV152, other inactivated virus vaccines for COVID-19 being developed in Phase III trials.[5][6]

As of February, BBIBP-CorV was being used in vaccination campaigns by certain countries in Asia,[7][8][9] Africa,[10][11][12] South America,[13] and Europe.[14][15] Lack of public data related to BBIBP-CorV could limit Sinopharm from distributing the vaccine within China and across a variety of other countries.[16][17]

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[18] and the Wuhan Institute of Biological Products.[19] 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.[18]

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.[19]

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.[20] 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.[20]

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.[21] By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks.[22] 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.[23] The vaccine had a 99% sero-conversion rate of neutralizing antibodies and 100% effectiveness in preventing moderate and severe cases of the disease.[24]

On September 2, Sinopharm began a Phase III trial in Casablanca and Rabat on 600 people.[25][26] In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.[27]

In August 2020, Sinopharm began a Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers.[28][29] In a November update, 7,700 people had volunteered in the Phase III trial.[30] Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.[31][32]

In Pakistan, Sinopharm began working with the University of Karachi on a vaccine trial with 3,000 volunteers.[33]

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.[34] In October, Phase III trials were expanded to include an additional 6,000 volunteers.[35] On January 26, a volunteer who received a placebo in the vaccine trials died of COVID.[36]

On September 16, Argentina began a Phase III trial on 3,000 volunteers through Elea Phoenix Laboratory.[37]

Manufacturing

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.[38] In an October update, Sinopharm said it may have the capacity to produce more than 1 billion doses in 2021.[39]

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.[40]

In December, Egypt announced an agreement between Sinopharm and Egyptian Holding Company for Biological Products & Vaccines (VACSERA) for the vaccine to be manufactured locally,[41] which would also be exported to African countries after being produced.[42]

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.[43]

Marketing and Distribution

Asia

In November 3, Bahrain granted emergency use authorization of BBIBP-CorV for frontline workers. Several ministers and senior officials received the vaccine, including Salman, Crown Prince of Bahrain.[30] 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.[44]

In February, Brunei received the first batch of Sinopharm vaccines donated by China.[45]

In January, Cambodia Prime Minister Hun Sen said China would provide a million doses of BBIBP-CorV.[46] Cambodia's Health Ministry granted emergency use authorization on February 4[47] and started the vaccination campaign on February 10 with the first batch of 600,000 doses.[48]

In China, Sinopharm obtained an EUA 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.[49] In October, it began offering the vaccine for free to students going abroad for higher studies.[50] On December 30, China's National Medical Products Administration approved BBIBP-CorV for general use in the country.[51][7] In February, Macau received the first 100,000 doses of 400,000 doses ordered from Sinopharm.[52]

In October, Indonesia reached an agreement with Sinopharm to deliver 15 million dual-dose vaccines in 2020.[53]

In January, Iraq approved of BBIBP-CorV for emergency use.[54]

In January, Jordan approved of BBIBP-CorV for emergency use after previously approving the Pfizer–BioNTech COVID-19 vaccine. Jordan started its vaccination campaign on January 13.[55]

In January, Laos began vaccinating medical workers at hospitals in Vientiane with BBIBP-CorV[56] and received another 300,000 doses in early February.[57]

In February, Nepal granted emergency approval for BBIBP-CorV, paving the way to bring 500,000 doses of BBIBP-CorV into the country under grant assistance.[58]

In December, Pakistan's purchased 1.2 million doses of BBIBP-CorV,[59] which was approved for emergency use on January 18,[60] and began a vaccination campaign on February 2.[9]

In January, Sri Lanka it would receive 300,000 doses of BBIBP-CorV donated by China arriving in February.[61]

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.[21] In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis.[23] 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.[8] In February 2021, an exclusive London club highlighted the UAE was running a Covid-19 vaccination programme for wealthy people. The UAE was offering BBIBP-CorV for paying foreign tourists. It was seen as the UAE’s strategy to “bring tourism into the area”, where it neglected the global scarcity of vaccine doses and the requirement to vaccinate the vulnerable.[62]

Africa

Egypt plans to buy 40 million doses of Sinpharm's vaccine[63] which was approved for regulatory use on January 3.[63] President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.[10]

Morocco placed orders for 41 million vaccine doses from Sinopharm and 25 million from AstraZeneca, for a total of 66 million doses.[64] Morocco granted emergency use approval for BBIBP-CorV on January 23,[65] and the first 500,000 doses arrived on January 27.[11]

In February, Namibia received a donation of 100,000 doses of BBIBP-CorV.[66]

In February, Senegal received 200,000 doses in Dakar. President Macky Sall said vaccinations would start soon.[67]

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.[68]

In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China,[69] and started its vaccination campaign on February 18.[12]

South America

In February, Bolivia purchased 400,000 doses on top of 100,000 doses donated by China, which were to arrive in February.[70]

In January, Peru announced an agreement to purchase 38 million doses of BBIBP-CorV.[71] Peru granted emergency approval for BBIBP-CorV on January 27[72] and started the vaccination campaign on February 9 with the first 300,000 doses.[13]

Europe

In February, Belarus received 100,000 doses of BBIBP-CorV.[73]

In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses.[74] The first 550,000 doses arrived in Budapest on February 16.[15]

In January, Montenegro agreed to delivery of doses of BBIBP-Corv by the end of January, according to the Health Ministry.[75]

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.[76]

In January, Serbia received one million doses of BBIBP-CorV, making it the first European country to receive BBIBP-CorV.[77] On January 19, Serbia approved the vaccine and Health Minister Zlatibor Lončar became the first person to receive a shot.[14]

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.[78] 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.[79] Zhengming Chen, a University of Oxford epidemiologist, said, "It's difficult to tell how well the vaccine works. I hope it is real."[17]

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.[17] 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.[7]

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."[16]

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.[80]

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.[81] 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.[82]

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.[83] The Chinese embassy in Japan later expressed its dissatisfaction at the unverified claims by Japanese news media.[84]

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External links

Original content from Wikipedia, shared with licence Creative Commons By-Sa - BBIBP-CorV