BBIBP-CorV, Sinopharm COVID-19 vaccine

• Inactivated novel coronavirus (2019-CoV) vaccine (Vero cells)
• Purified inactivated SARS-CoV-2 Vaccine

ref Lancet Infectious Diseases (2021), 21(1), 39-51.

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 technology with CoronaVac and BBV152, other inactivated virus vaccines for COVID-19 being developed in Phase III trials.^[6][7]

BBIBP-CorV is 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][18] Sinopharm expects to produce one billion doses of BBIBP-CorV in 2021.^[19] By February 21, Sinopharm said more than 43 million doses of the vaccine had been administered in total.^[20]

BBIBP-CorV vaccine contains a SARS-CoV-2 strain inactivated inside Vero Cells. Investigation shows this vaccine induces neutralizing antibodies in several mammalian species while also showing protective efficacy with SARS-CoV-2 challenge in rhesus macaques². As of August 2020, this vaccine is being tested for prophylaxis against COVID-19 in human clinical trials.

A vaccination certificate of BBIBP-CorV (Beijing Institute of Biological Products, Sinopharm).

Clinical research

Main article: COVID-19 vaccine

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^[21] and the Wuhan Institute of Biological Products.^[22] 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.^[21]

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.^[22]

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.^[23] 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.^[23]

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.^[24] By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks.^[25] 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.^[26] The vaccine had a 99% sero-conversion rate of neutralizing antibodies and 100% effectiveness in preventing moderate and severe cases of the disease.^[27]

On September 2, Sinopharm began a Phase III trial in Casablanca and Rabat on 600 people.^[28][29] In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.^[30]

In August 2020, Sinopharm began a Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers.^[31][32] In a November update, 7,700 people had volunteered in the trials.^[33] Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.^[34][35]

In Pakistan, Sinopharm began working with the University of Karachi on a trial with 3,000 volunteers.^[36]

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.^[37] In October, the trials were expanded to include an additional 6,000 volunteers.^[38] On January 26, a volunteer in the placebo group of the vaccine trials had died.^[39]

On September 16, Argentina began a Phase III trial with 3,000 volunteers.^[40]

Manufacturing

Sinopharm’s Chariman Yang Xioyun has said the company could produce one billion doses in 2021.^[19]

In October, Dubai’s G42 Healthcare reached manufacturing agreements to provide UAE and other regional states with BBIBP-CorV, with the UAE producing 75 to 100 million doses in 2021.^[41]

In December, Egypt announced an agreement between Sinopharm and Egyptian Holding Company for Biological Products & Vaccines (VACSERA) for the vaccine to be manufactured locally,^[42] which would also be exported to other African countries.^[43]

In December, AP reported Morocco plans to produce BBIBP-CorV locally.^[44]

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, deputy prime minister Branislav Nedimović noted.^[45]

In March, Belarus was looking to produce BBIBP-CorV locally.^[18]

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.^[20]

Asia

In February, Afghanistan was pledged 400,000 doses of BBIBP-CorV by China.^[82]

In November 3, 2020 Bahrain granted emergency use authorization of BBIBP-CorV for frontline workers.^[33] In December, Bahrain approved Sinopharm’s vaccine, citing data from Phase III clinical trials that showed an 86% efficacy rate.^[87]

In February, Brunei received the first batch of Sinopharm vaccines donated by China.^[84]

In January, Cambodia said China would provide a million doses.^[88] Cambodia granted emergency use authorization on February 4^[89] and started the vaccination campaign on February 10 with the first 600,000 doses.^[90]

In China, Sinopharm obtained an EUA in July.^[91] In October, it began offering the vaccine for free to students going abroad for higher studies.^[92] On December 30, China‘s National Medical Products Administration approved BBIBP-CorV for general use.^[93][8] In February, Macau received the first 100,000 doses of 400,000 doses.^[94]

In October, Indonesia reached an agreement with Sinopharm to deliver 15 million dual-dose vaccines in 2020.^[95]

In February, Iran approved emergency use of BBIBP-CorV,^[96] and received the first batch of 250,000 doses on February 28.^[97]

In January, Iraq approved BBIBP-CorV for emergency use^[98] and has signed agreements for 2 million doses. The first doses arrived on March 2.^[99]

In January, Jordan approved BBIBP-CorV for emergency use^[100] and started its vaccination campaign on January 13.^[101]

In March, Kyrgyzstan received a donation of 150,000 doses of the vaccine.^[102]

In January, Laos began vaccinating medical workers at hospitals in Vientiane ^[103] and received another 300,000 doses in early February.^[104]

In March, Lebanon received a donation of 50,000 doses at its request,^[105] for which it granted emergency use authorization on March 2.^[106]

In March, Maldives granted emergency approval for use. At the time of approval, the country had received 18,000 doses and was awaiting 200,000 additional doses.^[107]

In February, Mongolia received a donation of 300,000 doses.^[108] On March 10, Governor of Ulaanbaatar D. Sumiyabazar and Deputy Prime Minister S. Amarsaikhan received the first doses of BBIBP-CorV.^[109]

In February, Nepal approved the vaccine for emergency use, allowing a donation of 500,000 doses to enter the country.^[110]

In December, Pakistan‘s purchased 1.2 million doses,^[111] which was approved for emergency use on January 18,^[112] and began a vaccination campaign on February 2.^[10]

In March, Palestine said it would receive 100,000 doses donated by China.^[113]

In March 19, Sri Lanka approved the vaccine for emergency use, allowing a donation of 600,000 doses by China to enter the country.^[114]

On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following successful interim Phase III trials.^[24] In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis.^[26] 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.^[115]

Africa

In February, Algeria received a donation of 200,000 doses.^[83]

Egypt plans to buy 40 million doses of Sinpharm’s vaccine^[116] which was approved for regulatory use on January 3.^[116] President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.^[11]

In February, Equatorial Guinea received a donation of 100,000 doses which arrived on February 10. The country began vaccinations on February 15.^[56]

In March, Gabon received a donation of 100,000 doses which was the second vaccine approved for use in the country.^[117]

Morocco placed orders for 41 million vaccine doses from Sinopharm and 25 million from AstraZeneca, for a total of 66 million doses.^[118] Morocco granted emergency use approval on January 23,^[119] and the first 500,000 doses arrived on January 27.^[12]

In February, Mozambique received a donation of 200,000 doses^[120] and planned to start vaccinations on March 8.^[121]

In March, Namibia received a donation of 100,000 doses and announced the start of vaccinations in the Khomas and Erongo regions.^[122]

In March, Niger received a donation of 400,000 doses with vaccinations to begin on March 27.^[123]

In February, Senegal received 200,000 doses in Dakar^[124] and began vaccinating health workers on February 22.^[125]

In February, Sierra Leone received a donation of 200,000 doses.^[126] It was approved for emergency use and vaccinations began on March 15.^[127]

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.^[128]

In March, Republic of the Congo received 100,000 doses with vaccinations prioritizing the medically vulnerable and those over 50.^[129]

In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China,^[130] and started vaccinations on February 18.^[13] Zimbabwe later purchased an additional 1.2 million doses.^[131]

North America

In February, the Dominican Republic ordered 768,000 doses of BBIBP-CorV.^[132]

In March, Dominica received 20,000 doses of BBIBP-CorV which it began using in its vaccination campaign on March 4.^[133]

In March, Mexico announced it would order 12 million doses of BBIBP-CorV pending approval by its health regulator.^[134]

South America

In February, Argentina authorized emergency use of BBIBP-CorV^[135] ahead of the arrival of 904,000 doses on February 26.^[136]

In February, Bolivia purchased 400,000 doses on top of 100,000 doses donated by China,^[137] and started its vaccination campaign on February 26.^[15]

In March, Guyana received a donation of 20,000 doses of BBIBP-CorV.^[138] Vaccinations were to start on March 7.^[139]

In January, Peru purchased 38 million doses of BBIBP-CorV.^[140] Peru granted emergency approval for BBIBP-CorV on January 27^[141] 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.^[142] The first 500,000 doses arrived on March 2.^[143]

Europe

In February, Belarus received a donation of 100,000 doses^[144] and began using the vaccine on March 15.^[18]

In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses.^[145] The first 550,000 doses arrived in Budapest on February 16^[146] and vaccinations started on February 24.^[17] Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28.^[147]

In March, Moldova received 2,000 doses donated by the UAE^[148] which will be used to vaccinate doctors at the State University of Mediecne and Pharmacy starting on March 22.^[149]

In March 3, Montenegro received a donation of 30,000 doses of BBIBP-CorV.^[85]

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.^[150]

In January, Serbia received one million doses, making it the first country in Europe to receive BBIBP-CorV.^[151] On January 19, Serbia approved the vaccine and Health Minister Zlatibor Lončar became the first person to receive a shot.^[16]

Controversies

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.^[152] 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.^[153]

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.^[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.^[154]

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.^[155] 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.^[156]

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.^[157] The Chinese embassy in Japan later expressed its dissatisfaction at the unverified claims by Japanese news media.^[158]

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External links

• “How the Sinopharm Covid-19 Vaccine Works”. The New York Times.

How the Sinopharm Vaccine Works

By Jonathan Corum and Carl ZimmerUpdated March 22, 2021Leer en español

In early 2020, the Beijing Institute of Biological Products created an inactivated coronavirus vaccine called BBIBP-CorV. Clinical trials run by the state-owned company Sinopharm showed that it had an efficacy rate of 79 percent. China approved the vaccine and soon began exporting it to other countries.

A Vaccine Made From Coronaviruses

BBIBP-CorV works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface.

Spikes

Spike

protein

gene

CORONAVIRUS

To create BBIBP-CorV, the Beijing Institute researchers obtained three variants of the coronavirus from patients in Chinese hospitals. They picked one of the variants because it was able to multiply quickly in monkey kidney cells grown in bioreactor tanks.

Killing the Virus

Once the researchers produced large stocks of the coronaviruses, they doused them with a chemical called beta-propiolactone. The compound disabled the coronaviruses by bonding to their genes. The inactivated coronaviruses could no longer replicate. But their proteins, including spike, remained intact.

Beta-

propiolactone

INACTIVATED

CORONAVIRUS

Inactivated

genes

The researchers then drew off the inactivated viruses and mixed them with a tiny amount of an aluminum-based compound called an adjuvant. Adjuvants stimulate the immune system to boost its response to a vaccine.

Inactivated viruses have been used for over a century. Jonas Salk used them to create his polio vaccine in the 1950s, and they’re the bases for vaccines against other diseases including rabies and hepatitis A.

Prompting an Immune Response

Because the coronaviruses in BBIBP-CorV are dead, they can be injected into the arm without causing Covid-19. Once inside the body, some of the inactivated viruses are swallowed up by a type of immune cell called an antigen-presenting cell.

INACTIVATED

CORONAVIRUS

Engulfing

the virus

ANTIGEN-

PRESENTING

CELL

Digesting

virus proteins

Presenting

virus protein

fragments

HELPER

T CELL

The antigen-presenting cell tears the coronavirus apart and displays some of its fragments on its surface. A so-called helper T cell may detect the fragment. If the fragment fits into one of its surface proteins, the T cell becomes activated and can help recruit other immune cells to respond to the vaccine.

Making Antibodies

Another type of immune cell, called a B cell, may also encounter the inactivated coronavirus. B cells have surface proteins in a huge variety of shapes, and a few might have the right shape to latch onto the coronavirus. When a B cell locks on, it can pull part or all of the virus inside and present coronavirus fragments on its surface.

A helper T cell activated against the coronavirus can latch onto the same fragment. When that happens, the B cell gets activated, too. It proliferates and pours out antibodies that have the same shape as their surface proteins.

ACTIVATED

HELPER

T CELL

INACTIVATED

CORONAVIRUS

Activating

the B cell

Matching

surface proteins

B CELL

SECRETED

ANTIBODIES

Stopping the Virus

Once vaccinated with BBIBP-CorV, the immune system can respond to an infection of live coronaviruses. B cells produce antibodies that stick to the invaders. Antibodies that target the spike protein can prevent the virus from entering cells. Other kinds of antibodies may block the virus by other means.

ANTIBODIES

LIVE

VIRUS

Remembering the Virus

Sinopharm’s clinical trials have demonstrated that BBIBP-CorV can protect people against Covid-19. But no one can yet say how long that protection lasts. It’s possible that the level of antibodies drops over the course of months. But the immune system also contains special cells called memory B cells that might retain information about the coronavirus for years or even decades.

Vaccine Timeline

January, 2020 Sinopharm begins developing an inactivated vaccine against the coronavirus.

June Researchers report the vaccine produces promising results in monkeys. A Phase 1/2 trial shows that the vaccine doesn’t cause any serious side effects and enables people to make antibodies against the coronavirus.

A Sinopharm production plant in Beijing.Zhang Yuwei/Xinhua, via Associated Press

July A Phase 3 trial begins in the United Arab Emirates.

August Phase 3 trials begin in Morocco and Peru.

Preparing a Sinopharm dose in Lima, Peru.Ernesto Benavides/Agence France-Presse

Sept. 14 The U.A.E. gives emergency approval for Sinopharm’s vaccine to use on health care workers. Government officials and others begin to receive it.

November The chairman of Sinopharm says almost a million people in China have received Sinopharm vaccines.

Nov. 3 The ruler of Dubai, Sheikh Mohammed bin Rashid al-Maktoum, announces he received the vaccine.

Sheikh Mohammed before receiving the vaccine.Agence France-Presse

Dec. 9 The U.A.E. gives full approval to BBIBP-CorV, announcing it has an efficacy rate of 86 percent. But the government did not release any details with their announcement, leaving it unclear how they had come to their conclusions.

Dec. 13 Bahrain also approves the vaccine.

Vials of the Sinopharm vaccine at a packaging plant.Zhang Yuwei/Xinhua, via Associated Press

Dec. 30 Sinopharm announces that the vaccine has an efficacy of 79.34 percent, leading the Chinese government to approve it. The company has yet to publish detailed results of their Phase 3 trial.

Jan. 3, 2021 Egypt authorizes the vaccine for emergency use.

Sources: National Center for Biotechnology Information; Science; The Lancet; Lynda Coughlan, University of Maryland School of Medicine; Jenna Guthmiller, University of Chicago.

Data

/////////////BBIBP-CorV, Sinopharm,  COVID-19 vaccine, china, covid 19, corona virus, vaccine

#BBIBP-CorV, #Sinopharm,  #COVID-19 vaccine, #china, #covid 19, #corona virus, #vaccine