BBIBP-CorV

BBIBP-CorV
BBIBP-CorV, also known as the Sinopharm COVID-19 vaccine or BIBP vaccine, is one of two inactivated virus COVID-19 vaccines developed by Sinopharm's Beijing Institute of Biological Products (sometimes written as Beijing Bio-Institute of Biological Products, resulting in the two different acronyms BBIBP and BIBP for the same vaccine).

It completed Phase III trials in Argentina, Bahrain, Egypt, Morocco, Pakistan, Peru, and the United Arab Emirates (UAE) with over 60,000 participants.

BBIBP-CorV shares similar technology with CoronaVac and Covaxin, other inactivated virus vaccines for COVID-19.

Its product name is SARS-CoV-2 Vaccine (Vero Cell), not to be confused with the similar product name of CoronaVac.Peer-reviewed results published in JAMA of Phase III trials in United Arab Emirates and Bahrain showed BBIBP-CorV 78.1% effective against symptomatic cases and 100% against severe cases (21 cases in vaccinated group vs. 95 cases in placebo group).

In December 2020, the UAE previously announced interim results showing 86% efficacy.While mRNA vaccines like the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine showed higher efficacy of over 90%, those present distribution challenges for some nations as they require deep-freeze facilities and trucks.

BBIBP-CorV could be transported and stored at normal refrigerated temperatures.BBIBP-CorV is being used in vaccination campaigns by certain countries in Asia, Africa, South America, and Europe.

Sinopharm expects to produce one billion doses of BBIBP-CorV in 2021. By May, Sinopharm had supplied 200 million doses.On 7 May 2021, the World Health Organization approved the vaccine for use in COVAX. Sinopharm has signed purchase agreements for 170 million doses from COVAX.The other inactivated virus vaccine developed by Sinopharm is WIBP-CorV.

Medical uses

The vaccine is given by intramuscular injection into the deltoid muscle.

The initial course consists of two doses, and there is no evidence that a third booster dose dose is needed.

The World Health Organization (WHO) recommends an interval of 3 to 4 weeks between doses.

Effectiveness

Real-world test-negative analysis in Bahrain (based on 14 days post 2nd dose) indicated a vaccine effectiveness of 90% (95% CI, 88–91%) for adults aged 18–59, and 91% (87–94%) for those 60 year old or older. Due to low participation in studies, WHO experts expressed very low confidence in the safety of BBIBP-CorV for people with comorbidities, pregnant women and the elderly, while being confident in its overall efficacy.In April 2021, a study conducted by the Abu Dhabi Public Health Centre found the vaccine was 93% effective in preventing hospitalization and 95% effective against admission to intensive care. The study found no deaths related to COVID-19 in patients who had received both doses. It was unknown when the study was conducted or how many people were included in the research.On July 1, 2021, the Ministry of Health of Argentina reported that the effectiveness against death is 62% after the first dose and 84% after the second dose.

Efficacy

In May 2021, peer-reviewed results published in JAMA of Phase III trials in United Arab Emirates and Bahrain showed BBIBP-CorV 74% (61–82%) effective against cases including asymptomatic and symptomatic infections, 78% (95% CI, 65–86%) effective against symptomatic cases only, and nearly 100% against severe cases (0 cases in vaccinated group, 2 cases in placebo group),.

12,726 people received the vaccine and 12,737 people received the placebo in these trials.

These results were previously published with the WHO in April.In December 2020, UAE's Ministry of Health and Prevention previously announced interim analysis showing BBIBP-CorV to have a 86% efficacy against COVID-19 infection and nearly 100% efficacy in preventing moderate and severe cases.As July 1, 2021, six of the 71 COVID-19 deaths in Seychelles were among the fully vaccinated people.

Only one of the six was fully vaccinated by BBIBP-CorV, the remaining five had been fully vaccinated by Covishield, which was mainly reserved for people aged 60 years or more.

Variants

In February, lab studies of twelve serum samples taken from recipients of BBBP-CorV and ZF2001 retained neutralizing activity against the Beta variant although with weaker activity than against the original virus. For BBIBP-CorV, geometric mean titers declined by 1.6-fold, from 110.9 to 70.9, which was less than antisera from mRNA vaccine recipients with a 6-folds decrease.

Preliminary clinical data from Novavax and Johnson & Johnson also showed they were less effective in preventing COVID-19 in South Africa, where the new variant is widespread.

Manufacturing

As an inactivated vaccine like CoronaVac and Covaxin, BBIBP-CorV uses a more traditional technology that is similar to the inactivated polio vaccine.

Initially, a sample of SARS-CoV-2 strain 19nCoV-CDC-Tan-HB02 (HB02) from China capable of rapid multiplication was chosen.

Then, it was used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone, which deactivates them by binding to their genes, while leaving other viral particles intact.

The resulting inactivated viruses are then mixed with the adjuvant aluminium hydroxide.Sinopharm's Chairman Yang Xioyun has said the company could produce one billion doses in 2021.In March 2021, Sinopharm and Abu Dhabi G42 announced plans to produce up to 200 million doses annually in the UAE at a new plant to become operational in 2021. The UAE manufactured vaccine will be named Hayat-Vax.In December, Egypt announced an agreement between Sinopharm and Egypt's VACSERA for the vaccine to be manufactured locally.In March, Serbia announced plans to produce 24 million doses of BBIBP-CorV annually starting in October.In April, Bangladesh approved local production of BBIBP-CorV.In July, Morocco's Société Thérapeutique Marocaine announced it would produce 5 million doses a month.

History

Clinical trials

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 (BBIBP-CorV) and the Wuhan Institute of Biological Products (WIBP-CorV).

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.BBIBP-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, BBIBP-CorV can be transported and stored at normal refrigeration temperatures.

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.

Phase III

On July, Sinopharm began trials with 31,000 volunteers in the UAE in collaboration with G42 Healthcare, an Abu Dhabi-based company.

In June, Sinopharm began Phase III trials for children and adolescents aged 3–17 with 1,800 volunteers.On September, Sinopharm began trials in Casablanca and Rabat on 600 people.

In September, Egypt started trials with 6,000 people.In August, Sinopharm began trials in Bahrain with 6,000 people, later increased to 7,700 people.

Also in August, Jordan began trials with 500 people.In September, Peru began trails with 6,000 people which later expanded to 12,000 people.

On January 26, a volunteer in the placebo group of the trials had died.In September, Argentina began trials with 3,000 people.In Pakistan, University of Karachi conducted a trial with 3,000 volunteers.

Authorizations

In China, Sinopharm obtained an EUA in July 2020.On November 3, 2020, Bahrain granted emergency use authorization for frontline workers.In December 2020, Bahrain approved the vaccine.On December 30, 2020, China's National Medical Products Administration approved BBIBP-CorV for general use.On 7 May 2021, the World Health Organization added the vaccine to the list of vaccines authorized for emergency use for COVID-19 Vaccines Global Access (COVAX).In May 2021, Zambia approved use of the vaccine.In June 2021, Philippines approved the vaccine for emergency use.

Society and culture

Economics

By May, Sinopharm had supplied 200 million doses across all countries.

In July, Sinopharm signed advanced purchase agreements with GAVI to supply COVAX 60 million doses in the third quarter of 2021 and up to a total of 170 million doses by the first half of 2022.

Asia

In February 2021, Afghanistan was pledged 400,000 doses by China.In April 2021, Bangladesh approved emergency use and had received 5.1 million doses by July. The country purchased 15 million total doses.In February 2021, Brunei received the first batch of the vaccine donated by China, which has been approved for emergency use.In February 2021, Cambodia granted emergency use authorization and started the vaccination campaign on February 10. By June the country had received 3.2 million doses.In February 2021, Macau received the first 100,000 doses of 400,000 doses.In June 2021, North Korea was reported to have been importing doses of the vaccine since May.In April 2021, Indonesia approved emergency use. Indonesia is looking to procure 15 million doses of which 482,000 doses arrived by April. The vaccine will be used for a vaccination scheme known as "Gotong Royong", where companies or legal entities can arrange the free COVID-19 vaccine rollout for their employees.In February 2021, Iran approved emergency use and received 650,000 doses by April 15 of the same year.In January 2021, Iraq approved emergency use and signed agreements for 2 million doses. The first doses arrived on March 2.In January 2021, Jordan approved emergency use, By July 1.37 million people had received their first dose and 833,000 people had received their second.In April 2021, Kazakhstan approved emergency use of the vaccine, for which it had ordered 1 million doses.In March 2021, Kyrgyzstan received a donation of 150,000 doses and began vaccinations on March 29.In January 2021, Laos began vaccinating healthcare workers in Vientiane and received another 300,000 doses in early February.In April 2021, Lebanon received a donation of 90,000 doses after granting emergency use authorization on March 2.In March 2021, Maldives granted emergency approval for use. 100,000 doses were received on March 25 out of a total of 200,000 donated doses.By May 2021, Mongolia had received 4 million doses. On March 10, Governor of Ulaanbaatar D. Sumiyabazar and Deputy Prime Minister S. Amarsaikhan received the first doses.In February 2021, Nepal approved the vaccine for emergency use. Nepal will purchase 4 million doses in addition to 1.8 million donated doses.In January 2021, Pakistan approved the vaccine for emergency use and began a vaccination campaign on February 2. The country has purchased up to 23 million doses and received 6 million doses by July.In March 2021, Palestine received 100,000 doses donated by China.In April 2021, Philippines president Rodrigo Duterte received the vaccine after the food and drug regulator approved compassionate use of 10,000 doses for his security team.In April 2021, Syria received 150,000 dose donated by China.In March 2021, Sri Lanka approved emergency use. The country ordered 14 million doses on top of 1.1 million doses previously donated.In April 2021, Turkmenistan began vaccinating school teachers and medical personnel with the Sinopharm vaccine.On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following interim Phase III trials.

In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis.

In March, a small number of people who have reduced immunity against diseases, chronic illnesses, or belong to high-risk groups have been given a third booster dose. In May, due to concerns about effectiveness, Bahrain planned to give a third booster dose to some groups at risk, and the United Arab Emirates extended its third booster dose to anyone who had received the second dose more than six months ago.In June 2021, Thailand received one million doses.In June 2021, Vietnam received a donation of 500,000 doses and later licensed importing of 5 million more doses.

Africa

In February, Algeria received a donation of 200,000 doses.In March, Angola received a donation of 200,000 doses.In April, Cameroon took delivery of 200,000 doses.In January, Egypt approved use of the vaccine and had purchased 20 million doses, of which 1.5 million had arrived by April. President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.In March, Ethiopia received a donation of 300,000 doses.In February, Equatorial Guinea received a donation of 100,000 doses which arrived on February 10. The country began vaccinations on February 15.In March, Gabon received a donation of 100,000 doses which was the second vaccine approved for use in the country.In May, Kenya announced plans to buy the vaccine.Morocco has ordered 40.5 million doses, of which 8.5 million had been delivered by May. Morocco had granted emergency use approval on January 23.In March, Mauritania received a donation of 50,000 doses and started its vaccination campaign on March 26.In April, Mauritius received 100,000 doses and ordered an additional 500,000 doses.In February, Mozambique received a donation of 200,000 doses and planned to start vaccinations on March 8.In March, Namibia received a donation of 100,000 doses and announced the start of vaccinations in the Khomas and Erongo regions.In March, Niger received a donation of 400,000 doses with vaccinations to begin on March 27.In February, Senegal received 200,000 doses and began vaccinating health workers on February 22.In February, Sierra Leone received a donation of 200,000 doses. It was approved for emergency use and vaccinations began on March 15.In January, Seychelles began administering vaccinations with 50,000 doses it had received as a gift from the UAE.In April, Somalia received a donation of 200,000 doses and started vaccinations with the vaccine on April 14.In April, South Africa announced it would order 10 million doses of the vaccine.In March, Sudan received a donation of 250,000 doses.In March, Republic of the Congo received 100,000 doses with vaccinations prioritizing the medically vulnerable and those over 50.In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China, and started vaccinations on February 18. Zimbabwe purchased an additional 1.2 million doses.

Europe

In February, Belarus received a donation of 100,000 doses and began using the vaccine on March 15.In July, Bosnia and Herzegovina ordered 500,000 doses.In May, Georgia began vaccinations with BBIBP-CorV and received 1 million doses by July.In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses. Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28. 5.2 million doses were delivered to Hungary by May, fulfilling the contract.In March, Moldova received 2,000 doses donated by the UAE which will be used to vaccinate doctors starting on March 22.In May, Montenegro received 200,000 doses, which was used to launch the vaccination campaign starting May 4.In April, North Macedonia received the first 200,000 of 800,000 doses which arrived from Serbia which was used in the vaccination campaign starting May 4.On January 19, Serbia started vaccinations with BBIBP-CorV and was the first country in Europe to approve the vaccine.

By April, Serbia has received 2.5 million doses. In March, Serbia had signed an agreement for an additional 2 million doses.

North America

In February, the Dominican Republic ordered 768,000 doses of BBIBP-CorV.In March, Dominica received 20,000 doses of BBIBP-CorV which it began using in its vaccination campaign on March 4.In March, Mexico announced it would order 12 million doses of BBIBP-CorV pending approval by its health regulator.In May, Trinidad and Tobago received a donation of 100,000 doses. Another 200,000 and 800,000 doses were purchased and arrived June 14 and July 13, respectively; bringing total doses of BBIBP-CorV received to 1.1 million.In April, Barbados announced it would receive 30,000 doses of BBIBP-CorV, according to Prime Minister Mia Mottley.

South America

In February, Argentina authorized emergency use of BBIBP-CorV.

Eligibility was expanded to include people older than 60 on March 25. By June 4 million doses had arrived and 6 million more were ordered.In February, Bolivia started its vaccination campaign with BBIBP-CorV.

In June, Bolivia purchased 6 million doses in addition to 2.7 million doses it had already received.In March, Guyana received a donation of 20,000 doses and later purchased another 100,000 doses. Vaccinations started with elderly and healthcare workers.In January, Peru purchased 38 million doses of BBIBP-CorV.

Peru granted emergency approval on January 27 and started vaccinations on February 9.In March, Venezuela granted approval for the vaccine and the first 500,000 doses arrived on March 2.

Controversies

In February 2021, it was revealed former Peruvian President Martín Vizcarra and other senior politicians were vaccinated in November 2020 before the vaccines were made available to health professionals and the public.

They were vaccinated with extra doses that were brought in for the Phase III trials being conducted in the country by Cayetano Heredia University in Lima with 12,000 volunteers.In May 2021, Philippine President Rodrigo Duterte apologized for taking BBIBP-CorV which was not approved at the time. In response, Duterte said China should in the future only send CoronaVac, a separate vaccine which was approved in the Philippines at the time. Duterte said he only got the vaccine under a compassionate use clause, on recommendation from his doctor to get vaccinated.

Later in June, BBIBP-CorV was approved for emergency use.

References

External links

"How the Sinopharm Vaccine Works".

The New York Times.