The Sinopharm BIBP COVID-19 vaccine, also known as BBIBP-CorV, the Sinopharm COVID-19 vaccine, or BIBP vaccine, is one of two whole 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 that the vaccine is 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. The BIBP vaccine could be transported and stored at normal refrigerated temperatures.

The vaccine is being used in vaccination campaigns by certain countries in Asia, Africa, South America, and Europe. Sinopharm expects to produce one billion doses of the vaccine in 2021. By May, Sinopharm had supplied 200 million doses.

On 7 May 2021, the World Health Organization approved the BIBP vaccine for use in COVAX. Sinopharm has signed purchase agreements for 170 million doses from COVAX.

The similarly named Sinopharm WIBP COVID-19 vaccine is also an inactivated virus vaccine.

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

Effectiveness A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. Effectiveness is generally expected to slowly decrease over time.

Real-world test-negative analysis in Bahrain (based on 14 days post 2nd dose) indicated a vaccine effectiveness of for adults aged 18–59, and for those 60 year old or older. While confident in its overall efficacy, WHO experts expressed very low confidence in their current ability to determine the safety of the BIBP vaccine for people with comorbidities, pregnant women, and the elderly as they were under-represented in the studies.

In April 2021, a study 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 received both doses. It was unknown how many people were included in the research.

On 1 July, the Ministry of Health of Argentina reported the vaccine reduced deaths by 62% after the first dose and by 84% after the second dose.

On 22 July, Peru's National Institute of Health reported the vaccine reduced deaths by 94% after analyzing data from 361,000 people.

On 13 August, a study with 400,000 health workers in Peru from February to June 2021, during a wave mostly caused by the Lambda and Gamma variants, found a vaccine effectiveness of against infection and against death after two doses. With a single dose, the effectiveness was against infections and against death.

In June 2022, results from a non-randomized study of one million people in Bahrain, of whom 569,054 received the BIBP vaccine, found that the vaccine continued to reduce infection, hospitalization, and death when the Delta variant became dominant, though not as effectively as Pfizer–BioNTech, Oxford–AstraZeneca and Sputnik V.

+Initial effectiveness by variantDosesSeverity of illnessDeltaAlpha1SymptomaticHospitalization2AsymptomaticSymptomaticHospitalizationDeath

Efficacy

In December 2020, UAE's Ministry of Health and Prevention previously announced interim analysis showing the vaccine to have a 86% efficacy against COVID-19 infection and nearly 100% efficacy in preventing moderate and severe cases.

On 7 May 2021, the World Health Organization reported a vaccine efficacy of against symptomatic disease and against hospitalization.

In 26 May, peer-reviewed results published in JAMA of Phase III trials in United Arab Emirates and Bahrain showed the vaccine effective against cases including asymptomatic and symptomatic infections, effective against symptomatic cases, 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.

As of 1 July, six of the 71 COVID-19 deaths in Seychelles were among the fully vaccinated people. Only one of the six was fully vaccinated by the BIBP vaccine, 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 the BIBP vaccine, 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.

In June, a pre-print study with 282 recipients of the vaccine in Sri Lanka showed that: 95% seroconverted following 2 doses, a similar rate seen in natural infection, with significantly lower seroconversion for >60 year-olds (93%) compared to 20-39 year-olds (99%) 81% had ACE2 receptor blocking antibodies capable of naturalizing the virus at 6 weeks, with the antibody titres at a level also similar to natural infection the antibody levels against Delta and Beta were at similar levels seen in natural infection, although much lower against Alpha there was a 1.38-fold reduction in antibody titres against Delta compared to the original strain, in contrast with 10-fold reduction against Beta the vaccine also induced T cell and memory B cell responses, although at lower magnitudes than some other vaccines

Manufacturing As an inactivated vaccine like CoronaVac and Covaxin, the BIBP vaccine 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 vaccine will be branded Hayat-Vax.

In December 2020, Egypt announced an agreement between Sinopharm and Egypt's VACSERA for the vaccine to be manufactured locally.

In March 2021, Serbia announced plans to produce 24 million doses of the BIBP vaccine annually starting in October.

In April 2021, Bangladesh approved local production of the BIBP vaccine.

In July 2021, Morocco's Société Thérapeutique Marocaine announced it would produce 5 million doses a month.

In November 2021, Sinopharm announced that it will build a sterile bottling plant in Singapore to enhance the distribution of the vaccine.

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 (BIBP) and the Wuhan Institute of Biological Products (WIBP). Both vaccines are chemically inactivated whole virus vaccines for COVID-19.

On 15 October, the Beijing Institute of Biological Products published results of its Phase I (192 adults) and Phase II (448 adults) clinical studies for the BIBP vaccine, showing it 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.

The vaccine 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, the BIBP vaccine 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

In July 2020, Sinopharm began trials with 31,000 volunteers in the UAE in collaboration with G42 Healthcare, an Abu Dhabi-based company. In June 2021, Sinopharm began Phase III trials for children and adolescents aged 3–17 with 1,800 volunteers.

In September 2020, 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 trials with 6,000 people which later expanded to 12,000 people. On 26 January, a volunteer in the placebo group of the trials had died from COVID-19 related pneumonia.

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 30 December 2020, China's National Medical Products Administration approved the BIBP vaccine for general use. In July 2021, China approved the EUA for children and adolescents aged 3–17.

In September 2020, UAE approved for emergency use authorization. In December 2020, UAE approved for full authorization. In August 2021, UAE approved the EUA for children and adolescents aged 3–17.

On 3 November 2020, Bahrain granted emergency use authorization for frontline workers. In December 2020, Bahrain approved the vaccine.

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 BIBP vaccine for emergency use.

On 5 May 2021, EMA's human medicines committee (CHMP) has started a rolling review of the vaccine. The EU applicant for this medicine is the Italian company Life'On S.r.l.

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 On 10 June, Afghanistan received a donation of 700,000 doses of the BIBP vaccine from China.

In July, Armenia approved the purchase of doses of the BIBP vaccine.