Sinopharm COVID-19 Vaccine (BBIBP-CorV) Description
Sinopharm BBIBP-CorV COVID-19 is an inactivated vaccine made of virus particles grown in culture and lack disease-producing capability. This vaccine candidate was developed by Sinopharm and the Beijing Institute of Biological Products Co.
The Sinopharm BBIBP-CorV vaccine works by teaching the immune system to make antibodies against the SARS-CoV-2 beta coronavirus. Inactivated virus vaccines have been used for several decades, such as vaccines against rabies and hepatitis A. This development technology has been successfully applied in many well-known vaccines, such as the rabies vaccine.
Sinopharm's SARS-CoV-2 strain (WIV04 strain and GenBank number MN996528) was isolated from a patient in the Jinyintan Hospital, Wuhan, China. The virus was cultivated in a qualified Vero cell line for propagation, and the supernatant of the infected cells was inactivated with β-propiolactone (1:4000 vol/vol at 2 to 8 °C) for 48 hours. Following clarification of cell debris and ultrafiltration, the second β-propiolactone inactivation was performed in the same conditions as the first inactivation. The vaccine was adsorbed to 0.5-mg alum and packed into prefilled syringes in 0.5-mL sterile phosphate-buffered saline without preservative, says the WHO.
On December 31, 2020, China's National Medical Products Administration announced the experimental vaccine, developed by State-owned Sinopharm, was approved.
On May 7, 2021, the WHO announced the vaccine's approval. WHO’s Emergency Use Listing enables countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. WHO’s Strategic Advisory Group of Experts on Immunization has also completed its review of the vaccine. Based on all available evidence, WHO recommends the vaccine for adults 18 years and older in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized diseases was estimated to be 79%, all age groups combined.
The JAMA published 'A Randomized Clinical Trial: Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults on May 26, 2021, that concluded 'In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19 and serious adverse events were rare.' In this phase 3 randomized trial in adults, 2 whole-virus inactivated vaccines showed the efficacy of 72.8% and 78.1% against symptomatic COVID-19 cases. The 2 vaccines had rare serious adverse events at a frequency similar to the alum-only control, and the majority were not related to the vaccinations. An exploratory analysis found that the 2 vaccines induced measurable neutralizing antibodies, similar to results in the phase 1/2 trials.
The WHO's SAGE Working Group published its Sinopharm/BBIBP COVID-19 vaccine review on May 10, 2021. Sinopharm’s COVID-19 vaccine integrates a vaccine vial monitor that tells health workers whether the vaccine has been stored correctly and not exposed to excessive heat. Therefore, damaged, reported GAVI on May 14, 2021. The smart label, produced by Zebra Technologies and manufactured by Temptime Corporation, consists of a circle with a lighter-colored square in the middle that is made of colorless chemical that irreversibly develops color over time. This becomes darker to give a visual indication of cumulative heat exposure. Once a vial has been exposed to heat for a period beyond its optimal storage range, the color of the square becomes darker than the circle, indicating that the vaccine should no longer be used.
The Sinopharm BBIBP-CorV COVID-19 vaccine Drug Bank accession number: DB15807.
Sinopharm COVID-19 Vaccine (BBIBP-CorV) History
On August 13, 2020, JAMA published a study that concluded saying 'In this interim report of phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. This inactivated COVID-19 vaccine reported a low rate of adverse reactions and demonstrated immunogenicity, but a longer-term assessment of safety and efficacy will require phase 3 trials.'
In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and aluminum hydroxide (alum) adjuvant–only group (n = 24 in each group). They received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs. alum only [n = 28], and days 0 and 21 [n = 84] vs. alum only [n = 28]). On December 9, 2020, a media report stated, 'The new analysis also shows “99% seroconversion rate of neutralizing antibody and 100% effectiveness in preventing moderate and severe cases of the disease."
On January 15, 2021, China’s state media Zhongguo Jijian Jiancha Bao (China Disciplinary Supervision Newspaper) published the interview with Mr. Liu Jingzhen, Chairman of the state-owned China National Pharmaceutical Group (Sinopharm), on China’s first approved Covid-19 vaccine Sinopharm developed.
China National Pharmaceutical Group Co., Ltd. (Sinopharm) is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission of the State Council, with 128,000 employees and a full chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business and financial services.
Hayat-Vax COVID-19 Vaccine
Hayat-Vax is the same Sinopharm CNBG’s BiBP inactivated vaccine that was officially registered by the United Arab Emirates (UAE) Ministry of Health and Prevention on December 9, 2020, and subsequently in China by the Chinese Center for Drug Evaluation on December 30, 2020, following the updated Sinopharm interim study results submitted in China showing 79.34% efficacy. This first-ever ‘Made in UAE’ Hayat-Vax Covid-19 vaccine is producing 2 million vaccine doses per month.
Sinopharm COVID-19 Vaccine (BBIBP-CorV) Indication
The Sinopharm COVID-19 vaccine is indicated to prevent COVID-19 disease caused by infection with the SARS-CoV-2 virus. The BIBP-CorV vaccine can be transported and stored at normal refrigeration temperatures.
On March 26, 2021, the government of Pakistan published Sinopharm Vaccine Guidelines.
Sinopharm COVID-19 Vaccine (BBIBP-CorV) Indication For Pregnant and Lactating Women
As of May 10, 2021, the WHO stated, 'the available data on the COVID-19 vaccine BIBP in pregnant women are insufficient to assess either vaccine efficacy or vaccine-associated risks in pregnancy. However, this vaccine is an inactivated vaccine with an adjuvant used in many other vaccines with a documented good safety profile, including in pregnant women. The effectiveness of the COVID-19 vaccine BIBP in pregnant women is therefore expected to be comparable to that observed in non-pregnant women of similar age.
In the interim, the WHO recommends using the COVID-19 vaccine BIBP in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing before vaccination. In addition, WHO does not recommend delaying pregnancy or considering terminating pregnancy because of vaccination.
Vaccine effectiveness is expected to be similar in lactating women as in other adults. Therefore, WHO recommends the use of the COVID-19 vaccine BIBP in lactating women as in other adults. WHO does not recommend discontinuing breastfeeding after vaccination.
Sinopharm COVID-19 Vaccine (BBIBP-CorV) News
July 12, 2021 - Gavi announced today that it had signed advance purchase agreements with Sinopharm for its “BBIBP-CorV” inactivated virus vaccine against COVID-19. On behalf of the COVAX Facility, 60 million doses will be made available from July through October 2021. In addition, Gavi has the option to purchase a further 60 million doses in Q4 2021 and 50 million more doses in the first half of 2022, if necessary. This equates to a potential total of 170 million doses of the Sinopharm vaccine that could be made available to self-financing participants of the Facility and participants supported by the Gavi COVAX Advance Market Commitment.
July 2, 2021 - Local media reported China had officially informed the government of the Federation of Bosnia and Herzegovina that they had signed a contract for the supply of 500.000 doses of Sinopharm vaccine.
July 1, 2021 - News18 reported: Efficacy of China’s Sinopharm Vaccine Questioned after Seychelles Records Surge in COVID Cases.
June 29, 2021 - Xinhua reported Chinese nationals in Bangladesh recently received the second Sinopharm vaccine doses under China's "Spring Sprout" vaccine program.
June 10, 2021 - Local media reported the UAE's Ministry of Health and Prevention had initiated a Sinopharm “immune bridge study” for children aged three to 17 years.
June 7, 2021 - The Philippines Food and Drug Administration confirmed the emergency use of the Sinopharm COVID-19 vaccine.
June 5, 2021 - Vietnam confirmed it approved the Sinopharm COVID-19 vaccine.
June 2, 2021 - Reuters reported China National Pharmaceutical Group (Sinopharm) chairman Liu Jingzhen stated 'the company has the capacity to provide more than 1 billion COVID-19 vaccine doses to the world beyond China in the second half of 2021.
May 26, 2021 - The JAMA published a study that concluded: In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19. Data collection for the final analysis is pending.
May 19, 2021 - The United Arab Emirates is offering a booster jab to those who have received their initial two doses of China’s Sinopharm COVID-19 vaccine, the UAE’s official news agency WAM reported.
May 14, 2021 - Local media reported the ongoing Phase III clinical trials of the Sinopharm COVID-19 vaccine, which have been conducted in five Arab countries since the summer of 2020, show efficacy of 78.89 percent on people aged 18 and above.
May 14, 2021 - GAVI confirmed Sinopharm’s COVID-19 vaccine includes a vaccine vial monitor that tells health workers whether the vaccine has been stored correctly and not exposed to excessive heat, and therefore damaged.
May 10, 2021 - The WHO Strategic Advisory Group of Experts on Immunization has issued Interim recommendations for using the inactivated COVID-19 vaccine BIBP developed by Sinopharm/China National Pharmaceutical Group.
May 7, 2021 - The World Health Organization granted emergency approval for Sinopharm's COVID-19 vaccine. It is the first COVID-19 vaccine developed by a non-Western country to obtain WHO approval. “The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Health Products.
May 7, 2021 - The WHO's SAGE committee posted its technical analysis.
May 4, 2021 - Nature published an article: China’s COVID vaccines are going global, but questions remain.
April 15, 2021 - The spokesman of the Customs Administration of Iran confirmed the shipment of 400 thousand doses of COVID-19 vaccine has arrived at Imam Khomeini Airport in Tehran. The vaccines were donated to Iran by the Red Cross Society of China, said Rouhollah Latifi, adding that the Airbus 340 carrying the doses landed in Tehran at 6:50 local time.
April 7, 2021 - News article: China's vaccine helps the world fight the epidemic.
April 6, 2021 - The US-based NEJM published 'Susceptibility of Circulating SARS-CoV-2 Variants to Neutralization.' The editorial stated: 'Most of the vaccinee serum samples that were tested lost neutralizing activity, a finding that was consistent with the results of other recent studies of neutralization by convalescent serum or serum obtained from recipients of messenger RNA or BBIBP-CorV vaccines.'
April 5, 2021 - The first Ecuadorian government procurement by Sinovac dimension in producing new vaccines crown blessing Kerr arrived in Quito, Ecuador.
March 28, 2021 - The United Arab Emirates announced the commencement of the manufacturing of Hayat-Vax [Hayat means life in Arabic], which is the first indigenous COVID-19 vaccine in the region that will be manufactured by a newly created JV between Sinopharm CNBG and G42, the leading technology company based in Abu Dhabi.
March 19, 2021 - REVIEW: Immunogenicity of clinically relevant SARS-CoV-2 vaccines in nonhuman primates and humans.
March 16, 2021 - The BMJ reported 'Hungary is the only EU country using the BBIBP-CorV vaccine. It has ordered five million doses, which currently account for 21.3% of administered vaccinations.
March 12, 2021 - AFP reported Serbia will become the first European country to produce the Sinopharm coronavirus vaccine, announced President Aleksandar Vucic.
March 8, 2021 - The Lancet published: Adjuvantation helps to optimize COVID-19 vaccine candidate.
February 26, 2021 - EuroNews reported Hungary becomes the first EU nation to use China's Sinopharm vaccine against COVID-19.
February 21, 2021 - The National Medical Products Administration announced the Wuhan Institute of Biological Products, administered by State-owned Sinopharm, said it applied for conditional market approval. According to the company, interim results from late-stage human trials show its inactivated vaccine has an overall efficacy rate of 72.51 percent. Full inoculation with this vaccine requires two doses.
February 20, 2021 - Sinopharm announced its COVID-19 vaccine had administered 43 million doses worldwide.
February 19, 2021 - Hungary announced the Sinopharm vaccine's approval, targeting to vaccinate over 1 million by the end of February 2021.
February 3, 2021 - Local media reported Pakistan announced it has formally launched the coronavirus vaccination drive as the country continues to battle the coronavirus. Thousands of frontline health workers from both public and private sectors are being inoculated first. The federal government has distributed the Chinese-made coronavirus vaccines among Sindh, Punjab, Khyber Pakhtunkhwa, and Balochistan. Sindh received 84,000 doses of the vaccine, Punjab 70,000, KP 65,000, and Balochistan 10,300 doses.
January 29, 2021 - Hungary became the first EU member state to approve the Chinese "Sinopharm" vaccine for use, according to the country's chief health official, Cecilia Mueller. "Today, the National Institute of Pharmacy and Nutrition approved the use of the Sinopharm vaccine," she said. As a result, any vaccine administered to at least one million people worldwide may now be approved for use in Hungary — without being assessed by the country’s medicines regulator, reported the AP.
January 21, 2021 - The Lancet published a study that concluded: The inactivated SARS-CoV-2 vaccine, BBIBP-CorV, is safe and well-tolerated at all tested doses in two age groups. Humoral responses against SARS-CoV-2 were induced in all vaccine recipients on day 42. In addition, two-dose immunization with 4 μg vaccine on days 0 and 21 or days 0 and 28 achieved higher neutralizing antibody titers than the single 8 μg dose or 4 μg dose on days 0 and 14.
January 3, 2021 - "The Egyptian pharmaceutical authority approved on Saturday the Chinese Sinopharm vaccine," Hala Zayed said late Saturday. Zayed said Egypt plans to purchase 40 million doses of the Sinopharm vaccine.
January 2, 2021 - The inactivated COVID-19 vaccine developed by the Beijing Institute of Biological Products of Sinopharm CNBG has been granted conditional registration by the NMPA of China, the Chinese equivalent of FDA, according to a press conference of the State Council Joint Prevention and Control Mechanism on December 31, 2020.
December 31, 2020 - China's regulatory agency announced it had granted conditional market approval for its first COVID-19 vaccine during a news conference. The vaccine, developed by State-owned Sinopharm, was approved by China's top drug regulator, said Chen Shifei, deputy head of the National Medical Products Administration.
December 29, 2020 - Sinopharm announced its COVID-19 vaccine showed 79.34% efficacy, and it has requested regulatory approval to become China’s first approved COVID-19 vaccine for general public use.
December 13, 2020 - The National Health Regulatory Authority announced it has officially approved Sinopharm’s COVID-19 vaccine registration after submitting all related documentation by G42 Healthcare, the company’s exclusive distributor in the Middle East and North Africa. The Kingdom of Bahrain has participated in Phase III clinical trials of the vaccine as part of the 4 Humanity campaign, in which more than 7,700 volunteers signed up. The Authority had previously authorized the emergency use of Sinopharm’s vaccine based on preliminary results provided to frontline professionals in contact with COVID-19 patients.
December 9, 2020 - The UAE’s Ministry of Health and Prevention announced the official registration of the Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as a major step towards combating the global pandemic. The registration of this vaccine is a decision in response to the application submitted by Sinopharm CNBG.
December 6, 2020 - Morocco's Ministry of Health announced that the vaccine it will use in the upcoming national COVID-19 vaccination campaign is from Sinopharm, a state-owned Chinese pharmaceutical company.
November 18, 2020 - Local media reported, "Almost 1 million Chinese have been given an experimental Covid-19 vaccine developed by the state-owned Sinopharm under the government’s emergency use scheme," Liu Jingzhen, chairman of China National Pharmaceutical Group (Sinopharm), said in an interview with a Sichuan-based digital media company. “Until now, all our progress, from research to clinical trials to production and emergency use, we have been leading the world."
November 18, 2020 - Morocco's Minister of Health Khalid Ait Taleb reported “very positive” clinical trials of the COVID-19 vaccine on Moroccan volunteers. He said the results confirmed the safety and effectiveness of the COVID-19 vaccine that Morocco will use in the vaccination campaign.
October 11, 2020 - The Lancet published a review: SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates.
September 14, 2020 - The UAE granted emergency approval for health workers to use a COVID-19 vaccine in its third testing phase. Health minister Abdulrahman Al-Owais said the vaccine would be available for “first-line-of-defense heroes, who are most at risk of catching COVID-19, protecting them from any danger that they may be exposed to due to the nature of their work.”
September 5, 2020 - China National Biotec Group announced 4 more countries have agreed to run late-stage clinical tests of their coronavirus vaccine candidates. Trials have already begun in United Arab Emirates, Bahrain, Peru, Morocco, Argentina, and Jordan.
August 13, 2020 - Interim Analysis of 2 Randomized Clinical Trials. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes
July 17, 2020 - Sheikh Abdullah bin Mohammed Al Hamed, Chairman of the Department of Health - Abu Dhabi, was the first person given Phase III inactivated vaccine for Covid-19. The Department of Health - Abu Dhabi has announced the registration of 5,000 volunteers in Abu Dhabi.
July 1, 2020 - China National Biotec Group (CNBG) announced it had completed a new plant for coronavirus vaccines, doubling its capacity to more than 200 million doses a year. CNBG, a state-owned China National Pharmaceutical Group (Sinopharm) unit, has two COVID-19 vaccine candidates in human trials and plans a large-scale Phase 3 human testing in the United Arab Emirates.
June 28, 2020 - The 2nd vaccine developed by Sinopharm is safe and able to generate high titers of antibodies among participants in phase I and II clinical trials, according to a Weibo posting by Sinopharm Group. All the participants get 2 shots at either 3- or 4-week intervals that have generated neutralizing antibodies, measuring the vaccine’s ability to stimulate a specific immune response to the coronavirus.
June 23, 2020 - China and Afghanistan signed a clinical cooperation agreement on the spot, marking the official launch of the world's first international clinical trial (Phase III) of the new crown inactivated vaccine. The cooperation between Chinese and UAE technology companies marks new and important international anti-epidemic cooperation progress.
June 17, 2020 - A vaccine candidate developed by Sinopharm’s Wuhan Institute of Biological Products Co. has shown no serious adverse reactions during phase I and II clinical trials, according to a Weibo posting on Tuesday by China National Biotec Group, a subsidiary of the company’s parent. That sent Sinopharm shares up by 15% in Hong Kong to be the best performer in the MSCI Asia Pacific Index.
Sinopharm COVID-19 Vaccine (BBIBP-CorV) Clinical Trials
The Sinopharm COVID-19 inactivated vaccine did not show any severe adverse effects in the first two clinical trials. It is the first vaccine candidate in the world to show favorable immunogenicity and safety. The BBIBP-CorV COVID-19 Vaccine continues to be tested in clinical trials.