- Sinopharm COVID-19 Vaccine (BBIBP-CorV) 2022
- Sinopharm Omicron BA.x Subvariants
- Sinopharm Authorizations
- Sinopharm Recombinant Protein Vaccine (NVSI-06-07)
- Sinopharm History
- Sinopharm Dosage
- Hayat-Vax COVID-19 Vaccine
- Sinopharm Indication
- Sinopharm Women
- Sinopharm Children
- Sinopharm Side Effects
- Sinopharm News For 2019 - 2022
- Sinopharm COVID-19 Vaccine (BBIBP-CorV) Clinical Trials
Sinopharm COVID-19 Vaccine (BBIBP-CorV) 2022
The Sinopharm COVID-19 (BBIBP-CorV, COVILO) is an inactivated vaccine made of virus particles grown in culture and lacks the disease-producing capability. This vaccine was developed by China National Pharmaceutical Group Co., Ltd. (Sinopharm) and the Beijing Institute of Biological Products Co in 2020.
The Sinopharm BBIBP-CorV vaccine teaches the immune system to make antibodies against the SARS-CoV-2 beta coronavirus. For several decades, inactivated virus vaccines, such as vaccines against hepatitis A, have been successfully applied. In addition, this development technology has been successfully used 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.
On December 31, 2020, China’s National Medical Products Administration announced the experimental BBIBP-CorV vaccine, developed by a State-owned Sinopharm, was Approved.
On May 7, 2021, the WHO announced the vaccine’s approval, becoming Emergency Use Listed to expedite regulatory approvals to import and administer vaccines. WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) also completed its vaccine review. And the WHO published ‘Evidence Assessment: Sinopharm/BBIBP COVID-19 vaccine.’ Based on available evidence, the vaccine efficacy for symptomatic and hospitalized diseases was estimated to be 79% for all age groups combined.
The JAMA Network published an Original Investigation on October 29, 2021, that concluded, ‘In this cohort study of 663,602 participants, the use of non-mRNA COVID-19 vaccines was associated with a significant reduction in all-cause death, COVID-related death, and documented infection with the use of 1 dose and even more with the use of 2 doses.’ The phase 3 study (HUN-VE) conducted across three continents published an interim analysis on November 25, 2021; the effectiveness of Sinopharm in preventing Covid-19-related death varied between 67.5% and 100% according to age ≥ seven days after the second dose, with an adjusted overall efficacy of 87.8%.
On June 10, 2022, the WHO Strategic Advisory Group of Experts reconfirmed Interim recommendations for using the inactivated COVID-19 vaccine BIBP developed by China National Biotec Group (CNBG), Sinopharm. The predecessor was the Central Epidemic Prevention Department of the Beiyang Government.
The Sinopharm BBIBP-CorV COVID-19 vaccine Drug Bank accession number: DB15807. CAS Number: 2503126-65-4. ATC code: J07BX03. Sinopharm BBIBP-CorV Recent Phase 3 studies: ChiCTR2000034780; NCT04510207; NCT04612972; NCT04612972. WHO Evidence Assessment in 2021.mmission
China National Pharmaceutical Group Co., Ltd. (Sinopharm) is a large healthcare group directly under the State-owned Assets Supervision and Administration 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. The vaccine is also manufactured by G42 Healthcare (Hayat-Vax).
Sinopharm Omicron BA.x Subvariants
Sinopharm’s Omicron variant vaccine candidate was approved for human clinical trials in Hong Kong on April 16, 2022. The Sinopharm candidate will be tested as boosters in adults who have already received two or three vaccine doses, China National Biotec Group Company Limited confirmed. A study published by the journal Nature on January 13, 2022, stated BBIBP-CorV vaccine ‘retains some potency against Omicron — although, as researchers at the Translational Health Science and Technology Institute in Faridabad, India, put it in their non-peer-reviewed study, the immune responses remain “sub-optimal”.
A non-peer-reviewed study assessed the serum neutralizing activity using a pseudovirus-based neutralization assay in 292 healthcare workers who had administered a third homologous boosting vaccination 8 to 9 months after completion of the priming two-dose inactivated vaccination to investigate whether the newly identified Omicron variant could escape serum antibody neutralization elicited by the booster vaccination. The third booster dose with BBIBP-CorV led to a significant rebound in neutralizing immune response against SARS-CoV-2. The neutralization GMT on day 28 after the third booster dose was 6.1 times higher than the GMT on day 28 after the second dose. The Omicron variant did cause significantly lower neutralization sensitivity than the wild-type strain of the booster elicited serum, with about a 20.1-fold reduction.
On January 5, 2022, the SCMP reported an assessment from World Health Organization incident manager Abdi Mahamud found Sinopharm Covid-19 vaccine offers protection against severe illness, hospitalization, and death from the Omicron variant despite declines in protective antibodies.
As of August 2022, the Sinopharm COVID-19 Vaccine is authorized/approved in about 90 countries and Listed by the WHO. In Thailand, the vaccine is known as COVILO. Separately, Sinopharm (Wuhan) Inactivated (Vero Cells) vaccine is approved, and the UK authorized it for international visitors, as did Australia. June 2021, a vaccination drive resumed in parts of Bangladesh with the China-donated Sinopharm vaccines.
Sinopharm Recombinant Protein Vaccine (NVSI-06-07)
Sinopharm’s recombinant protein COVID-19 vaccine was developed by the scientific research team of the CNBG of Sinopharm Group. On April 27, 2022, Sinopharm’s second-generation recombinant protein new crown vaccine of Sinopharm Group obtained the clinical trial approval document issued by the State Drug Administration. Pre-clinical effectiveness studies and preliminary human trials have shown that the second-generation vaccine has broad-spectrum protection against various variant strains and is currently the only second-generation vaccine approved for emergency use. It uses structural biology and computational biology to independently design, develop, and uses genetic engineering technology to construct engineered cell lines and recombinant expression Antigen protein, clear target, and strong pertinence. After immunization, it can induce the body to produce targeted neutralizing antibodies, thereby blocking the combination of the virus and the recipient cells and exerting a protective effect.
On January 4, 2022, a non-peer-reviewed study found that the heterologous boost with NVSI-06-07 was safe, well-tolerated, and immunogenic in adults primed with a full regimen of BBIBP-CorV. Compared to a homologous boost with a third dose of BBIBP-CorV, incremental increases in immune responses were achieved by the heterologous boost with NVSI-06-07 against the SARS-CoV-2 prototype strain, Omicron variant, and other VOCs. The optimal booster strategy was the heterologous boost with NVSI-06-07 over six months after priming with two doses of BBIBP-CorV.
On December 27, 2021, the UAE Ministry of Health and Prevention approved the emergency use of Sinopharm’s new recombinant protein vaccine as a booster injection. The new crown vaccine has broad-spectrum protection against a variety of mutant strains. The UAE has carried out relevant research on the vaccine, and it will be used as a booster for people who have been vaccinated with two doses of Sinopharm’s China Bio-New Crown Inactivated Vaccine.
Media reported on April 3, 2022, that human clinical trials had been approved to proceed.
On January 15, 2021, China’s state media Zhongguo Jijian Jiancha Bao (China Disciplinary Supervision Newspaper) published an 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.
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 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, two whole-virus inactivated vaccines showed the efficacy of 72.8% and 78.1% against symptomatic COVID-19 cases. The two 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 two vaccines induced measurable neutralizing antibodies, similar to the phase 1/2 trials results.
Study results support using a 4 μg dose and two-shot regimen of BBIBP-CorV. A small-scale Chinese study showed that the third shot of Sinopharm’s COVID-19 vaccine leads to increased antibody levels that decrease months after a second dose. According to the WHO, on September 2, 2021, the vaccine was adsorbed to 0.5-mg alum and packed into prefilled syringes in 0.5-mL sterile phosphate-buffered saline without preservative.
On October 11, 2021, the WHO stated, ‘People aged 60 and older who received the Sinopharm vaccines should get a third dose. “When implementing this recommendation, countries should initially aim at maximizing 2-dose coverage in that population, and after that administer the third dose, starting in the oldest age groups”.
Cambodia announced the fourth round of vaccinations on January 14, 2022, responding to the omicron variant, with high-risk groups among the first to receive the additional boosters.
A non-peer-reviewed clinical study published on Feb. 21, 2022, demonstrated that the 4th dose is safe and capable of recalling waned immune responses six months after the 3rd dose. However, greater suppression of the induction of overall Neutralizing antibodies (NAbs) and NAbs targeting the RBD was found in participants with stronger immune responses after the 3rd dose.
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 produces 2 million vaccine doses per month.
The Sinopharm COVID-19 vaccine is indicated to prevent COVID-19 disease caused by infection with the SARS-CoV-2 virus. The BIBBP-CorV vaccine can be transported and stored at normal refrigeration temperatures. However, individuals with a history of anaphylaxis to any vaccine component should not take it, says the WHO. In addition, anyone with a body temperature over 38.5ºC should postpone vaccination until they no longer have a fever.
From the available data as of September 2, 2021, the WHO says the COVID-19 vaccine BIBP in pregnant women is insufficient to assess either vaccine efficacy or vaccine-associated risks in pregnancy. However, this vaccine is an inactivated vaccine with an adjuvant routinely used in many other vaccines with a good safety profile in pregnant women. In the interim, WHO recommends using the COVID-19 vaccine BIBP in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks. The WHO does not recommend pregnancy testing before vaccination. In addition, the WHO does not recommend delaying pregnancy or considering terminating pregnancy because of vaccination.
Vaccine effectiveness is expected to be similar in lactating women to other adults. Therefore, WHO recommends using the COVID-19 vaccine BIBP in lactating women as in other adults. WHO does not recommend discontinuing breastfeeding after vaccination.
Sinopharm’s vaccine was approved for emergency use on children aged between 3 and 17 by the China National Biotec Group on August 18, 2021. China will allow people aged between 3 and 17 to get shots of COVID-19 vaccines in June 2021, making it the first country to announce the approval of vaccines for such a young age group. Argentina issued similar approval in October 2021.
Data from phase one and two clinical trials published in The Lancet Infectious Diseases showed that a vaccine developed by Sinopharm’s Beijing Institute of Biological Products was safe in participants aged three to 17. The inactivated COVID-19 vaccine BBIBP-CorV is safe and well-tolerated at all tested dose levels in participants aged 3–17 years. BBIBP-CorV also elicited robust humoral responses against SARS-CoV-2 infection after two doses. These findings support the use of a 4 μg dose and two-shot regimen of BBIBP-CorV in phase 3 trials in the population younger than 18 years to further ascertain its safety and protection efficacy against COVID-19.
On November 18, 2021, Argentina’s Ministry of Health released a report that found the Sinopharm vaccine had the least number (153) of Events Supposedly Attributable to Vaccination or Immunization in children aged 3 to 11, with 90 of them classified as related.
Sinopharm Side Effects
The ‘Side Effects and Perceptions Following Sinopharm COVID-19 Vaccination’ study published on August 9, 2021, found the 1st and 2nd dose post-vaccination side effects were mild and predictable, and there were no hospitalization cases. The most common side effects of post 1st dose (≤49 years old vs.>49 years) were normal injection site pain, fatigue, and headache. In contrast, pain at the vaccination site, fatigue, lethargy, headache, and tenderness were the most side effects of the post 2nd dose in both groups. The side effects in both doses were more prevalent among the participants ≤ 49-year-old group. Among females vs. males, side effects were more common in females than in both doses.
The Lancet reported on September 15, 2021, adverse reactions occurred predominantly after the first dose and showed similar frequency after the first vaccination in participants aged 3–17 years and participants aged 18–59 years or 60 years or older. The most common adverse reactions were pain and fever, transient or resolved in days. In addition, there were three grade 3 white blood cell count abnormal changes in the vaccination group, but all were clinically insignificant.
Sinopharm News For 2019 – 2022
August 1, 2022 – Xinhua reported WHO representative to Cambodia Li Ailan called on people to get their booster doses of COVID-19 vaccines.
August 1, 2022 – ANTARA reported East Java Governor Khofifah Indar Parawansa emphasized that health workers were prioritized for receiving the fourth dose of the COVID-19 vaccine.
July 26, 2022 – The journal Wiley Online published: Evaluation of response to different COVID-19 vaccines in vaccinated healthcare workers in a single center in Iran. The titers of Anti-SARS-CoV-2-nucleocapsid antibody were low in all of these four vaccines.
June 28, 2022 – The Lancet published a study that indicated a heterologous booster dose with ChAdOx1 nCoV-19, Sputnik V, or BNT162b2 vaccines markedly increases the neutralizing activity against the omicron variant in older people who have received two doses of BBIBP-CorV.
June 14, 2022 – According to the health ministry, Myanmar has some 3.62 million school children aged 5 to 12, and they are currently being inoculated with China’s Sinopharm vaccine.
May 31, 2022 – SCMP reported Sinopharm and the University of Hong Kong had launched the city’s first clinical trial for an Omicron-targeting vaccine, which could be ready for the public by November 2022.
May 28, 2022 – Study results: The efficacy of different vaccines differed significantly; the highest effectiveness was observed with the Pfizer vaccine, followed by AstraZeneca and Sinopharm, with effectiveness ranging from 94%, 89%, and 74%, respectively.
May 19, 2022 – Local media reported COVID-19 vaccines arrived in Myanmar’s Yangon. The Chinese Embassy in Myanmar confirmed five million doses arrived at the Yangon International Airport yesterday. According to the embassy, China has supplied about 46 million COVID-19 vaccine doses to Myanmar.
April 28, 2022 – Hong Kong will start clinical tests of Omicron-specific vaccines developed by Sinopharm in May 2022, reported the Global Times. An estimated 1,800 people will be involved in the test of the Sinopharm vaccine.
April 10, 2022 – Sinopharm’s subsidiary China National Biotec Group urged the elderly and those with chronic diseases to accept booster shots, as they have been proven effective in preventing severe cases and deaths in the face of Omicron virus variant.
April 3, 2022 – Bloomberg reported the China National Pharmaceutical Group Co. said its second-generation recombinant protein Covid-19 vaccine received approval for human clinical trials.
March 28, 2022 – Vaxxinity, Inc. announced that it has begun dosing participants in a Phase 3 pivotal trial of the UB-612 booster candidate with the Sinopharm vaccine.
March 25, 2022 – Novavax Inc. announced a Phase III clinical study is launching in the United Arab Emirates with people who have been previously vaccinated with Sinopharm’s COVID-19 vaccine and will assess the safety and immunogenicity of a single booster dose of Novavax’s COVID-19 vaccine.
March 19, 2022 – Bloomberg News reported that China-based Vaccine Makers Upgraded Shots to Fight Omicron.
March 11, 2022 – Jamacia’s Ministry of Health & Wellness invited the public to attend a COVID-19 vaccination site to receive their first, second, or booster dose of the AstraZeneca, Pfizer, Sinopharm, or J&J vaccine for persons 18 years and older.
March 9, 2022 – Two hundred thousand doses of Sinopharm COVID-19 vaccines have been donated to the United Nations Relief and Works Agency for Palestine Refugees in the Near East by the Government of the People’s Republic of China.
February 21, 2022 – A non-peer-reviewed study found that immune responses could not be endlessly elevated, while suppression of heightened immune responses focusing on one subunit together with a shift of immune responses to other subunits would occur after repeated vaccination.
February 4, 2022 – Brazil’s Alberto Fernández negotiated an agreement for the local production of the Sinopharm vaccine.
January 28, 2022 – The Philippines DOH Undersecretary Maria Rosario Vergeire confirmed fully vaccinated Philipinos may now receive Sinopharm COVID-19 booster shots.
January 19, 2022 – Local media reported The Philippines President Rodrigo Duterte did not experience any adverse effects from a Sinopharm booster shot.
January 7, 2022 – Reuters reported a study found the protein-based COVID-19 vaccine made by Sinopharm when given as a booster after two doses of Sinopharm, elicited a stronger antibody response against the Omicron variant than a third dose of the original.
December 29, 2021 – The new recombinant protein COVID-19 vaccine development arm of Sinopharm, announced a new Covid-19 vaccine that protects against multiple coronavirus variants has been approved for emergency use in the United Arab Emirates.
December 18, 2021 – A non-peer-reviewed study demonstrated that a third booster dose of BBIBP-CorV led to a significant rebound in neutralizing immune response against SARS-CoV-2, while the Omicron variant showed extensive but incomplete escape of the booster elicited neutralization.
November 29, 2021 – Bloomberg reported that China’s President Xi Jinping pledged to supply another 1 billion vaccines to African countries.
November 28, 2021 – Trinidad and Tobago received 84,000 doses of the Sinopharm COVID-19 Vaccine.
November 20, 2021 – The AP reported Iran now fully vaccinated 44 million people and generally uses the Sinopharm vaccine.
November 19, 2021 – The Public Health Agency of Canada announced people vaccinated with the Sinopharm COVID-19 vaccine comply with border entry guidelines.
November 8, 2021 – The UK announced beginning November 22, 2021, the government will recognize the Sinopharm vaccine for inbound travel.
November 3, 2021 – Tanzania has received 500,000 Sinopharm vaccine doses as a donation from China, reported Africa News.
November 2, 2021 – Taiwan’s Central Epidemic Command Center reported the first case of a breakthrough infection in a person who had received one dose each of China’s Sinovac and Sinopharm.
November 1, 2021 – Australia’s Therapeutic Goods Administration officially listed Sinopharm’s COVID-19 vaccine as a ‘recognized vaccine.’
October 26, 2021 – Bahrain health authorities announced that Sinopharm vaccines would be administered for all children aged three to 11 years old.
October 25, 2021 – VOA reported certain areas in China would begin vaccinating children (3-11).
October 22, 2021 – Bangkok media reported Thailand’s Department of Disease Control plans to offer booster vaccinations for those who received two Sinopharm vaccine doses.
October 20, 2021 – Serbia media confirmed a joint venture to build a vaccine-producing factory in the country has launched.
October 15, 2021 – Yale Medicine published an article: Although each vaccine is unique, all of them offer strong protection against severe disease.
October 14, 2021 – The journal Nature published an article: China’s COVID vaccines have been crucial — now immunity is waning.
October 7, 2021 – The WHO published highlights from the meeting of the Strategic Advisory Group of Experts on Immunization.
October 5, 2021 – Local media in Thailand reported the Thai Red Cross Society is offering COVID-19 vaccine jabs to 5,000 migrant workers.
October 2, 2021 – Local media reported Argentina’s drug regulator ANMAT approved the use of the Sinopharm vaccine for children aged three to 11 years of age.
October 1, 2021 – The government of Georgia received one million doses of the Chinese Sinopharm vaccine, the Ministry of Health reports. Vaccination with Sinopharm is available for citizens over 18 years. Two doses are required for the vaccination which is given at 21-28 day intervals.
September 20, 2021 – Local media reported the Chulabhorn Royal Academy began its COVID-19 vaccination campaign to inoculate schoolchildren in Bangkok and neighboring provinces with the Sinopharm Covid-19 vaccine.
September 15, 2021 – The Lancet published the results from a limited study that found the inactivated COVID-19 vaccine BBIBP-CorV is safe and well-tolerated at all tested dose levels in participants aged 3–17 years. BBIBP-CorV also elicited robust humoral responses against SARS-CoV-2 infection after two doses.
September 13, 2021 – Local media reported Jamaica is expected to receive doses of the Chinese-created Sinopharm COVID-19 vaccine before the end of 2021.
September 12, 2021 – Zhang Yuntao, chief scientist of China National Biotec Group, a subsidiary of Sinopharm, made the remarks during an aired interview with China Media Group. The company debuted four upgraded vaccines targeting the SARS-CoV-2 Delta and Beta variants during the 2021 China International Fair for Trade in Services (CIFTIS) held in Beijing, China.
September 2, 2021 – The WHO published: The Sinopharm COVID-19 vaccine: What you need to know.
August 30, 2021 – Singapore’s healthcare institutions began offering the Sinopharm COVID-19 vaccine amid “overwhelming” demand from the public.
August 29, 2021 – United Arab Emirates Twitter account said people who took two Sinopharm COVID-19 vaccine doses more than six months ago must receive a booster shot.
August 24, 2021 – The UAE’s Sharjah Social Services Department announced that certain seniors who wish to receive the third vaccine dose of Sinopharm can now register for vaccination.
August 18, 2021 – Local media reported an institute in Wuhan, China, under the CNBG, has isolated the Delta variant of the novel coronavirus and is accelerating development on a Delta-specific COVID-19 vaccine.
August 2, 2021 – The United Arab Emirates announced the approval of the Sinopharm COVID-19 vaccine for children aged 3-17. In May 2021, the UAE Ministry of Health and Prevention had approved the emergency use of the Pfizer-BioNTech Comirnaty vaccine for children between the ages of 12 and 15 following a strict assessment.
July 19, 2021 – A non-peer-reviewed study reported Sinopharm’s COVID-19 vaccine-elicited weaker antibody responses against the Delta coronavirus variant. Findings: Gender and time since the second dose had little association with the antibody titers. Age, however, was highly relevant: measurable antibody levels were present in about 90% of individuals below 50, but antibody production after BBIBP-CorV vaccination was strongly reduced with increasing age. In addition, a large number of elderly subjects, reaching 25% at 60 years and up to 50% at ages over 80, were found not to produce any protective antibody.
July 16, 2021 – UPI reported Hungarian Prime Minister Viktor Orbán announced a third COVID-19 vaccine dose would be administered on a case-by-case basis, beginning August 1, 2021, after local media reported Hungarians Sinopharm vaccine did not reach the required level of antibodies against the novel SARS-CoV-2 coronavirus.
July 12, 2021 – Gavi and UNICEF 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 that China had officially informed the Federation of Bosnia and Herzegovina that they had signed a contract to supply 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 that China National Pharmaceutical Group (Sinopharm) chairman Liu Jingzhen stated ‘the company can 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, treating 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, 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 became 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. The company’s interim results from late-stage human trials show that 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 that Pakistan announced it has formally launched the coronavirus vaccination drive as it continues to battle it. 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 the Chinese Sinopharm vaccine on Saturday,” 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 its vaccine for the upcoming national COVID-19 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.
A randomized, double-blind, controlled, phase 1/2 trial was done at Shangqiu City Liangyuan District Center for Disease Control and Prevention in Henan, China. In phases 1 and 2, healthy participants were stratified according to age (3–5 years, 6–12 years, or 13–17 years) and dose group. Individuals with a history of SARS-CoV-2 or SARS-CoV infection were excluded. All participants were randomly assigned, using stratified block randomization (block size eight), to receive three doses of 2 μg, 4 μg, or 8 μg of vaccine or control (1:1:1:1) 28 days apart. The primary outcome, safety, was analyzed in the safety set, which consisted of participants who had received at least one vaccination after being randomly assigned and had any safety evaluation information. The secondary outcomes were geometric meant titer (GMT) of the neutralizing antibody against infectious SARS-CoV-2 and were analyzed.
Phase 3 study in Iran – Comparison of the safety, efficacy, and immunogenicity of Fakhravac and Sinopharm SARS-CoV-2 vaccines, in adults aged 18 and over; a phase III randomized, non-inferiority clinical trial was last updated on August 29, 2021.