Sinopharm Covilo COVID-19 Vaccine
The Sinopharm COVILO COVID-19 (BBIBP-CorV) 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. On December 31, 2020, China's National Medical Products Administration announced the experimental BBIBP-CorV vaccine, developed by a State-owned Sinopharm, was Approved. COVILO is a World Health Organization (WHO) List and pre-qualified vaccine. On May 7, 2021, the WHO approved the vaccine, 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 Sinopharm 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.
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 is 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 mission.
China National Pharmaceutical Group Co., Ltd. (Sinopharm) is a significant 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. TChina National Biotec Group Company Limited confirmed that theSinopharm candidate will be tested as boosters in adults who have already received two or three vaccine doses, 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, which found Sinopharm Covid-19 vaccine offers protection against severe illness, hospitalization, and death from the Omicron variant despite declines in protective antibodies.
Sinopharm Authorizations
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, the Sinopharm (Wuhan) Inactivated (Vero Cells) vaccine is approved, and the UK authorized it for international visitors, as did Australia. In June 2021, a vaccination drive resumed in parts of Bangladesh with the China-donated Sinopharm vaccines.
Sinopharm Recombinant Protein Vaccine (NVSI-06-07)
The scientific research team of the CNBG of Sinopharm Group developed Sinopharm's recombinant protein COVID-19 vaccine. 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 design, develop, and use genetic engineering technology independently 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 complete 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 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.
Sinopharm History
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 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 most were unrelated to the vaccinations. An exploratory analysis found that the two vaccines induced measurable neutralizing antibodies, similar to the phase 1/2 trial results.
Sinopharm Dosage
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 then 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, more significant 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.
Sinopharm Indication
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.
Sinopharm Women
From the available data as of September 2, 2021, the WHO says the COVID-19 vaccine BIBP in pregnant women is insufficient to assess vaccine efficacy or vaccine-associated risks in pregnancy. However, this vaccine is inactivated 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 Children
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 a 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. BBIBP-CorV also elicited robust humoral responses against SARS-CoV-2 infection after two doses. These findings support using a 4 μg dose and two-shot regimen of BBIBP-CorV in phase 3 trials in the population younger than 18 years further to 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 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 ppost-firstdose (≤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 common side effects of the post-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, that adverse reactions occurred predominantly after the first dose and showed similar frequency after the first vaccination in participants aged 3–17 years and 18–59 years or 60 years or older. The most common adverse reactions were pain and fever, which were transient or resolved in days. In addition, three grade 3 white blood cell count abnormal changes were in the vaccination group, but all were clinically insignificant.
Sinopharm Vaccine News
October 6, 2022 - A Case Report published by Wiley Online identified the first case of herpetic endotheliithis and secondary stromal keratitis following inactivated COVID-19 vaccination who experienced a relapse due to poor adherence.
August 20, 2022 - BMC published: Real-world study of the effectiveness of BBIBP-CorV (Sinopharm) COVID-19 vaccine in the Kingdom of Morocco. Conclusions: The effectiveness of Sinopharm's BBIBP-CorV was consistent with phase III clinical trial results. Two doses of BBIBP-CorV were highly protective against COVID-19-associated serious or critical hospitalization in working-age adults under real-world conditions and moderately effective in older adults. Booster dose vaccination was associated with complete protection, regardless of age, although only a small proportion of subjects received booster doses.
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-nthe ucleocapsid 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.
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 the Omicron virus.
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 9, 2022 - The Government of the People's Republic of China donated two hundred thousand doses of Sinopharm COVID-19 vaccines to the United Nations Relief and Works Agency for Palestine Refugees in the Near East.
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 and a shift of immune responses to other subunits would occur after repeated vaccination.
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 the neutralizing immune response against SARS-CoV-2, while the Omicron variant showed extensive but incomplete escape of the booster elicited neutralization.
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 2, 2021 - The WHO published The Sinopharm COVID-19 vaccine: What you need to know.
August 2, 2021 - The United Arab Emirates announced the apprapprovedID-19 vaccine for children aged 3-17. In May 2021, the UAE Ministry of Health and Prevention 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, many elderly subjects, reaching 25% at 60 years and up to 50% at ages over 80, were found not to produce any protective antibody.
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 2twoinactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19. Data collection for the final analysis is pending.
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.
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, accounting for 21.3% of administered vaccinations.
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 using 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 that 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.
December 13, 2020 - The National Health Regulatory Authority 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 officially registered the Beijing Institute of Biological Product's inactivated COVID-19 vaccine as a significant step towards combating the global pandemic. The registration of this vaccine is a decision in response to the application submitted by Sinopharm CNBG.
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 ito be nactivated 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 can 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 two 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 inactivatedcrown-inactivatedperation between Chinese and UAE technology companies marks new and essential international anti-epidemic cooperation progress.
June 17, 2020 - A vaccine candidate developed by Sinopharm's Wuhan Institute of Biological Products Co. has shown no severe 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 increased Sinopharm shares by 15% in Hong Kong to be the best performer in the MSCI Asia Pacific Index.
Sinopharm COVID-19 Vaccine Clinical Trials
The Sinopharm COVID-19 inactivated vaccine showed no severe adverse effects in the first two clinical trials. It is the first vaccine candidate in the world to lead 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.