BBIBP-CorV COVID-19 Vaccine (New Crown) 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’s Wuhan Institute of Biological Products Co. and the Chinese Center for Disease Control and Prevention (CDC).
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.
On December 31, 2020, China's National Medical Products Administration announced the experimental vaccine, developed by State-owned Sinopharm, was approved.
The Sinopharm BBIBP-CorV COVID-19 vaccine, also known as New Crown, drug bank accession number: DB15807.
BBIBP-CorV COVID-19 Vaccine (New Crown) 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 will turbocharge the world-leading vaccination activities across 205 medical centers in UAE.
The vaccine plant is located in KIZAD will become operational in 2021, and over its phased development will have a production capacity of 200 million doses per annum across three filling lines and five automated packaging lines. The JV is already producing Hayat-Vax with its partner, Julphar in UAE with an initial capacity of 2 million vaccine doses per month.
BBIBP-CorV COVID-19 Vaccine (New Crown) Indication
The Sinopharm New Crown COVID-19 vaccine candidate is indicated to prevent COVID-19 disease caused by infection with the SARS-CoV-2 virus.
No pediatric or pregnancy vaccine efficacy data has been disclosed.
BIBP-CorV can be transported and stored at normal refrigeration temperatures.
BBIBP-CorV COVID-19 Vaccine (New Crown) News
March 28, 2021 - The United Arab Emirates (UAE) 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. 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. 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.
BBIBP-CorV COVID-19 Vaccine (New Crown) Clinical Trials
The announcement of phase 3 clinical trials for the inactivated new crown vaccine, which may consist of whole, inactivated agents developed by China National Pharmaceutical Group Sinopharm (Sinopharm), was held online in China's Beijing and Wuhan, and the UAE's Abu Dhabi.
The New Crown COVID-19 inactivated vaccine candidate had not shown any severe adverse effects in the first two phases of clinical trials. It is the first vaccine candidate in the world to show favorable immunogenicity and safety.
Phase 1/2 Clinical Trial ChiCTR2000032459: Evaluation of the safety and immunogenicity of inactivated novel coronavirus (2019-CoV) vaccine (Vero cells) in a healthy population aged 3 years and above: a randomized, double-blind, placebo parallel-controlled phase I/II clinical trial. The vaccine clinical trial involved 2,128 volunteers aged 3 and above, which started on April 29, 2020. The vaccine receivers inoculated with two injections in different procedures and doses have produced high titers of antibodies.
Sinopharm said that the candidate demonstrated a good safety profile so far, with the trial participants still under observation. The results revealed a good safety record, with no cases of severe adverse effects found in the clinical trials. For those receiving two middle-dose injections at intervals of 14 days and 21 days, the seroconversion rate of neutralizing antibodies reached 97.6 percent. For those receiving two middle-dose injections at an interval of 28 days, the seroconversion rate of neutralizing antibodies reached 100 percent.
Clinical Trial NCT04510207: Chinese Clinical Trial ChiCTR2000034780: A Phase 3 Study to Evaluate The Efficacy, Safety, and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above (COVID-19) -- Last Update Posted: October 30, 2020.
Multicenter, Randomized, Double-Blind, Parallel Placebo-Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in 45000 Healthy Population Aged 18 Years Old and Above. Locations for this trial include Bahrain, Egypt, Jordan, and United Arab Emirates. Estimated Completion Date: September 16, 2021.
Clinical Trial NCT04612972: Phase 3 Study to Evaluate the Efficacy, Safety, and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Adult Population In Peru (Cov-Peru). Last Update Posted on November 3, 2020. The primary objective is to evaluate the protective efficacy of inactivated SARS CoV 2 Vaccine (Vero Cell) after the full course of immunization in preventing diseases caused by the SARS CoV 2 in 6000 healthy subjects aged 18 years old and above in Peru. Estimated Completion Date: September 1, 2021.
Clinical Trial NCT04560881: Randomized, Double-Blind, Placebo Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in 3000 Argentine Healthy Population Aged Between 18 and 85 Years-- Last Update Posted November 27, 2020
Inactivated Virus Vaccine inactivates the virus obtained by culture by heating or chemical methods. The inactivated virus loses its pathogenicity and retains the virus capsid's main antigenic characteristics, stimulating the specific immune response in the human body. The inactivated SARS-CoV-2 vaccine (Vero cell) is prepared by inoculating African green monkey kidney cells (Vero cell) with the SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying, and adding aluminum hydroxide adjuvant. After inoculating the vaccine, the recipients can produce an immune response to prevent diseases caused by SARS-CoV-2. Estimated completion date: December 1, 2021.