Candidate: BBIBP-CorV
Category: VAX
Type: Inactivated vaccine using nonliving viruses, bacteria or other pathogens that have lost disease-producing capacity to stimulate the immune system to develop an immune response.
2021 Status: Antibody Rebound from Booster Dose—A team of Chinese researchers posted a preprint September 15 in medRxiv showing a 7.2-fold rebound in the presence of antibodies in 50 of 63 previously vaccinated healthcare workers who volunteered for a third booster dose of BBIBP-CorV at the First Affiliated Hospital of Sun Yat-sen University (FAH-SYSU) in Guangzhou,China–from 9.2 AU/ml to 66.8 AU/ml one week after the third vaccination. Antibody presence had declined over five months between the first and second doses of the vaccine, from a first-dose peak of 31.2 AU/ml, though SARS-CoV-2-specific memory B, CD4+ , and CD8+ T cells persisted in the peripheral blood 5 months after the second vaccination, the researchers reported.
Vaccine Safety Shown in Children—A team of Chinese researchers published a study September 15 in The Lancet Infectious Diseases showing BBIBP-CorV to be safe and well tolerated at all tested dose levels in participants aged 3–17 years, based on a Phase I/II trial conducted at Shangqiu City Liangyuan District Center for Disease Control and Prevention in Henan, China. BBIBP-CorV also elicited robust humoral responses against SARS-CoV-2 infection after two doses.
“Our findings support the use of a 4 μg dose and two-shot regimen BBIBP-CorV in phase 3 trials in the population younger than 18 years to further ascertain its safety and protection efficacy against COVID-19,” the researchers concluded.
78% Efficacy Rate–In the trial, 216 eligible participants were randomly assigned to vaccine (24 for each dose level [2/4/8 μg] in each of three age cohorts [3–5, 6–12, and 13–17 years]) with 72 randomized to control (24 for each age cohort) in Phase I. In Phase II, 540 eligible participants were randomly assigned and allocated to vaccine (60 for each dose level [2/4/8 μg] in each of three age cohorts, while 180 were randomized to control (n=180, 60 for each age cohort).
In study data published May 26 in JAMA (Journal of the American Medical Association), a team of Chinese researchers showed a 78.1% efficacy rate for SARS-CoV-2 HB02 (4 µg/dose), the vaccine developed by the Beijing Institute of Biological Products and China National Biotech Group Co Ltd (CNBG), the vaccine and bioscience subsidiary of state-owned China National Pharmaceutical Group (Sinopharm Group).
The data came from a prespecified interim analysis of a randomized clinical trial included 40,382 participants who received at least one dose of a two-dose inactivated vaccine series eveloped from either HB02 or another vaccine candidate co-developed by Sinopharm and Beijing Institute of Biological Products, SARS-CoV-2 WIV04 (5 µg/dose) strains, or an aluminum hydroxide–only control. The study’s primary endpoint was the incidence of symptomatic COVID-19 at least 14 days after the second injection.
WHO Grants Emergency Use Listing—The World Health Organization (WHO) on May 6 granted an emergency use listing (EUL) to Sinopharm for the vaccine developed by state-owned China National Pharmaceutical Group (Sinopharm Group) with Beijing Institute of Biological Products under Sinopharm’s vaccine and bioscience subsidiary China National Biotec Group (CNBG).
WHO recommended the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. The EUL marked the WHO’s first granted to a non-Western vaccine developer.
2020 Status: Conditional approval granted–China’s National Medical Products Administration (NMPA) on December 30 granted conditional approval to the vaccine developed by state-owned China National Pharmaceutical Group (Sinopharm Group) through its vaccine and bioscience subsidiary China National Biotec Group (CNBG) with CNBG’s Beijing Institute of Biological Products. The announcement was made December 31 by Chen Shifei, deputy head of the NMPA.
Sinopharm announced interim clinical results on December 30 showing that its vaccine achieved 79.34% efficacy in preventing COVID-19 symptoms in healthy participants, and achieved a 99.52% antibody positive conversion rate after two doses. CNBG Chairman Yang Xiaoming told China’s state-owned Global Times news outlet—published under the auspices of the Chinese Communist Party’s People’s Daily newspaper—that the data on safety and efficacy collected to date in the Phase III clinical trials was better than expected. Yang also said CNBG’s production capacity of COVID-19 inactivated vaccines reached 120 million doses at the end of 2020, and will expand to one billion doses per year in 2021.
A Sinopharm spokesperson told the Global Times the interim results were mainly based on data from trials conducted in the United Arab Emirates, the vaccine’s largest test base. The UAE and Bahrain have both approved the vaccine.
CNBG said June 28 that the vaccine candidate co-developed with CNBG’s Beijing Institute of Biological Products showed itself to be safe and to generate high tiers of antibodies in a Phase I/II trial.
The randomized, double-blind, placebo-controlled trial enrolled 1,120 healthy volunteers ages 18-59, who received two doses of the vaccine at undisclosed low, medium, or high dosages at 14, 21, and 28 days. CNBG said the vaccine showed itself to be safe and effective, but Chinese news reports offered no numerical data supporting that assertion.
The results were revealed during a blind review of data from the Phase I/II clinical trial, held simultaneously in Beijing and Henan. CNBG researchers joined officials from the State Council Joint Prevention and Control Mechanism Research Group on Vaccine R&D and the State Food and Drug Administration in attending the meeting.
On June 23, Sinopharm said it received approval to conduct a Phase III trial in the United Arab Emirates of one of its two vaccine candidates, but did not specify if it was the CNBG/Beijing candidate or a candidate that CNBG is co-developing with another of its entities, the Wuhan Institute of Biological Products, and the Chinese Academy of Sciences (Wuhan Institute of Virology).
In April, CNBG said its second inactivated vaccine targeting COVID-19 won clinical trial approval from China’s National Medical Products Administration. The vaccine is co-developed by a unit of CNBG, Beijing Institute of Biological Products Co Ltd., and the Chinese Center for Disease Control and Prevention.
Sinopharm is China’s largest pharmaceutical company with more than 1,500 subsidiaries, including six publicly listed entities. Sinopharm has set aside a fund of 1 billion yuan (about $142 million) to support R&D of the vaccine, and another it is co-developing with the Chinese Academy of Sciences (Wuhan Institute of Virology).
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
