Candidate: Vaccine to prevent COVID-19
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.
Status: Conditional approval granted December 30, 2020–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: