Candidate: Vaccine to prevent COVID-19
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: In study data published May 26 in JAMA (Journal of the American Medical Association), a team of Chinese researchers showed a 72.8% efficacy rate for SARS-CoV-2 WIV04 (5 µg/dose), the vaccine developed by the Wuhan Institute of Virology 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 WIV04 or another vaccine candidate co-developed by Sinopharm and Beijing Institute of Biological Products, SARS-CoV-2 HB02 (4 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.
2020 Status: China National Biotech Group Co Ltd (CNBG), the vaccine and bioscience subsidiary of state-owned China National Pharmaceutical Group (Sinopharm Group), said June 23 that 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/Wuhan candidate or a candidate that CNBG is co-developing with another of its entities, the Beijing Institute of Biological Products, and the Chinese Center for Disease Control and Prevention.
CNBG said on June 16 that the vaccine developed by Sinopharm and a CNBG entity, the Wuhan Institute of Biological Products, produced high-titer 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. Patients who received two medium doses at 14 and 21 days experienced a neutralizing antbody conversion rate of 97.6%, while the seroconversion rate for patients receiving those doses at 28 days was 100%. The rates for low- and high-dose patients were also not disclosed, though CNBG did say no adverse reactions occurred during the trial.
The results were revealed in a blind review and phased blinding meeting attended by Sinopharm researchers and officials from the State Council Joint Prevention and Control Mechanism Vaccine Class, and the National Ministry of Science and Technology Biotechnology Development Center.
China’s National Medical Products Administration approved Phases I and II simultaneously through a fast-track channel based on solid results from preclinical studies, state-owned China Daily reported April 30.
State-run news agency Xinhua reported on April 25 that the Wuhan Institute of Biological Products and the Wuhan Institute of Virology, part of the Chinese Academy of Sciences, had advanced their COVID-19 vaccine candidate to a Phase II trial that began a day earlier. The virology institute has been linked by U.S. Secretary of State Mike Pompeo to “enormous evidence” that it is the source of the global COVID-19 pandemic, a contention denied by Chinese officials.
Sinopharm announced that 96 participants in three age groups had received the vaccine in Phase I as of April 23. “The vaccine has shown good safety so far and vaccine receivers are still under observation,” Xinhua reported.
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 which it is codeveloping with CNBG and another of its entities, Beijing Institute of Biological Products, as well as the Chinese Center for Disease Control and Prevention.
Through the state-owned Assets Supervision and Administration Commission, China has offered both vaccines to employees of some large state-owned companies who plan to travel overseas, Bloomberg News reported in June, citing unnamed “people familiar with the matter.”
As of May, both CNBG vaccine candiates had been tested on 2,000 people with no reported “no obvious adverse reaction,” Sinopharm Chairman Liu Jingzhen told China’s Surging News Network during a media event showcasing the Beijing Institute of Biological Products’ new “crown” vaccine production facility. According to that report. batch production exceeds 3 million doses, and the annual production capacity after the mass production reaches 100-120 million doses—a figure that will double when the Wuhan Institute of Biological Products completes its own vaccine plant.
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
