By Daniel R. Lucey M.D., MPH, FIDSA
Today the World Health Organization updated its DRAFT landscape of COVID-19 candidate vaccines. In a nine-page table format, WHO lists 30 candidate vaccines in clinical evaluation, and 139 candidate vaccines in preclinical evaluation. For all 169 candidate vaccines, information is provided for the name of the developer and the type of candidate vaccine.
A brief overview on the six candidate vaccines in Phase 3 follows:
- University of Oxford (UK)/AstraZeneca, non-replicating vector, ChAdOx 1-5. One study ongoing in Brazil (Sao Paolo). One dose IM. Control is the licensed vaccine for meningococcal ACYW135. Second study planned for U.S. at 62 specified locations. Will use two doses IM separated by 28 days.
- Sinovac (China), inactivated virus vaccine, two doses IM at day 0 and 14. One study ongoing in health care workers in Brazil at 12 specified locations. Estimated 8,870 participants. Separate analyses by age below 60 or 60 and above. (Butantan Institute sponsor and collaborator). Placebo control. two doses IM 14 days apart. Second study is planned for Indonesia (Hasan Sadikan Hospital/Medical School, Padjadjaran University, Bandung). Placebo controlled. In healthy adults 18-59. Two IM doses 14 days apart.
- Wuhan Institute of Biological Products/Sinopharm (China). Inactivated virus vaccine. Two doses IM either days 0 and 14 or Days 0 and 21. Placebo control. Location to be in United Arab Emirates (UAE). Shaikh Khalifa Medical City, Abu Dhabi.
- Beijing Institute of Biological Products/Sinopharm (China). Inactivated virus vaccine. Two doses IM either Days 0 and 14 or Days 0 and 21. Placebo control. Location Abu Dhabi, UAE. Planned number of participants 5,000.
- Moderna/NIAID (U.S.). LNP-encapsulated mRNA. 2 doses IM Days 2 and 29. Began July 27 in USA. Placebo control. 30,000 participants with half receiving vaccine, half placebo. Of note, ”Primary Outcome Measures” include “Number of participants with a first Occurrence of COVID-19 starting 14 days after Second Dose of mRNA-1273 [Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)]”. (The other three primary outcome measures pertain to adverse events or reactions).
- BioNTech/Fosun Pharma/Pfizer (Germany/China/USA). 3 LNP-mRNAs. Two doses IM 28 days apart. Began July 27 in U.S. Placebo control. Vaccine chosen for Phase 3 is “BNT-162b2”. Estimated 29, 481 participants. 113 study sites, mostly in the U.S. Additional sites in Caba, Argentina and Salvador and Sao Paulo, Brazil.
- Today’s WHO update lists the Russian vaccine from the Gamaleya Research Institute, using a non-replicating adenovirus, only under the Phase 1 column. On August 11, Russia approved this vaccine.
- The Chinese CanSino Biological Inc./Beijing Institute of Biotechnology using a non-replicating adenovirus 5 vector is listed only under Phase 1 and Phase 2, but not Phase 3. During the last week of June China approved this vaccine, but only for their military.
The pace of information about these and multiple other candidate vaccines will accelerate in the coming weeks and months of 2020. This writer will attempt to keep up with “Vaccine Watch” blogs here at the IDSA/HIVMA Science Speaks blog.
Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee.He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus here since Jan. 6.