COVID-19 vaccine trials ramp up as world awaits efficacy data

Public health authorities and government officials across the world are anxiously waiting for preliminary results from large-scale studies of COVID-19 vaccine candidates as they firm up distribution plans for the ones that pass muster with regulators. Data readouts could start as early as month-end or early October.

A search in ClinicalTrials.gov identified the following Phase 3 trials:

AstraZeneca’s (with University of Oxford) (NYSE:AZN) AZD1222: 100-subject open-label study in Russia. Two doses 28 days apart. Estimated start date: August 26. Estimated primary completion date: March 5, 2021. Estimated study completion date: March 5, 2021.

AZD1222: Global 30K-subject randomized parallel assignment study. Two doses 28 days apart. Estimated start date: August 17. Estimated primary completion date: December 2. Estimated study completion date: October 5, 2022.

University of Oxford’s ChAdOx1. Single dose and two doses 4-6 weeks apart. 12,330-subject study in the UK. Estimated start date: May 28. Estimated primary completion date: August 2021. Estimated study completion date: August 2021.

University of Oxford’s ChAdOx1. Single dose and two doses 4-12 weeks apart. 5K-subject study in Brazil. Estimated start date: June 2. Estimated primary completion date: September 2021. Estimated study completion date: September 2021.

Sinovac Life Sciences’ (NASDAQ:SVA) Absorbed COVID-19 (inactivated) Vaccine. 8,870 subject study in Brazil. Two doses 14 days apart. Start date: July 21. Estimated primary completion date: September 2021. Estimated study completion date: October 2021.

Gamaleya Research Institute’s Gam-COVID-Vac. 40K-subject study in Russia. Two doses 21 days apart (+/- 2 days). Estimated start date: August 31. Estimated primary completion date: May 1, 2021. Estimated study completion date: May 1, 2021.

China National Biotec Group’s Vero Cell inactivated vaccine. 45K-subject study in Bahrain and UAE. Two doses 21 days apart. Estimated start date: July 16. Estimated primary completion date: March 16, 2021. Estimated study completion date: September 16, 2021.

Fundació Institut Germans Trias i Pujol’s RUTI Vaccine. Two doses 14 days apart (+/- 3 days). 315-subject study in Spain. Estimated start date: July 30. Estimated primary completion date: December. Estimated study completion date: December.

CanSino Biologics’ Ad5-nCoV (AAV5 vector). Single dose. 40K-subject study in China. Estimated start date: August 30. Estimated primary completion date: December 30, 2021. Estimated study completion date: January 30, 2022.

NPO Petrovax’s Ad5-nCov (AAV5 vector). Single dose. 500-subject study in Russia. Estimated start date: September 7. Estimated primary completion date: November 30. Estimated study completion date: July 31, 2021.

Moderna’s (NASDAQ:MRNA) mRNA-1273. Two doses 28 days apart. 30K-subject study in U.S. Estimated start date: July 27. Estimated primary completion date: October 27, 2022. Estimated study completion date: October 27, 2022.

PT Bio Farma’s SARS-CoV-2 Vaccine (inactivated). Two doses 14 days apart. 1,620-subject study in Indonesia. Estimated start date: August 10. Estimated primary completion date: January 2021. Estimated study completion date: September 2021.

Pfizer (NYSE:PFE)/BioNTech’s (NASDAQ:BNTX): BNT162b2. Two doses 21 days apart. Global 29,481-subject study. Estimated start date: April 29. Estimated primary completion date: April 19, 2021. Estimated study completion date: November 14, 2022.

Johnson & Johnson’s (NYSE:JNJ) Ad26.COV2.S. Single dose. Global 60K-subject study. Estimated start date: September 5. Estimated primary completion date: March 10, 2023. Estimated study completion date: March 10, 2023.

Sanofi (NASDAQ:SNY) and adjuvant supplier GlaxoSmithKline (NYSE:GSK) launched a Phase 1/2 study of their vaccine candidate last week. A Phase 3 should start by year-end.

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