The COVID-19 vaccine candidate from Johnson & Johnson began its Phase 3 trials today.
The single-dose vaccine trials will involve up to 60,000 adult participants at almost 215 sites in the US and internationally.
During the first phase and second phase of a trial, the vaccine is given to only a smaller group of volunteers. It is in the third phase that the vaccine is administered to thousands of people and analyzed for safety and efficiency before it is approved to be used on the world population.
Johnson & Johnson’s Chief Scientific Officer Dr. Paul Stoffels said that today the first participants will receive the vaccine doses developed by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson.
In the United States, after AstraZeneca, Moderna and Pfizer/BioNTech, Johnson & Johnson is now the fourth company to start large-scale clinical trials for a COVID-19 vaccine. Although two doses are needed for the other vaccine candidates, Johnson & Johnson’s candidate will be tested as a single-dose vaccine that, Stoffels said, should quicken the process.
Initial results from the Phase 1 and 2 vaccine studies in the United States and Belgium indicate that a single dose of the vaccine induces an immune response and is sufficiently safe to progress into large-scale trials.
The trials will be performed in Argentina, the United States, Brazil, Chile, Colombia, Mexico, Peru and South Africa. Stoffels said the organization aims to make participant diversity data public and is committed to testing the vaccine in children after it has been shown to be effective in the adult population.
In cooperation with the UK government, Johnson & Johnson also plans to conduct a separate Phase 3 trial to test the vaccine’s efficiency when two doses are administered.
Johnson & Johnson has used the human adenovirus technology for its COVID-19 vaccine. The company has already used the same technology in its vaccine for Ebola, as well as for the Zika and HIV vaccines candidates. The firm said that the technology has now been used to vaccinate more than 100,000 individuals against these diseases.
The initial trials will help decide if the technology can be used to stop symptomatic COVID-19. If the vaccine is found to be safe and effective, Johnson & Johnson says it expects the first doses to be approved by the US Food and Drug Administration for emergency use by the beginning of 2021. It is on target to make a billion doses a year, the company reports.
In order to overcome the virus, which appeared less than 10 months ago, public health authorities and infectious disease experts believe that world would need a variety of drugs and vaccines.