Johnson & Johnson’s COVID 19 vaccine begins its phase 3 trials in the United States from today. Trials for a single dose vaccine will include almost 60,000 adult participants at nearly 215 sites in the US and internationally.
On Wednesday, the phase 3 trials of the vaccine begin immediately with the first participants getting their doses of the vaccine, Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels said on a call with reporters. The vaccine candidate was developed by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson.
Fourth company to start Phase 3
Now, Johnson & Johnson has become the fourth company in the United States to begin its large scale clinical vaccine trials in phase 3, after Moderna, Pfizer/BioNTech, and AstraZeneca.
According to Stoffels, While all other vaccine candidates require two doses of studies, Johnson & Johnson candidate will be studied as single-dose vaccines which would accelerate the results.
Stoffels said, “We are convinced that a single dose could be very effective.”
What initial reports suggest?
Initial reports from the vaccine phase 1 and 2 trails in the United States and Belgium showed that a single dose vaccine triggers an immune response and is safe enough to move into large scale clinical trials of phase 3. The Phase 3 trial is being conducted in collaboration with Operation Warp Speed, the federal government’s coronavirus vaccine effort.
The Johnson & Johnson vaccine trails will run in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States.
Stoffels said that company plans to make information about the participants’ public and will test the vaccine on children after it is considered to be safe in the adult population.
However, Johnson & Johnson plans to run a separate phase 3 trial in collaboration with the UK government to study the effectiveness of two doses vaccine.
Human Adenovirus technology
The human adenovirus technology used in the vaccine has also been used by Johnson & Johnson in other vaccines approved by the European Commission to respond to Ebola, as well as Zika and HIV vaccine candidates. The company has claimed that the technology has been used to vaccinate more than 1 lakh people for these diseases.
Operation Warp Speed Vaccine lead Dr. Matthew Hepburn said on a call with reporters, The trails beginning from Wednesday will help in determining whether the technology will be helpful in preventing the symptomatic COVID 19. The endpoint is similar to the trials of the other three Coronavirus vaccine candidates.