J&J to begin human trials of COVID-19 vaccine in July
American pharma giant Johnson & Johnson has announced that it will be starting human trials of its experimental COVID-19 vaccine sooner than previously planned. The accelerated timeline from the company comes as the world races to develop a vaccine for the deadly respiratory disease and stop the global pandemic caused by it. Here is more about it.
Clinical human trials starting in July
According to Johnson & Johnson's latest announcement, Ad26.COV2-S, the company's leading candidate vaccine for COVID-19, will be going into clinical human trials by mid-July. Originally, the candidate was slated to go into trials in September, but the company was able to fast-track the work on the back of promising results in pre-clinical trials and discussions with the regulatory authorities.
What we know about this vaccine?
J&J began working on Ad26.COV2-S back in January using the same technology it had employed to develop a vaccine for Ebola. The formula uses a killed strain of the novel coronavirus, which causes the disease, to trick the body of the patient into thinking that the virus has attacked and generate an immune response or antibodies required to fight off the actual infection.
Early indicators suggest it will be safe and effective
J&J CEO Alex Gorsky had previously said, "We have very good early indicators that not only can we depend on this to be a safe vaccine base but also one that will ultimately be effective based on all the early testing and modeling." "This is a bit of a moonshot for J&J, but it's one we feel is very, very important," he added.
What will happen in human trials?
In the upcoming clinical trials, set to take place in Belgium and the US, J&J will test the vaccine on 1,045 healthy individuals, which will include adults aged between 18 and 55 and elderly over 65. The company will use the vaccine against a placebo and then analyze the collected data to evaluate its safety, reactogenicity (response to vaccination), and immunogenicity (immune response).
Work to fast-track late stage trial also going on
If the results of these trials come out promising, J&J will also try to fast-track late-stage trials that involve a much larger population. Notably, the company is already in talks with NIAID in connection to the matter. And, it is also working to expand its manufacturing capacity and supply over a billion doses of the vaccine if it is confirmed to be working.
10 vaccines are already in clinical trials
Apart from J&J's vaccine, 10 other candidates, mainly from China and the US, are in clinical trials. Among these, Moderna Therapeutics' mRNA-1273 is the leading candidate. It is already moving through Phase-2 of clinical human trials and is expected to go into larger Phase-3 stage sometime in July. The early results of the vaccine have also been promising.
So, when it will be available?
Experts suggest that the vaccine would be available in 12-18 months from now. At the moment, Moderna is at the forefront of this race and going by its current trial timeline, the vaccine should be available for emergency use by early 2021.
