Johnson & Johnson has made one more step closer towards a vaccine to fight off the coronavirus. Even though they may be a couple months behind the other companies that have already made it to phase 3 trials, their new vaccine has possibly more advantages over the others.
In an interview yesterday, Chief Science Officer of Johnson & Johnson, Paul Stoffels, said the company might be able to determine by the end of the year if the vaccine is safe and effective.
The new vaccine uses and adenovirus to carry a gene from the coronavirus into human cells. Theses cells then produce coronavirus proteins can potentially prime the immune system to fight off a later infection by the virus, and only requires one dose. Moderna’s and Pfizer’s vaccines are both required to be given twice within a few weeks apart.
Adenovirus vaccines are required to be kept refrigerated but not frozen. Freezing requirements of the vaccine could make it very difficult to distribute, especially to places that do not have advanced medical facilities. The vaccines that are currently being tested by Pfizer and Moderna are required to be frozen and given to people within a few weeks of each other, which could pose a problem.
A ½ trial that Johnson & Johnson held between the United States and Belgium showed positive results that allowed the company to move to Phase 3 trials and report the results as soon as possible.
Johnson & Johnson plans to recruit up to 60,000 people from the United States, Argentina, Brazil, Chile, Columbia, Mexico, Peru and South Africa as part of their Phase 3 testing. The trials are twice the amount as the others that began in the United States so far. Johnson and Johnson plans to manufacture as many as 1 billion doses by 2021.
The trials will be overseen by a Data and Safety Monitoring Board (DSMB) in order to review vaccine safety and effectiveness. The National Institutes of Health director, Dr. Francis Collins said, “all three vaccines being organized and supported by the federal government’s Operation Warp Speed – J&J’s, Moderna’s and AstraZeneca’s – share a common DSMB. Pfizer is running its own trial and has a separate DSMB.”
“Until they are convinced that there’s something that looks promising, nothing is unblinded and sent to the FDA. So everybody should feel pretty reassured,” Collins said.
https://www.nytimes.com/2020/09/23/health/covid-19-vaccine-johnson-and-johnson.html