KNOXVILLE, Tenn. (WATE) – The Johnson & Johnson COVID-19 vaccine has met the requirements for the emergency use authorization review process and will face a public hearing Friday.
The company will go in front of the FDA’s independent advisory committee, and that group will then decide whether the vaccine receives emergency use authorization.
50 people in Knoxville took part in Phase 1 clinical trials for the Johnson & Johnson vaccine, through AMR.
The company, formerly known as Volunteer Research Center, has been involved in all of the major COVID-19 vaccine clinical trials including Pfizer-BioNTech and Moderna.
“This undertaking was a partnership between government, pharmaceutical companies, by regulatory agencies, to enable this to happen. It’s all unprecedented. It’s also some ways a reflection of the progress that’s been made with vaccines over the last several years,” said Dr. William Smith, CEO of AMR.
Smith has led clinical trials for vaccines, even before COVID-19, but says rolling out vaccines with efficacy rates above 50% is something that’s rarely seen.
What are the facts about the Johnson & Johnson COVID-19 vaccine?
This vaccine was found to be 85% effective by FDA scientists as well as being 85% effective at preventing severe illness in clinical trials. Data also shows this vaccine is 66% effective at preventing COVID-19 cases with any symptoms.
Dr. Smith notes that the Johnson and Johnson vaccine also protects against all COVID-19 variants.
Compared to other COVID-19 vaccines given emergency use authorization, Johnson & Johnson’s vaccine is similar. Clinical trials show that there are mild side effects, like soreness at the injection site, headache, or fatigue.
What the FDA did not find: serious safety concerns.
Full data and Johnson & Johnson’s report can be read online.
Can I join a COVID-19 vaccine clinical trial in Knoxville?
The answer: AMR is still involved in clinical studies that require volunteers.
To participate in a study call: (865) 305-DRUG (3784) or go online.