main data from the Phase III ENSEMBLE clinical study, which was trialed on 43,783 people.
The single-shot vaccine’s effectiveness and safety against severe and moderate Covid-19 were evaluated in a double-blind, randomized, placebo-controlled experiment. According to the data, the vaccine candidate was 85 percent effective against the severe Covid-19 illness. After 28 days of immunization, it also offered protection against the disease-related risk of hospitalization and mortality.
Paul Stoffels, executive committee vice-chairman and chief scientific officer of Johnson & Johnson, expressed pride over the vaccine’s clearance. He said, “Today marks the first major regulatory approval for the Johnson & Johnson Covid-19 vaccine and an important moment to recognise the dedication of everyone involved in our Covid-19 vaccine development, our partners, the regulators and clinical study participants”. He added, “We are proud to have a Covid-19 vaccine available to protect people around the world and will continue to work to ensure global access.”
The single-dose vaccine was developed utilizing the company’s AdVac vaccine platform, which was previously utilized to design and manufacture their Ebola vaccine regime. Additionally, the company’s experimental Zika, respiratory syncytial virus (RSV) vaccine, and human immunodeficiency virus (HIV) vaccine were also manufactured using the same platform. Johnson & Johnson vaccine is projected to be stable for two years at -25°C to -15°C and for a maximum of six months at 2 to 8°C temperatures when refrigerated regularly.
