Johnson & Johnson’s single-dose vaccine candidate was found to be 57% effective in South African participants.
The topline safety and efficacy data were based on a study conducted in eight countries across three continents, with 43 783 participants accruing 468 symptomatic cases of COVID-19. Those infected with the new variant were also included in the study.
The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.
The vaccine candidate was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.
It also demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation), with no reported cases among participants who had received the vaccine, 28 days post-vaccination.
“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson in a statement.
“A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”
The Company is committed to bringing an affordable COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending regulatory authorisations.
It intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorisation.