Johnson & Johnson one-dose vaccine effective against COVID-19, less so against South African variants
According to a press release, the study vaccine met all secondary and primary high school points, with baseline safety and efficacy data based on 43,783 participants who collected 468 typical cases of COVID-19. The ENSEMBLE level 3 study is designed to assess the efficacy and safety of a Janssen vaccine candidate in protection against moderate-to-severe COVID-19, with combined primary endpoints of 14 days and 28 days out after vaccination.1
Among all participants from different areas and including those with emerging variant viral infection, the vaccine candidate was 66% overall effective in COVID-19 inhibition moderate to severe at 28 days after vaccination. The defense began as early as day 14.1 Notably, the protection rate was 72% in the United States, 66% in Latin America, and 57% in South Africa at 28 days after vaccination, suggesting lower efficacy against the variant. appearing in South Africa.1
The first U.S. cases of the South African variant were found in South Carolina, according to the CDC. While there is currently no evidence that the variant causes a more severe disease, preliminary data suggest that it may spread more easily and rapidly than other variants.2
“Our aim is to create a simple, effective solution for as many people as possible, and to maximize the impact of helping to end the pandemic,” he said. Alex Gorsky, MBA, chairman of the Board of Directors and CEO of Johnson & Johnson, in a press release. “We are proud to have reached this important milestone and our commitment to tackling this global health crisis continues to be a crisis for everyone, everywhere.”1
The vaccine candidate was 85% effective in preventing serious infection across all areas studied at 28 days after vaccination in adults 18 years of age and older. Efficacy over time went unrecognized on vases in vaccine participants after day 49, according to the press release.1
The candidate also demonstrated complete protection against hospitalization and COVID-19-related death at 28 days after vaccination and had a clear impact on cases requiring medical intervention. There were no reports of COVID-19 requiring hospitalization among participants who received the Janssen COVID-19 vaccine candidate at 28 days after vaccination.1
“These key findings with a single-image COVID-19 vaccine candidate represent a promising time,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in a press release. “The potential to significantly reduce the burden of a major disease, by providing effective and well-tolerated vaccines with only 1 vaccine, is an essential part of the global public health response. ”1
The safety profile was consistent with other vaccine candidates using Janssen AdVac technology among more than 200,000 people to date. Total fever rates were 9% and stage 3 fever was below 0.2%. Reported overall adverse events were higher among participants who received the placebo compared to the active vaccine candidate and no anaphylaxis was observed.1
The press release noted that the vaccine candidate is compatible with normal vaccine circulation channels and is expected to remain stable for 2 years at 4 negative Fahrenheit rates, of which at least 3 months may be at temperatures between 36 and 46 degrees Fahrenheit. If approved, the company said it will administer the vaccine using the same cold chain technologies they use today to transport drugs and other vaccines.1
“Changing the course of the pandemic requires a major vaccine to create herd immunity, and a single-dose regimen with quick and easy delivery and storage provides a solution that can reach as many people as possible. , ”Mathai Mammen, MD, PhD, Janssen ‘s global head of research & development, said in the press release. “The ability to avoid hospitals and deaths would change the game in fighting the pandemic.”1
REFERENCE
Johnson & Johnson cites Janssen COVID-19 vaccine candidate key points in interim analysis of ENSEMBLE Level 3 test [news release]. Johnson & Johnson; January 29, 2021. https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its -phase-3-ensemble-trial. Accessed January 29, 2021.