Johnson & Johnson has said its single-dose Covid-19 vaccine candidate was 66 per cent effective overall in preventing moderate to severe Covid-19, 28 days after vaccination, among all participants including those from countries infected with an emerging viral variant. The onset of protection was observed as early as day 14. The level of protection against moderate to severe Covid-19 infection was 72 per cent in the United States, 66 percent in Latin America and 57 percent in South Africa, 28 days post-vaccination. The investigational single-shot is compatible with standard vaccine distribution channels, and provides important tool in pandemic setting. The largest pharmaceutical corporation based in the United States of America, announced the efficacy and safety data from the large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE), on Friday, January 29, 2021, demonstrating that its Covid-19 vaccine met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of Covid-19, Johnson & Johnson said in a statement. The vaccine is in development at its Janssen Pharmaceutical Companies. Meanwhile, rival vaccines from Pfizer/BioNTech and Moderna were both found to be more effective – at around 95 percent effective in protecting people against Covid-19 in trials when administered in two doses. And, those trials were conducted before the emergence of new variants of this infectious viral respiratory disease. Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer at Johnson & Johnson said that the firm embarked on the global effort to combat the Covid-19 pandemic a year ago, and “has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine.” “Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” Gorsky said. “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere,” he observed. Prevention of severe Covid-19 According to the interim analysis of the Phase 3 trial, the vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. There was a clear effect of the vaccine on Covid-19 cases requiring medical intervention (hospitalisation, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), with no reported cases among participants who had received the Janssen COVID-19 vaccine, 28 days post-vaccination. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “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,” Stoffels indicated. Protection was generally consistent across race, age groups, including adults over 60 years of age (13,610), and across all variants and regions studied. They include South Africa where nearly all cases of Covid-19 (95%) were due to infection with the B.1.351 lineage – a variant of SARS-CoV-2, the virus that causes Covid-19. Researchers have expressed worry that this Covid-19 variant identified in South Africa might evade available therapeutics and vaccines. The firm said that trial participants of the phase 3 study continue to be followed for up to two years for assessments of safety and efficacy. Therefore, these data may be updated based on ongoing analysis. The comprehensive available data set will be submitted to a peer-reviewed journal in the coming weeks.
