Interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine

Background This interim guidance has been developed on the basis of the advice issued by the Strategic Advisory Group of Experts (SAGE) on Immunization at its extraordinary meeting on 15 March 2021 (1). Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the reported interests can be found on the SAGE meeting website and SAGE Working Group website. The guidance is based on the evidence summarized in the Background document on Janssen Ad26.COV2.S (COVID-19) vaccine and the Background paper on COVID-19 disease and vaccines. Both these documents are available on the SAGE COVID-19 webpage: www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials. Methods SAGE applies the principles of evidence-based medicine and has set in place a thorough methodological process for issuing and updating recommendations (2). A detailed description of the methodological processes as they apply to COVID-19 vaccines can be found in the SAGE evidence framework for COVID-19 vaccines (3). This framework contains guidance on considering data emerging from clinical trials in relation to the issuance of vaccine-specific evidence-based recommendations. General goal and strategy for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine The COVID-19 pandemic has caused significant morbidity and mortality throughout the world, as well as major social, educational and economic disruptions. There is an urgent global need to develop effective and safe vaccines and to make them available at scale and equitably across all countries. Ad26.COV2.S vaccine against COVID-19 is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein. This vaccine does not contain adjuvants, preservatives, materials of animal origin, or fetal tissue. A single dose of Ad26.COV2.S has an efficacy of 66.9% (95% confidence interval (CI): 59.0,73.4) against symptomatic SARS-CoV-2 infection, 76.7% (95% CI: 54.6, 89.1) against severe COVID-19 disease after 14 days, and 85.4% (95% CI: 54.2, 96.9) after day 281. Vaccine efficacy against hospitalisations was 93.1% (95% CI: 72.7, 99.2). Vaccine efficacies were maintained across genders, age and ethnicities. At the time of analysis, the median follow-up was 58 days, with 55% of participants having had 2 months and more of follow-up. More detailed data on the efficacy and safety of this vaccine can be found in the Background document on Ad26.COV2.S. These data reviewed by WHO support the conclusion that the known and potential benefits of Ad26.COV2.S outweigh the known and potential risks. As sufficient vaccine supply will not be immediately available to immunize all who could benefit from it, countries are recommended to use the WHO Prioritization Roadmap (4) and the WHO Values Framework (5) as guidance for their prioritization of target groups. As long as vaccine supplies are very limited (stage I in the WHO Prioritization Roadmap), in settings with community transmission, the Roadmap recommends that priority be given initially to health workers and older people with and without comorbidities. As more vaccine becomes available, additional prioritygroups should be vaccinated as outlined in the WHO Prioritization Roadmap (4), taking into account national epidemiological data, vaccine-specific characteristics as outlined in product information approved by regulatory authorities, and other relevant considerations.