A panel of medical experts on Friday endorsed the Johnson & Johnson single-dose Covid-19 vaccine for emergency use, paving the way for the Food and Drug Administration to authorize the shot. Photo: Johnson & Johnson/Handout
- Based on the totality of scientific evidence available, do the benefits of the Johnson's COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older?
- That concludes the vote. Since a majority voted yes, we do have a favorable vote.
- I have to say [INAUDIBLE].
- I think what we're starting to see is [INAUDIBLE].
- We enrolled more than 44,000 participants and conducted a study in multiple countries during the height of the pandemic. It offers substantial protection, especially against severe COVID-19, including hospitalization and death irrespective of the variant. It is well tolerated and safe, and it is a single dose regimen with storage and transportation conditions that are compatible within existing distribution channels. Specifically Johnson's single dose vaccine has demonstrated early onset of protection against symptomatic COVID-19.
- In the United States where study participants reflected the diversity of the overall US population, vaccine efficacy against moderate to severe COVID-19 with 70% to [INAUDIBLE] protection. Against all symptomatic disease was consistent with the primary endpoint, and the high levels of protection were consistent across subgroups, countries, and regions, in particular areas of high incidence of circulating variant. The known and potential benefits of As26 outweigh the known and potential risk.
- This one dose regimen offers important logistical and practical advantages for mass vaccination campaigns. It can lead to the ability to reach both individual and herd immunity more quickly. Essentially it simplifies the process. People only have to make one appointment for their complete vaccination. A one dose vaccination decreases the burden on the health care system and health care providers, and as such this single dose regimen also decreases health utilization costs.