Johnson’s and Johnson’s one dose COVID-19 vaccine endorsed by the FDA

J&J’s sin­gle-dose vac­cine review was released today by the FDA committee. This review is an advisory document to brief the FDA’s Vaccines and Related Biological Products Advisory Committee.

While this vaccine may not have pro­duced the remarkable protection of the mR­NA vaccines from Pfizer and Moderna, it was still strongly en­dorsed by the FDA re­view­ers. They believe that it could pro­vide ro­bust pro­tec­tion, particularly against severe COVID-19 disease.

The FDA con­firmed that in a trial of just un­der 40,000 vol­un­teers, the vac­cine was 66% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19, 72% ef­fec­tive in the Unit­ed States, presumably due to presence of fewer variant viruses. This means that the number of infections in the 20,000 immunized people was 66% less than in the 20,000 controls.

Al­though that’s significantly less than the 95% protection from either the Mod­erna or Pfiz­er-BioN­Tech vaccines, the J&J shot was 85% ef­fec­tive at stop­ping se­vere dis­ease 28 days af­ter ad­min­is­tra­tion. Mortality was also eliminated as there were sev­en deaths in the place­bo group but none in the vac­cine group.

J&J vaccine is a genetically modified Adenovirus that contains the DNA from the SARS-CoV-2 Spike protein

There was evidence that the im­mune re­sponse strength­ened over time, as infections stopped eventually over time, but the study showed pro­tec­tion be­gan af­ter just 14 days.

COVID-19 clinical illness was lower in individuals given the J&J vaccine (blue line) than controls (red line). Infections decrease most day 28 after vaccination.

My guess is that this vaccine will show even better efficacy in the two dose trials currently underway. This certainly provides another option at a time of vaccine shortages!

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

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