J&J to Release Vaccine Trial Results Next Week, on Track to Deliver 100 Million Doses

Johnson & Johnson (J&J) said it plans to release late-stage trial data for its COVID-19 vaccine candidate next week — a single-dose shot that could help the Biden administration exceed its goal of 100 million vaccinations in 100 days.

The company expects to release data from its global phase 3 study “early next week” and plans to file for an Emergency Use Authorization shortly afterward, a J&J spokesperson told FDAnews.

J&J struck an estimated $1 billion deal with the U.S. government in August 2020 to supply 100 million doses, with an option to negotiate further agreements for an additional 200 million doses (DID, Aug. 6, 2020). The company said it is on track to supply the 100 million doses by June.

J&J has also committed to supplying the European Union up to 400 million doses (DID, Oct. 22, 2020).

The single-dose vaccine, which is derived from a common cold virus modified to carry a gene from the SARS-CoV-2 virus, has clear advantages over the two other FDA-authorized vaccines from Pfizer/BioNTech and Moderna as it requires just a single dose and can be stored at normal refrigeration temperatures.

J&J cut enrollment of its late-stage ENSEMBLE I trial in December from 60,000 to 40,000, after concluding a smaller cohort would be sufficient (DID, Dec. 11, 2020). Although the vaccine’s exact efficacy is not yet known, an interim analysis from a phase 1/2a study showed that a single vaccine dose delivered a strong immune response and was well-tolerated. ― Jason Scott