FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective

Wednesday, February 24, 2021

Source: Drug Discovery & Development

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective.

The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA application for the vaccine developed by its Janssen unit on Feb. 4.

According to the FDA briefing, the J&J vaccine candidate is 66% effective at preventing moderate and severe cases of COVID-19, falling within the administration’s standards for authorization, while it is also safe to use. The vaccine proved to be 85.4% effective in preventing severe cases while completely preventing hospitalizations and deaths. There were seven deaths in J&J’s Ensemble Phase 3 clinical trial, all of which occurred in the placebo group.

Should J&J’s vaccine candidate receive EUA, it would be the third, following those developed by Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE). However, it would be the first single-dose vaccine, as the previously authorized ones require two shots administered weeks apart.

The single-dose COVID-19 vaccine is estimated to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). J&J plans to ship it using the same cold chain technologies it uses to transport other medicines.

FDA’s analysis did reveal lower efficacy for the vaccine in South Africa, where a major variant of COVID-19 originated, as the U.S. efficacy came in at 72% compared to 57% in South Africa. Additionally, reduced efficacy was observed in a subgroup of adults over 60 years old with underlying conditions, but no deaths or cases requiring medical intervention occurred a month after those in the group received vaccines.

Johnson & Johnson expects to have product available to ship immediately following FDA authorization, as well. Johnson & Johnson set its target to produce 1 billion doses in 2021 and expand production after that. The company has committed to not-for-profit pricing during the pandemic assuming its single-dose vaccine is authorized by FDA and other regulators. J&J is also investigating a two-dose regimen for its vaccine.

The Hill reported that the company said it will have about 4 million doses prepared for immediate shipping after authorization, with a plan to provide 20 million doses by the end of March and 100 million by the summer.

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