Johnson & Johnson's Single-Dose COVID-19 Vaccine Receives Unanimous 22-0 Support from FDA Advisory Committee

Recently, at the meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened by the U.S. FDA, experts discussed the Emergency Use Authorization (EUA) application for Ad26.COV2.S, the COVID-19 vaccine developed by Johnson & Johnson. Ultimately, the attending experts voted 22:0 in favor, supporting that, based on existing scientific evidence, the benefits of Johnson & Johnson’s COVID-19 vaccine outweigh the risks when used in individuals aged 18 years and older. Based on the advisory committee’s recommendation and the previous pace of COVID-19 vaccine approvals, the FDA is expected to grant emergency use authorization for Ad26.COV2.S in the near future. This will be the first COVID-19 vaccine to receive an EUA that provides protection against COVID-19 with a single-dose regimen.

Ad26.COV2.S is a candidate COVID-19 vaccine that uses the adenovirus serotype 26 (Ad26) vector to express the SARS-CoV-2 spike protein. The latest data released by the FDA previously showed that Ad26.COV2.S had an efficacy of 66.9% in preventing symptomatic COVID-19 14 days after vaccination, and 66.1% 28 days after vaccination. In subgroup analyses, there was no significant difference in vaccine efficacy between adults aged 18–59 years and older adults aged 60 years and above.

In preventing severe COVID-19, Ad26.COV2.S demonstrated a vaccine efficacy of 76.7% at 14 days post-vaccination, which increased to 85.4% at 28 days post-vaccination. A total of seven COVID-19-related deaths occurred during the trial, all in the placebo group and all from clinical trial sites in South Africa. No deaths were reported in the vaccine group.

▲ Cumulative curves of the number of COVID-19 patients in the vaccine group and the control group (Source: Reference [2])

Ad26.COV2.S remains stable for up to 2 years at -20°C and maintains stability for 3 months at 2–8°C. Therefore, existing standard channels can be used for vaccine storage, transportation, and distribution, facilitating vaccine deployment during a pandemic.

“We are deeply grateful to the VRBPAC members for their thorough review of the data on Johnson & Johnson’s single-dose COVID-19 vaccine candidate,” said Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “We believe our COVID-19 vaccine candidate has the potential to help change the course of the pandemic, and we are prepared to make it available as soon as possible to protect the public.”

References:

[1] Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee. Retrieved February 26, 2021, from https://www.prnewswire.com/news-releases/johnson--johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-us-fda-advisory-committee-301236740.html

[2] Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Briefing Document- FDA. Retrieved February 24, 2021, from https://www.fda.gov/media/146217/download

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