Johnson & Johnson Submits Emergency Use Authorization Application to U.S. FDA for Investigational Single-Dose Janssen COVID-19 Vaccine

Johnson & Johnson announced today that its Janssen subsidiary has submitted an application to the U.S. FDA seeking Emergency Use Authorization (EUA) for its investigational single-dose COVID-19 vaccine candidate. This EUA submission is based on the overall efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, in which the single-dose vaccine met all primary and key secondary endpoints.

Janssen’s investigational COVID-19 vaccine leverages the company’s AdVac vaccine platform, which is also used to develop and manufacture the Ebola vaccine, as well as to construct its investigational vaccines against Zika virus, respiratory syncytial virus (RSV), and HIV. To date, the safety profile observed in more than 200,000 individuals has been consistent with that of other investigational vaccines using Janssen’s AdVac technology.

This investigational COVID-19 vaccine is compatible with standard vaccine distribution channels. If authorized, Janssen’s investigational single-dose vaccine is estimated to remain stable for two years at -20°C and for three months in most standard refrigerators at 2°C–8°C. The company will use the same cold-chain technology currently employed for standard vaccines to transport the vaccine.

Previously announced results from the Phase 3 clinical trial showed that this COVID-19 vaccine achieved 66% efficacy in preventing moderate and severe COVID-19 28 days after a single dose. Meanwhile, its efficacy in preventing severe disease reached 85%, and it provided complete protection against COVID-19-related hospitalizations and deaths.

“Today, the submission of our Emergency Use Authorization (EUA) for our investigational single-dose COVID-19 vaccine is a critical step toward reducing the global disease burden and ending the pandemic,” said Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “We are working with great urgency to make our COVID-19 vaccine available to the public as soon as possible.”

The company has begun submitting rolling applications to multiple regulatory authorities outside the United States and will file a conditional marketing authorization application (cMAA) with the European Medicines Agency in the coming weeks.

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a reputable hospital.

References:

[1] Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate. Retrieved February 4, 2021, from https://www.prnewswire.com/news-releases/johnson--johnson-announces-submission-of-application-to-the-us-fda-for-emergency-use-authorization-of-its-investigational-single-shot-janssen-covid-19-vaccine-candidate-301222768.html

▽Follow [WuXi AppTecDe】WeChat Official Account