FDA Says 'rapidly Works Toward' Emergency Use Approval Of J&J's Single-shot COVID-19 Vaccine

(RTTNews) - The U.S. Food and Drug Administration said that it will rapidly work toward finalization and issuance of an emergency use authorization of Johnson & Johnson's (JNJ) single-shot COVID-19 vaccine candidate.

The FDA's statement comes after positive advisory committee meeting outcome regarding the COVID-19 vaccine.

Johnson & Johnson said that the U.S. FDA's Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend Emergency Use Authorization for the company's single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.

The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial.

The company said it is prepared to supply its vaccine immediately upon emergency use authorization and expects to deliver enough single-dose vaccine candidate by the end of March to enable the full vaccination of more than 20 million people in the U.S. The company plans to deliver 100 million single-dose vaccines to the U.S. during the first half of 2021.

According to Johnson & Johnson, the COVID-19 single-dose vaccine candidate is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at minus 20 degree celsius and a maximum of three months at routine refrigeration at temperatures of 2 degree celsius to 8 degree celsius.

Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as an Emergency Use Listing with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.