Johnson & Johnson Seeks Emergency WHO Nod For Single-dose COVID-19 Vaccine

(RTTNews) - Johnson & Johnson (JNJ) said Friday that it has submitted for Emergency Use Listing to the World Health Organization or WHO for the investigational single-dose Janssen COVID-19 vaccine candidate.

The company said that the Emergency Use Listing process expedites access to products in many countries around the world and is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

Johnson & Johnson filed for emergency use authorization of its single-dose COVID-19 vaccine candidate in the United States on February 4, 2021. It also submitted a Conditional Marketing Authorisation Application in the European Union on February 15, 2021. In addition, rolling submissions for the investigational single-dose COVID-19 vaccine have been initiated in several countries worldwide.

Moderna and Pfizer vaccines, which are now being distributed in the US, are administered as two doses, and the Pfizer vaccine requires ultra-cold storage.

In a phase III trial, dubbed ENSEMBLE, which included participants from different geographies and including those infected with an emerging viral variant, Janssen's COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.

The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination, according to Johnson & Johnson.

If authorized, Johnson & Johnson's investigational single-dose vaccine is estimated to remain stable for two years at minus 20 degree celsius, at least three months of which can be stored in most standard refrigerators at temperatures of 2 degree Celsius to 8 degree Celsius.

In December 2020, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance in support of the COVAX Facility. They expect to enter into an Advance Purchase Agreement that would provide up to 500 million doses of the Janssen vaccine to COVAX through 2022.