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US CDC Committee Recommends Johnson & Johnson's Single-Shot COVID-19 Vaccine For Adults 18 And Older

Johnson & Johnson (JNJ) said Sunday that the U.S. Centers for Disease Control and Prevention's or CDC Advisory Committee on Immunization Practices or ACIP has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization issued by the U.S. Food and Drug Administration.

The company noted that the ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services (HHS) for review and adoption.

The company's single-shot COVID-19 vaccine received emergency use authorization from the FDA on February 27, 2021. The company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

The company noted that it has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines 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-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S.

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 its filing for 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.

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