FDA Authorizes J&J’s COVID-19 Vaccine for Emergency Use
Johnson & Johnson (J&J) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of J&J, to prevent COVID-19 in individuals 18 years of age and older.
The EUA marks the third COVID-19 vaccine to receive an EUA from the FDA. Pfizer and Moderna received an EUA for their respective two-dose mRNA COVID-19 vaccines in December (December 2020).
The terms of the EUA allow use of the vaccine while more data are gathered. J&J says it plans to file for a biologics license application (BLA) with the FDA later in 2021.
The FDA’s decision for the EUA to J&J was based on the totality of scientific evidence, including data from a Phase III study that demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied and showed protection against COVID-19-related hospitalization and death, beginning 28 days after vaccination.
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has also recommended J&J’s single-shot COVID-19 vaccine for individuals 18 years of age and older under the EUA issued by the FDA. The ACIP recommendation will be forwarded to the Director of the CDC and the US Department of Health and Human Services for review and adoption. ACIP is a body of independent health experts that advises the CDC on the types of populations and circumstances for which vaccines should be used.
Manufacturing and supply
J&J has begun shipping its COVID-19 vaccine (as reported on February 27, 2021) and says it expects to deliver enough single-shot vaccines by the end of March (March 2021) to enable the full vaccination of more than 20 million people in the US. The company plans to deliver 100 million single-shot vaccines to the US during the first half of 2021. The US government will manage allocation and distribution of the vaccine in the US. This will be prioritized according to the populations identified by the ACIP guidelines.
J&J’s COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels. The vaccine is estimated to remain stable for two years at -4 °F (-20 °C), and a maximum of three months at routine refrigeration at temperatures of 36-46 °F (2 to 8 °C). The company will ship the vaccine using the same cold-chain technologies it uses to transport other medicines.
The COVID-19 vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus, the virus that causes COVID-19. The company’s COVID-19 vaccine uses its AdVac vaccine platform, a proprietary technology that was also used to develop and manufacture Janssen’s Ebola vaccine regimen (which was approved by the European Commission) and construct its investigational Zika, respiratory syncytial virus, and HIV vaccines.
Additional regulatory review
Earlier this month (February 2021), J&J submitted an application for conditional marketing authorization to the European Medicines Agency as well as filed for an Emergency Use Listing with the World Health Organization for its COVID-19 vaccine. In addition, rolling submissions for the vaccine have been initiated in several countries globally.