FDA Authorizes Emergency Use Of Johnson & Johnson’s Single-dose COVID-19 Vaccine
The U.S. Food and Drug Administration on Saturday authorized Johnson & Johnson’s (JNJ) single-dose COVID-19 vaccine for emergency use.
It is the first single-shot COVID-19 vaccine and the third COVID-19 vaccine for emergency use in the U.S. – the other two being Pfizer/BioNTech’s BNT162b2 and Moderna’s mRNA-1273.
The FDA has issued emergency use authorization for the vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
The emergency use authorization follows a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee on Friday.
The vaccine, known as Ad26.COV2.S, was found to be 85 percent effective at preventing COVID-19 in clinical trials. Phase 3 Ensemble study showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination, Johnson & Johnson said in a statement.
An emergency use authorization means that the FDA has given the drug a special authorization to be used during an emergency period. Johnson & Johnson would have to file a separate application for its vaccine to be fully approved by the FDA. The company plans to file for a Biologics License Application with the FDA later in 2021.
The company noted that it has begun shipping its COVID-19 vaccines to the U.S. government 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.
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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