Johnson & Johnson (NYSE:JNJ) said Wednesday that its subsidiary Janssen Biotech Inc is requesting approval from the United States Food and Drug Administration for its single-dose COVID-19 vaccine candidate.
What Happened: The multinational pharma company said in a statement that it is asking for an emergency use authorization from the FDA based on the results of the vaccine’s Phase 3 clinical trial.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” said Johnson & Johnson’s Chief Scientific Officer Paul Stoffels.
The drugmaker said it will also submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks.
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26 to discuss the EUA for Janssen's vaccine, according to a statement issued Thursday.
The two approved vaccines face logistics problems as they require ultracold temperatures for storage.
The Janssen candidate can be shipped with “standard vaccine distribution” channels, according to Johnson & Johnson.
The single-dose Janssen shot eliminates the need for a second dose required in the case of Pfizer and Moderna vaccines.
The vaccine is estimated to remain stable for two years at minus four degrees Fahrenheit (minus 20 degrees Celsius) and can be stored for three months under standard refrigeration at 36 to 46 degrees Fahrenheit (two to eight degrees Celsius).
Johnson & Johnson will start vaccine supply with 2 million doses after it receives the EUA from FDA, according to a Government Accountability Office report.
The company said it expects to supply 100 million doses to the U.S. in the first half of this year.
Price Action: Johnson & Johnson shares rose nearly 1.8% to $164.95 in the after-hours session on Thursday after closing 0.93% higher at $161.99.