Johnson & Johnson asks FDA to authorize COVID vaccine
- 05 February 2021
US pharmaceutical company Johnson & Johnson filed an application Thursday with the Food and Drug Administration (FDA) requesting emergency use authorization for its single-dose Janssen COVID-19 vaccine candidate, APA reports quoting Anadolu Agency.
"Today's submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic," Dr. Paul Stoffels, vice chairman of the Executive Committee and chief scientific officer at Johnson & Johnson, said in a statement.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," said Stoffels.
While Pfizer and Moderna require two doses of their vaccines to be effective, Johnson & Johnson's only requires one dose.
According to the company, the new vaccine can remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C).
Last week, the company said its vaccine candidate has a 66% overall effectiveness in preventing moderate to severe COVID-19, 28 days after vaccination.
Its Phase 3 clinical trials were based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
"With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible," said Stoffels.