J&J submits FDA application for COVID-19 vaccine
05 Feb 2021
VaccineEmergency Use Authorization
Johnson & Johnson on Feb. 4 submitted an application to the FDA for emergency use authorization of its COVID-19 vaccineCOVID-19 vaccine, a single-shot vaccine that would alleviate scarcity issues the global vaccine supply chain is facing if approved.
The vaccine uses a single shot regimen, as opposed to the two-dose regimen Pfizer and Moderna use. It also uses an adenovirus, which creates coronavirus proteins within the body that could prepare the immune system to fend off COVID-19. Adenovirus vaccines do not need to be stored in frozen settings and can remain stable in refrigerated conditions for months, unlike Pfizer and Moderna's vaccines.
Johnson & Johnson said Jan. 29 its vaccine is 66 percent effective in preventing moderate to severe COVID-19 cases 28 days after participants received their shot, with the earliest onset of protection being observed just 14 days after receiving the shot. The announcement was based on data from a phase 3 clinical trial that took place in the U.S., Latin America and South Africa.
The drugmaker found the vaccine to be 85 percent effective in preventing severe COVID-19 cases 28 days after vaccination. Johnson & Johnson also said its vaccine showed complete protection against COVID-related hospitalization and death.
"Upon authorization of our investigational COVID-19 vaccineCOVID-19 vaccine for emergency use, we are ready to begin shipping," Paul Stoffels, MD, Johnson & Johnson's chief scientific officer, said in a news release. "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."
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