Johnson & Johnson asks FDA for single-shot COVID-19 vaccine EUA

Johnson & Johnson has applied for a COVID-19 Emergency Use Authorization (EUA) from the FDA, the company announced on Thursday, February 4. The application pertains to J&J's Janssen COVID-19 vaccine candidate, a single-shot product that is ready to be shipped to distributors 'immediately following authorization,' Johnson & Johnson said.

On January 29, Johnson & Johnson announced that its single-shot COVID-19 vaccine is 66-percent effective overall at preventing severe and moderate cases of COVID-19. The post-vaccination protection was observed as early as 14 days after administration, the company had said, with the 66-percent figure referring to 28 days post-vaccination.

Now, less than a week later, the company has applied for an Emergency Use Authorization, stating that it expects to be ready to ship its product as soon as authorization is given. The company goes on to state that its Janssen vaccine is 'compatible with standard vaccine distribution channels' and has a shelf life of two years when kept at -4F.

In a statement, Johnson & Johnson's Paul Stoffels, MD, said:

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. Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. 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.

The application follows J&J's Phase 3 ENSEMBLE study, which was a double-blind randomized clinical trial involving adults ages 18 and older. The test took place in eight countries to cover 'a diverse and broad population,' according to the company. The vaccine is expected to be available starting next month.