Johnson & Johnson submits its COVID-19 vaccine for EAU

(Photo by David Ramos/Getty Images)

Johnson & Johnson today announced that Janssen Biotech has submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization for its single-dose COVID-19 vaccine.

The company said it expects to have the product available to ship immediately following authorization and to supply 100 million doses to the U.S. in the first half of 2021.

However, Dr. Anthony Fauci, chief medical officer on COVID-19 vaccine efforts for the Biden Administration, said it could become available next month.

"If FDA determines it meets their standards, the vaccine could be available this March," Dr. Anthony Fauci said by Twitter during a Q& A on Thursday.  

Johnson & Johnson said its EUA submission is based on efficacy and safety data from its Phase 3 clinical trial, demonstrating that the single-dose vaccine has met all primary and key secondary endpoints.

WHY THIS MATTERS

The Johnson & Johnson candidate is expected to be the third vaccine available in the United States.

It lacks the 94 to 95% efficacy rate of the Pfizer-BioNTech and Moderna vaccines that are currently being distributed. 

The company said last week that its vaccine candidate is 72% effective in the U.S. and 66% effective overall at preventing moderate to severe COVID-19 at 28 days after vaccination. It is 85% effective overall in preventing severe disease, and it has demonstrated complete protection against COVID-19-related hospitalization and death, as of day 28.

However, the Johnson & Johnson vaccine has three important advantages to the vaccines already in distribution:

• It requires only one dose, not two. 
• It needs only the refrigerator for storage, as opposed to freezer temperatures. T
• The company can make billions of doses, rather than millions, Fauci said last week. 

THE LARGER TREND

The federal government has been working to speed up the production, distribution and administration of the COVID-19 vaccine, working against spreading variants first reported in the U.K. and South Africa.

Hospitalizations have reportedly slowed over the last 20 days after a post-holiday surge. Over 26 million cases and over 455,000 deaths have been reported in the United States.

It's been close to a year since mid-March 2020, when all 50 states and four territories reported cases of the coronavirus.

Vaccine supply, which began going out in December, has been short of demand as states announce phases for inoculation. To speed up vaccinations, federal COVID-19 Vaccine Coordinator Jeff Zients announced this week that, starting February 11, a million doses of the vaccine will be shipped directly to 6,500 pharmacies to get shots into arms, following individual state guidelines.

Janssen Pharmaceuticals is owned by New Jersey-based Johnson & Johnson and became part of Johnson & Johnson Pharmaceutical Research and Development, now renamed to Janssen Research and Development. 
 
ON THE RECORD

"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 [for] putting an end to the pandemic," said Dr. Paul Stoffels, vice chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

"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."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com