Johnson & Johnson Seeks Emergency Use Approval For COVID Vaccine

NEW BRUNSWICK, NJ — On Thursday, Johnson & Johnson announced it had filed with the U.S. Food and Drug Administration for emergency-use authorization of its single-dose coronavirus vaccine, developed by its subsidiary Janssen Biotech, Inc.

If approved, public health experts say the Johnson & Johnson/Janssen vaccine would be a game changer in the battle against coronavirus. That's because it only requires one shot instead of two, and also does not require such cold storage temps. It can be stored in temperatures similar to a household refrigerator.

The only other two approved COVID vaccines on the market, Pfizer/BioNTech and Moderna, both require two shots. New Jersey residents have experienced difficulty not just scheduling their first shot, but also scheduling their second dose as well.

"This vaccine has the potential to vaccinate up to 100 million Americans by the summer,” said Dr. Jeffrey Carson, at professor of medicine at Rutgers Robert Wood Johnson Medical School and Rutgers Biomedical and Health Sciences. (Dr. Carson is the same doctor running the Rutgers' early treatment coronavirus trial using hydroxychloroquine, ribavirin and other drugs; they need trial participants.)

The J&J vaccine is 66 percent effective at preventing moderate to severe COVID, but it is more effective (85 percent) at preventing hospitalization and death.

What's key to know about Johnson & Johnson's COVID vaccine is that it uses long-standing viral vaccine techniques: Under Johnson & Johnson, which has its global headquarters in New Brunswick, Janssen has worked since 2015 trying to find a vaccine for Ebola, which is a much more lethal virus than coronavirus.

Janssen used its prior research on Ebola, Zika, RSV and HIV viruses to develop its coronavirus vaccine. That prior vaccine technology has been tested on more than 200,000 people worldwide in the United States, Latin America and South Africa.

No anaphylaxis was observed in those ongoing vaccine trials, said the company. The only side effects observed so far have been low-grade fevers. In fact, overall serious adverse events reported were higher in participants who received a placebo as compared to the active vaccine candidate, said Johnson & Johnson.

How the Johnson & Johnson vaccine is different than mRNA vaccines: While both the Moderna and Pfizer vaccines use messenger RNA to create a protein that prompts an immune response in the body, the Johnson & Johnson vaccine uses an adenovirus – a type of virus that causes the common cold – that has been made unable to replicate. The adenovirus carries a gene from the coronavirus into human cells, which then produce the coronavirus spike protein, but not the coronavirus itself.

This spike protein is what triggers the immune system to fight off a subsequent infection by the virus. Johnson & Johnson has used this type of vaccine technique for years on its Ebola vaccine and in investigational vaccines for HIV and RSV. Hence, there is long-term safety data for their type of vaccine, said the company.

While the CDC says mRNA vaccines are safe, it is a new type of vaccine technology that has rarely been used until now.

Johnson & Johnson's coronavirus vaccine was tested on 43,783 participants, with 468 symptomatic cases of COVID-19. Their coronavirus vaccine trial was conducted in eight countries across three continents. 840 of those J&J trial participants were patients at Rutgers/Rutgers Robert Wood Johnson Medical School, enrolled from the university community and throughout New Jersey.

"A review of adverse events indicated that a single-dose of Janssen’s COVID-19 vaccine candidate was generally well-tolerated," said the company.

“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,” said Dr. Paul Stoffels, 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.”

Johnson & Johnson expects to have the vaccine available to ship immediately following authorization.

Another benefit to the Johnson & Johnson vaccine is that it does not have to be stored in temperatures as cold as Pfizer/BioNTech's and Moderna's. Johnson & Johnson's single-dose vaccine is estimated to remain stable for two years at -4°F (-20°C) and can be stored for at least three months at 35 to 46° F, similar to a household refrigerator.

The Pfizer and Moderna vaccines required sub-zero special refrigeration and there is a risk of them expiring if they are unused.

The FDA will now review J&J’s submission and will convene a panel to publicly discuss the data on Feb. 26, reported Politico. The FDA will likely make a decision within weeks.

Be the first to know what's happening in your town and area. Sign up to get Patch emails and don't miss a minute of local and state news: https://patch.com/subscribe