Johnson & Johnson Requests Emergency Use Authorization From FDA For Third U.S. COVID Vaccine
PITTSBURGH (KDKA) -- Johnson & Johnson has applied for emergency use authorization from the FDA.
This third possibility as a choice under EUA would be a welcomed addition when the country's supply of vaccine is stretched thin.
"To have an option with more manufacturers, more vaccine availability is definitely a good thing," says AHN Infectious Diseases specialist Dr. Nitin Bhanot.
This vaccine has some advantages. It's a single shot and can be shipped and stored at refrigerator temperatures, making it easier to be at a doctor's office.
"You can put it in the fridge for about three months," says Dr. Bhanot. "The PCPs have it, and they can give it to patients, they walk in, they get a shot."
In contrast to the Pfizer and Moderna versions, this vaccine does not use mRNA. Johnson & Johnson uses a modified common cold virus, an adenovirus, to carry coronavirus spike protein for the body to react against.
"You're not giving live virus, you're not giving the adenovirus in the form that can cause disease, and you're just giving the spike protein," Dr. Bhanot said.
In studies, the vaccine is 66 percent effective at preventing moderate or severe disease. Moderate disease means a positive test and one major issue — such as pneumonia, a blood clot or low oxygen levels — or two minor symptoms. Severe means critically ill or on a ventilator.
In the beginning, vaccine makers hoped for just 50 percent, which is around where common vaccines are, Dr. Bhanot said.
"Even if it's 70 percent effective, it's great," he said. "The influenza vaccine efficacy is like — 50 percent, 40 percent — but we recommend that because the severity of disease goes down with the influenza shot."
It works better in some parts of the world than others — 72 percent in the U.S. compared to 57 percent in South Africa. This could be related to emerging variants.
Against severe disease, it's 85 percent effective a month after the vaccine for people 18 years and older. According to Johnson & Johnson, no one in the vaccine group needed to go to the hospital or intensive care.
The FDA will now review the studies and its vaccine advisory panel will meet at the end of the month. If it gets authorization, immunizations with the J&J product could begin in March.
