FDA/CDC

FDA grants emergency use authorization to Johnson & Johnson COVID-19 vaccine


 

Looking beyond the numbers

The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines.

However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.

“One of the things that these vaccines do very well is they minimize severe disease,” Dr. Kraft said. “As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our armamentarium to fight this virus.”

“If you can give something that prevents people from dying, that is a true path to normalcy,” Dr. Goepfert added.

More work to do

“The demand is strong from all groups right now. We just have to work on getting more vaccines out there,” Dr. Shah said.

“We are at a point in this country where we are getting better with the distribution of the vaccine,” he added, “but we are nowhere close to achieving that distribution of vaccines to get to everybody.”

Dr. Goepfert, Dr. Shah, and Dr. Kraft disclosed no relevant financial relationships. Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA Health Care System.

A version of this article first appeared on Medscape.com.

Pages

Recommended Reading

Alien cells may explain COVID-19 brain fog
MDedge Emergency Medicine
CDC chief lays out attack plan for COVID variants
MDedge Emergency Medicine
Ivabradine knocks down heart rate, symptoms in POTS
MDedge Emergency Medicine
Organ transplant patient dies after receiving COVID-19–infected lungs
MDedge Emergency Medicine
Pandemic puts patients with psoriatic disease off seeking medical help
MDedge Emergency Medicine
Variants spur new FDA guidance on COVID vaccines, tests, drugs
MDedge Emergency Medicine
New cases of child COVID-19 drop for fifth straight week
MDedge Emergency Medicine
Janssen/J&J COVID-19 vaccine cuts transmission, new data show
MDedge Emergency Medicine
Myocardial injury seen on MRI in 54% of recovered COVID-19 patients
MDedge Emergency Medicine
J&J COVID-19 vaccine wins unanimous backing of FDA panel
MDedge Emergency Medicine