FDA Officially Authorizes the Johnson & Johnson Coronavirus Vaccine For Emergency Use
Update: On Saturday, Feb. 27, the FDA approved Johnson & Johnson’s single-dose coronavirus vaccine for emergency use – it is the third vaccine granted an emergency use authorization in the US behind mRNA-based shots from Pfizer and Moderna. This authorization allows Johnson & Johnson to distribute its vaccine to people 18 and older.
This adenovirus-based vaccine is 85 percent effective in preventing severe cases of COVID-19. According to the FDA, when a person receives the vaccine, adenovirus type 26 (Ad26) delivers a piece of the DNA that makes the spike protein present in the SARS-CoV-2 virus. Due to this, “the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2,” the FDA states.
A committee of vaccine experts acting as advisers to the CDC will meet on Sunday to discuss whether certain populations should be prioritized for the vaccine, according to The New York Times. Shipments of the vaccine could begin arriving as soon as Tuesday, and Johnson & Johnson has pledged to provide the US with 100 million doses by the end of June, The New York Times also reports. The company said it expects to deliver enough single-dose shots by the end of March to fully vaccinate more than 20 million Americans.
Original post: Johnson & Johnson has officially applied for FDA emergency use approval for its single-dose COVID-19 vaccine. If approved, the next step will be for the CDC’s Advisory Committee on Immunization Practices to determine whether the vaccine is safe to give to Americans, a process that may take two to three weeks, as it did for Pfizer’s and Moderna’s COVID-19 vaccines.
The application is “a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, in a statement. He added that the company is “ready to begin shipping” the vaccine as soon as it’s approved.
Read on for more on this important vaccine and what we know about its effectiveness.
Johnson & Johnson Coronavirus Vaccine Effectiveness
On Feb. 24, the one-shot Johnson & Johnson coronavirus vaccine was determined to be safe and effective against COVID-19 and prevented hospitalizations and death, according to a review posted by the FDA. According to The Washington Post, the Johnson & Johnson vaccine was 85 percent effective at preventing severe illness, but when moderate cases were factored in, it was only 66 percent effective overall. The New York Times reported that the vaccine was also 64 percent effective overall in South Africa, where most of the cases are from a variant of the virus, which is up seven points from previously released data.
“We know this vaccine prevents 85 percent of the severe disease,” said Nancy M. Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry, according to The Washington Post. “It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important.”
The New York Times reported that the FDA could authorize the one-shot vaccine as soon as Feb. 27, depending on a vote from the FDA vaccine advisory panel. This would add a third approved vaccine to the market, after the Moderna and Pfizer-BioNTech vaccines. Unlike the other two vaccines on the market, Johnson & Johnson’s vaccine only requires one shot, which makes it more accessible for people, especially in low-income communities. It also can be stored at normal refrigeration for up to three months. Moderna and Pfizer-BioNTech vaccines, on the other hand, are stored at below-freezing temperatures (minus four degrees Fahrenheit for Moderna and minus 94 Fahrenheit for Pfizer), making storage and distribution more complex.
Why Did Johnson & Johnson Pause Its Vaccine Trial?
On Oct. 23, 2020, Johnson & Johnson resumed its large-scale Phase 3 “Ensemble” human trial that began in September and was paused in mid-October. According to The Washington Post, a man who received a vaccination during the trial suffered a stroke that could have been triggered by an infection, but after an investigation, “no clear cause” was identified, and there was no evidence that the vaccine was the cause.
After 11 days of this pause, trial recruitment resumed, “following consultation with the U.S. Food and Drug Administration (FDA)” and other regulators around the world, Johnson & Johnson said in an Oct. 23 news release.
– Additional reporting by Sam Brodsky
POPSUGAR aims to give you the most accurate and up-to-date information about the coronavirus, but details and recommendations about this pandemic may have changed since publication. For the latest information on COVID-19, please check out resources from the WHO, CDC, and local public health departments.