Johnson & Johnson asks FDA to authorize its Covid-19 vaccine

“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,” Dr. Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, said in a statement.

As the FDA looks at the results, it will schedule a public meeting of its Vaccines and Related Biological Products Advisory Committee, an independent group of experts who will also look at the data and make a recommendation that the agency takes into consideration when it makes a decision.

If the FDA decides to authorize the vaccine, next the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meets to discuss whether the vaccine should be given to Americans and if so, who should get it first.

This same regulatory process for Pfizer took a little over three weeks. For Moderna it was a little more than two.

The Johnson & Johnson vaccine is a little different than the other Covid-19 vaccines. The vaccine, made through a collaboration of J&J’s vaccine division, Janssen Pharmaceutical, and Beth Israel Deaconess Medical Center in Boston, is delivered in a single shot. Pfizer and Moderna’s require two. It’s considered versatile since it is considered stable for up to three months kept in regular refrigerated temperatures and doesn’t need the deep freeze like Pfizer’s.

Johnson & Johnson’s Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, according to the company. The vaccine is 85% effective overall at preventing hospitalization and death in all regions where it was tested.

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Its efficacy against moderate and severe disease ranged from one country to another: 72% in the US, 66% in Latin America and 57% in South Africa. This was measured starting one month after the shot.

In the South African arm of the clinical trial, the majority of the cases were due to a variant known as B.1.351, which is more transmissible and which carries mutations that make it less susceptible to the antibody immune response — including antibodies that would be prompted by vaccination. People who did get a moderate case of Covid-19 in the trial tended to develop a milder course of the disease with fewer symptoms, according to the company.

The J&J vaccine works a little differently than the Moderna and Pfizer vaccines. Those two use messenger RNA, genetic instructions delivered in a fat droplet that prompt the body to make what looks like a piece of the virus. With the J&J vaccine the genetic material is delivered in a a common cold virus called an adenovirus, which has been disabled so it doesn’t replicate itself or make people sick.

The US government has ordered 100 million doses and J&J says it can meet this commitment by June. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” Stoffels said.

source: cnn.com