Advisory Committee unanimous recommendation…Prevention of hospitalization and death related to corona
The U.S. Food and Drug Administration (FDA) has approved the emergency use of Johnson & Johnson’s single-dose COVID-19 vaccine.
Johnson & Johnson announced on the 27th of last month (local time) that the FDA has decided on an emergency use approval (EUA) for the use of a single dose Corona 19 vaccine developed by its subsidiary Janssen Pharmaceuticals for the prevention of Corona 19 in adults over the age of 18.
Johnson & Johnson’s vaccine is the third COVID-19 vaccine approved by the FDA to prevent SARS-CoV-2.
This decision is based on full scientific evidence, including data from the phase 3 clinical ENSEMBLE trial.
At ENSEMBLE, Janssen’s vaccine was found to be 85% effective in preventing severe disease from 28 days after vaccination in all regions, and was found to help prevent hospitalization and death related to COVID-19.
The day before, the FDA’s Vaccine Biological Products Advisory Committee (VRBPAC) unanimously recommended the approval of the emergency use of Johnson & Johnson’s single dose Corona 19 vaccine.
The conditions of emergency use authorization allow the vaccine to be used while more data is being collected.
Johnson & Johnson plans to submit a biologics license application (BLA) for the vaccine to the FDA within this year.
Alex Gorsky, Chairman of the Board of Directors and Chief Executive Officer of Johnson & Johnson, said, “This milestone is the result of an unprecedented collaboration of global health leaders with our dedicated team that shares the goal of providing the public with a single dose vaccine. “We are committed to doing everything we can to help put an end to this epidemic in the United States and around the world.”
Dr. Paul Stopels, Vice-Chairman and Chief Science Officer of Johnson & Johnson’s Executive Committee, said, “This global pandemic, given that the Johnson & Johnson single dose COVID-19 vaccine has been shown to be prophylactic, especially in countries where different mutations are prevalent. “We think it’s an important tool in the fight against the disease.”9 “This vaccine, which blocks the most dire consequences of COVID-19 and hospitalization and death, will help ease the burden on people and healthcare systems around the world.”
Johnson & Johnson is working to provide a COVID-19 vaccine on a non-profit basis for use in an emergency pandemic. It has begun shipping the Corona 19 vaccine and is expected to provide enough vaccines by the end of March to complete vaccinations to more than 20 million people in the United States.
Johnson & Johnson plans to supply 100 million doses of vaccine in the United States during the first half of this year. The U.S. government manages the allocation and distribution of vaccines in the U.S. and will be prioritized according to the population identified by the U.S. Centers for Disease Control and Prevention (CDC) Immunization Advisory Committee (ACIP) guidelines.
In addition, Johnson & Johnson recently submitted an application for conditional marketing authorization for the Corona 19 vaccine to the European Medicines Agency (EMA), and applied for listing on the Emergency Use List (EUL) with the World Health Organization (WHO). In addition, several countries around the world have initiated a companion screening procedure for a single dose of the COVID-19 vaccine.
Johnson & Johnson’s single dose COVID-19 vaccine is compatible with standard vaccine storage and distribution channels and is easy to deliver to remote locations. It is stable for 2 years at minus 20 degrees Celsius, and is stable for up to 3 months when stored frozen at 2-8 degrees Celsius. Johnson & Johnson plans to ship the vaccine using the same cold chain technology currently used to ship treatments for cancer, immune diseases and other medicines.
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