Johnson & Johnson asks the FDA to approve the Covid-19 vaccine

Johnson & Johnson asks the FDA to approve the Covid-19 vaccine

by

“Today’s submission for Emergency Use Authorization for our experimental single-dose COVID-19 vaccine is a key step in reducing the disease burden for people around the world and ending the pandemic,” Dr. Paul Stoffels , Scientific Director of Johnson & Johnson, said in a statement.

The FDA has scheduled a public meeting of its Vaccine and Related Biological Products Advisory Committee for February 26. The independent group of experts will analyze the data and make a recommendation that the agency will take into account when making a decision.

This means that a USA will not arrive before the end of the month, if the FDA decides to grant one. But adding a third vaccine to the mix would add both supply and flexibility to the United States’ efforts to vaccinate the population.

If the FDA decides to authorize the vaccine, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will meet to discuss whether the vaccine should be administered to Americans and, if so, who should get it first.
The Johnson & Johnson Covid-19 vaccine is 66% effective in global testing, but 85% effective against serious illnesses, says the company
That same regulatory process by Pfizer took just over three weeks. For Moderna it was a little more than two.
The Johnson & Johnson vaccine is slightly different from the two authorized Covid-19 vaccines. The vaccine, made through a collaboration of the vaccines division of J&J, Janssen Pharmaceutical, and Beth Israel Deaconess Medical Center in Boston, is administered in a single injection. Pfizer and Moderna require two.

Janssen is considered versatile as it is considered stable for up to three months kept in regular refrigeration temperatures and does not need deep freezing like that of Pfizer.

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

Some states begin to ease restrictions as Covid-19 hospitalizations and cases decrease

Its effectiveness against moderate and severe illnesses varied from country to country: 72% in the United States, 66% in Latin America and 57% in South Africa. This was measured from one month after the injection.

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

The J&J vaccine works a little differently from the Moderna and Pfizer vaccines. These two use messenger RNA, genetic instructions provided in a drop of fat that causes the body to produce what appears to be a piece of the virus. With the J&J vaccine, the genetic material is distributed in a common cold virus, called adenovirus, which has been disabled so as not to replicate or cause disease in people.

The US government has ordered 100 million doses and J&J says it can fulfill that commitment until June. “After the authorization of our experimental vaccine COVID-19 for emergency use, we are ready to begin shipping,” said Stoffels.

.Source