Johnson & Johnson asks FDA to approve vaccine Covid-19

Johnson & Johnson asks FDA to approve vaccine Covid-19

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“Today’s submission for the emergency consent of our COVID-19 vaccine for investigation is an important step towards reducing the disease burden on humans worldwide and putting an end to the pandemic,” said Dr. Paul Stoffels, chief scientific officer at Johnson & Johnson, said in a statement.

The FDA has scheduled a public meeting of its advisory committee on vaccines and related biological products for February 26th. The independent group of experts will look at the data and make a recommendation that the agency takes into account when making its decision.

This means that an EUA will not arrive before the end of the month if the FDA decides to grant one. But if a third vaccine were added to the mixture, it would provide both the supply and flexibility of the American efforts to vaccinate the population.

If the FDA decides to approve the vaccine, the U.S. Centers for Disease Control and Prevention’s advisory committee will meet on immunization practices to discuss whether the vaccine should be given to Americans, and if so, who should get it first.
Johnson & Johnson Covid-19 vaccine is 66% effective in worldwide trials, but 85% effective against serious diseases, says the company
The same regulatory process for Pfizer took just over three weeks. For Moderna, it was a little over two.
The Johnson & Johnson vaccine is slightly different from the two authorized Covid-19 vaccines. The vaccine, made through a collaboration between 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 need two.

Janssen is considered versatile, as it is considered stable for up to three months and is kept in regular refrigeration temperatures and does not need the freezer like Pfizer’s.

According to the company, Johnson & Johnson’s Covid-19 vaccine has been proven to be 66% effective in preventing moderate to severe illness. The vaccine is generally 85% effective in preventing hospitalization and death in all regions where it has been tested.

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

Its effectiveness against moderate and severe diseases varies from country to country: 72% in the USA, 66% in Latin America and 57% in South Africa. It was measured from a month after the shot.

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

The J&J vaccine works a little differently than the Moderna and Pfizer vaccines. These two use messenger RNA, genetic instructions derived in a fat droplet, which stimulates the body to make a piece of the virus appear. With the J&J vaccine, the genetic material is administered in a cold virus, called an adenovirus, which is eliminated so that it cannot repeat itself or make people sick.

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

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