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

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“Today’s emergency use authorization for our single-use COVID-19 vaccine is a critical step towards reducing the burden of disease for humans worldwide and ending 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 Vaccines and Related Biological Products Advisory Committee on Feb. 26. The independent group of experts will review the data and make a recommendation that the agency takes into account when making a decision.

This means that there will not be an EUA until 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 America’s struggling 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 on Immunization Practices will meet to discuss whether the vaccine should be given to Americans and, if so, who should get it first.
The Johnson & Johnson Covid-19 vaccine is 66% effective in global studies, but 85% effective against serious diseases, company says
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 bit different from the two approved 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, will be delivered all at once. Pfizer and Moderna’s need two.

Janssen’s is considered versatile as it is considered stable for up to three months at normal refrigeration temperatures and does not require a freezer like Pfizer’s.

According to the company, Johnson & Johnson’s Covid-19 vaccine was found to be 66% effective in preventing moderate and severe disease in a global phase 3 study. The vaccine is 85% effective in preventing hospitalization and death in all regions where it was tested.

Some states are beginning to relax restrictions as Covid-19 hospitalizations and cases decline

Efficacy against moderate and severe diseases varied from country to country: 72% in the US, 66% in Latin America and 57% in South Africa. This was measured from one month after admission.

In the South African arm of the clinical trial, the majority of 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 antibody’s immune response – including antibodies induced by vaccination. People who got 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 slightly differently than the Moderna and Pfizer vaccines. The two use messenger RNA, genetic instructions delivered in a fat droplet that prompt the body to make something that resembles a piece of the virus. With the J&J vaccine, the genetic material is delivered in a cold virus called an adenovirus that has been turned off so it doesn’t replicate itself or make people sick.

The US government has ordered 100 million doses and J&J says it will be able to deliver on this commitment by June. “After approval of our COVID-19 emergency vaccine, we are ready to start shipping,” said Stoffels.

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