(CNN) – Johnson & Johnson officially asked the juveniles to the EE.UU Food and Drug Administration. an emergency use authorization for his vehicle against covid-19.
“The presentation today of the authorization of the use of our emergency vehicle for the covid-19 unique injection investigation is a fundamental step in reducing the burden on people everywhere and to end the pandemic”, dijo el Dr. Paul Stoffels, Johnson & Johnson’s scientific director, said in a statement.
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While the FDA is analyzing the results, it will hold a public meeting of its Committee on Vacancies and Related Biological Products, an independent group of experts that will also analyze the data and have a recommendation that the agency has in mind. .
If the FDA decides to authorize the vaccine, the Assessment Committee on the Practice of Immunization of the Centers for Control and Prevention of Diseases of the EU. will be reunited to discuss if the vacancy should be administered to the stadiums and, if so, who should receive the first.
This is the same regulatory process as Pfizer this week. Para Moderna has a few more dos.
What makes it different from Johnson & Johnson’s vacancy
The Johnson & Johnson vacancy is a little different from the other covid-19 vacancies. The vaccine, prepared in collaboration with a vaccine division of the vaccine division of J&J, Janssen Pharmaceutical and Beth Israel Deaconess Medical Center, is administered in a single injection. Pfizer y Moderna’s required dos. It is considered versatile that it is considered stable up to three months maintained at regular refrigerated temperatures and does not need the controller like Pfizer.
It was demonstrated that the Johnson & Johnson vaccine had a 66% efficiency in the prevention of moderate and severe illnesses in a phase 3 global survey, according to the company. The vaccine has a global efficacy of 85% to prevent hospitalization and death in all regions where it is tested.
Its efficacy against moderate and severe diseases varies from country to country: 72% in EE.UU., 66% in Latin America and 57% in South Africa. This is the middle of a month after the injection.
In the South African part of the clinical trial, the Mayor of the cases debated a variant known as B.1.351, which states that it is most contagious and has many mutations that are less susceptible to the antiquated immune response, including antiquities which was provoked by the evacuation. People who have a moderate case of covid-19 in this case tend to develop a life-long course of illness and minor symptoms, according to the company.
The J&J vacancy works in a different way during the days. With the Modern and Pfizer vaccine, the new coronavirus gene is administered in a litter box. With the J&J vaccine, the gene is transmitted by a virus that does not replicate or infect individuals.
The governor of EE.UU. has ordered 100 million doses and J&J says it can complete this compromise in June. “Through the authorization of our evacuation against the covid-19 in investigation for emergency use, we are listed to start sending”, said Stoffels.