Sunday, November 10

Johnson & Johnson requests FDA clearance for its COVID-19 vaccine

Johnson & Johnson solicita autorización de FDA para su vacuna contra COVID-19

J&J Covid Vaccine – 26 requires a single dose.

Photo: JUSTIN TALLIS / AFP / Getty Images

A third coronavirus vaccine has applied for emergency use authorization from the Food and Drug Administration (FDA). Johnson & Johnson submitted its application on Thursday for authorization of its single dose COVID vaccine – 19.

In a statement issued Thursday, the company said that if the emergency use permit is granted, its goal is to supply 100 million doses of vaccines in the first half of 2021 .

Unlike Pfizer and Moderna, Johnson & Johnson’s Janssen vaccine can be stored for at less three months to 36 – 46 degrees Fahrenheit, compatible with standard vaccine distribution channels, the company said.

The vaccine has been shown to have a 66% effective overall in preventing COVID – 19 in ranges of moderate to severe, four weeks after the administration of the injection.

Johnson & Johnson said that the vaccine was 72% effective in the United States, compared to 66% in Latin America and 57% in South Africa.

However, the vaccine has an efficacy of 85% in preventing severe forms of COVID- 19. And the efficacy of the treatment increased over time, said the company, no COVID cases – 19 in vaccinated participants, after 49 days.

FDA is expected to hold the first meeting of external advisors on enforcement on 26 February. If advisers favor the vaccine, a decision authorizing its use could come very soon after.