Wednesday, February 24

FDA confirms efficacy and safety of Johnson & Johnson’s vaccine – El Tiempo Latino

The declaration paves the way for the emergency approval of this new option in the fight against the pandemic

During study conducted to test the COVID-19 vaccine candidate in Janssen research. (Photo: J&J)

Johnson & Johnson’s single-dose vaccine protects against COVID-19, according to an analysis conducted Wednesday, February 24, by the U.S. Food and Drug Administration (FDA, for its acronym in English). This declaration paves the way for the emergency approval requested on February 5.

FDA scientists confirmed that overall, the vaccine is about 66% effective in preventing COVID-19, including newer variants of the virus. “No specific safety concerns were identified in subgroup analyzes for age, race, ethnicity, medical comorbidities, or previous SARS-CoV-2 infection,” the analysis notes.

Based on this new data, on Friday, February 26, the agency’s independent advisers will debate whether the evidence is strong enough to recommend the application.

Johnson & Johnson developed the vaccine with Beth Israel Deaconess Medical Center in Boston.

As an advantage over Moderna and Pfizer vaccines, Johnson & Johnson’s single-dose drug does not require special refrigeration and can be stored in conventional chambers for three months, making it easy to distribute.

Data

J&J tested its single-dose option on 44,000 people in the United States, Latin America, and South Africa. Because different mutated versions of the virus are circulating in various countries, the researchers analyzed the results geographically.

The drugmaker previously announced that the vaccine worked better in the US with 72% effectiveness, compared to 66% in Latin America and 57% in South Africa.

Still, in all countries it was effective against the most severe symptoms. Furthermore, the first results of the study showed no hospitalizations or deaths in the 28 days after vaccination.

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While the numbers are still lower than those achieved by Moderna and Pfizer, all of the world’s COVID-19 vaccines have been tested differently, making comparisons nearly impossible.

According to the company, once its emergency use is approved, four million doses will be distributed immediately.

European regulators and the World Health Organization are also considering the J&J vaccine. Worldwide, the company aims to produce around 1 billion doses by the end of the year.



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