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FDA Analysis finds Johnson & Johnson Vaccine Safe and Effective

On Wednesday, in an analysis released, The U.S. Food and Drug Administration said that the Johnson & Johnson vaccine meets the requirements for emergency use authorization. Another step of progress towards authorizing the third vaccine shot for the U.S. has been made.

According to the analysis, the Johnson & Johnson vaccine‘s efficacy was 66.9% across all geographic areas for at least 14 days after the shot. Even after 28 days of the dose, the effectiveness was 66.1%. The committee that decides whether the vaccine is safe and working is an independent group. The group will meet on Friday to make its authorization recommendation to the FDA.

The FDA releases an analysis of the clinical trial data of the company when the vaccine is approved. The trial data looked right to the FDA. The study said, « There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection. »

After reviewing the data for the Johnson & Johnson vaccine, the FDA has said that it is « consistent with the recommendations set forth in the FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19. »

Regarding the South African variants of the Covid-19, the J&J vaccine seems to work better than the initial data shown. According to the FDA, this vaccine shows a 64% efficacy rate in South Africa. The interim data released by the company in January showed 7 points lesser than this rate. The company has made additional sequencing of the cases in the study.

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