US FDA releases  the  analysis report for Johnson & Johnson COVID-19 vaccine

US FDA releases  the  analysis report for Johnson & Johnson COVID-19 vaccine.    US FDA released a vaccine analysis report developed by Johnson & Johnson: It can prevent moderate to severe COVID-19 infections. After vaccination, side effects will occur, including soreness at the injection site, fatigue, headache, joint pain, fever and other symptoms.

The U.S. Food and Drug Administration (FDA) released an analysis report on the 24th, stating that the COVID-19 vaccine candidate developed by Johnson & Johnson, a subsidiary of Johnson & Johnson Pharmaceuticals, can prevent moderate to severe COVID-19 infections and meets the FDA’s emergency use authorization standards ( EUA).

According to the Associated Press, the 62-page report confirmed the results disclosed by Johnson & Johnson in January. The vaccine named “JNJ-78436725” uses a single-dose vaccine program, which is effective in preventing moderate to severe COVID-19 infections. The effectiveness of is about 66%, and the effectiveness of preventing severe COVID-19 infection is about 85%. According to the FDA, the vaccine requires only one dose, which will help speed up safe vaccination.

The Phase 3 clinical trial of this vaccine was launched on September 23, 2020 and has so far recruited 44,000 subjects in the United States, Latin America and South Africa.

According to the report, there is evidence that the vaccine is effective in preventing new coronavirus infection 28 days after vaccination. The report pointed out that it is not yet clear how effective the vaccine will prevent mutated new coronaviruses. Johnson & Johnson’s test results show that the vaccine is 72% effective in preventing moderate to severe COVID-19 infections in the United States, and 66% and 57% in Latin America and South Africa, respectively.

According to the report, side effects will occur after vaccination, including soreness at the injection site, fatigue, headache, joint pain, fever and other symptoms. The report also stated that the vaccine’s effectiveness and safety for people of different races are consistent.

According to CNN, the FDA’s independent advisory group will meet on the 26th to decide whether to recommend that the FDA issue emergency use authorization for this vaccine.

This is the third FDA evaluation of the COVID-19 vaccine. It is a recombinant adenovirus vector vaccine that can be stored in the refrigerator (2 to 8 degrees Celsius) for three months. Prior to this, the FDA granted emergency use authorization to two vaccines jointly developed by the German Biotech Company and Pfizer Pharmaceuticals Co., Ltd. and developed by Moderna in the United States.

They are both mRNA (messenger ribonucleic acid) vaccines and must be stored frozen. Both vaccines adopt a two-dose vaccine program, and their effectiveness in preventing COVID-19 infection is about 95%. The Associated Press stated that since the scope and procedures of phase 3 clinical trials of different COVID-19 vaccines are different, their effectiveness in preventing COVID-19 infections cannot be compared by numbers.

As of now, more than 500,000 people in the United States have died from the new coronavirus infection. Due to logistics issues and bad weather, the vaccination rate in the United States has been slower than expected. According to data from the US Centers for Disease Control and Prevention, as of February 24, the United States had distributed more than 82.11 million doses of the vaccine, and approximately 65 million people had received at least one dose of the vaccine, of which nearly 20 million had completed two doses of the vaccine.

(source:internet, reference only)

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