(Xinhua News Agency) On February 27, the U.S. Food and Drug Administration approved the emergency use authorization application for the COVID-19 vaccine developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. This is the third COVID-19 vaccine authorized for emergency use in the United States. It is a single-dose vaccine approved for individuals aged 18 years and older.
In a statement, the U.S. Food and Drug Administration (FDA) said that this Emergency Use Authorization allows the COVID-19 vaccine to be distributed across the United States. Before approving the Emergency Use Authorization, the FDA comprehensively evaluated the vaccine’s safety, efficacy, and manufacturing quality information. Data show that the vaccine is effective in preventing SARS-CoV-2 infection, and its known and potential benefits outweigh its known and potential risks.
In a statement, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), pointed out that the pandemic has claimed more than 500,000 lives in the United States. The approval of the Johnson & Johnson vaccine adds to the available COVID-19 vaccines, which are the most effective way to prevent COVID-19, and will help the United States control the epidemic.
She stated that, following an open and transparent scientific evaluation process, the U.S. Food and Drug Administration (FDA) has approved three COVID-19 vaccines. The FDA strictly adhered to the safety, efficacy, and manufacturing quality standards required for vaccines to receive Emergency Use Authorization.
The Johnson & Johnson vaccine is a recombinant adenovirus vector vaccine and the third vaccine to receive emergency use authorization in the United States. Last December, the U.S. Food and Drug Administration (FDA) successively approved emergency use authorization applications for two COVID-19 vaccines: one jointly developed by Pfizer Inc. of the United States and BioNTech SE of Germany, and the other developed by Moderna, Inc., a U.S. biotechnology company. Both of these vaccines are messenger RNA (mRNA) vaccines and require two doses.
According to the U.S. FDA website, clinical trial data show that the Johnson & Johnson vaccine provides approximately 67% efficacy against moderate to critical COVID-19 at least 14 days after a single dose, and approximately 66% efficacy at least 28 days after a single dose. In terms of safety, the most common side effects of the Johnson & Johnson vaccine are injection site pain, headache, fatigue, myalgia, and nausea, which are mostly mild to moderate in severity and last for one to two days. (Tan Jingjing)