The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for a single-dose COVID-19 vaccine developed by Janssen Pharmaceuticals, which is part of Johnson & Johnson, according to news releases.
The EUA follows a unanimous vote by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021.
Johnson & Johnson has begun shipping its COVID-19 vaccine, which the FDA authorized for use in people 18 years old or older. The company expects to deliver enough single-shot vaccines by the end of March to vaccinate more than 20 million people in the United States. It is contractually obligated to deliver 100 million doses of the vaccine during the first half of 2021.
The Janssen COVID-19 vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
The FDA said the effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the United States.
Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67 percent effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66 percent effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. Additionally, the vaccine was 85 percent effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.
Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorization Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.
