J&J Vaccine Approved for Emergency Use

Inoculations with the first one-dose vaccine to combat COVID-19 are slated to begin in the United States in the first week of March 2021, after FDA issued an Emergency Use Authorization (EUA) for Janssen’s adenovirus type 26 (Ad26) vaccine on Feb. 27, 2021.

FDA announced the EUA following the unanimous recommendation of the vaccine by FDA's Vaccines and Related Biological Products Advisory Committee on Feb. 26. Two days later, on Feb. 28, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention endorsed safety and effectiveness of the vaccine for individuals age 18 and older.

"This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world—all of whom shared a goal of bringing a single-shot vaccine to the public," said Alex Gorsky, chairman and chief executive officer at Johnson & Johnson in a press statement. "We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world."

The EUA for the vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The company reported in a press statement that it plans to file for a biologics license application with FDA later in 2021. The company “is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use,” according to the press statement.

The vaccine, developed on the company’s AdVac vaccine platform, uses Ad26 to deliver a piece of the DNA that is used to make the spike protein of the SARS-CoV-2 virus; the vaccine triggers the human immune system to produce an immune response against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Effectiveness data from an ongoing randomized, placebo-controlled study of nearly 40,000 participants found the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination, FDA reported.

Clinical trial participants reported mild to moderate side effects including pain at the injection site, headache, fatigue, muscle aches, and nausea following vaccination, which lasted 1–2 days. Data are not available to demonstrate how long the vaccine will provide protection, or if it prevents transmission of SARS-CoV-2 from person to person.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, in an FDA press statement. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

Johnson & Johnson estimates the vaccine will remain stable for two years at -4 °F (-20 °C), and up to three months at routine refrigeration at temperatures of 36–46 °F (2 to 8 °C).

The vaccine will be distributed by the US government with several million doses in the initial shipment. Johnson & Johnson expects to deliver 20 million doses by the end of March 2021 and 100 million single-shot vaccines during the first half of 2021.

Johnson & Johnson has applied for emergency approval with the European Medicines Agency, the World Health Organization, and in several countries worldwide.

Sources: FDA and Janssen Pharmaceutical Companies of Johnson & Johnson