FDA Grants Emergency Use Authorization for Johnson & Johnson’s Single-Dose COVID-19 Vaccine

Today, the U.S. FDA issued the third Emergency Use Authorization (EUA) for a COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 18 years and older.

FDA’s Evaluation of the Existing Safety Data for This Vaccine

The Johnson & Johnson (Ad26.COV2.S) COVID-19 vaccine is administered as a single dose. The existing safety data supporting the Emergency Use Authorization (EUA) include an analysis of 43,783 participants enrolled in randomized, placebo-controlled trials currently being conducted in South Africa, certain countries in South America, Mexico, and the United States. Among the participants, 21,895 received the vaccine, and 21,888 received a saline placebo. The median follow-up period after vaccination was 8 weeks. The most commonly reported side effects were injection site pain, headache, fatigue, myalgia, and nausea. Most of these side effects were mild to moderate in severity and lasted for 1–2 days.

As part of the Emergency Use Authorization (EUA), the FDA stated that Johnson & Johnson and vaccine providers must report the following events to the Vaccine Adverse Event Reporting System (VAERS): serious adverse events, cases of multisystem inflammatory syndrome, and COVID-19 cases resulting in hospitalization or death.

FDA’s Evaluation of Existing Efficacy Data for the Vaccine

Data supporting the validity of the Emergency Use Authorization (EUA) include randomized, placebo-controlled studies conducted in South Africa, certain countries in South America, Mexico, and the United States among participants with no prior evidence of SARS-CoV-2 infection. Among these participants, 19,630 received the vaccine and 19,691 received a saline placebo. Overall, the vaccine demonstrated approximately 67% efficacy in preventing moderate to severe/critical COVID-19 occurring at least 14 days post-vaccination, and approximately 66% efficacy in preventing moderate to severe/critical COVID-19 occurring at least 28 days post-vaccination. Furthermore, the vaccine showed approximately 77% efficacy in preventing severe/critical COVID-19 at least 14 days post-vaccination, and approximately 85% efficacy in preventing severe/critical COVID-19 at least 28 days post-vaccination. Currently, there are no data to determine the duration of protection provided by the vaccine, nor is there evidence that the vaccine prevents person-to-person transmission of SARS-CoV-2.

▲ Cumulative Curve of the Number of COVID-19 Patients in the Vaccine Group and the Control Group

The Johnson & Johnson COVID-19 vaccine uses an adenovirus type 26 (Ad26) vector to express the unique “spike” protein of the novel coronavirus. Although adenoviruses are a group of relatively common viruses, the Ad26 strain used in the vaccine—which can cause cold-like symptoms and conjunctivitis—has been modified so that it cannot replicate in the human body or cause disease. After vaccination, the body temporarily produces the spike protein, which is non-pathogenic but triggers the immune system to learn a defensive response, thereby generating an immune response against SARS-CoV-2.

Dr. Janet Woodcock, Acting Commissioner of the FDA, stated, “This vaccine’s authorization expands access to vaccines, which are the best medical prevention method for COVID-19, helping us combat this pandemic that has already claimed more than 500,000 lives in the United States. Through open and transparent scientific review processes, the FDA has now authorized three COVID-19 vaccines.” The FDA has determined that the Johnson & Johnson COVID-19 Vaccine meets the statutory criteria for issuance of an Emergency Use Authorization (EUA). All available data clearly demonstrate that the Johnson & Johnson COVID-19 Vaccine is effective in preventing COVID-19. The data also show that the known and potential benefits of the vaccine outweigh its known and potential risks, supporting Johnson & Johnson’s request for use of the vaccine in individuals aged 18 years and older.

Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), stated, “Following a thorough analysis of the data, FDA scientists and physicians have determined that this vaccine meets the Agency’s expectations for safety and effectiveness under an Emergency Use Authorization (EUA). With today’s authorization, we are adding another vaccine to our medical toolkit to combat this virus.”

Notably, Johnson & Johnson previously stated that, pending FDA Emergency Use Authorization (EUA), it expected to produce 20 million vaccine doses by the end of March and 100 million doses by the end of the second quarter. Because Ad26.COV2.S requires only a single dose to confer protection and remains stable for up to two years at -20°C and for three months at 2–8°C, it can be stored, transported, and distributed through existing standard channels, thereby facilitating vaccine deployment during the pandemic. Johnson & Johnson has submitted an application to the World Health Organization (WHO) seeking WHO Emergency Use Listing. This vaccine may play a crucial role in expanding COVID-19 vaccination coverage in low-income countries.