The U.S. Food and Drug Administration issued an emergency use authorization for Johnson & Johnson’s single-dose COVID-19 vaccine on Saturday that allows the vaccine to be administered in the U.S. to people 18 years old and up.
“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. “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.”
Gov. Phil Murphy said on Friday that the state is expected to receive up to 70,000 doses of the vaccine next week.
The FDA has determined that Johnson & Johnson’s COVID-19 vaccine has met the statutory criteria for the issuance of an emergency use authorization. Federal officials said available data provides clear evidence that the vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks.
The 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.
“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus.”
The vaccine is administered as a single dose. Safety data to support the authorization included an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received a saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea. Most of these side effects were mild to moderate in severity and lasted one to two days.
Overall, the vaccine was about 67% effective in preventing moderate to severe COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe COVID-19 occurring at least 28 days after vaccination. The vaccine was about 77% effective in preventing severe COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe COVID-19 occurring at least 28 days after vaccination.
There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe cases of COVID-19 in the vaccine group versus 34 cases in the placebo group.
It is still unclear how long the vaccine will provide protection, and there is no evidence yet that the vaccine prevents the transmission of SARS-CoV-2 from person to person.