WASHINGTON — The US Food and Drug Administration (FDA) authorized Johnson & Johnson's COVID-19 vaccine Saturday. It is the first single dose COVID-19 vaccine available in the US, and is one that "checks nearly all the boxes."
The FDA announced in a statement that it has issued "an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
"The EUA allows the Janssen COVID-19 Vaccine to be distributed in the US for use in individuals 18 years of age and older," it added.
In this regard, Acting FDA Commissioner Janet Woodcock said "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."
For his part, President Joe Biden said, "This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis. We know that the more people get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track."
"I want to be clear: This fight is far from over," he warned. "As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse. There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable. We must continue to remain vigilant, act fast and aggressively," he stressed.
The FDA had already approved vaccines developed by Pfizer-BioNTech and Moderna.
With more than 28.5 million confirmed COVID-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can't come soon enough.
"A third safe and effective vaccine is very welcome news," Andy Slavitt, the White House's senior for COVID Response, tweeted on Friday.
"We need a vaccine that can be quickly mass produced," Dr. Greg Poland, head of the Mayo Clinic's Vaccine Research Group, said Friday. "We'd want to see a reasonable duration of efficacy and protection.
The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical COVID-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.
"One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue," Dr. Paul Offit, a vaccine adviser to the FDA, told CNN's Wolf Blitzer on Friday. The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.
Overall, non-fatal serious adverse events were infrequent, according to the FDA's analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines.
More research is needed, but the FDA analysis also hinted that the J&J vaccine may help prevent asymptomatic infections. A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease — not just keep the vaccinated from getting sick.
With so much positive data, an independent group of advisers voted unanimously on Friday to recommend the emergency use authorization of the J&J vaccine. — Agencies
