Wasting no time, officials at the U.S. Food and Drug Administration (FDA) met over the weekend to grant emergency use authorization (EUA) to Johnson & Johnson’s coronavirus (COVID-19) vaccine.
Hours earlier, an FDA advisory committee concluded a day-long meeting by recommending emergency use of the vaccine, finding that it is safe and effective in preventing the virus.
Eligible Americans who have been frustrated in trying to schedule an appointment to get vaccinated may suddenly find it is easier. Johnson & Johnson said it has millions of doses of the vaccine that it can begin distributing this week.
“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 Dr. Janet Woodcock.
Woodcock notes there are now three approved vaccines in the supply chain and that all of them met standards set out in an “open and transparent scientific review process.”
Distribution has begun
The company has already begun shipping its COVID-19 vaccine to distribution points and expects to deliver enough by the end of March to enable the full vaccination of more than 20 million people in the U.S.
The vaccine holds an advantage over the two previously approved vaccines because it only requires a single dose. Part of the distribution bottlenecks surrounding the Pfizer and Moderna vaccines have occurred because they require two shots, both of which have to be scheduled at the same time.
In clinical trials, the Johnson & Johnson vaccine was less effective than the Pfizer and Moderna vaccines, but the testing was done at a time when new, more contagious variants of the virus were circulating around the world. However, scientists said the vaccine appeared to protect people from serious forms of COVID-19.
100 million doses in 2021
Johnson & Johnson said it plans to deliver 100 million single-shot doses of the vaccine to the U.S. during the first half of this year. The U.S. government will manage the allocation and distribution and recipients will be prioritized according to guidelines set by the Centers for Disease Control and Prevention (CDC).
“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,”said Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer.
Stoffels said a vaccine that protects against COVID-19, especially against the direct outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems around the world.