Johnson & Johnson Applies for FDA’s Emergency Use Authorization for Covid-19 Vaccine—Here’s Why That Takes Time

Independent experts will review data from over 40,000 trial participants and meet on February 26 to make a recommendation

A pharmacy technician's gloved hands hold a dose of the Johnson & Johnson Covid-19 vaccine
If approved, the Johnson & Johnson vaccine could become available as soon as March. Photo by Michael Ciaglo/Getty Images

Last week, Johnson & Johnson applied to the U.S. Food and Drug Administration for emergency use authorization of its Covid-19 vaccine, Jen Christensen reports for CNN.

The company announced at the end of January that its vaccine is 85 percent effective at preventing severe cases of Covid-19, and 66 percent effective overall at preventing moderate cases of the disease, NPR’s Ailsa Chang reported at the time. The next step is for the FDA to independently review the data gathered from the tens of thousands of people who participated in the clinical trials. On February 26, an FDA advisory committee will hold a public meeting to make a recommendation about whether or not the vaccine should be approved.

If approved, the Johnson & Johnson vaccine could become available as soon as March. The company has committed to providing 100 million doses to the United States by the end of June, Noah Weiland reports for the New York Times.

"The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response," says Johnson & Johnson’s chief scientific officer Paul Stoffels to NPR’s Dustin Jones. "Eighty-five percent efficacy in preventing severe Covid-19 disease and prevention of Covid-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of Covid-19."

The Johnson & Johnson vaccine has a few key differences from the Moderna and Pfizer-BioNTech vaccines that have already been approved. For one thing, Moderna and Pfizer’s vaccines each require two shots, given three or four weeks apart, but Johnson & Johnson’s vaccine is just one shot. While the other vaccines need to be stored at super-cold temperatures, the Johnson & Johnson vaccine just needs a standard refrigerator for storage up to three months, Jonathan Corum and Carl Zimmer write for the New York Times.

According to Johnson & Johnson, its vaccine was 72 percent effective in the United States during its clinical trials, 66 percent effective in Latin America and 57 percent effective in South Africa. No one who was vaccinated died of Covid-19 during the clinical trials, per CNN. No vaccinated participants tested positive for Covid-19 after 49 days had passed from their injection, per NPR.

The FDA’s job is to analyze the data gathered from over 43,000 clinical trial participants and check their work, looking for both safety and efficacy before it can be approved. When the FDA reviewed Pfizer’s emergency use authorization application, it took 20 days; for Moderna’s application, it took 18 days. So while it may seem like a long time to wait until February 26 for news on the Johnson & Johnson vaccine, it is all part of ensuring vaccines are rolled out safely.

“Taking the time to review a vaccine during a pandemic might seem like rearranging deck chairs on the Titanic — but it’s actually inspecting the lifeboats before you leave port,” Mary Beth Griggs writes for the Verge. As an independent board of experts, the FDA can review the clinical trial data without a business interest in mind.

If the vaccine is approved, it will become the third Covid-19 vaccine available in the United States. The New York Times report that Johnson & Johnson expects to have about seven million doses ready for distribution by March, and about 30 million by early April.