Johnson & Johnson's Single-Shot Janssen COVID-19 Vaccine Gets FDA EUA

As anticipated, Johnson & Johnson has received an Emergency Use Authorization (EUA) from the FDA for its single-shot Janssen COVID-19 vaccine. With this authorization in place, Johnson & Johnson's product is the third COVID-19 vaccine to be distributed in the United States, one that can be stored in a refrigerator, which reduces the logistical burden.

Unlike the Pfizer and Moderna vaccines, Johnson & Johnson's COVID-19 vaccine doesn't require a second dose, helping address the issue of people who fail to return for their second dose. Likewise, the ability to refrigerate the vaccines rather than keeping them at colder temperatures will ease the burden in places that lack the appropriate cold storage equipment.

The FDA announced its latest COVID-19 vaccine authorization on Saturday, stating that it can be administered to adults ages 18 and older. The authorization was granted following a review of the data provided by Johnson & Johnson, with the FDA noting that 'the data provides clear evidence that the ... vaccine may be effective in preventing COVID-19.'

In a statement, Acting FDA Commissioner Janet Woodcock, MD, said:

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. 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.

Put simply, Johnson & Johnson's Janssen COVID-19 vaccine teaches the recipient's immune system to react against the SARS-CoV-2 virus, helping to prevent infections or reduce their severity. According to the FDA, the single-shot vaccine was around 77-percent effective at protecting against severe and critical COVID-19 cases starting 14 days after the vaccination took place. At the 28-day mark, the effectiveness jumped to 85-percent.