In what may prove to be a shot in the arm for the COVID-19 vaccination effort, the Food and Drug Administration issued an Emergency Use Authorization February 27 for Johnson & Johnson’s COVID vaccine.
In its decision, the FDA cited data collected from almost 40,000 study participants that show a single dose of J&J’s vaccine was 85% effective in preventing severe COVID-19 illness at least a month after vaccination. The studies were conducted on participants in the United States, South Africa, and Brazil.
“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, M.D.
Johnson & Johnson’s drug comes with two logistical advantages over those produced by Pfizer and Moderna. First, unlike the other U.S.-authorized vaccines, which recipients receive in two doses spaced several weeks apart, J&J says their vaccine can be administered in one dose, with best immunity achieved after 28 days.
The second is how the new vaccine can be stored. According to Mathai Mammen, head of Janssen R&D at Johnson & Johnson, the vaccine remains stable, or usable, for up to three months at the temperature of a home refrigerator or for up to two years at negative four degrees Fahrenheit. Pfizer and Moderna’s vaccines, need to be stored in freezers and used shortly after thawing: Logistical challenges have led some vaccine distributors to throw out spoiled doses or give them out haphazardly to anyone nearby willing to take them.
J&J’s vaccine is different because it fights the virus using another virus. Like Moderna and Pfizer’s vaccine, Johnson & Johnson’s vaccine trains the body to produce and protect against a specific protein used by the COVID virus. But where Moderna and Pfizer use messenger RNA to deliver the protein blueprints to the body’s cells, Johnson & Johnson uses a neutered adenovirus that can’t reproduce for the same purpose.
“The adenovirus is well known in the human population,” notes Dr. Mammen: in the wild, the adenovirus is better known as the cause for the common cold. This is also not the first time Johnson & Johnson has fought virus with virus: the company’s Ebola vaccine used the same technique. Mammen also credits the adenovirus delivery system with the drug’s tolerance for warmer temperatures.
“I know I speak on behalf of all of us when I say how proud and grateful we are for this opportunity to contribute our single-shot vaccine to the global effort to defeat COVID-19,” said Johnson & Johnson CEO Alex Gorsky. In a release, he said his company was committed to making the vaccine available on a “not-for-profit basis.”
In a statement to the press, President Biden called the news “exciting,” but said the pandemic situation could still reverse. “We are moving in the right direction,” he said, but told Americans to continue exercising caution.
