Johnson & Johnson Files For Emergency Approval Of Its Single-Shot Vaccine

If the Food and Drug Administration signs off, the vaccine would be the third approved for use in the United States.

“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” Paul Stoffels, the chief scientific officer at Johnson & Johnson, said in a statement. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping.”

The company said it could deliver 100 million doses within the U.S. by the end of June. Authorization could come within weeks after the FDA convenes an expert panel to review Johnson & Johnson’s trial data.

The vaccine is 66% effective at preventing moderate and severe cases of COVID-19, but 85% effective at preventing the virus’ most serious symptoms, the company has said, based on data from the U.S. and seven other countries. Like some other vaccines, it is less effective against the new strain of the virus that first appeared in South Africa. The Johnson & Johnson shot is just 57% effective against that mutation.

However, after 28 days post-vaccine, no one who was infected with the coronavirus required hospitalization or died, and any infection resulted in milder illnesses. Those results carried over to the South African variant, according to Johnson & Johnson.

While the vaccine is not as effective at preventing COVID-19 as those created by Moderna and Pfizer, which are both around 95% effective at doing so, the fact that it requires only one shot could be very beneficial in the fight against the pandemic. It can also be stored in regular refrigerators for months and does not need to be transported in ultracold freezers like some other vaccines.

“Frankly, simple is beautiful,” Dr. Matt Hepburn, the U.S. government’s vaccine response leader, told The Associated Press last month.

Other drug manufacturers have made headway with their own vaccines in recent weeks. Novavax, a small company based in Maryland, said its vaccine is more than 89% effective, although less so against the South Africa strain. And AstraZeneca said its vaccine, created in partnership with Oxford University, can provide greater protection than initially thought if the second dose is delayed by three months. With greater flexibility before patients need a second shot, countries with limited supplies could give more people their first jabs.