A Food and Drug Administration report on Wednesday endorsed a single-shot vaccine from Johnson & Johnson for emergency use, putting the U.S. one step closer to having a third weapon in its arsenal against COVID-19.
The new analyses said the vaccine was 72% effective overall in the U.S. and 64% effective in South Africa, which is battling an aggressive strain that makes up most of their transmission and may generally diminish the power of vaccines.
The shots were 86% effective against the most severe cases in the U.S. and 82% effective against severe cases in South Africa.
All told, the analyses said the vaccine “is consistent with the recommendations set forth in FDA’s guidance.”
The FDA posted the findings in briefing documents ahead of a Friday meeting with outside advisers. If the panel endorses the vaccine, it would set the stage for emergency approval by Saturday or within days.
The J&J vaccine has a pair of advantages. It is delivered in one shot, so recipients don’t have to schedule a return visit and providers don’t have to divide their supply between returning persons and initial vaccinations.
Also, it can last at normal refrigeration temperatures for up to three months, making it easier to store than the pair of messenger-RNA shots in use.
However, the U.S. expects to get a limited supply — the low single-digit millions — from J&J in the first week.
The company is contracted to provide the U.S. with 100 million doses through the end of June, so U.S. officials are looking for ways to “bring forward” as many of those doses as possible instead of waiting until later weeks.
