U.S. gets third vaccine in J&J’s 1-dose shot
WASHINGTON — The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
Health experts are anxiously awaiting a one-and-done option to help speed vaccinations, as they race against a virus that already has killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.
The FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death.
One dose was 85 percent protective against the most severe COVID-19 illness, in a massive study that spanned three continents — protection that remained strong even in countries such as South Africa, where the variants of most concern are spreading.
“This is really good news,” Dr. Francis Collins, director of the National Institutes of Health, said Saturday. “The most important thing we can do right now is to get as many shots in as many arms as we can.”
Shipments of a few million doses to be divided among states could begin as early as Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the U.S., and 100 million by summer.
On Sunday, a U.S. advisory committee will meet to recommend how to prioritize use of the single-dose vaccine. And one big challenge is what the public wants to know: Which kind of vaccine is better?
“In this environment, whatever you can get — get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the vaccine’s benefits outweigh its risks.
Data is mixed on how well all the vaccines being used around the world work.
In the U.S., the two-dose Pfizer and Moderna shots were 95 percent protective against symptomatic COVID-19. J&J’s one-dose effectiveness of 85 percent against severe COVID-19 dropped to 66 percent when moderate cases were rolled in. But there’s no apples-to-apples comparison because of differences in when and where each company conducted its studies, with the Pfizer and Moderna research finished before concerning variants began spreading.
NIH’s Collins said the evidence of effectiveness shows no reason to favor one vaccine over another.
“What people I think are mostly interested in is, is it going to keep me from getting really sick?” said NIH’s Collins. “Will it keep me from dying from this terrible disease? The good news is all of these say yes to that.”
The J&J vaccine also is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.
The FDA said studies detected no serious side effects. The FDA said there is “a remote chance” that people may experience a severe allergic reaction to the shot, a rare risk seen with the Pfizer and Moderna vaccines.
The vaccine has been authorized for emergency use in adults 18 and older for now.
J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along.
The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that spurs cells to make those harmless spike copies.