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% 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, told The
Associated Press Saturday. “The most important thing we can do right now is to
get as many shots in as many arms as we can.”
J&J initially
is providing a few million doses and shipments to 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.
J&J also is
seeking authorization for emergency use of its vaccine in Europe and from the
World Health Organization. The company aims to produce about 1 billion doses
globally by the end of the year. On Thursday, the island nation of Bahrain
became the first to clear its use.
“This is exciting news for
all Americans, and an encouraging development in our efforts to bring an end to
the crisis,” President Joe Biden said in a statement. “But I want to be clear:
this fight is far from over,” he added, encouraging people to stick with masks
and other public health measures.
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 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, prompting reports
in some countries of people refusing one kind to wait for another.
In the U.S., the
two-dose Pfizer and Moderna shots were 95% protective against symptomatic
COVID-19. J&J’s one-dose effectiveness of 85% against severe COVID-19
dropped to 66% 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 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?” Collins said. “Will it keep me from dying from this terrible disease?
The good news is all of these say yes to that.”
Also, J&J is
testing two doses of its vaccine in a separate large study. Collins said if a
second dose eventually is deemed better, people who got one earlier would be
offered another.
The FDA cautioned
that it’s too early to tell if someone who gets a mild or asymptomatic
infection despite vaccination still could spread the virus.
There are clear
advantages aside from the convenience of one shot. Local health officials are
looking to use the J&J option in mobile vaccination clinics, homeless
shelters, even with sailors who are spending months on fishing vessels —
communities where it’s hard to be sure someone will come back in three to four
weeks for a second vaccination.
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.
“We’re chomping at
the bit to get more supply. That’s the limiting factor for us right now,” said
Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staffers were
readying electronic health records, staffing and vaccine storage in
anticipation of offering J&J shots soon.
The FDA said
studies detected no serious side effects. Like other COVID-19 vaccines, the
main side effects of the J&J shot are pain at the injection site and flu-like
fever, fatigue and headache.
An FDA fact sheet for
vaccine recipients says 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. Such reactions are treatable, and vaccine recipients are
supposed to be briefly monitored after the injection.
The vaccine has
been authorized for emergency use in adults 18 and older for now. But like
other manufacturers, J&J is about to study how it works in teens before
moving to younger children later in the year, and also plans a study in
pregnant women.
All COVID-19
vaccines train the body to recognize the new coronavirus, usually by spotting
the spikey protein that coats it. But they’re made in very different ways.
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. It’s the same technology the company used in
making an Ebola vaccine, and similar to COVID-19 vaccines made by AstraZeneca
and China’s CanSino Biologics.
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.
The AstraZeneca
vaccine, already used in Britain and numerous other countries, is finishing a
large U.S. study needed for FDA clearance. Also in the pipeline, Novavax uses a
still different technology, made with lab-grown copies of the spike protein,
and has reported preliminary findings from a British study suggesting strong
protection.
Still other
countries are using “inactivated vaccines,” made with killed coronavirus by
Chinese companies Sinovac and Sinopharm.
(Written by AP writers Lauran Neergaard and Matthew Perrone.
Contributions from AP writers Alfonso Ricardo-Zaldivar and Marion Renault.)