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J&J's 1-Dose Shot Cleared 02/28 09:01
WASHINGTON (AP) -- 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.
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