By Peter Loftus and Thomas M. Burton
The first single-dose Covid-19 vaccine, a shot from Johnson
& Johnson, was authorized for use, a big boost for a
mass-vaccination campaign rushing to end the deadliest pandemic in
more than a century.
The vaccine's authorization on Saturday, the third issued by the
U.S. Food and Drug Administration, will give health authorities a
desperately needed new source of doses as they scramble to ramp up
inoculations ahead of elusive emerging strains.
J&J said it has begun shipping the vaccine to the U.S.
government, which is managing allocation and distribution. That
indicates first doses could be administered during the coming
"There is light at the end of the tunnel, but we cannot let our
guard down now or assume that victory is inevitable. We must
continue to remain vigilant, act fast and aggressively, and look
out for one another, " President Biden said.
The shot's addition to the country's vaccination drive comes at
a precarious moment in the pandemic in the U.S. Newly reported
cases, hospitalizations and deaths have been dropping in recent
weeks, but remain higher than peaks seen last summer and
Also, new variants are spreading. More than 2,100 cases linked
to variants first identified in the U.K., South Africa and Brazil
have now been detected in the U.S., according to the Centers for
Disease Control and Prevention.
J&J's shot wasn't as effective in studies as two Covid-19
vaccines, from Pfizer Inc. and Moderna Inc., that have been
previously authorized. It also didn't work as well against at least
one new strain of the virus -- the one first identified in South
Africa -- as against the original strain of the virus.
Health authorities say J&J's vaccine still works well, and
are encouraging eligible people to get whatever shot they can.
Also, the vaccine showed preliminary signs, according to
J&J, of curbing spread of the virus among people who don't show
symptoms. They have been a significant source of transmission.
J&J's single-dose shot could greatly simplify the
vaccination drive, which has been complicated by the need to give
two doses, three or four weeks apart, as required by the two
vaccines cleared earlier.
The J&J vaccine also has more favorable temperature
requirements for distribution and storage, making it easier for
sites, including many in rural areas, that lack expensive freezers
to give the shots.
Some studies have shown that the Pfizer and Moderna vaccines
provide good protection after just one shot, but the research is
ongoing and regulators haven't signed off on any change.
Likewise, the Pfizer and Moderna vaccines can be stored for
longer at higher temperatures than was initially thought, but
storage and handling of J&J's shot will still be easier.
Pfizer's vaccine can be stored in a regular refrigerator for five
days, while J&J's can stay there for at least three months.
Limited initial supplies, however, will probably blunt any early
impact from the addition of the newly authorized shot. J&J
expects to have just 4 million doses ready to ship right away. The
company has said it would deliver 20 million doses by the end of
J&J expects output will quickly increase, so that the
company can deliver a total of 100 million doses for use in the
U.S. by the end of June.
"This milestone follows a year of incredible work by our
dedicated teams and unprecedented collaboration with health leaders
around the world -- all of whom shared a goal of bringing a
single-shot vaccine to the public," J&J Chief Executive Alex
Gorsky said in a statement. "We will do everything we can to help
bring this pandemic to an end, in the United States and throughout
The FDA authorized the vaccine's use in adults. Like other
leading Covid-19 vaccine developers, J&J compressed a process
that normally takes years into months. The FDA, likewise, moved
relatively quickly to authorize the shot's use.
The agency turned to an emergency-use authorization process
created by federal law to deal with situations like the current
The FDA's standard review, resulting in an approval, usually
takes months. Yet the agency said it still held J&J's vaccine
to virtually the same kinds of standards for safety and
effectiveness it would normally require.
The FDA based its decision on a study of about 44,000 volunteers
18 years old and older.
The study found J&J's vaccine was 66.1% effective at
protecting people from developing moderate and severe cases of
Covid-19 at least 28 days after vaccination, and was generally
Its overall effectiveness, however, wasn't as high as that from
the first two vaccines to be authorized in the U.S. Shots from
Pfizer and partner BioNTech SE and from Moderna were more than 94%
effective in their late-stage studies.
And the J&J vaccine appeared to be less effective against
the South Africa variant. Other Covid-19 vaccines also have shown
less potency against virus variants. South Africa began rolling out
the J&J vaccine in mid-February.
The effectiveness of J&J's vaccine was mostly consistent
across various demographic subgroups, though it was lower in people
60 years and older with underlying medical conditions like diabetes
and high blood pressure -- and among American Indian and Alaska
Yet J&J's vaccine had relatively high efficacy against
severe Covid-19 disease, even in places where the variants have
spread. The vaccine was 85.4% effective against severe Covid-19 at
least 28 days after vaccination.
The most common side effects among people who received the
vaccine were injection-site pain, headache and fatigue. Most were
mild to moderate. J&J has received preliminary reports of two
cases of severe allergic reactions in vaccine recipients, one of
which was anaphylaxis.
"With today's authorization, we are adding another vaccine in
our medical toolbox to fight this virus. At the same time, the
American people can be assured of the FDA's unwavering commitment
to public health through our comprehensive and rigorous evaluation
of the data submitted for vaccines to prevent COVID-19," said Peter
Marks, director of the FDA division that reviews vaccines.
J&J's is the first Covid-19 vaccine in the U.S. to trigger
immune protection by using another virus modified so it doesn't
cause disease, in this case a version of a virus that causes the
The modified cold virus carries DNA that, once injected,
instructs the body's cells to make a protein resembling the spike
protein found on the surface of the new coronavirus.
This, in turn, causes an immune response that can later protect
people if they are exposed to the real coronavirus.
AstraZeneca PLC and the University of Oxford have used a similar
approach for their Covid-19 vaccine, which is authorized in the
U.K. and other countries but not in the U.S. Vaccines developed in
Russia and China also use such viral vectors.
Viral-vector vaccines have been in development for many years,
but only recently has the technology yielded vaccines, targeting
the deadly Ebola disease, that gained approval from government
regulators. J&J developed one of the Ebola vaccines.
The Pfizer and Moderna Covid-19 vaccines use a different design
called messenger RNA, but share a similar goal of inducing the
body's own cells to make the coronavirus spike protein that
mobilizes immune defenses.
J&J, based in New Brunswick, N.J., has said it is making the
vaccine available on a not-for-profit basis during the pandemic
emergency. The shot could generate about $4.7 billion in sales for
J&J this year, Bernstein analysts estimated.
The U.S. government agreed last year to buy 100 million doses of
J&J's vaccine for $1 billion, or $10 a dose, with options to
buy more, and provided additional funding for clinical trials and
other vaccine development activities at J&J.
The CDC told state officials Friday that they can begin ordering
doses of J&J's vaccine on Sunday and that shipments are
expected to arrive within two days of order placement, a state
health official said.
The company also has signed vaccine supply contracts with the
European Commission and other countries.
It is manufacturing the drug substance for the vaccine at plants
in Baltimore, the Netherlands and India. Additional steps in the
production process and filling vials with the vaccine are taking
place at facilities in Indiana, Michigan, Pennsylvania, Spain and
Each vial of the vaccine contains five doses.
McKesson Corp., a drug wholesaler, is serving as the centralized
distributor for the J&J vaccine, and will work with logistics
partners such as FedEx Corp., to send the doses to hospitals,
pharmacies and other vaccination sites around the U.S.
Because of the limited supply of Covid-19 vaccine doses, states
continue to give priority to certain groups for vaccination, such
as healthcare workers, the elderly and adults with high-risk health
conditions. Some states also have reserved initial supplies for
certain occupations like police and educators.
Government officials have said that the general population could
start to get access to the vaccines in the spring or summer.
J&J is testing its vaccine in 12- to 17-year-olds in a
separate study, and is also studying whether two doses of the
vaccine, given about eight weeks apart, are more effective against
The company expects results of a large study testing the
two-dose regimen later in the year.
J&J also has begun work on a potential new vaccine that
would better target the virus variant first identified in South
Africa, and has said it would monitor additional variants that may
warrant a modified vaccine.
Write to Peter Loftus at email@example.com and Thomas M.
Burton at firstname.lastname@example.org
(END) Dow Jones Newswires
February 27, 2021 20:30 ET (01:30 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.