By Jared S. Hopkins and Julie Wernau
Hospitals, state health departments and the federal government
are racing to decide how to use up millions of Johnson &
Johnson's Covid-19 vaccine doses that are set to expire this
month.
The prospect of so many doses going to waste in the U.S. when
developing nations are desperate for shots would add pressure on
the Biden administration to share stockpiled vaccines. But there
are few practical solutions to administering them quickly in the
U.S. or distributing them in time to foreign countries, according
to those involved in the vaccination drive.
The stockpile is, in part, an unintended consequence of the
U.S.'s decision in April to temporarily suspend administration of
J&J doses to assess a rare blood-clot risk. The pause forced
states and providers to cancel large blocks of appointments that
were never rescheduled, leaving a surplus of supply, and in some
areas increasing hesitancy over the J&J vaccine's safety,
according to industry officials.
Some hospitals and states say that vaccines from Pfizer Inc. and
partner BioNTech SE, as well as Moderna Inc., are due to expire
later this summer, but the stockpiles so far are largely of J&J
doses. Pfizer's vaccine expires six months after manufacture.
Moderna's vaccine can remain frozen for up to six months, during
which it can be refrigerated for one month.
Philadelphia has 42,000 J&J doses set to expire, most of
which came from a Federal Emergency Management Agency clinic at the
city's convention center a few days before the pause, a city
spokesman said. Pennsylvania, West Virginia, Oklahoma, Ohio and
Arkansas are among states that report having thousands of J&J
doses set to expire this month and have been unable to redistribute
them.
"There's no way at the end of June that we're not going to have
a couple thousand expiring," said Danielle Hilborn, who helps
oversee Covid-19 vaccines for McLaren Health Care Corp. The
hospital system based outside Flint, Mich., has more than 3,500
J&J doses set to expire this month, despite having moved doses
among its hospitals. The hospital system also shipped 1,100 Pfizer
doses to a county health department.
While it is the responsibility of states to order vaccines to
match demand, states and healthcare providers say the pause in the
J&J vaccine rollout left them with far more unused doses than
they had planned for. They are seeking federal guidance to
redistribute the expiring doses and meanwhile have had to
improvise, with some offering lottery tickets or gift certificates
to entice people to get vaccinated. Some health systems have
redistributed the J&J doses inside and outside their networks,
and some states have rerouted them to physician offices, pharmacies
or other states.
The efforts have had limited success because of the nation's
slowdown in overall vaccinations and because many states and
vaccination sites also have expiring J&J supply and don't see
demand for more doses. Just over half of the 21.4 million J&J
shots distributed to providers have been administered, according to
data from the Centers for Disease Control and Prevention, compared
with 83% for shots from Moderna as well as Pfizer and its partner,
BioNTech.
Even with the setbacks specific to J&J, the federal
government could have begun more effective messaging about
vaccination benefits earlier and managed vaccine inventory better
to mitigate the issue of expiring doses, said Saad Omer, director
of the Yale Institute for Global Health.
"We were hit with an immunization delivery program in December
without any preparation," Dr. Omer said. "Why did we not prepare
for the microplanning?"
J&J stores doses frozen until shipment by the government, at
which point they are refrigerated. Doses can be refrigerated for
three months, and the drugmaker is studying whether the shelf life
can be extended, a company spokesman said.
Many drugs and vaccines can remain effective for years, but all
eventually start to lose potency. Typically, expiring prescription
drugs and vaccines for other diseases are sent to other healthcare
facilities, overseas or back to manufacturers, hospital officials
said.
Covid-19 vaccines come with expiration information, which is
determined by manufacturers based on testing data that is later
cleared by regulators. Vaccines might still work after the
expiration dates, according to manufacturing experts, but data was
limited when the vaccines were authorized.
The issue of expiring doses is the latest setback for J&J's
Covid-19 vaccine effort. An accident at a contract manufacturer's
plant led to the contamination of material that could have yielded
up to 15 million doses and led to a halt in production of the
J&J vaccine there.
White House coronavirus adviser Andy Slavitt said during a media
briefing Tuesday, in response to questions about expiring J&J
vaccine doses, that just a small amount of the authorized vaccines
distributed in the U.S. will go unused and that it is unrealistic
to expect none to be wasted in the vaccination campaign. He said
states ordered the doses, which "should end up in people's arms,"
and suggested that governors with expiring stockpiles work with the
U.S. Food and Drug Administration, which is reviewing whether
J&J doses might have longer shelf lives.
An administration official said recalling doses that have
already been shipped out to vaccination sites to potentially
redistribute them would be logistically and legally
challenging.
State health departments and hospital officials say the guidance
from states and the CDC is to destroy or discard expired doses.
Michigan, additionally, has worked with the CDC to try to
redistribute vaccines to other states. The CDC didn't respond to
requests for comment.
In early April, U.S. regulators paused the use of J&J's
vaccine after reports of rare but severe blood clots. In response,
vaccination sites across the country canceled thousands of
appointments and instead offered people Pfizer or Moderna doses.
Regulators lifted the pause 10 days later, with J&J and
regulators adding language to the vaccine's label warning of a risk
of blood clots.
By then, patient demand for Covid-19 vaccines shifted from mass
vaccination to smaller community settings amid lingering concerns
about the rare clots, according to industry and state
officials.
The regulatory pause and overall slowdown in vaccinations has
left UofL Health in Louisville, Ky., with more than 6,000 J&J
doses that expire this month, after having administered about 2,600
since early April, said Dr. Jason Smith, chief medical officer. "My
bet is that we will wind up wasting some of that, unfortunately,"
he said.
To use them, the health system is trying to reach physician
offices outside its network, Dr. Smith said.
Pennsylvania's Department of Health said it worked with the CDC
and Chester County to try to transfer the county's 50,000 expiring
J&J doses to Oregon. The deal fell through when Oregon
experienced a decline in demand and no longer wanted them, a
Pennsylvania health department spokesman said.
The full extent of expiring Covid-19 vaccines is unknown because
providers aren't required to report it to the federal government,
said Jessica Daley, a pharmacist and executive at Premier Inc., a
large group-purchasing organization for hospitals.
Premier is asking members whether they have expiring vaccines,
and at least a dozen have said they have expiring J&J doses,
Ms. Daley said. "It's not as simple as just moving the vaccine
somewhere else," she said.
Some states say they have asked the U.S. government whether
doses can be shipped to developing nations. Doing so faces
significant logistical and legal hurdles, according to the United
Nations Children's Fund, because those countries are wary of using
vaccines after expiration dates and may not be able to administer
them quickly.
Sabrina Siddiqui contributed to this article.
Write to Jared S. Hopkins at jared.hopkins@wsj.com and Julie
Wernau at Julie.Wernau@wsj.com
(END) Dow Jones Newswires
June 08, 2021 19:49 ET (23:49 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Johnson and Johnson (NYSE:JNJ)
Historical Stock Chart
From Apr 2024 to May 2024
Johnson and Johnson (NYSE:JNJ)
Historical Stock Chart
From May 2023 to May 2024