NEW YORK, June 7 (Reuters) - Safety concerns about Johnson &
Johnson's COVID-19 vaccine along with overall flagging
demand for vaccinations have slowed its U.S. rollout to a crawl,
leaving close to half of the 21 million doses produced for the
United States sitting unused.
J&Js vaccine was supposed to be an important tool for
reaching rural areas and vaccine hesitant Americans because it
requires only one shot and has less stringent storage
requirements than the two-dose vaccines from Pfizer Inc
/BioNTech SE and Moderna Inc.
But Americans have largely eschewed it over the six weeks it
has been back in use after a pause to study a rare safety issue,
according to data from the U.S. Center for Disease Control and
Prevention (CDC) and interviews with health officials and
pharmacists in eight states across the country.
"We went from having a waiting list to give somebody a shot
to having maybe one shot a day or four shots a day," Michelle
Vargas, owner of independent Lamar Family Pharmacy in Lamar,
South Carolina, said of plunging demand for the J&J shot in the
small rural community. "They're concerned for their safety. I
think that's the biggest hurdle right now."
In the week ended May 25, fewer than 650,000 Americans
received the J&J shot, accounting for about 5% of total
vaccinations administered and down from nearly 3 million in the
week leading up to the pause, CDC data shows.
Demand for all the vaccines has slowed since mid-April, but
the drop has been significantly steeper for the J&J shot.
The slowdown may mean some J&J doses will expire unused at a
time when global demand for any COVID-19 vaccine is high. J&J
doses will be among the 25 million donated by the United States
announced by the White House last Thursday.
At least 13 lots of the vaccine have expiration dates of
June 27 or earlier, according to a J&J website. It is not clear
how many doses that reflects, but the vaccine has a 3-month
shelf life and most doses were sent out by early April,
including 11 million in the first week. J&J has another 100
million doses on hand but shipment timing is uncertain.
A J&J spokesperson declined to comment on the number of
doses expiring before the end of June.
J&J is working with the U.S. government and health
authorities to support use of its vaccine, the spokesperson said
in a statement, calling it an important tool in the global fight
"We remain committed to helping end this deadly pandemic as
quickly as possible," J&J said.
'LET'S JUST STICK WITH PFIZER AND MODERNA'
The CDC and Food and Drug Administration paused use of the
J&J vaccine for nearly two weeks in mid-April to investigate
links to cases of a very rare, potentially life-threatening
condition called thrombosis with thrombocytopenia syndrome
(TTS), which involves blood clots and low platelet counts.
Regulators decided that the vaccine's benefits outweigh the
risk. The condition has also been linked to AstraZeneca's
David Kohll, pharmacist at Kohll's Pharmacy with six
locations in Nebraska, said before the safety issue, several
companies arranged for him to provide J&J vaccines to employees.
"Some of them are trucking companies and some others with
more blue-collar or hard-to-get-to employees. They wanted us to
go with all J&J," Kohll said. After the safety pause, "probably
80 percent of them said 'Let's just stick with Pfizer and
Public health officials said during the pause they found the
Pfizer and Moderna vaccines were adequate substitutes in the
mobile and walk-up clinics where they had been using J&J.
"Once we get them in for the first dose, we've got them and
they will come back for the second dose," said Dr. Karen
Landers, a public health official in Alabama.
Use of J&J's shot has fallen in states like Wyoming and
Alabama with low vaccine uptake and in places like Maine and
Oregon, where vaccination rates are high, according to state and
Not everyone has seen a sharp drop-off in demand for the J&J
vaccine. Richard Stryker, who runs the Bayshore Pharmacy in
Atlantic Highlands, N.J., said he has seen plenty of interest,
particularly from seniors who are at lower risk for the clotting
issue and prefer the single injection.
J&J has said it is not currently selling the vaccine for a
profit. The lower demand this year is immaterial to its
financials, SVB Leerink analyst Danielle Antalffy said at the
time of the safety pause.
But competitors Pfizer, BioNTech and Moderna could benefit
as developed countries sign future deals for booster shots.
Pfizer and BioNTech's EU deal alone could be worth at least $16
billion - as much as double that if all options are exercised -
for the companies through 2023, based on current prices.
Rollout of the J&J shot has had other stumbles as well.
Regulators shut down production at the largest U.S. plant making
the vaccine due to cross-contamination at the site with the
AstraZeneca shot. No new doses have been distributed in the
United States since mid-May.
U.S. regulators are deciding whether it is safe to release
up to 100 million doses of J&J's vaccine produced at that plant.
The dwindling U.S. demand could provide additional flexibility
to donate millions of doses.
(Reporting by Michael Erman; Editing by Caroline Humer and Bill