By Michael Erman
NEW YORK (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&J’s 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.
Graphic: U.S. vaccinations by manufacturer
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 against COVID-19.
"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 COVID-19 vaccine.
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 Moderna.'"
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 CDC data.
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 Berkrot)