Unused Johnson & Johnson Covid doses pile up as FDA waits to see if shelf life can be extended

The Biden administration is encouraging states to keep hundreds of thousands of near-expiring Covid vaccine doses from Johnson & Johnson, as there is a possibility that additional data will show that the vaccinations are viable past their month-end expiration date.

Dr. Janet Woodcock, acting commissioner for the Food and Drug Administration, told state officials during a call to the White House Tuesday that they could save expired doses until new data shows whether the vaccines are safe, according to several state officials.

State health officials have strongly warned vaccine administrators against using expired doses. Now, however, the FDA seems optimistic that Johnson & Johnson’s expiration dates – which will go into effect later this month – could be extended, according to state officials who participated in the call.

“This is really welcome news,” said Dr. Joseph Kanter, Health Officer for the Louisiana Department of Health. Louisiana has 14,000 J&J cans that are phasing out this month. “I think there will be less waste at the end of the day.”

The federal government has shipped 21.4 million doses of the company’s vaccine to the states, but just over half – 11.2 million – have been administered, according to the Centers for Disease Control and Prevention. The amount is a fraction of Pfizer-BioNTech’s Covid vaccine shipments, which are approaching 200 million doses, as well as Moderna’s shot, which is more than 150 million doses.

As the demand for vaccinations across the country has declined, state officials have stepped up public pleading to get a vaccination. You have had discussions with the Biden administration about how to keep a flood of J&J cans – at least hundreds of thousands – from being wasted. On Monday, Ohio Governor Mike DeWine said that 200,000 J&J cans would expire on June 23 and the state has no legal way to ship unused cans to other states or countries.

As part of the Trump administration’s Operation Warp Speed ​​initiative, the federal government awarded J&J a $ 1 billion contract to supply 100 million doses of its Covid vaccine.

The J&J single-dose vaccine will last three months in the refrigerator and two years if frozen. Extending the expiration date is seen as a more viable option for quickly storing thousands of doses rather than redistributing them to other states or countries, state officials say.

“There aren’t many states right now that need more vaccines than they have available,” said Dr. Marcus Plescia, Chief Medical Officer of the Association of State and Territorial Health Officials. “There is enough out there.”

Federal officials believe data on June doses expiring from an ongoing stability study will arrive in about a month, two state officials said.

“We continue to do stability tests to extend the shelf life of our Covid-19 vaccine before it expires,” said a J&J spokesman. “We’ll share more information when we can.”

The White House declined to state the number of J&J doses nationally due to expire this month. The FDA declined to comment on Woodcock’s remarks.

J&J was once considered critical to the U.S. vaccination effort to convince people on the fence to get the single dose, and has played a humble role. Officials attribute this in part to federal regulators, who temporarily stopped use in April after reports of rare but serious blood clots.

“That just seems to have slowed demand,” said Plescia. The company had previously announced that it would deliver the 100 million cans by the end of June.

As far as Jim Mangia, executive director of St. John’s Well Child and Family Center, can tell, demand stalled when the FDA approved the resumption of use of the J&J vaccine. Mangia said its network of 26 clinics in the Los Angeles area had more than 14,000 doses available that district officials refused to take back.

He said patients who liked the one-time benefit requested it before the safety concern, but there have been no requests since then. “If we offer it, everyone will say no,” he said.

Mangia said its clinic network sees the overall distribution of vaccines remaining constant as the sites expand opening hours and host Friday night vaccine events for those concerned about being out of work due to possible side effects. However, given the lack of interest in J & J’s vaccine, he doesn’t think moving the expiration date would improve matters.

Officials in West Virginia have more than 20,000 doses of J & J’s vaccine available, but little residue from other Covid vaccines, said state Covid Tsar Dr. Clay Marsh, who is also the vice president of West Virginia University Health Sciences. Officials offered the surplus to other states, but there were no buyers. Marsh said they reached out to the federal government to ship the unused cans to countries that need them, but learned that logistics are challenging.

“When we are unable to use something that can save lives, we try to find out if there is anyone who can,” he said.

According to the CDC, 52% of Americans had received at least one dose of Covid vaccine by Tuesday.

Officials have also publicly fingered the leaking doses, with some state and local officials calling for more federal aid to redistribute the doses already administered. Meanwhile, Andy Slavitt, White House Senior Advisor on Covid-19 Response, stated in a call to reporters Tuesday that doses of vaccine ordered by state officials “should end up in the arms of the people” and governors working directly with the FDA proper storage should work together.

“There are many people across the country, in every state, who have not yet been vaccinated, who are eligible, who are at risk and who need to be vaccinated,” he said.

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