Biden administration officials are increasingly concerned Johnson & Johnson may not deliver the 20 million doses of coronavirus vaccine it promised would be available by the end of this month, according to three senior administration officials.
The full tranche of vaccine Johnson & Johnson committed in February to delivering may not be ready to ship until the second or third week of April, the officials said, potentially complicating preparations for states expecting millions of J&J shots.
Johnson & Johnson spokesperson Jake Sargent told POLITICO that the company “expect[s] to deliver 20 million single-shot vaccines by the end of March.” But three individuals with knowledge of the situation, including two senior administration officials, say the current production process may be subject to logistical complications and regulatory delays. The White House did not comment.
Notably, J&J is shipping components from Europe to a U.S. "fill and finish" facility before sending the doses to the federal government, officials said. The company is also waiting for the Food and Drug Administration to authorize two key American partners, Emergent BioSolutions and Catalent, who’d send out “tens of millions” of usable shots, according to a person familiar with the process. That authorization is expected to materialize in the coming days, one individual with knowledge of the matter said, adding that it’s believed the number of doses released would be in the “millions.”
One senior Biden official said the administration does not expect the full 20 million dose shipment to be significantly postponed. But any delay would likely inflame tensions between the administration and J&J who have for weeks accused each other of creating unnecessary logjams in the rollout.
Emergent has been working on J&J’s vaccine production since early last year, and said in a statement that it plans to produce 1 billion vaccines this year for J&J and AstraZeneca, another partner in the vaccine race. But Emergent was not included in J&J’s original emergency use application, and their doses have sat unused.
The situation has frustrated administration officials as they look to deliver on President Joe Biden’s directive to offer vaccines to all U.S. adults by May.
“There is a slowness to J&J getting stuff done,” said a person familiar with the process. “They are slow to address some of this stuff. No one thinks they move fast.”
Roughly 4 million doses of J&J’s single-shot vaccine were available when the FDA authorized use of the vaccine at the end of February, after the company fell behind on its production schedule. But last month, the company told Congress that it could deliver 20 million doses to the U.S. government by the end of March.
Biden administration officials had originally banked on the single-dose J&J shot to accelerate the country’s return to normalcy, hoping it would dramatically accelerate efforts to vaccinate over 300 million Americans. As of Monday, 4.3 million of the company’s vaccines have been delivered to states, retail pharmacies, community health centers and federal vaccine sites, according to the CDC.
The White House has tiptoed around whether J&J will meet its 20 million shot commitment. Andy Slavitt, a senior adviser to the White House’s Covid team, said on Monday there will be “a nice increase” in the single-shot vaccine this week.
“We’re working with them very closely,” Slavitt said. “I wouldn’t signal to you they’re going to be far away from the numbers that they have projected at all — give or take a little bit — and obviously we’re holding them accountable and working closely with them.”
Earlier this month, the White House directed states to broadly open up eligibility for vaccinations to all adults by May 1 and laid out how the country could return to some normal activities by July 4. But those goals can only be reached through a dramatic increase in shots.
White House officials have told governors to expect roughly 4 to 6 million J&J shots next week, according to one source and notes of a call last week between administration officials and governors. Multiple states told POLITICO they are receiving some J&J vaccine this week, but there are no forecasts yet for individual allotments next week. The Biden administration has sought to give states a three-week window into the number of doses they’ll receive.
In an attempt to boost the J&J supply, pharmaceutical giant Merck will help manufacture J&J’s coronavirus vaccine. The Biden administration announced it brokered the deal earlier this month, after J&J was unable to meet its original pledge to provide 12 million doses of its vaccines by the end of February.
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