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04:08 - Source: CNN
CNN  — 

Officials in President Joe Biden’s administration are not confident that Johnson & Johnson will meet its self-imposed deadline to deliver 20 million coronavirus vaccines by the end of March, despite optimistic statements from the company.

The US Food and Drug Administration granted Johnson & Johnson’s coronavirus vaccine emergency use authorization nearly a month ago, but the company has struggled to ramp up production, been slow to submit paperwork and failed to meet production timelines laid out in the company’s contract with the federal government. With only days left to deliver nearly 14.8 million vaccines, administration officials are hedging their bets on whether Johnson & Johnson will deliver based on past behavior.

While the Biden administration has worked to ramp up supply of all three authorized vaccines, the Johnson & Johnson product has multiple advantages over the other two because it’s one dose instead of two and lasts in a refrigerator for three months as opposed to being frozen.

“At this point in time, I don’t want to commit to what’s going to happen over the course of the coming week. We’ll leave that to the company,” Andy Slavitt, the White House’s Covid-19 senior adviser, told reporters Monday.

As the Covid-19 pandemic swept the nation last spring, the US government signed a $450 million contract with Johnson & Johnson for vaccine research and development. In August, the federal government announced it would pay the company another $1 billion for 100 million doses of its potential coronavirus vaccine, months before the company would win authorization from the FDA. Under that contract, Johnson & Johnson was scheduled to have 37 million doses ready by the end of March and 100 million by the end of June. But now the company is at risk of not meeting the 20 million mark by the end of this month.

Despite efforts by the federal government to compress production timelines, Johnson & Johnson only had four million doses ready to ship when it was authorized by the FDA at the end of February. An additional 1.2 million doses have gone out since, meaning the company must have another 14.8 million ready in the next week to meet its goal.

Johnson & Johnson told CNN Monday that it is still on track to meet its March deadline. In February, the company promised to “deliver enough single-doses by the end of March to vaccinate more than 20 million Americans,” at a congressional oversight subcommittee in February.

Administration officials, who spoke on the condition of anonymity in order to comment on internal discussions, said they aren’t willing to guarantee those millions will be ready within the next week. They’re hopeful, but not positive, because the delivery schedule has not accelerated in the way officials had hoped, one told CNN.

Though they have been frustrated privately, the Biden administration has been hesitant to publicly criticize Johnson & Johnson over delays. The government has worked closely with the company to speed up the process, including using the Defense Production Act to obtain materials and equipment and the President recently announced they had brokered a rare partnership between Johnson & Johnson and the pharmaceutical giant Merck & Co. to make more vaccines, though the results of that joint venture won’t be felt until later this year.

In February, Johnson & Johnson said it had been working to expand its own manufacturing capacity with third-party vaccine manufacturers.

One part of the manufacturing chain, Catalent in Bloomington, Indiana, that does what’s known as the fill/finish part of the manufacturing process is still waiting on the sign-off from the US Food and Drug Administration to ship its doses. That plant has had teams working around the clock to fill vials with the Johnson & Johnson vaccine, so when it does get the green light, that should boost the number of available Johnson & Johnson vaccines immediately.

Catalent told CNN on Monday that it hopes to get the FDA sign-off sometime this week, and an administration official echoed that.

The official told CNN the reason Catalent has not received FDA authorization to release the doses for shipment is because Johnson & Johnson has often been slow to submit the appropriate paperwork and data, delaying the entire release process, which must follow strict protocol to obtain final clearance.

An administration official raised the possibility that Johnson & Johnson could miss its March deadline to reach 20 million coronavirus vaccines, only to reach it days later.

But, as officials and public health experts have noted, with the pandemic killing Americans daily, every day – and dose – counts.