Biden administration not convinced Johnson & Johnson will hit 20million target by month-end

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The U.S. Food and Drug Administration granted emergency use clearance for Johnson & Johnson’s coronavirus vaccine nearly a month ago, but the company has struggled to ramp up production, has been slow to submit documents and did not meet the production deadlines set in the company’s contract with the federal government. With just a few 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 increase the supply of the three licensed vaccines, the Johnson & Johnson product has multiple advantages over the other two as it is one dose instead of two and lasts in the refrigerator for three months instead of being frozen.

“At this time, I don’t want to commit to what’s going to happen over the next week or so. We’ll leave that to the company,” said Andy Slavitt, White House senior Covid-19 adviser. journalists Monday.

As the Covid-19 pandemic swept the country 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 an additional $ 1 billion for 100 million doses of its potential coronavirus vaccine, months before the company obtained FDA clearance. Under this contract, Johnson & Johnson was to have 37 million doses ready by the end of March and 100 million by the end of June. But now the company may not hit the 20 million mark by the end of the month.

Despite the federal government’s efforts to reduce production times, Johnson & Johnson had only four million doses ready to ship when it was cleared by the FDA at the end of February. An additional 1.2 million doses have since been distributed, which means the company must have an additional 14.8 million next week to meet its target.

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

Administration officials, who spoke on condition of anonymity to comment on internal discussions, said they are unwilling to guarantee those millions will be ready within the next week. They are optimistic, but not positive, as the delivery schedule has not accelerated as officials had hoped, one of them told CNN.

Although they were privately frustrated, the Biden administration was hesitant to publicly criticize Johnson & Johnson over the delays. The government has worked closely with the company to speed up the process, including using the Defense Production Act to procure materials and equipment and the President recently announced that he has negotiated a rare partnership between Johnson & Johnson and the Pharmaceutical giant Merck & Co. more vaccines, although the results of this joint venture will not be felt until later this year.

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In February, Johnson & Johnson said it was working to develop its own manufacturing capacity with third-party vaccine makers.

Part of the manufacturing line, Catalent in Bloomington, Indiana, that does what is known as the fill / finish portion of the manufacturing process is still awaiting approval from the United States Food and Drug Administration to ship its doses. . This factory has had crews working around the clock to fill vials with the Johnson & Johnson vaccine, so when it gets the go-ahead it should immediately increase the number of Johnson & Johnson vaccines available.

Catalent told CNN on Monday that he hoped to get FDA approval this week, and an administration official echoed that.

The official told CNN that the reason Catalent had not received FDA clearance to release the doses to be shipped is that Johnson & Johnson was often late in submitting the correct documents and data, delaying the entire package. the release process, which must follow a 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, the pandemic is killing Americans every day, every day – and doses – count.

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