Biden’s management is not confident that Johnson & Johnson will reach the goal of 20 million by the end of the month

The Food and Drug Administration granted Johnson & Johnson the emergency use authorization for Johnson & Johnson’s coronavirus vaccine for almost a month, but the company has been struggling to increase production, has been slow to send paperwork and has not met deadlines for production stipulated in the company’s contract with the federal government. With just a few days to deliver about 14.8 million vaccines, government officials are limited to whether Johnson & Johnson will deliver based on past behavior.

Although the Biden administration has worked to increase the supply of all three authorized vaccines, the Johnson & Johnson product has several advantages over the other two because it is one dose instead of two and lasts three months in the refrigerator, instead of being frozen. .

“Right now, I don’t want to commit to what’s going to happen over the next week. We’re going to leave that to the company,” said Andy Slavitt, senior adviser at Covid-19 at the White House. reporters Monday.

When 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 authorization. Under this 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 reaching the 20 million mark by the end of this month.

Despite the federal government’s efforts to shorten production schedules, Johnson & Johnson had only four million doses ready for shipment when it was authorized by the FDA in late February. Since then, another 1.2 million doses have been launched, which means that the company must have another 14.8 million doses ready next week to meet its goal.

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

Government officials, who spoke on condition of anonymity to comment on internal discussions, said they were not willing to guarantee that these millions would be ready next week. They are hopeful, but not positive, because the delivery schedule has not been accelerated in the way that the authorities expected, one of them told CNN.

Although they were particularly frustrated, the Biden government hesitated to publicly criticize Johnson & Johnson because of the delays. The government worked closely with the company to accelerate the process, including using the Defense Production Act to obtain materials and equipment, and the president recently announced that he has negotiated a rare partnership between Johnson & Johnson and pharmaceutical giant Merck & Co. to manufacture more vaccines, although the results of this joint venture will not be felt until the end of this year.

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

A part of the manufacturing chain, Catalent in Bloomington, Indiana, which does what is known as part of filling / finishing the manufacturing process is still waiting for approval from the U.S. Food and Drug Administration to send its doses. This factory had teams working 24 hours a day to fill bottles with the Johnson & Johnson vaccine, so when it gets the green light, the number of Johnson & Johnson vaccines available is expected to increase immediately.

Catalent told CNN on Monday that it hopes to obtain FDA approval later this week, and a government official agreed with that.

The official told CNN that the reason Catalent did not receive authorization from the FDA to release doses for shipment is because Johnson & Johnson often took time to send the appropriate paperwork and data, delaying the entire release process, which should follow a strict protocol to obtain the final authorization.

Being vaccinated is a game changer

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

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

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