Notably, J&J is shipping components from Europe to a “fill and finish” facility in the United States before sending doses to the federal government, officials said. The company is also hoping that the Food and Drug Administration will authorize two major American partners, Emergent BioSolutions and Catalent, who would send “tens of millions” of usable injections, according to a person familiar with the process. The forecast is that this authorization will take place in the next few days, said an expert on the subject, adding that he believes that the number of doses released would be in the order of “millions”.
A senior Biden official said the government does not expect the total shipment of 20 million doses to be significantly delayed. But any delay would likely ignite tensions between the government and J&J, which for weeks have accused each other of creating unnecessary bottlenecks in implementation.
Emergent has been working on vaccine production for J&J since the beginning of 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 the Emergent was not included in J&J’s original emergency use app and its doses remained unused.
The situation frustrated government officials, who seek to comply with President Joe Biden’s directive to offer vaccines to all adults in the United States by May.
“There is a sluggishness for J&J to do things,” said a person familiar with the process. “They take a long time to deal with some of these things. Nobody thinks they move fast. “
Approximately 4 million doses of the J&J single-dose vaccine were available when the FDA authorized the use of the vaccine in late February, after the company delayed its production schedule. But last month, the company told Congress that it could deliver 20 million doses to the United States government by the end of March.
Biden government officials had initially focused on injecting a single dose of J&J to accelerate the country’s return to normalcy, hoping that it would dramatically accelerate efforts to vaccinate more than 300 million Americans. On Monday, 4.3 million of the company’s vaccines were delivered to states, pharmacies, community health centers and federal vaccination sites, according to the CDC.
The White House suspected whether J&J would deliver on its 20 million attempted pledge. Andy Slavitt, a senior adviser on the Covid team at the White House, said on Monday that there will be “a good increase” in the single injection vaccine this week.
“We are working closely with them,” said Slavitt. “I would not signal that they are going to be a long way from the numbers they have designed – a little more or less – and, of course, we are holding them accountable and working closely with them.”
Earlier this month, the White House instructed states to widely open vaccination eligibility to all adults by May 1 and defined how the country could return to normal activities by July 4. But these goals can only be achieved through a dramatic increase in shots.
White House officials told governors to expect about 4 to 6 million doses of J&J next week, according to a source and notes from a call last week between government officials and governors. Several states have told POLITICO that they are getting some J&J vaccine this week, but there are no predictions for individual batches yet next week. The Biden government has sought to give states a three-week window on the number of doses they will receive.
In an attempt to increase J&J’s supply, pharmaceutical giant Merck will help manufacture the J&J coronavirus vaccine. The Biden government announced that it brokered the deal earlier this month, after J&J failed to deliver on its original promise to provide 12 million doses of its vaccines by the end of February.