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Biden taps Gayle Smith to serve as global Covid coordinator

Biden taps Gayle Smith to serve as global Covid coordinator

Win McNamee/Getty Images
Win McNamee/Getty Images

The White House says the US will still have enough vaccines for all Americans by the end of next month, despite problems with a single batch of “drug product” resulting in the loss of 15 million doses of Johnson & Johnson’s vaccine.

“We are still on track to have the number of doses we need to vaccinate all adult Americans by the end of May,” Psaki said Monday. “This was not even a facility that was approved by the FDA.” 

She continued, saying the US was “not betting on these doses,” and that Johnson & Johnson “has assured us that we will be getting the 24 million doses that they have promised in April.”  

Pressed by CNN’s Kaitlan Collins on if the issues could add to vaccine hesitancy across the United States, Psaki responded, “we haven’t seen that.” 

“This is why the FDA approval process is in place,” she said. “In many ways it was the process working, because the FDA had not approved the site. There were steps taken to address what some of the issues were, and we also have a range of contingency plans.” 

“When we all talk in here about, ‘why did we order so many doses, why are we at the point where we are sharing doses with every country around the world?’ Part of it is because we need to plan for things coming up. Things like this come up,” she said. 

“We have to plan for a range of contingencies,” Psaki added. “That’s one of the many reasons that we’re going to still be in a place where we have enough vaccines for adult Americans by the end of May.”  

Some background: As CNN previously reported, a source familiar with Johnson & Johnson’s vaccine manufacturing process told CNN Saturday the loss was not a major setback. 

Johnson & Johnson has said a single batch of “drug product” failed quality control inspection and had been discarded. The company’s vaccine currently being distributed in the US is made at a plant in the Netherlands, but Emergent BioSolutions, a contract manufacturer, was producing doses at a facility in Baltimore. The factory was awaiting authorization from the US Food and Drug Administration when the contamination problem was reported.

“Once the plant is back up and running, the way this particular vaccine is made in these large batches, making up for this batch should not be a major setback. It should be a setback of just a few weeks,” the source told CNN. 

Emergent was also making vaccine for AstraZeneca, whose vaccine is yet to be authorized in the US. Like Johnson & Johnson’s, AstraZeneca’s vaccine uses a virus to carry genetic material – a so-called viral vector.

Emergent and Johnson & Johnson have said quality control measures caught the problem. None of the vaccine being made at the plant had been shipped out to be put into vials or distributed and officials have stressed that no one had been put at risk because of the contamination.

CNN reported the company has been assisting in the production of Covid-19 vaccines for Johnson & Johnson and AstraZeneca for months, according to a source familiar with the situation.

In addition to the batch of 15 million doses that had to be discarded, Emergent has successfully produced 115 million doses of Johnson & Johnson’s vaccine, which are in various stages of the supply chain, the source said.

The source added that it’s “not that unusual” for the pharmaceutical industry to have to discard batches of vaccine, and the fact that Emergent and J&J detected the contamination before any of the impacted doses shipped “showed the system worked.”

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