The White House says the United States will continue to have enough vaccines for all Americans by the end of next month, despite problems with a single batch of “pharmaceutical product” resulting in the loss of 15 million doses. of the Johnson & Johnson vaccine.
“We are still on track to have the number of doses we need to vaccinate all American adults by the end of May,” Psaki said Monday. “This wasn’t even an FDA-approved facility.”
He went on to say that the United States “did not bet on these doses” and that Johnson & Johnson “has assured us that we will achieve the 24 million doses they have promised in April.”
Pressed by CNN’s Kaitlan Collins on whether the problems could add hesitation to the United States, Psaki responded, “We haven’t seen it.”
“That’s why the FDA approval process is underway,” he said. “In many ways, the process worked because the FDA had not approved the site. Steps were taken to address what some of the issues were, and we also have a number of contingency plans.”
“When we all talk here about” why did we order so many doses, why are we at the point where we share doses with every country in the world? “Part of that is because we have to plan for things to come. Things like this come up,” he said.
“We need to plan a number of contingencies,” Psaki added. “That’s one of the many reasons we’ll still be in a place where we have enough vaccines for American adults by the end of May.”
Some background: As previously reported by CNN, a source familiar with Johnson & Johnson’s vaccine manufacturing process told CNN on Saturday that the loss was not a major setback.
Johnson & Johnson has said a single batch of “pharmaceutical product” failed the quality control inspection and had been discarded. The company’s vaccine, which is currently distributed in the U.S., is manufactured at a plant in the Netherlands, but Emergent BioSolutions, a contract manufacturer, was producing doses at a Baltimore facility. The factory was awaiting authorization from the U.S. Food and Drug Administration when the contamination problem was reported.
“Once the plant is back in operation, the way this particular vaccine is made in these large batches, compensating for this batch should not be a major setback. It should be a setback of a few weeks,” the source told CNN .
Emergent was also preparing the vaccine against AstraZeneca, the vaccine of which has not yet been authorized in the US. Like Johnson & Johnson, the AstraZeneca vaccine uses a virus to transport genetic material, the so-called viral vector.
Emergent and Johnson & Johnson have said quality control measures have captured the problem. None of the vaccines manufactured at the plant had been sent for vialing or distribution and officials have stressed that no one had been put at risk due to the contamination.
CNN reported that 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 15 million-dose batch that had to be ruled out, Emergent has successfully produced 115 million doses of the Johnson & Johnson vaccine, which are in various stages of the supply chain, the source said.
The source added that “it is not so unusual” for the pharmaceutical industry to have to discard batches of vaccines and that the fact that Emergent and J&J detected the contamination before any of the affected doses occurred “showed that the system worked.”