The White House says the United States 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 plant approved by the FDA.”
She went on to say that the United States “did not bet on these doses” and that Johnson & Johnson “has assured us that we will get the 24 million doses they promised in April.”
Pressured by CNN’s Kaitlan Collins on whether the problems could increase vaccine hesitation across the United States, Psaki replied, “We have not seen that.”
“This is why the FDA approval process is in place,” she said. “In many ways, it was the process that worked because the FDA had not approved the site. Steps were taken to solve some of the problems, and we also have a number of contingency plans. ”
“When we all talk in here about, ‘why did we order so many doses, why are we right at the point where we share doses with all the countries around the world?’ Part of that is because we need to plan for things to come up. Things like this come up, ”she said.
“We have to plan a number of unforeseen expenses,” Psaki added. “That’s one of the many reasons we’ll 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 production process told CNN on Saturday that 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 distributed in the United States, is manufactured at a plant in the Netherlands, but Emergent BioSolutions, a contract manufacturer, produced doses at a plant in Baltimore. The factory was awaiting permission from the U.S. Food and Drug Administration when the pollution problem was reported.
“Once the plant is up and running again, the way in which this vaccine is produced in these large batches must not be a major setback. It should be a setback in a few weeks, “the source told CNN.
Emergent also made vaccine for AstraZeneca, whose vaccine has not yet been approved in USA. Like Johnson & Johnson, AstraZeneca’s vaccine uses a virus to carry genetic material – a so-called viral vector.
Emergent and Johnson & Johnson have said quality control measures captured the problem. None of the vaccine made on the plant was sent out to be put in vials or distributed, and officials have stressed that no one was at risk due to the contamination.
CNN reported that the company has been assisting with the production of Covid-19 vaccines for Johnson & Johnson and AstraZeneca for several months, according to a source familiar with the situation.
In addition to the 15 million doses to be discarded, Emergent has successfully produced 115 million doses of Johnson & Johnson’s vaccine, which are in various phases of the supply chain, the source said.
The source added that it is “not uncommon” for the pharmaceutical industry to have to dispose of batches of vaccine, and the fact that Emergent and J&J discovered the contamination before any of the affected doses were sent showed that the system worked . “