The Dutch plant that delivered the initial supply of Johnson & Johnson vaccine doses to the US also distributed doses on a varied schedule, causing a further slowdown across states, according to the New York Times.
As of Friday morning, at least 112 million people in the US, or 33.7% of the population, had received their first doses of the COVID-19 vaccine. More than 66 million people have been fully vaccinated, CDC data shows.
Johnson & Johnson, with the aid of President Joe Biden’s administration, has been put in charge of a Baltimore vaccine production plant that ruined 15 million doses of its COVID-19 vaccine and has moved to stop British drugmaker AstraZeneca Plc from utilizing the facility to avoid any future mistakes, senior federal health officials said on Saturday.
The extraordinary decision, which was first reported by The New York Times, was put into action by the US Department of Health and Human Services and will allow the Emergent BioSolutions plant to focus on making the single-dose Johnson & Johnson COVID-19 vaccine.
Johnson & Johnson confirmed the move on Saturday, stating that it was “assuming full responsibility regarding the manufacturing of drug substance” at Emergent.
“Specifically, the company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent,” Johnson & Johnson said in a statement.
The change comes after the disclosure that Emergent, which is a manufacturing partner to both AstraZeneca and Johnson & Johnson, mixed up ingredients from the two coronavirus vaccines in a case of human error, causing regulators to delay authorization of the facility’s vaccine production.
The mixup ruined nearly 15 million Johnson & Johnson doses.
The error did not impact any vaccines that are currently being delivered or used, according to the Times report.
The Biden administration has made note of the delay and has not shifted its stated goal of having enough vaccines for all adult Americans by the end of May.
According to the Times report, federal officials are concerned that the mixup could dampen confidence in the vaccines just as Biden is aggressively pushing for mask mandates to remain in place as new COVID-19 variants spread throughout the US.
Meanwhile, there are concerns about the two-dose AstraZeneca vaccine, which has had a troubled rollout in Europe due to a risk of rare blood clots possibly linked to the vaccine. However, the United Kingdom’s drug regulator deemed the vaccine as safe.
AstraZeneca said that it would work with the Biden administration to find an alternative site for its vaccine production, which has not yet been authorized in the US.
“AstraZeneca and the US government continue to work closely together to support agreed upon plans for the development, production and full delivery of the vaccine,” the company wrote in a statement.
With three vaccines authorized in the US – from Johnson & Johnson, Pfizer-BioNTech, and Moderna – it is unclear if there will even be a need for an additional vaccine.
Dr. Anthony Fauci, the nation’s top infectious-disease expert, said as much in a recent interview with Reuters.
“That’s still up in the air,” Fauci said. “My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca.”
However, a federal official said that the HHS is in talks with AstraZeneca “to adapt its vaccine to combat new coronavirus variants,” according to the Times report.
As of Sunday, nearly 30.7 million Americans have tested positive for the coronavirus and more than 554,000 people have died of the illness, based on data compiled by Johns Hopkins University.
The mishap was due to human error, according to The Times, when workers at the plant mixed up the vaccine ingredients. The Food and Drug Administration is currently investigating the incident.
But the company has been cited on multiple occasions by the Food and Drug Administration for quality control issues, ranging from cracked vials and poorly trained employees to problems managing mold and other contaminants within one of its facilities, according to records obtained by AP through the Freedom of Information Act.
When Johnson & Johnson first went to Emergent in April of last year to produce their vaccine, Emergent’s Bayview facility was described as a contract testing laboratory that “did not manufacture products for distribution,” according to FDA records obtained by the AP. At the time, it also didn’t have the capacity for making millions of doses of the COVID-19 vaccine.
In a recent inspection, the FDA cited the company’s Bayview plant on “data integrity concerns” after a review found that the facility had failed to ensure that electronic testing data “was protected from deletion or manipulation,” the AP reported.
The Bayview plant was criticized for not following proper testing and lab procedures, according to the report. The FDA also cited the facility for not having a proper method for discarding rejected materials after an inspector wrote that “separate or defined areas to prevent contamination or mix-ups are deficient” at the plant.
In December 2017, another Emergent plant in Canton, Massachusetts, was also cited for not correcting “continued low level mold and yeast isolates” found in the facility.
A 2018 inspection of the company’s Baltimore facility found that “procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequately established and followed,” according to the AP report.
A spokesman for the FDA told the AP that the agency “cannot comment on any particular company or any potential or ongoing compliance matters.”
Representatives from Emergent did not immediately return Insider’s request for comment regarding the report, but Emergent spokesman Matt Hartwig told AP in a statement that the company’s “rigorous quality checks” found the spoiled batch that did not meet its standards.
“Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” he wrote in the email to AP.
Despite the factory mixup, the Biden administration still expects to reach its goal of having enough vaccines to make every American adult eligible for a vaccine by the end of May, The Times reported.
White House Press Secretary Jen Psaki said Thursday that none of the already available doses of the Johnson & Johnson vaccines were impacted by the factory mixup, and that the company still expects to deliver 24 million doses in April and 100 million doses by the end of May.
“Obviously, these are doses that the U.S. government has purchased, but we also have plenty of doses from Pfizer and Moderna regardless,” Psaki said.
In an interview on “CBS This Morning,” top US infectious disease expert Dr. Anthony Fauci responded to the incident, saying that “human errors do happen.”
“The good news about this, despite the fact that it’s really quite unfortunate that about 15 million doses are not going to be able to be used, you do have checks and balances, and you see that,” Fauci said, “and that’s the reason why the good news is that it did get picked up.
“That’s the reason that nothing from that plant has gone into anyone that we’ve administered to,” Fauci continued.
During an interview on CNBC’s Closing Bell on Thursday, Emergent BioSolutions CEO Bob Kramer said that it was “unfortunate,” that a mixup occurred at its Baltimore facility producing Johnson & Johnson and Astrazeneca COVID-19 vaccines.
“It’s one batch,” Kramer repeated when pressed on what exactly went wrong, not specifying or confirming whether that batch amounted to 15 million doses.
On CNBC Thursday, Kramer pushed back on the report, saying there wasn’t cross-contamination of ingredients, but that doses were pulled because of an “out of specification result for one batch of product.”
“It isn’t the case that an ingredient from one impacted the other, one batch of product was determined to be inconsistent, and was pulled aside,” he told CNBC.
Kramer said he doesn’t expect a significant delay in FDA authorization for production at the Emergent BioSolutions plant in Baltimore.