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Politico: Biden team knew two weeks ago about Johnson & Johnson failure

Should we question the timing? Some governors might after using allocation projections to open up vaccinations to all adults. While the White House gave indications of full speed ahead, they already knew that millions of vaccine doses from Johnson & Johnson would likely get taken off the table, according to Politico.

Not only does this call into question the press forward on accelerated vaccine access, it might draw more scrutiny to one of the Biden administration’s signature improvements to the nation’s vaccination plan:

Senior Biden administration health officials, including some within the White House, knew two weeks ago that a Johnson & Johnson contractor’s production problems could delay delivery of a significant number of future vaccine doses, according to three senior administration officials. …

But two senior officials working on the federal government’s Covid-19 response told POLITICO that it became clear earlier this month that there were significant problems at Emergent’s West Baltimore plant, where the company was producing the active ingredient — or drug substance — for J&J’s vaccine. The officials said they had not known the exact details of the situation.

A third senior official said the Department of Health and Human Services found out last week that Emergent had botched the 15 million doses, and how. “It was no secret that Emergent did not have a deep bench of pharmaceutical manufacturing experts,” that official said.

The federal government expects that Emergent’s problems will delay future shipments of Johnson & Johnson’s vaccine, and distribution of doses to states will be patchy during the next several weeks, two other senior administration officials said. One of those officials said that Johnson & Johnson should still to be able to deliver the doses it promised under its contract with the federal government by the end of April.

It’s not clear how much of this information got shared with governors before it went public yesterday. Politico’s team reports that the White House warned of “sketchy” delivery expectations over the next few weeks, but there’s no indication that they got wind of the scope of the shortfalls. Fifteen million doses of J&J represents the potential to fully vaccinate almost 5% of the entire US population, and those doses are clearly a critical part of attempting to get full vaccination among US adults by summer.

The news actually gets worse this morning. Emergent might not be the only J&J partner with safety and quality issues. Politico reported separately late yesterday that a whistleblower has filed a complaint about pharmaceutical giant Merck and its production facility, as it’s being converted to produce the J&J vaccine:

Food and Drug Administration inspection officials downplayed critical safety and hygiene concerns at a Merck factory that is being retrofitted to help produce Johnson & Johnson’s coronavirus vaccine, according to a complaint filed by the Office of Special Counsel.

Former FDA safety officer Arie Menachem alleges in the complaint that inspectors downgraded the Merck facility in Durham, N.C., from a category requiring immediate corrective action to a less-urgent category after a 2017 inspection — without following established procedure and despite serious hygiene and public health concerns the safety officer later discovered. …

The special counsel details what Menachem allegedly found during a 2018 inspection, including that Merck improperly disposed of biohazard bins used to collect employees’ waste and that employees were “soiling their uniforms rather than taking bathroom breaks which would have required them to disrobe and leave manufacturing areas.” The whistleblower also accused Merck of “intentionally destroying evidence” of those violations, according to the complaint.

Vanity Fair raised the same concerns in December, while Merck was producing its own vaccine candidate in the same facility:

On his first afternoon at Merck’s Durham plant, Menachem’s concern deepened when his FDA supervisor belatedly emailed him a 19-page document, sent to the agency from a confidential informant at the facility. The allegations described a biohazard nightmare. Workers appeared to be defecating and urinating in their uniforms, and feces had been found smeared on the floor of the plant’s production area, the letter alleged. In a sterile manufacturing plant, bathroom breaks can be difficult to take because they require additional time, which could serve as one possible explanation for the events inside the Merck plant. Ungowning can take 15 minutes, regowning can take 15 minutes, and on a night shift, there may be no one else to cover an essential worker during that time, Menachem said.

The problem was so serious that Cintas, which supplied and laundered uniforms for the plant’s technicians, had complained to Merck about the unsanitary condition of the gowning, the letter stated. “I was shocked and incredibly scared,” Menachem recalled of the complex inspection that lay before him. “I felt such a heavy burden of responsibility.”

But perhaps even more troubling, the document included an 11-page letter that the informant had first sent to the FDA in January 2016, which did not seem to have been forwarded to investigators. That letter included similar allegations: Fecal matter had been found on sterile garments and on the floor of controlled areas; a urine-filled glove had been tied up and placed in a trash container in a critical production area; technicians had been caught on video dancing in clean room suites, thus sending potentially dangerous particulates into the air. The allegations suggested a manufacturing plant that was out of control, and that prioritized production at the expense of patient safety. …

Given the severity of the allegations, Menachem again asked his supervisor for backup. For the agency’s previous three inspections of the Merck plant, the FDA had sent at least two investigators. That approach allowed them to fan out across the facility and question staff separately, to ensure they got a candid picture of the manufacturing plant’s operations. It was also recommended FDA procedure to have two investigators present when dealing with a whistleblower. Menachem said his supervisor not only denied his request for help, but blocked him from pursuing an adequate investigation, even after he was able to corroborate key aspects of the whistleblower’s allegations. That obstruction put the public at risk, he contended.

Vanity Fair confirmed this account of Menachem’s Merck inspection, and events inside Team Biologics, through interviews with four current or former FDA employees, including Menachem, a detailed review of documents, and an analysis of Team Biologics inspection data. One person with knowledge of the Merck investigation described it as “malfeasance” by the FDA.

That may leave Biden with egg on his face. One of the most notable positive additions to the Trump administration’s vaccine plan that Biden made was arranging the partnership between Merck and Johnson & Johnson in January, almost two months after Vanity Fair’s exposé. Merck tapped out of the vaccine race in January, leaving its massive production capabilities on the sidelines. Biden’s team acted quickly to play matchmaker, and the payoff was supposed to be tens of millions of safely produced vaccine doses, starting almost immediately. If the FDA knew that this production facility was compromised, why didn’t it alert the White House? And if it did alert the White House, why did they push this marriage using this particular facility as the solution to production limitations?

It’s not as if J&J didn’t make those questionable calls on its own, though. That brings us back to Emergent, which has its own spotty record, the Associated Press reports this morning:

The company at the center of quality problems that led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.

Emergent BioSolutions, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the U.S. by the end of May. But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017. …

The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized the company for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.”

On the same day, Johnson & Johnson, in a separate news release, heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of the vaccine globally by the end of 2021.

Other problems cited by the FDA during the April 2020 inspection included failures by the Bayview plant “to ensure that electronically held data generated during analytical testing” of material “was protected from deletion or manipulation.” The FDA’s lead investigator, Marcellinus Dordunoo, wrote that Emergent hadn’t investigated what he described as “data integrity concerns.”

In other words, these are slender reeds on which our nation’s vaccination plans rest. There are no indications that any of the doses produced had safety issues other than the misproduction already reported, and the previously delivered doses came from J&J’s approved production facility in the Netherlands.  That facility can’t hope to keep up with the delivery commitments to the US on its own, let alone the new commitments J&J has made in Africa.

Given the ongoing issues at these facilities and the knowledge of those by the FDA and even the media, one has to wonder why the Biden administration (and the Trump administration for that matter) didn’t intervene — or at least warn that these dose projections were unreliable. If people are signing up for vaccinations that can’t be delivered, the backlash will be enormous, and could have been entirely avoidable.