Pfizer’s Vaccine Plant Has History of Recalls

By Sarah Jane Tribble, Kaiser Health News

Wednesday, March 10, 2021 (Kaiser News) – Pfizer management knew that last year there was a “mold problem” at the Kansas plant that was now scheduled to produce the covid-19 vaccine that the drug maker had a urgently needed, according to a Food and Drug Administration inspection report.

This story also aired on The Daily Beast. It can be reposted for free.

The McPherson, Kansas facility, which FDA inspectors say is the nation’s largest manufacturer of sterile injectable controlled substances, has a long, troubled history. Almost a decade of FDA inspection, recalls and reprimand reports reviewed by KHN show the facility to be a repeat offender. FDA investigators have repeatedly noted in reports that the plant has failed to control quality and contamination or conduct a thorough investigation after production failures.

The 1970s manufacturing site has had persistent mold problems over the years and has been the subject of at least four intensive FDA inspections since Pfizer resumed operations in late 2015, during the acquisition of Hospira. As the January 2020 inspection ended, FDA investigators seemed increasingly frustrated.

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Pfizer plant managers told investigators they knew there was bacteria or mold throughout the facility at different times of the year. In a Jan. 17, 2020 facility inspection report obtained by KHN, one of three FDA experts who visited wrote that Pfizer said it was fixing the issues and added “more mold response cleanup ”after a 2018 inspection and“ yet there are still unexplained deviations. “

After the January 2020 inspection report, Pfizer immediately developed and implemented a corrective action plan, company spokesperson Eamonn Nolan told KHN. Neither Pfizer nor the FDA responded to requests for a copy of the plan.

Nolan, in an email last week, said “significant investments have been made” in resources, equipment and facility. He said all improvements related to covid manufacturing will be completed before vaccine production begins. He declined to provide details on when production of the vaccine began, but said the site is currently operating in a good state of manufacture, meaning it has met a regulatory standard enforced by the FDA.

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“We are confident in the ability of the McPherson site to manufacture a high quality COVID-19 vaccine,” he wrote.

Large clinical trials have shown Pfizer’s vaccine to be 95% safe and effective against covid.

News that the plant will be a fill and finish site for the Pfizer-BioNTech covid vaccine means eyes will be more vigilant on the facility. “That alone should be helpful,” said Barbara Unger, a former executive in the pharmaceutical industry who now performs manufacturing audits for companies.

It is not known whether FDA investigators returned to check production practices at McPherson or plan to visit before vaccine production begins. The FDA did not respond to specific questions. FDA spokeswoman Abigail Capobianco wrote in an email that the public “can be assured that the agency has used all the tools and information available to assess compliance.”

Pfizer’s emergency use authorization letter for its mRNA vaccine includes guarantees, such as quarterly reports to the FDA and a company quality review for each batch of drug manufactured at least 48 hours prior. its distribution.

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The factory’s manufacturing issues can be traced in FDA reports dated 2011 through last year. Several former FDA staff and industry experts said the ongoing challenges at McPherson underscore how agency officials must strike a balance between aggressively pursuing a company’s manufacturing practices and the need to maintain the supply of drugs to patients.

“I don’t envy the choices of the FDA,” Unger said, describing a balancing act. “What is the greatest risk to public health?”

The site produces a wide range of sterile generic drugs used in hospitals, and its issues have played a role in some major health system shortages, particularly for injectable opioid pain relievers, according to an FDA release in 2018.

The FDA rejected Pfizer’s biosimilar version of Amgen’s anemia drug Epogen due to concerns about the fill / finish plant in 2017. That same year, John Young, who was Chairman of the Pfizer Group, told investors that the company had submitted “corrective and preventive action.” plan ”for installation.

This is the same language used after the January 2020 inspection, which indicated that there were contamination issues for the site but not in the drugs. And it was Young, now Pfizer’s chief commercial officer, who told Congress last month that Pfizer had added production lines at the McPherson site to help meet demands for covid-19 vaccines.

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The facility’s field recall and alert log includes drug vials with particles of glass and cardboard and, as one client complained, a “little bug or speck of dust.”

A 2017 FDA warning letter – which is a strong rebuke to the agency – said contaminants such as cardboard and glass found in the vials presented a “serious risk of harm to patients” and indicated that the manufacturing process for sterile injectables was “stopped”. control. “

FDA records show that several lots of vancomycin hydrochloride, a drug injected into hospital patients who have an infection that penicillin does not treat, were recalled in 2016 and 2017.

John Avellanet, FDA compliance expert and director at Cerulean Associates, reviewed the 2020 inspection reports. He said he was concerned the fixes were minimal, but “out of the front.”

“They might have solved it in one case, like the cardboard particles. But for some reason, they were never able to resolve the contamination, ”Avellanet said. “Everything they do for quality control testing doesn’t seem to work, because if it worked, they wouldn’t continue to have these contamination issues.”

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Pfizer stopped manufacturing McPherson in December 2017, even though the FDA had surrendered two months earlier and improved the facility’s inspection rating. McPherson management has suspended production and rejected batches of finished products after finding mold on equipment in a filling area, according to an FDA inspection report. The facility returned to production weeks later.

When the FDA returned to inspect in late summer 2018, it found that procedures to prevent microbiological contamination of drugs were lacking. He also noted a lack of training for employees, employees not following procedures, clogged surfaces and internal tests that did not ensure drugs met standards.

In 2019, when CEO Albert Bourla took over as CEO of Pfizer, he told analysts it would be another tough year for US hospitals to get their hands on sterile injectables due to ongoing work at the McPherson plant. .

Since then, the coronavirus pandemic has hampered the FDA’s ability to inspect plants, according to a recent report from the United States Government Accountability Office. The agency ended non-urgent foreign and domestic inspections in March 2020 out of concern for staff safety and has since resumed some visits to domestic factories.

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John Fuson, a partner at Crowell & Moring law firm and former deputy chief counsel for the FDA, said the agency had sent surveys to manufacturers to help it prioritize inspections. Not to mention directly from the Pfizer factory, Fuson said the FDA did not have the resources to do all the inspections “we might like them to do.”

It is not known how much oversight the Pfizer McPherson facility has exercised over the past year. In 2020, pharmaceutical company Gilead Sciences signed a multi-year agreement with Pfizer to produce its covid treatment remdesivir at the Kansas plant. Gilead spokesperson Arran Attridge wrote in an email that Gilead is “evaluating the facilities of our manufacturing partners” to ensure they are in compliance with regulations.

FDA inspectors visited the McPherson plant every year before the pandemic, according to FDA public records. The factory received ratings from VAI, or Voluntary Indicated Action, or OAI, Official Indicated Action, depending on the inspection. John Godshalk, a former FDA investigator who worked on vaccines, said an VAI is one of the most common inspection ratings given. This means that the FDA “trusts the company to correct” observations made during inspections, he said.

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The FDA gave the Pfizer McPherson facility a VAI rating in January 2020 – and company executives were so happy they said in their third quarter financial records that the agency had ‘modernized’ the plant. .

Prior to January 2020, the McPherson plant appears to be operating with the most severe OAI rating since its 2018 inspection, according to FDA reports. Former FDA investigator Godshalk said an OAI warned the company. It’s “what you don’t want as a business,” he said.

Pfizer employs approximately 1,500 people at the McPherson plant, as well as contractors. Kasi Morales, executive director of McPherson Industrial Development Co., said the facility was the largest employer in the industrial town about an hour north of Wichita, Kansas, and not far from Interstate 70, a thoroughfare major east-west across the country.

The 2020 inspection report that led to McPherson’s “improved” rating listed repeated observations involving quality control procedures not fully followed and “contamination” by mold and bacteria on surfaces due to humidity and cleaning practices.

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No contamination was found in the drugs themselves upon inspection, but investigators described seeing operators “lean and talk over sterilized items being unpacked.”

Notably, the 2020 inspection report indicates very early on that Pfizer had made “significant changes in direction” since the previous inspection in 2018. This last inspection was spread over three weeks from December 2019 to January 2020 and the inspectors have writes that “the management was cooperative and no refusals were met. “

Christopher Smith, vice president of quality operations for sterile injectables at Pfizer in the United States and the European Union, was periodically at the McPherson plant during the visit. In the end, he “expressed his displeasure” with several of the 2020 sightings made by investigators and “repeatedly asked for clarification.”

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