Wednesday , June 16 2021

The company involved in 15 million discarded doses of J&J vaccine has a history of quality control violations



While Johnson & Johnson’s coronavirus vaccine is delivered in one go, both Pfizer and Moderna require two vaccines.

LightRocket via Thiago Prudêncio / SOPA Images / Getty Images

  • The AP reported that one of the companies producing the J&J vaccine has a history of quality control violations.
  • Emergency Biosolutions are specified by the FDA for quality control issues, including mold and cracked bottles.
  • The company is at the center of the confusion that led to the 15 million doses of vaccine being thrown away on Wednesday.
  • For more articles, go to www.BusinessInsider.com..

At the center of the confusion that resulted in roughly 15 million discarded doses of the Johnson & Johnson vaccine, the company has a history of quality control violations, the Associated Press reported.

A manufacturing facility in Baltimore under Emergent Biosolutions, one of eight companies producing the Johnson & Johnson vaccine, disrupted one batch of the Johnson & Johnson vaccine, delaying production and halting future shipments, The New York Times reported on Wednesday.

According to The Times, the mishap was caused by human error when workers at the factory scrambled the vaccine components. The Food and Drug Administration is currently investigating the case.

However, according to records obtained by the AP through Freedom, the company has been cited many times by the Food and Drug Administration for quality control issues, from cracked bottles and poorly trained employees to problems managing mold and other contaminants at one of its facilities. Information Law.

A nurse loads a syringe with a dose of Johnson & Johnson’s COVID-19 vaccine on March 9, 2021 in Athens, Ohio.

When Johnson & Johnson first went to Emergent to produce their vaccines in April of last year, according to FDA records obtained by the AP, Emergent’s Bayview facility was described as a contract testing lab “not producing products for distribution”. It also did not have the capacity to make millions of doses of Covid-19 vaccine.

According to the AP, in a recent review, the FDA cited the company’s Bayview facility of “data integrity concerns” after determining that the facility was unable to guarantee that electronic test data was “protected from deletion or manipulation”.

According to the report, the Bayview facility has been criticized for not following proper testing and laboratory procedures. The FDA also stated that the facility did not have an appropriate method for discarding rejected materials, after an inspector wrote that “separate or defined areas are insufficient to avoid contamination or disturbances” at the facility.

In December 2017, another Emergency plant in Canton, Massachusetts was reported for failing to fix “ongoing low-level mold and yeast isolates” found at the facility.

According to the AP report, a 2018 review of the company’s Baltimore facility found that “procedures designed to prevent microbiological contamination of drug products claimed to be sterile were not adequately established and followed.”

An FDA spokesperson told AP that the agency “cannot comment on any particular company or any potential or ongoing compliance issues”.

Emergent representatives did not immediately return Insider’s request for comment on the report, but Emergency spokesman Matt Hartwig told AP that the company found the spoiled party that did not meet the standards of “stringent quality controls”.

“While it’s disappointing to dispose of a plethora of drug substances, it sometimes happens during vaccine production, a complex and multi-step biological process,” he wrote in an email to the AP.

Despite the confusion at the factory, the Biden administration expects to reach its goal of having enough vaccines to fit every American adult by the end of May, reports The Times.

White House Press Secretary Jen Psaki said on Thursday that none of the current doses of Johnson & Johnson vaccines were affected by factory confusion, and the company still expects to deliver 24 million doses in April and 100 million doses by the end of May. .

“Obviously, these are the US government-bought doses, but we also have plenty of doses from Pfizer and Moderna,” Psaki said.

In an interview on “CBS This Morning”, leading US infectious diseases specialist Dr. Anthony Fauci responded by saying “human errors do occur.”

“The good news about this is that although it is really quite unfortunate that about 15 million doses will not be available, you have controls and balances and you see it,” Fauci said, “and this is the reason why the good news is being held.

“That’s why nothing from that plant goes to anyone we rule,” Fauci continued.

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