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The Baltimore firm on the coronary heart of the J&J vaccine drawback has posted well being quotes prior to now – York Dispatch

RICHARD LARDNER and LINDA JOHNSON, The Associated Press

Posted April 1, 2021 at 6:52 p.m. ET

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The company at the center of quality issues that caused Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a number of quotes from U.S. health officials about quality control issues.

Emergent BioSolutions, a little-known company at the heart of the vaccine supply chain, was a key in Johnson & Johnson's plan to ship 100 million doses of its vaccine to the US by the end of May. However, the company has been spearheaded repeatedly by the Food and Drug Administration over issues such as poorly trained staff, cracked vials, and mold in one of its facilities. This is based on records received by The Associated Press under the Freedom of Information Act. The records include inspections at emergent facilities since 2017.

Johnson & Johnson said Wednesday that a batch of vaccine made by Emergent at its Baltimore factory known as Bayview cannot be used because it does not meet quality standards. It was unclear how many doses were involved or how the problem would affect future shipments of J & J's vaccine. The company said in a statement it still plans to dispose of 100 million cans by the end of June and intends to "dispose of those cans by the end of May".

J&J partnered with Emergent in April 2020, commissioning the lesser-known company to manufacture the vaccine that J&J was developing with federal funding. At the time, Emergent's Bayview facility was not designed to produce millions of doses of a potential COVID-19 vaccine. This is evident from the FDA records describing the facility as a contract testing laboratory where "no products were made for sale". Improvements in technology and human resources were required before Bayview could begin manufacturing what is known as "drug substance" material for the vaccine. This is a two-month process during which the necessary biological cells are grown.

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FILE – This file photo taken on March 25, 2021 shows a box of Johnson & Johnson's COVID-19 vaccine in a Washington state clinic refrigerator. A batch of Johnson & Johnson's COVID-19 vaccine has not met quality standards and cannot be used, the drug giant said late Wednesday, March 31, 2021. The drug maker did not say how many doses were lost, and it did wasn't clear how the problem would affect future deliveries. (AP Photo / Ted S. Warren) (Photo: Ted S. Warren, AP)

The FDA inspected Emergent's Bayview facility in April 2020 when the agreement with J&J was announced. The federal agency criticized the company for having problems considering a possible treatment for anthrax, according to records received from the AP. The FDA's chief investigator cited the company for failing to "train employees in the specific operations they perform as part of their role and current good manufacturing practice."

On the same day, Johnson & Johnson announced in a separate press release that it was partnering with Emergent to meet the pharmaceutical giant’s goal of delivering more than 1 billion doses of the vaccine worldwide by the end of 2021.

Other issues cited by the FDA during the April 2020 inspection were failures by the Bayview facility "to ensure that electronically stored data generated" from material "during the analytical review was protected from deletion or tampering." FDA lead investigator Marcellinus Dordunoo wrote that Emergent had not investigated what he called "data integrity concerns".

The inspection was the latest in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a Canton, Massachusetts facility where the FDA said the company "continued to have low levels of mold and" yeast isolates "in the Facility found. Nearly a year later, agency investigators asked why Emergent had an unwritten policy at a separate facility in Baltimore known as Camden, which dispenses anthrax vaccine, "not having routine compliance audits to be carried out ".

Emergent's revenue skyrocketed during the Trump administration, rising from around $ 523 million in 2015 to over $ 1.5 billion in 2020. alone.

Emergent is one of around 10 companies Johnson & Johnson is working with to accelerate the manufacture of its recently approved vaccine. The Bayview factory where the tainted vaccine was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment.

President Joe Biden has pledged to have enough vaccines for all adults in the United States by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by the end of May, as well as J & J.'s 100 million single-dose shots.

A federal official said Wednesday evening the government's goal could be achieved without additional J&J doses.

A J&J spokesperson said earlier Wednesday that the company had hit its late March target, and the Centers for Disease Control and Prevention's online vaccine tracker showed that J&J had about 6.8 million doses for that Had provided US vaccine efforts. J&J has shipped finished vaccines to the US from its factory in the Netherlands.

J&J announced that more manufacturers and quality experts will be deployed to Emergent's factory to oversee production of the COVID-19 vaccine. This move should allow an additional 24 million doses of vaccine to be delivered by April.

J&J continues to expect to sell more than 1 billion vaccine doses worldwide by the end of the year.

The J&J vaccine has been seen as critical to vaccination campaigns around the world because it only requires one shot and, unlike some other vials that must be kept frozen, it can be shipped and stored at standard refrigeration temperatures. The company has also pledged to sell the vaccine for no profit, but only during the pandemic emergency.

The problem with the vaccine lot was first reported by the New York Times. The FDA said it was aware of the situation but declined to comment.

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