Hogan: 'Major Screw Up' At Baltimore Vaccine Facility Ruined 15 Million Johnson & Johnson Doses; Emergent Defends Record Following Report of Past Issues
BALTIMORE (WJZ/CBS NEWS) -- Maryland Governor Larry Hogan said he learned yesterday along with the public about the mix-up at Baltimore's Emergent BioSolutions plant weeks ago that reportedly ruined almost 15 million doses of the Johnson & Johnson vaccine.
"It was not mentioned by The White House on our Tuesday call. We at this point don't know the exact impact that it's going to have although we've been lead to believe by our federal partners that it's not going to directly impact our allocations at least for the foreseeable future, and we're hoping that is the case," Hogan told reporters. "I don't think it gives Baltimore a bad name. I mean obviously, there was some major screw-up at this plant with human error of some type."
The facility has yet to be approved by the Food and Drug Administration, and none of the vaccines manufactured here have been given to the general public.
"It was human error. The FDA is investigating this," said Dr. Anthony Fauci, a senior adviser to the President. "All the doses that have been distributed to us—that have been administered—did not come from that plant so this is not related in any way to any of the J&J doses that people have already gotten."
Fauci said, "You have checks and balances and the good news about this, despite the fact that it's really quite unfortunate that about 15 million doses now are not going to be able to be used, but you do have checks and balances. ...It did get picked up."
Emergent makes the active ingredients for Johnson and Johnson and AstraZeneca vaccines at the Baltimore Bayview facility.
The New York Times was first to report that workers accidentally swapped materials for the two vaccines, and by the time quality control checks caught the error, millions of doses had already been spoiled.
Emergent told WJZ they will destroy the tainted vaccines and stressed they perform "rigorous quality checks." The company said it was "confident" the FDA would approve vaccines manufactured at Bayview and "...The quality control systems worked as designed to detect and isolate this single batch."
Here is Emergent's full statement to WJZ:
"At Emergent, safety and quality are our top priorities. Our Bayview facility has been designed and validated to meet all current Good Manufacturing Practices. In addition, there are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly. Importantly, the quality control systems worked as designed to detect and isolate this single batch. Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process. We continue to manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements. We are very proud of the role the Emergent team is playing in support of the response to COVID-19 and look forward to continuing to do our part to help stem this pandemic."
Baltimore Mayor Brandon Scott received the Johnson & Johnson vaccine himself last month. He told WJZ Investigator Mike Hellgren he wants to make sure people know what happened at Emergent has not impacted any doses given to the public.
"It's unfortunate. Any time you have humans involved in something, there's going to be human error," Mayor Scott said. "...As someone who actually received the Johnson & Johnson vaccine and knows that it's safe, I'm just going to let people know that it is, and we've seen that they're putting things in place to try to prevent things in the future."
Baltimore City's Health Commissioner Dr. Letitia Dzirasa told Hellgren she has received no indication that the incident will affect the city's vaccine supply.
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But it could be at least two weeks until all of the vaccine produced for Johnson & Johnson in Baltimore —including three lots manufactured after the discarded batch—are cleared by the ongoing investigation, which federal officials believe is the main remaining hurdle before Emergent's vaccine factory can be cleared by regulators.
Vaccine manufacturing is a complex process and discarded batches are not uncommon, especially in the early stages of production. However, errors invite extra scrutiny from both the company and regulators to trace how the lapse occurred and ensure the mistake won't be repeated.
J&J said it was putting more of its manufacturing and quality experts inside Emergent's factory to supervise the production of the COVID-19 vaccine, a move meant to enable the delivery of an additional 24 million vaccine doses through April.
J&J said it still expects to deliver more than one billion vaccine doses globally by the end of the year.
The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.
The Associated Press reports that Emergent 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 AP through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017.
J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal funding.
At the time, Emergent's Bayview facility wasn't scaled for making millions of doses of a potential COVID-19 vaccine, according to the FDA records that describe the plant as a contract testing laboratory that "did not manufacture products for distribution." Upgrades in technology and personnel were required before Bayview could begin making what's known as "drug substance" material for the vaccine, a two-month process during which the required biological cells are grown.
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."
The inspection was the most recent in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a plant in Canton, Massachusetts, in which the FDA said the company hadn't corrected "continued low-level mold and yeast isolates" found in the facility. Nearly a year later, agency investigators questioned why Emergent had "an unwritten policy of not conducting routine compliance audits" at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.
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