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FDA Reveals Details of Problems at Third-Party Maker of JNJ Shot

'Cross contamination' issues found at Emergent BioSolution's Maryland facility, according to memo.

The Food and Drug Administration late Friday revealed further details of conditions at the former manufacturer of Johnson & Johnson's  (JNJ) - Get Report COVID vaccine that has contributed to the waste of millions of doses of the shot. The revelations could add another blow to confidence in the one-shot vaccine that was once hoped to speed up the nation's now slowing efforts to immunize Americans from the novel coronavirus. 

The Maryland facility of Emergent BioSolutions  (EBS) - Get Report was found by FDA officials to lack proper procedures for waste removal and failed to keep separate manufacturing of the J&J shot and a similar one by  AstraZeneca  (AZN) - Get Report, which is not approved for use in the U.S. but is used in much the rest of the world.

Cross contamination was found with AstraZeneca’s adenovirus-vectored vaccine that was being manufactured in other parts of the facility, according to the memo, written by Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. 

FDA officials concluded that the most probable cause was that bioreactor materials were contaminated in a common weigh and dispense area through contact with the "waste path for materials" from the AstraZeneca vaccine manufacturing area.

"There is no evidence that contamination of the vaccine, even at a low level of contamination, would have no impact on the safety and effectiveness of the vaccine," found the FDA. Therefore, the FDA determined that the facility was not operating in compliance with proper requirements during the time most the batches in question were manufactured and they "failed to meet the Agency’s expectations for quality" and are not suitable for use and most should be discarded.

The memo comes after a news report in the New York Times that tens of millions of doses of the J&J, or Janssen, shot was going to waste. 

Emails seeking comment from J&J and Emergent were not immediately answered Sunday. 

Emergent did say in a statement last month that it has a "comprehensive quality enhancement plan" and "already started making improvements and we are fully committed to making the necessary short- and long-term enhancements to meet or exceed FDA’s standards."

Its problems at the Maryland facility were first revealed months ago.

The FDA had not yet authorized Emergent's Baltimore facility "to manufacture or distribute" any of the affected Janssen’ COVID-19 vaccine or components, according to the memo, and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the United States. The site was also used for the manufacturing of the AstraZeneca COVID-19 vaccine from August 2020 through April 2021.

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The FDA has also said separately Friday that it's not yet ready to include the Emergent BioSolutions plant as an authorized manufacturing facility for Janssen shot, but it did allow for some batches of a vaccine drug substance of the Janssen COVID-19 vaccine to be used in the U.S. or exported to other countries under certain conditions. 

Other Vaccine Woes

The J&J shot, as with the one by AZN,  has coincidentally been under scrutiny because of their link to a rare blood clotting problem. While most nations have continued using the shots after a pause earlier in the year, at least one, Denmark has ruled that the benefits of using the J&J shot "do not outweigh the risk" of possible clotting.

The FDA memo also comes after federal health authorities say they are probing a possible link between rare cases of heart inflammation, or myocarditis, in younger people and the vaccines by Pfizer  (PFE) - Get Report and Moderna  (MRNA) - Get Report. That issue was first raised in Israel, as early as February, when a 19-year-old man was hospitalized with myocarditis less than a week after getting his second dose of the vaccine, according to a report in the Jerusalem Post.

“The fact that the symptoms started immediately after the vaccination raises the suspicion that an immunological reaction may have caused the inflammation,” Dr. Abdulhadi Farojeh told the Post at the time. 

Months later, in April, reporter Patricia Kime of revealed that the Defense Department was tracking more than a dozen cases of heart inflammation in military health patients who had gotten the Pfizer or Moderna jabs. 

More recently, reports of American teens with myocarditis following the shots have trickled out, including one of an Oregon 15-year-old who ended up in the emergency room after getting the Pfizer shot. 

Officials at the Centers for Disease Control and Prevention and the FDA, however, have stressed that despite the relatively rare side effects of the shots, they are safe for the vast majority of people, and highly effective at preventing COVID-19 symptoms. 

"The incidents of this are tiny compared to the number of people who are getting vaccinated," Dr. Juan C. Alejos, the medical director of the pediatric heart transplant and cardiomyopathy program at UCLA Health, told TheStreet in an interview on Sunday. "It's so rare that we forget how bad COVID can be."

To date, more than 43% of Americans are fully vaccinated and slightly more than half the entire population is at least partially vaccinated, according to CDC numbers. 

As of Friday's close, JNJ was down slightly to $164.96, falling by a few cents after hours on the New York Stock Exchange; EBS was down 3% to $63.51 but up some after hours; PFE was down to $40.15 on NYSE and its vaccine partner, BioNTech was down to $238.55 on Nasdaq; MRNA, however, was up slightly to $218.85 on Nasdaq.

This story has been updated with additional information.