The Food and Drug Administration on Friday night revealed more details of the conditions at Johnson & Johnson’s former manufacturer. (JNJ) – Get report COVID vaccine that has contributed to the waste of millions of injection doses. The revelations could add another blow to confidence in the single-shot vaccine that was once expected to accelerate the nation’s now-slowed efforts to immunize Americans against the novel coronavirus.
The Maryland Facility of Emergent BioSolutions (EBS) – Get report FDA officials determined that it lacked proper waste disposal procedures and did not maintain separate manufacturing of the J&J injection and a similar one by AstraZeneca. (AZN) – Get report, which is not approved for use in the US but is used in much of the rest of the world.
Cross-contamination was found with AstraZeneca’s adenovirus-vector vaccine that was being manufactured elsewhere in the facility, according to the memo, written by Dr. Peter Marks, director of the FDA’s Center for Biological Research and Evaluation.
Emails seeking comment from J&J and Emergent were not immediately returned Sunday.
Emergent said in a statement last month that it has a “comprehensive quality improvement plan” and “has already started making improvements and we are fully committed to making the necessary short-term and long-term improvements to meet or exceed FDA standards. “.
His problems at the Maryland facility were first revealed months ago.
The FDA has not yet cleared Emergent’s Baltimore facility “to manufacture or distribute” any of the components or Janssen’s COVID-19 vaccine, according to the memo, and, to date, no COVID-vaccine has been distributed. 19 manufactured at this plant for use in the United States. The site was also used for the manufacture of the AstraZeneca COVID-19 vaccine from August 2020 to April 2021.
J & J’s injection, like AZN’s, has coincidentally been under scrutiny due to its link to a rare blood clotting problem. While most nations have continued to use the injections after a hiatus earlier in the year, at least one, Denmark has ruled that the benefits of using the J&J injection “do not outweigh the risk” of possible clotting.
The FDA memo also comes after federal health authorities say they are investigating a possible link between rare cases of heart inflammation or myocarditis in younger people and Pfizer vaccines. (PFE) – Get report and Modern (MRNA) – Get report. That problem was first raised in Israel, as early as February, when a 19-year-old man was hospitalized with myocarditis less than a week after receiving his second dose of the vaccine, according to a report in the Jerusalem Post.
“The fact that the symptoms started immediately after vaccination raises the suspicion that an immune reaction may have caused the inflammation,” Dr. Abdulhadi Farojeh told Mail at the time.
Months later, in April, Reporter Patricia Kime from Military.com revealed that the Department of Defense was tracking more than a dozen cases of heart inflammation in military health patients who had been hit by Pfizer or Moderna.
More recently, there have been reports of American adolescents with myocarditis after injections, including one of a Oregon 15 years who ended up in the ER after receiving the injection from Pfizer.
Officials from the Centers for Disease Control and Prevention and the FDA, however, have emphasized that despite the relatively rare side effects of the injections, they are safe for the vast majority of people and highly effective in preventing Symptoms of COVID-19.
To date, more than 43% of Americans are fully vaccinated and just over half of the entire population is at least partially vaccinated, according to CDC figures.
As of Friday’s close, JNJ dipped slightly to $ 164.96, dropping a few cents after hours on the New York Stock Exchange; EBS was down 3% to $ 63.51 but was up slightly after business hours; PFE fell to $ 40.15 on the NYSE and its vaccine partner, BioNTech fell to $ 238.55 on Nasdaq; The mRNA, however, rose slightly to $ 218.85 on Nasdaq.
This story has been updated.