(NEXSTAR) – Human error has caused a mistake in the Baltimore manufacturing plant, ruining approximately 15 million future doses of the Johnson & Johnson COVID-19 vaccine. New York Times Report..
Workers at AstraZeneca and J & J maker Emergent BioSolutions confused the main components of the coronavirus vaccine, the newspaper said. Currently, all J & J doses distributed throughout the United States were produced in the Netherlands with federal approval, so the error does not affect the current vaccine flow.
However, according to The Times, which was scheduled for tens of millions of doses in April, this mistake would affect the planned scale of vaccine supply from the Baltimore plant.
Johnson & Johnson said in a statement to Nexter that it was conducting “test runs and quality checks” at the factory and is still waiting for permission to “manufacture the drug substance for the COVID-19 vaccine.” Said. According to the company, the spoiled batch “did not go through the filling and finishing stages of the manufacturing process.”
J & J did not say how many doses the batch would give, and immediately asked the question of whether a batch that failed quality control would eventually reach Americans if not compromised. I didn’t answer.
“This is an example of strict quality control applied to each batch of API,” the statement read. “This issue was identified and addressed by Emergent and shared with the US Food and Drug Administration (FDA).”
According to the company, it is pleased to have provided “a single vaccine sufficient to enable complete vaccination of more than 20 million people in the United States by the end of March,” and plans to provide 100 million single vaccines. is. May.
Emergent Biosolutions did not respond to the request for comment.
See the full Johnson & Johnson text below.
Since January 2020, Johnson & Johnson has worked directly with governments, health authorities and other businesses to end the pandemic. We continue to expect to deliver the COVID-19 vaccine more than 1 billion times by the end of 2021.
We are pleased to have achieved our commitment to provide sufficient single-shot vaccines by the end of March to enable full vaccination of more than 20 million people in the United States. This is part of a plan to deliver 100 million single-shot vaccines to the United States in the first half of 2021, with the goal of delivering these doses by the end of May.
As with the production of complex biopharmaceuticals and vaccines, the start of a new process involves test runs and quality checks to verify production and ensure that the final product meets our high quality standards. included. This approach involves assigning dedicated specialists to companies that are part of a global manufacturing network to support safety and quality.
This quality control process identified batches of APIs that did not meet the quality standards of Emergent Biosolutions, a site that has not yet been approved for the production of APIs for the COVID-19 vaccine. This batch did not advance to the filling and finishing stages of the manufacturing process.
This is an example of strict quality control applied to each batch of API. This issue was identified and addressed by Emergent and shared with the US Food and Drug Administration (FDA).
Quality and safety remain our top priorities. Therefore, while continuing to work with the FDA and Emergent for an Emergency Use Authorization for the Emergent Bayview Facility, Johnson & Johnson will provide additional manufacturing, technical operations, and quality experts to supervise, direct, and supervise everything on the emergence of Emergent. And support Johnson & Johnson COVID-19 vaccine manufacturing. These steps will allow us to work with the US Department of Health and Human Services to safely deliver an additional 24 million single vaccinations by April.
15 million J&J vaccine doses lost due to factory error, report says Source link 15 million J&J vaccine doses lost due to factory error, report says