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FDA Report On The Johnson & Johnson Vaccine

The United States Food and Drug Administration has announced on Wednesday that there will be a pause in Johnson & Johnson Covid-19 vaccine production. The facility at which the contamination of the doses occurred, the Emergent BioSolutions facility was the site at which the contamination of the vaccine occurred. Both the Food and Drug Administration and the Johnson & Johnson company are analyzing a number of potential flaws and issues in the vaccine.

FDA Report On The Johnson & Johnson Vaccine

On Tuesday, the Food and Drug Administration completed its inspection of the Emergent’s Bayview  facility at Baltimore. In accordance, documents and details were released focusing on the problems that could affect the quality of the vaccine during manufacture. 

FDA Report On The Johnson & Johnson Vaccine

The FDA inspection highlighted the areas where the company was found lacking- mainly incomplete investigation that were supposed to look into cross contamination, written procedures that were not followed during manufacture, facilities that were not properly maintained and a lack of training for employees.

The production of Johnson & Johnson vaccine was temporarily paused by both the acting FDA commissioner, Dr. Janet Woodcock and the director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks.

 In a joint statement released by Dr. Woodcock and Dr. Marks it was stated, “For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality.”

It is reported that the Emergent facility has been making Covid-19 vaccines under contract for both the Johnson & Johnson vaccine and the AstraZeneca vaccine. Reports show that 15 million doses of the vaccine could have been made that do not possess the proper standards and quality needed. Thus, they have been taken out of production. 

A new report by the Food and Drug Administration has shown that the Emergent facility has not properly supervised or investigated cross contamination of a viral vaccine. Moreover the report highlights that a poorly conceived review of how people moved in the facility could be another cause for contamination. According to the report, “There is no assurance that other batches have not been subject to cross-contamination.”

The Johnson & Johnson Company has announced its goal to ensure that all efforts will be made to regain authorization in order to manufacture the Covid-19 vaccine at Emergent’s Bayview manufacturing site. The company released a statement on Wednesday saying, “Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively.”

The Johnson & Johnson Company stated, “We are working around the clock to develop and broadly activate our manufacturing capabilities to supply our COVID-19 vaccine worldwide, and we appreciate the ongoing and extensive collaborations and partnerships we have with governments, health authorities and other companies to help end this pandemic.” The Johnson & Johnson Company’s plan is to increase the number of vaccination sites. The company plans on having at least 10 manufacturing facilities up and running as well as setting up an internal manufacturing facility in the Netherlands. 

The reason behind the pause in production is not due to the oversights detailed in the FDA reports. Rather the halt on Covid-19 vaccine production stems from cases where blood clots have affected people who have taken the vaccine. The United States Center for Disease Control and Prevention as well as the Food and Drug Administration called for a halt in production of vaccines by the company when six cases if blood clots related to the vaccine arose. 

Dr. Fauci stated, “The decision of what to do with this vaccine as a vaccine product is not going to be influenced by that. It’s going to be influenced by the data and safety – not in what’s going on there. But you can be assured, and the American public can be assured, that no vaccines are going to go out of there unless the FDA is quite confident in them.”

Link

https://edition.cnn.com/2021/04/21/health/fda-emergent-johnson–johnson-vaccine-bn/index.html

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