On Wednesday, US authorities released documents showing that the pharmaceutical company Johnson & Johnson in June 2020 knew that there was a significant risk associated with production at the vaccine factory in Baltimore, according to Washington Post.
Months later, in March 2021, the drug company discovered that 15 million doses of their corona vaccine had been destroyed as a result of an error and had to be discarded.
The pharmaceutical company Janssen is part of Johnson & Johnson. Therefore, their corona vaccine is often referred to as the Janssen vaccine in Norway and Europe.
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Surveys
The documents were released by a committee set up to investigate the incident and manufacturing errors committed by the company Emergent BioSolutions, which manufactures the vaccine doses for Johnson & Johnson in the United States.
The committee writes in one report that Emergent was warned in several cases in 2020 that there was a significant risk of contamination at the factory. The warnings came both during internal inspections and during inspections carried out by the FDA, Johnson & Johnson and AstraZeneca.
At the vaccine factory in question, it was found, among other things, that there were recurring problems related to mold, hygiene, and training of employees. “The strategy to avoid contamination at the vaccine factory is deficient,” Johnson & Johnson stated in an audit in June 2020.
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sorry
The Washington Post writes that another June 2020 report commissioned by the Trump administration states that Emergent’s vaccine production had been exposed to significant risk due to the need to quickly acquire new employees.
– We have implemented a number of measures, says Emergent CEO Robert Kramer, and states that this includes moving the production of the AstraZeneca vaccine, which also took place at the Baltimore factory.
– We apologize for our lack of control, and I will personally assure you that we will do what is necessary to resume production in a safe manner.
Kramer says that none of the doses produced by Emergent BioSolutions have been made available in the United States.
Weeks before the scandal was discovered, Kramer sold shares in his own company worth ten million dollars, but says that the sale was predetermined and was done automatically, and that it thus had nothing to do with the incident.
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Janssen vaccine
Johnson & Johnson’s coronary vaccine, often referred to as the Janssen vaccine, has been approved by the European Medicines Agency (EMA). However, the vaccine is associated with the same rare and serious side effects as the AstraZeneca vaccine, and the vaccine has therefore been paused in Norway’s vaccination program.
The rare and serious condition is called WHITE, and is characterized by blood clots, low platelet counts and bleeding. In the USA, it is estimated that 0.7 out of 100,000 women under the age of 50 develop VITT as a result of vaccination with the Janssen vaccine.
However, the government has decided that the individual will be able to choose to take the Janssen vaccine in Norway. This scheme will be in place after the Norwegian Directorate of Health has investigated whether there should be guidelines for who should be able to make this choice, and how the health service should inform people who are facing this choice.