EU rejects contaminated J&J COVID shots
June 11, 2021
The European Medicines Agency (EMA) said Friday that some batches of the Johnson & Johnson COVID-19 vaccine should not be used.
The American Food and Drug Administration (FDA) announced Friday that several batches from the Baltimore plant where they were made would have to be thrown out. American newspaper New York Times said the FDA determined that about 60 million doses made at the plant could not be used.
The EMA said the vaccines on the continent that came from the plant, which were made at a similar time, should not be used as a precaution.
It was not immediately clear how many vaccine doses that were in Europe could be affected. In a statement, the EMA stated, "authorities in the EU are doing everything possible to safeguard supplies and mitigate the effects of any delay in the delivery of this vaccine."
As of June 11, nearly 1,150,000 Johnson & Johnson shots were administered in Germany, just under 2% of the total vaccine doses given in the country.
Issues with the vaccine
The contamination occurred in April. Production of the vaccine at the site was stopped after the active substance in the Johnson & Johnson vaccine was contaminated with materials that were being used for another vaccine made at the plant.
Due to the contamination, the EU said it would not expect Johnson & Johnson to deliver the 55 million vaccine doses it had committed to shipping to the bloc by the end of June.
The single-dose vaccine was approved for use in the EU in March, but was temporarily paused in the US after it was discovered that very rare, potentially fatal, blood clots could be linked to the vaccine. However, FDA Director Janet Woodcock said in April that the "benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals."
kbd/aw (AP, Reuters)