Johnson & Johnson to toss 60 MN doses of COVID-19 vaccine made at Baltimore plant: Report

 

The US FDA told Johnson & Johnson to discard about 60 million doses of its COVID-19 vaccine that were produced at a troubled Baltimore plant.

The US Food and Drug Administration has reportedly told Johnson & Johnson to discard about 60 million doses of its COVID-19 vaccine that were produced at a troubled Baltimore plant. According to NBC News, the FDA ordered the vaccines to be tossed after determining they were “not suitable for use”. However, two people familiar with the decision told the media outlet that the FDA is planning to allow Johnson & Johnson to distribute 10 million doses that were manufactured at the same facility. 

The doses in question were produced at the Emergency BioSolutions plant in Baltimore. As per reports, the facility threw away ingredients for 15 million does in late April because of contamination with materials from the AstraZeneca vaccine, which was also manufactured at the same plant. At that time the FDA’s subsequent inspection of the Baltimore facility revealed that it had serious problems with unsanitary conditions and had failed to properly train workers.  

Following the inspection, FDA required Johnson & Johnson to take full control of the facility. Now, after an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product, the US agency authorised some batch for use but not others. The FDA updated its letter of authorization for J&J to help “facilitate potential export to other countries”. The agency also added that it is still reviewing other batches from the Baltimore plant for potential distribution. 

J&J’s shelf life extended to 4 1/2 months 

FDA’s recent move comes after the agency extended the shelf life of Johnson & Johnson doses from three months to four and a half months. The company has said that its COVID-19 vaccine’s single-shot efficacy is 66 per cent in preventing moderate and severe disease in a global Phase 3 trial and 85 per cent efficient against severe disease. It also said in a statement that its vaccine was 72 per cent effective against moderate and severe disease in the United States. 

The COVID-19 vaccines that are already in the market have shown efficacy as high as 95 per cent with even higher in some cases. However, public health experts in countries where there are no vaccines have told NBC News that they prefer the one-shot Johnson & Johnson vaccine citing its ease of administration since second appointments are not necessary. J&J’s level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination. 


Source: https://www.republicworld.com/world-news/global-event-news/johnson-and-johnson-to-toss-60-mn-doses-of-covid-19-vaccine-made-at-baltimore-plant-report.html

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