It was reported that 15 million doses of the pharmaceutical company Johnson & Johnson Corona 19 vaccine were discarded due to the incorrect mixing of other Corona 19 vaccine ingredients.
In the US, vaccines cannot be produced and shipped as soon as they are approved. It must be approved by the US Food and Drug Administration FDA for each vaccine production facility and regularly inspected. In addition, in the case of Corona 19 vaccine, manufacturers must submit the results of quality control tests 48 hours before shipment of the vaccine. In the United States, when a polio vaccine was released due to a production error in 1955, more than 40,000 victims were reported. Accordingly, a strict quality control process is required for vaccine manufacturing.
The discovery of a problem at the Baltimore plant of Emergent BioSolutions, which subcontracted the manufacture of this vaccine, was due to the vaccine quality control process. In one report, it was reported that the original solution of the AstraZeneca Corona 19 vaccine was used to manufacture the original Johnson & Johnson vaccine that did not meet strict quality standards due to human error. Reportedly, the western Baltimore plant was concerned from the FDA that there was also quality control issues in the manufacture of an anthrax vaccine approved in 2015.
The U.S. Department of Health and Welfare said it was aware that a problem had occurred in the Baltimore plant west of Emergent Bio Solutions in early March 2021. According to a senior official from the Ministry of Health and Welfare, Immergent Biosolution has discovered that there are no pharmaceutical manufacturing experts. This means that no one can directly oversee the vaccine production process.
Johnson & Johnson contaminated vaccine stock solution was found in the quality control process, so it is not processed and provided as a vaccine. The federal government has asked Johnson & Johnson to directly supervise the production of the Emergent Biosolution vaccine, a senior official at the Ministry of Health and Welfare said.
Johnson & Johnson aims to ship 20 million doses of COVID-19 vaccine for domestic use in the U.S. by the end of March and 100 million by the end of May, but it will take days to weeks to put a new production process on track and reach regulatory standards. to be. In addition, if the Johnson & Johnson vaccine is assumed to be $10 each, the loss of Johnson & Johnson is estimated to be $150 million. Related information can be found here.