Apr 02, 2021 11:00:00

Johnson & Johnson's 15 million COVID-19 vaccines were discarded due to a manufacturing error. Why was the manufacturing error discovered?

Approximately 15 million doses were discarded because the new coronavirus infection (COVID-19) vaccine from pharmaceutical company Johnson & Johnson (J & J) was mistakenly mixed with ingredients from another COVID-19 vaccine. It was reported that.

Some Johnson & Johnson Covid Vaccine Doses Delayed in US by Factory Mix-Up --The New York Times

https://www.nytimes.com/2021/03/31/world/johnson-and-johnson-vaccine-mixup.html

White House knew more than a week ago of J & J contractor vaccine-supply problems --POLITICO
https://www.politico.com/news/2021/03/31/johnson-johnson-vaccine-15-million-ruined-478776

Why Johnson & Johnson throwing out 15 million COVID-19 vaccine doses shouldn't scare you
https://theconversation.com/why-johnson-and-johnson-throwing-out-15-million-covid-19-vaccine-doses-shouldnt-scare-you-158300

In the United States, vaccines cannot be manufactured and shipped as soon as they are approved, and each vaccine manufacturing facility must be approved and regularly tested by the US Food and Drug Administration (FDA). In addition, for COVID-19 vaccines, the manufacturer must submit the results of the quality control test 48 hours before the vaccine is shipped. In the United States, in 1955, the circulation of polio vaccine that was not inactivated due to a manufacturing error caused more than 40,000 victims, and in response to this, very strict quality for vaccine production occurred. A management process is required.

It was the quality control process for this vaccine that turned out to be a problem at the West Baltimore plant of Emergent BioSolutions, which was contracted to manufacture the vaccine.

The Washington Post reports that 'a human error in mistaken for AstraZeneca's COVID-19 vaccine stock solution produced a J & J vaccine stock solution that did not meet strict quality standards.' According to the Associated Press , the West Baltimore plant was also worried by the FDA as having quality control problems in the production of anthrax preventive vaccines approved in 2015.

The US Department of Health and Human Services was aware that there was a problem at the West Baltimore plant of Emergent Bio Solutions in early March 2021. A senior health and welfare official told Politico that Emergent BioSolutions had been found to have no specialists in drug manufacturing. This means that no one could directly oversee the vaccine production process.

J & J's contaminated vaccine stock solution was discovered during the quality control process and will not be processed and shipped as a vaccine. The federal government has requested J & J to directly supervise vaccine production for Emergent BioSolutions, a senior health and welfare official said.

J & J has set a goal of shipping 20 million doses of COVID-19 vaccine to the United States by the end of March and 100 million doses by the end of May, but to get the new production process on track and reach regulatory standards. Is expected to take days to weeks. Assuming that each J & J vaccine costs $ 10 (about 1,000 yen), J & J's loss is estimated to be $ 150 million (about 16.5 billion yen).