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| Scathing FDA report finds J&J Covid vaccine plant where 15mn doses were ruined is unsanitary, staff training inadequate | Scathing FDA report finds J&J Covid vaccine plant where 15mn doses were ruined is unsanitary, staff training inadequate |
| (2 months later) | |
| US health inspectors have ordered a Baltimore plant that was manufacturing Johnson & Johnson's Covid-19 vaccine to rectify a series of issues that could potentially contaminate the jab and seriously jeopardize its safety. | US health inspectors have ordered a Baltimore plant that was manufacturing Johnson & Johnson's Covid-19 vaccine to rectify a series of issues that could potentially contaminate the jab and seriously jeopardize its safety. |
| The 12-page report by the Food and Drug Administration (FDA) laid bare a litany of health and safety issues at the Maryland factory, where production of J&J's Janssen jab was halted last month after 15 million doses were spoiled. | The 12-page report by the Food and Drug Administration (FDA) laid bare a litany of health and safety issues at the Maryland factory, where production of J&J's Janssen jab was halted last month after 15 million doses were spoiled. |
| The alarming details, published on Wednesday, are the result of an FDA probe conducted between April 12 and April 20 at the plant owned by Emergent Biosolutions Inc. | The alarming details, published on Wednesday, are the result of an FDA probe conducted between April 12 and April 20 at the plant owned by Emergent Biosolutions Inc. |
| After reviewing CCTV footage and visiting the site in person, inspectors made a number of observations, including that the building housing the production line was not kept in a clean condition, and staff were not properly trained to prevent cross-contamination. | After reviewing CCTV footage and visiting the site in person, inspectors made a number of observations, including that the building housing the production line was not kept in a clean condition, and staff were not properly trained to prevent cross-contamination. |
| Peeling paint on the walls and floors was spotted, which inspectors said “impacts the firm's ability to adequately clean and disinfect the area.” | Peeling paint on the walls and floors was spotted, which inspectors said “impacts the firm's ability to adequately clean and disinfect the area.” |
| Employees in one manufacturing area were seen throwing unsealed bags of medical waste into an elevator and removing their protective clothing near raw materials. | Employees in one manufacturing area were seen throwing unsealed bags of medical waste into an elevator and removing their protective clothing near raw materials. |
| Personal hygiene was also flagged as a problem, with one member of staff who moved between different manufacturing zones only recorded once in the plant's shower logbook. | Personal hygiene was also flagged as a problem, with one member of staff who moved between different manufacturing zones only recorded once in the plant's shower logbook. |
| Other issues cited included staff not cleaning equipment properly and the “failure to conduct thorough investigations” related to a leak as a batch was filled. | Other issues cited included staff not cleaning equipment properly and the “failure to conduct thorough investigations” related to a leak as a batch was filled. |
| The FDA has informed Emergent Biosolutions Inc. of the issues and the company is now required to respond. | The FDA has informed Emergent Biosolutions Inc. of the issues and the company is now required to respond. |
| The concerns raised in the report may take months to resolve, according to experts cited by Reuters. The FDA and J&J have not released a date for production to restart. | The concerns raised in the report may take months to resolve, according to experts cited by Reuters. The FDA and J&J have not released a date for production to restart. |
| In a statement on Wednesday, J&J pledged to ensure that the FDA's observations at the plant are addressed “promptly and comprehensively.” | In a statement on Wednesday, J&J pledged to ensure that the FDA's observations at the plant are addressed “promptly and comprehensively.” |
| The company added that it would bolster global production capacity by enlisting 10 manufacturing sites across different countries in addition to its own plant in Leiden, the Netherlands. | The company added that it would bolster global production capacity by enlisting 10 manufacturing sites across different countries in addition to its own plant in Leiden, the Netherlands. |
| The FDA said its investigation into the Baltimore plant is unrelated to an ongoing review of extremely rare cases of blood clotting in people who have received the Janssen vaccine. | The FDA said its investigation into the Baltimore plant is unrelated to an ongoing review of extremely rare cases of blood clotting in people who have received the Janssen vaccine. |
| Last week the regulator recommended a pause in the jab's US rollout to allow its investigation of clots to take place. | Last week the regulator recommended a pause in the jab's US rollout to allow its investigation of clots to take place. |
| A review of the US clotting cases carried out by the European Medicine Agency found a possible link between the condition and the inoculation, but said the benefits of the vaccine outweigh its risks. | A review of the US clotting cases carried out by the European Medicine Agency found a possible link between the condition and the inoculation, but said the benefits of the vaccine outweigh its risks. |
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