Moderna: enquiry into Covid vaccine batch ends in Japan
(CercleFinance.com) - Moderna today released the findings of an investigation report that was triggered after foreign particles were found in a batch of its Covid vaccine distributed by its partner Takeda in Japan.
The batch was suspended on 26 August and recalled on 2 September, along with two other batches in the same series, as a precautionary measure.
The report states that the stainless steel particles in question did not pose any undue risk to patient safety and did not adversely affect the benefit/risk profile of the product.
The presence of these particles is likely to be due to friction between two pieces of metal installed in the closure module of the production line as a result of incorrect assembly resulting from human error, it says.
The investigation report states that improved operating procedures will help mitigate the risk of this problem recurring. These actions will be directly supervised and confirmed by Moderna, in collaboration with Takeda.
Copyright (c) 2021 CercleFinance.com. All rights reserved.
The batch was suspended on 26 August and recalled on 2 September, along with two other batches in the same series, as a precautionary measure.
The report states that the stainless steel particles in question did not pose any undue risk to patient safety and did not adversely affect the benefit/risk profile of the product.
The presence of these particles is likely to be due to friction between two pieces of metal installed in the closure module of the production line as a result of incorrect assembly resulting from human error, it says.
The investigation report states that improved operating procedures will help mitigate the risk of this problem recurring. These actions will be directly supervised and confirmed by Moderna, in collaboration with Takeda.
Copyright (c) 2021 CercleFinance.com. All rights reserved.