This article is from the source 'rtcom' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.
You can find the current article at its original source at https://www.rt.com/usa/526353-fda-approves-janssen-covid-vaccine-batches/
The article has changed 3 times. There is an RSS feed of changes available.
| Version 1 | Version 2 |
|---|---|
| FDA approves some J&J Covid-19 vaccine batches from Baltimore site previously responsible for contamination | FDA approves some J&J Covid-19 vaccine batches from Baltimore site previously responsible for contamination |
| (about 1 month later) | |
| The US Food and Drug Administration (FDA) has approved two batches of Johnson & Johnson’s Janssen Covid-19 vaccine manufactured at a factory in Baltimore, which was previously hit by a string of hygiene and contamination issues. | The US Food and Drug Administration (FDA) has approved two batches of Johnson & Johnson’s Janssen Covid-19 vaccine manufactured at a factory in Baltimore, which was previously hit by a string of hygiene and contamination issues. |
| The regulator announced on Friday that two lots of doses of the vaccine made at the Emergent BioSolutions facility are “suitable for use”, despite recent concerns that conditions at the plant could compromise the safety of vaccines. | The regulator announced on Friday that two lots of doses of the vaccine made at the Emergent BioSolutions facility are “suitable for use”, despite recent concerns that conditions at the plant could compromise the safety of vaccines. |
| In April, FDA inspectors flagged a series of health and safety concerns at the plant, where the previous month’s production of the Janssen jab had been stopped after 15 million doses were ruined in an inadvertent contamination. | In April, FDA inspectors flagged a series of health and safety concerns at the plant, where the previous month’s production of the Janssen jab had been stopped after 15 million doses were ruined in an inadvertent contamination. |
| The reported issues included the personal hygiene of staff, inadequate training and a failure to keep surfaces clean. | The reported issues included the personal hygiene of staff, inadequate training and a failure to keep surfaces clean. |
| The FDA said in a statement on Friday it had made its decision to use some doses from the site following a review and in light of the “current Covid-19 public health emergency.” | The FDA said in a statement on Friday it had made its decision to use some doses from the site following a review and in light of the “current Covid-19 public health emergency.” |
| It did, however, add that it was still “not yet ready to include the Emergent BioSolutions plant in the Janssen EUA [Emergency Use Authorization] as an authorized manufacturing facility.” | It did, however, add that it was still “not yet ready to include the Emergent BioSolutions plant in the Janssen EUA [Emergency Use Authorization] as an authorized manufacturing facility.” |
| The regulator also confirmed it had determined that “several other batches are not suitable for use,” while others remain under review. | The regulator also confirmed it had determined that “several other batches are not suitable for use,” while others remain under review. |
| On Friday the New York Times, citing anonymous sources, said the FDA had ordered J&J to discard 60 million doses of the Janssen jab produced at the Baltimore site, due to their “possible contamination.” | On Friday the New York Times, citing anonymous sources, said the FDA had ordered J&J to discard 60 million doses of the Janssen jab produced at the Baltimore site, due to their “possible contamination.” |
| Reuters reported it had confirmed via sources close to the matter that J&J has already thrown away around 10 million doses. | Reuters reported it had confirmed via sources close to the matter that J&J has already thrown away around 10 million doses. |
| Think your friends would be interested? Share this story! | Think your friends would be interested? Share this story! |