WASHINGTON / NEW YORK – The United States Food and Drug Administration (FDA) decided to release for use two batches of Johnson & Johnson vaccines made at the troubled Emergent Biosolutions plant in Baltimore, although it ordered many more to be thrown away, not to mention meet the conditions to be applied.
The FDA made this announcement this Friday in a statement in which it does not give figures, although the US media does provide them: according to The New York Times, there are 60 million doses that must be discarded, compared to 10 million that are saved and that are authorized for use.
Johnson & Johnson, in a statement, confirmed the authorization of regulators to use two batches of the vaccine produced in that plant, but did not want to give figures on doses or make any reference to those that should be destroyed.
“Today’s decision represents progress in our continued efforts to make a difference in this pandemic on a global scale and we appreciate the close collaboration with the FDA and global health authorities,” said Kathy Wengel, the company’s head of Global Supply Chain. .
In its press release, the FDA explains on the other hand that at the moment it cannot authorize the production of the aforementioned plant in the state of Maryland again, but it continues to work with the management of the manufacturing company and with the pharmaceutical company itself to achieve it.
In April, Johnson & Johnson took over the supervision of this plant from the manufacturer Emergent BioSolutions, where some 15 million doses – according to data then published by The New York Times – of the American pharmaceuticals vaccine against covid-19 were damaged during its production.
The two rounds of released vaccines have been cleared for emergency use in the United States or in countries to which they are exported.
These vaccines now also have a longer shelf life, because the FDA also confirmed on Friday what J&J already announced on Thursday, the six-week extension of the expiration date of this vaccine, so that its refrigerated storage period goes from three months to four and a half.