04/01/2021 9:15
Clarín.com
World
Updated 04/01/2021 9:15 AM
About 15 million doses of the
Johnson & Johnson's
coronavirus vaccine is
no longer useful due to an error in a production plant in the
United States,
where two different vaccines were mixed.
Johnson & Johnson's entire batch of vaccine failed to meet quality standards and is now unusable, the company reported Wednesday.
Apparently, at the facility, owned by
Emergent BioSolutions
, ingredients from the J&J and AstraZeneca vaccine were "accidentally" mixed a fortnight ago,
spoiling
up to 15 million Johnson & Johnson doses and forcing the regulatory authorities to delay the authorization of the factory's production lines.
Emergent Biosolutions' Baltimore plant.
Photo: EFE
The same plant produces both doses of the J&J formula and the pharmaceutical AstraZeneca, intended to combat covid-19.
In parallel, J&J has decided to
strengthen the supervision
of Emergent BioSolution, to avoid
future
quality
problems
in production.
This postponement does not affect the doses currently being used in the US, as they have been
produced in the Netherlands
, where the production lines are approved by US regulatory authorities.
However, it was expected that starting in April, Johnson & Johnson's vaccine would begin to be produced in large quantities at the Baltimore plant, something that
has
now
been called into question
.
When contacted by AFP, J&J said it identified a batch of doses at a Baltimore plant of Emergent BioSolutions "that did not meet quality standards" but did not confirm the specific number of affected vaccines.
The company also said the batch "never advanced to the final stages of the manufacturing process."
"Quality and safety remain our top priorities," he said.
Laboratory in the crosshairs
The New York Times reported that problems with quality control could affect future placements of this single-dose vaccine and that an investigation by the United States Food and Drug Administration (FDA) was awaited.
Johnson & Johnson said it was dispatching more experts to the site to "oversee, direct and support all production of the covid-19 vaccine," of which it expects to deliver an additional 24 million doses "during April."
The J&J vaccine has been praised for being single-dose and because it does not require as low temperatures for storage as Moderna and Pfizer, which simplifies its distribution.
AFP, EFE and AP
ap