Emergent Approved to Export Vaccines in Latest COVID-19 Update

Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.

On August 6th, 2021, FDA released an update on various matters related to COVID-19. Among these topics was an update on Emergent BioSolutions, a manufacturer who has come under fire for their mishandling production of COVID-19 vaccines.

However, FDA has now approved certain lots of the AstraZeneca vaccine made at the facility suitable for export. While the AstraZeneca vaccine is not approved for use within the United States, it is used by various countries overseas.

Emergent’s Baltimore facility made headlines when it was revealed that production errors resulted in the loss of 15 million doses of Johnson & Johnson’s (J&J’s) COVID-19 vaccine. This came amid additional alleged violations concerning cross-contamination and safety procedures.

On April 16th, 2021, FDA requested a shutdown of production at the facility as they attempted to resolve the problems at the facility. This measure lasted for months, but production was allowed to resume on July 29th.

According to FDA, these vaccine lots were thoroughly tested for quality. The decision was made with the understanding of the global emergency being caused by COVID-19 and its variants.

FDA did not disclose what number of vaccines were eligible for export in their update.

Source: FDA