AstraZeneca COVID-19 Vaccine Drug Substances Found Acceptable for Export

The US Food and Drug Administration (FDA) announced on January 4, 2022, that it had found an additional three lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent Biosolutions facility in Baltimore, Maryland, to be acceptable for use for potential export and vaccine production.

The FDA stated it had 'conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency.'

As of January 5, 2022, the AstraZeneca vaccine known internationally as Vaxzevria is not authorized for use in the U.S.

The European Medicines Agency authorized Vaxzevria in February 2021. Since then, over 1 billion vaccine doses have been distributed.

Three versions of the AstraZeneca vaccine are produced, including Vaxzeria, the AstraZeneca-SKBio (Republic of Korea), and the Serum Institute of India (CoviShield), which has been Listed for emergency use by WHO.

Recently, the UK's Health Security Agency confirmed on Dec. 10, 2021, a limited study found three doses of the AstraZeneca vaccine were around 75% protective against the Omicron virus variant.