J&J Takes Over COVID Vaccine Manufacture at Emergent

Johnson & Johnson has announced that it is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at contract manufacturer Emergent BioSolutions Maryland facility. Specifically, J&J is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company’s specialists already at Emergent. In addition:

• All Johnson & Johnson COVID-19 vaccine doses distributed to date have met rigorous J&J and regulatory quality standards.

• The company continues to work closely with the FDA toward the Emergency Use Authorization (EUA) of the Emergent Bayview facility.

• J&J expects to deliver nearly 100 million single-shot doses of its COVID-19 vaccine to the U.S. Government by the end of May.

In a related development, AstraZeneca has announced that it will relocate production of its vaccine drug substance AZD1222 from the Emergent facility. The company will work with the US Government to identify an alternative location for domestic drug substance production of AZD1222. AstraZeneca is currently progressing submission to the FDA for Emergency Use Authorization of AZD1222. (Sources: J&J and AstraZeneca Websites, 03 April, 2021)