The US Department of Health & Human Services (HHS) has put Johnson & Johnson in charge of the Emergent BioSolutions’ Bayview facility in Baltimore, which ruined around 15 million doses of its COVID-19 vaccine Ad26.COV2.S. Johnson & Johnson said it was “assuming full responsibility” of the facility and reiterated that it will deliver 100 million doses of its COVID-19 vaccine to the US government by the end of May.
Johnson & Johnson remarked that it 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 specialists already at Emergent.” Johnson & Johnson added that it continues to work closely with the FDA toward the emergency use authorization of the Emergent Bayview facility.
Doses of the Johnson & Johnson’s vaccine ruined last week occurred after workers accidentally mixed its ingredients and those for the AstraZeneca’s vaccine. Johnson & Johnson said it had identified a batch of drug substance that did not meet quality standards at the Emergent plant. The FDA also initiated an investigation into the error. Meanwhile, AstraZeneca said it would move the production of its COVID-19 vaccine AZD1222, now also known as Vaxzevria, out of the facility to another location, as it works with the federal government to carry out plans to produce its vaccine in the US.
Emergent’s task order increased by $23 million
Emergent said it had received a contract modification to increase the original task order by $23 million from the HHS’ Biomedical Advanced Research and Development Authority (BARDA) unit to purchase biologics manufacturing equipment that is specific to the Johnson & Johnson vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of its Baltimore facility. Emergent added that it expects to align with the US government and AstraZeneca on a mutually agreed ramp down of manufacturing for AstraZeneca’s COVID-19 vaccine bulk drug substance.