Biden admin probes risk of low-level contamination in vaccines made at troubled plant

The Food and Drug Administration has asked Johnson & Johnson and AstraZeneca to assess any potential health risks from minor cross-contamination of their Covid-19 vaccines, two people familiar with those conversations told POLITICO.

The agency requested the analyses because it cannot rule out low-level contamination of doses of both vaccines manufactured by contractor Emergent BioSolutions.

In March, Emergent’s Baltimore facility accidentally contaminated 15 million Johnson & Johnson doses with the active ingredient of AstraZeneca’s vaccine. Production at the plant stopped in April and the FDA began investigating the matter.

The agency has been trying to determine whether Emergent also contaminated any of the other millions of doses of the J&J and AstraZeneca vaccines it made. While available testing methods can identify major contamination problems, they are not always capable of tracing small amounts of contamination.

To clear the doses manufactured at Emergent as safe, the FDA has asked AstraZeneca and J&J to assess any risks from possible trace contamination — a process that has taken several weeks. The agency is expected to make an announcement in the coming days about whether the shots made by Emergent are fit for use.

Some of the doses included in the risk assessment include AstraZeneca shots the U.S. government has already shipped to Mexico and Canada, the two individuals familiar with the matter said. The U.S. sent those doses abroad in March before the Biden administration became aware of the contamination at the Emergent plant in Baltimore. Canadian and Mexican officials said at the time that AstraZeneca assured them that the doses were safe for use.

The FDA declined to comment. AstraZeneca did not respond to requests for comment.

“The quality and safety of our COVID-19 vaccine are paramount,” J&J spokesperson Jake Sargent said. “We continue to work with FDA and Emergent toward adding Emergent’s [Baltimore] facility to Johnson & Johnson’s existing Emergency Use Authorization as soon as possible.”