Even on a day when there finally was good news about Emergent BioSolutions’ heavily scrutinized manufacturing facility in Baltimore—as it has been cleared to produce COVID-19 vaccines—there also was another dose of bad news involving the plant.
According to a report from Reuters based on inspection records and accounts from regulators, millions of doses of the AstraZeneca COVID-19 vaccine that were produced by Emergent in Baltimore, were supplied to Mexico and Canada before U.S. inspectors had certified the facility.
While the report surrounds Emergent, which is under investigation by Congress, others are culpable in this misstep, including AstraZeneca and the governments of the three countries, which skirted regulations in their haste to get shots in the arms of America’s neighbors.
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The incident happened in late March when the Biden administration, facing criticism for sitting on stockpiles of vaccines, sent 2.5 million vaccine doses to Mexico and 1.5 million to Canada.
Regulators in both countries told Reuters that they accepted the vaccines based on approval of the plant by the European Medicines Agency. But the EMA told Reuters that the sanction was based on a remote inspection that covered only the portion of the Baltimore plant producing Johnson & Johnson’s COVID-19 vaccine. Health Canada told Reuters that it assumed that both vaccines would be manufactured to the same standard.
The following month, the FDA shut down production at the plant after it discovered cross contamination between vaccines Emergent was producing for J&J and AZ. Subsequent investigation revealed that the plant had accumulated and failed to remedy many FDA violations.
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It took more than three months for Emergent to satisfy the FDA that it was fit to resume vaccine production. The endorsement came on Thursday when the plant was cleared to manufacture the J&J shot.
There is no evidence of contamination in the vaccines provided to Mexico or Canada and neither country has reported adverse reactions that can be traced to those shipments. AZ told Reuters that vaccines produced by Emergent were subject to rigorous testing and were verified by independent regulators.