AstraZeneca’s Covid-19 vaccines shipped from the United States to Mexico were manufactured in a plant that the US authorities ordered to suspend production due to serious sanitary failures when investigating how it contaminated millions of doses of a vaccine from another company, but the Pharmaceutical assured that the batches sent to Mexico were verified under the required standards.
The AstraZeneca vaccines shipped to Mexico were manufactured under contract at an Emergent BioSolutions company plant in Baltimore, Maryland, which is now under investigation by the Food and Drug Administration (FDA), the federal agency charged with regulating the sector.
AstraZeneca confirmed that the batches shipped to Mexico and Canada were made at that facility. In a statement, a spokesperson reported that in March the United States government ordered the company to send batches of what was contracted for the United States to Mexico and Canada.
“We can confirm that the batches of the AstraZeneca COVID-19 vaccines manufactured at the Emergent plant that was delivered to Mexico and Canada met the stringent requirements that we are required to follow. Safety examinations and required quality control measures were performed at every step of the production process. All the verifications were carried out before releasing the lots. The quality information of the manufacturing plants involved was appropriately submitted to the regulatory agencies in each country to support the authorization and approval of shipments from this supply chain, ”the company stated.
Meanwhile, Johnson & Johnson vaccine production at that plant was suspended by authorities after some 15 million doses of that vaccine had to be discarded when some were found to have been contaminated.
An FDA report issued this week criticized Emergent for its failure to conduct a thorough investigation into vaccine contamination, and also pointed to sanitary problems in its production processes, including unclean conditions, lacking in production procedures, unhealthy physical conditions. health and poorly trained personnel.
For now, all vaccines produced and not yet distributed at the plant are under quarantine, and more production is on hold, severely casting doubt on whether Johnson & Johnson could meet its commitment to deliver millions of doses to the federal government.
The FDA reported Wednesday in its report that “there is no guarantee that other batches have not been subjected to cross contamination” – as the initial contamination was from mixing materials from AstraZeneca’s vaccines with those from Johnson & Johnson.
At the same time, the New York Times and the Ap agency among other media revealed that Emergent has had previous problems, some detected since last year, with its processes and handling of its products and now suspicions are generated about how despite this it obtained lucrative contracts