Sunday , May 16 2021

La Jornada – Vaccines sent by the USA to Mexico, made in a plant suspended due to sanitary failures



New York. AvidZeneca’s Covid-19 vaccines, shipped from the United States to Mexico, were manufactured at a plant ordered by U.S. authorities to suspend production due to serious sanitary failures during an investigation into contaminating millions of doses of another company’s vaccines, but in Mexico they are verified according to the required standards.

The AstraZeneca vaccines delivered to Mexico were manufactured under contract at the Emergent BioSolutions plant in Baltimore, Maryland, which is now under investigation by the Food and Drug Administration (FDA), the federal agency in charge of regulating the sector.

AstraZeneca confirmed that the batches delivered to Mexico and Canada were made at that factory. In a statement, a spokesman reported that in March, the U.S. government ordered the company to send batches of what was contracted for the United States to Mexico and Canada.

“We can confirm that the AstraZeneca COVID-19 series of vaccines produced in the emergency facility, which were delivered to Mexico and Canada, met the stringent requirements we must follow. Safety tests and necessary quality control measures were carried out at every step of the production process. All checks were performed before the lots were released. Data on the quality of the production facilities involved have been appropriately provided to regulatory agencies in each country to support the approval and approval of shipments from this supply chain, ”the company said.

Authorities, meanwhile, have suspended production of the Johnson & Johnson vaccine at the plant after about 15 million doses of the vaccine had to be discarded once they were found to be contaminated.

An FDA report released this week criticized Emergent for failing to conduct a thorough vaccine contamination investigation, and pointed to sanitary problems in manufacturing processes, including unclean conditions, lack of manufacturing procedures, unhealthy physical condition, health and poorly trained staff.

For now, all vaccines have been manufactured and have not yet been distributed in the quarantined plant, and larger production is pending, which seriously casts doubt on whether Johnson & Johnson could meet its obligation to deliver millions of doses to the federal government.

The FDA reported on Wednesday that “there is no guarantee that other batches have not been exposed to cross-contamination” – because the initial contamination was caused by mixing materials from the AstraZeneca vaccine with those from Johnson & Johnson.

At the same time, the New York Times and the Ap agency, among other media, revealed that Emergent had previous problems, which some have discovered since last year, with its processes and handling of its products and now doubts are being raised as to how lucrative contracts awarded by the Donald Trump administration.




Source link