AstraZeneca (AZ) said on the 22nd that it had to stop production of the new crown vaccine commissioned by Emergent BioSolutions in Baltimore because of a serious flaw in the production process. The vaccine was not approved for use in the United States, and tens of millions of doses have been sitting in the plant, but millions were sent to Canada and Mexico in March at the direction of the Biden administration.
Astellicom’s New Crown vaccine, produced in Baltimore, was halted due to a serious defect, but millions of doses have been shipped to Canada and Mexico. (Reuters)
The New York Times reported that according to production records at the Emergent plant, former plant supervisors and government officials, the plant discarded five batches of AZ New Crown vaccine, each equivalent to 2 million to 3 million doses, from early October last year to January this year because of contamination or suspected contamination.
The White House said in March that under Trump, the federal government had promised to buy 300 million doses of AZ New Crown vaccine, so “commercial loan” to Mexico 2.5 million doses and Canada 1.5 million doses of the vaccine.
It is not known whether Canadian and Mexican drug regulatory officials had inspected the Emergent pharmaceutical plant before accepting those AZ New Crown vaccines, and whether U.S. officials had warned that the drug plant was faulty.
Canada: Thousands of doses left to test the rest of the distribution
Biden administration officials have declined to comment on the matter at this time. The Canadian government said it has received and distributed those AZ new crown vaccine, leaving only a few thousand doses for quality testing; as for the vaccine sent to Mexico, the current whereabouts are unknown.
AZ: Only when it is safe will it be shipped out of the plant
Astellicom issued a statement that the new vaccine sent to Mexico and Canada “meets the strict requirements that our company is required to follow” and that “necessary safety testing and quality control measures” were done at every step of the production process before shipping out of the plant.
The New York Times reported in March that Emergent’s Baltimore plant had botched the mixing of 15 million doses of a new vaccine developed by Joules; employees at the plant had mixed up the formulas for the Joules and AZ vaccines.
After the news broke, federal officials ordered major changes at the plant; the Biden administration ordered Emergent to stop production of the AZ vaccine and tasked Pearson with running the plant.
The Food and Drug Administration (FDA) inspectors of the plant’s report on the 21st announcement to the public, concluded that Emergent may also be contaminated to more vaccine preparations; in addition, the drug plant’s staff training, sterilization health problems.
Biden’s decision to ship out the package is still controversial
The Biden administration’s role in arranging shipments of the new Crown vaccine to Canada and Mexico has been called into question after it was revealed that the vaccine was produced at the Emergent plant; according to a New York Times report, federal public health officials and the FDA knew about problems at the plant long before the recent report came out.
The FDA has not approved the release of vaccines produced by Emergent to the U.S. market; by rule, it is the responsibility of the importing country’s regulators to determine the safety of drugs or biologicals produced in the U.S. for export to other countries.
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