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The reputation of the American company was badly affected when hundreds of thousands of doses of the vaccine were withdrawn from the market in Japan following reports of impurities found in the vials.
The services are also investigating the deaths of two men who were injected with vaccines from a contaminated batch. However, the cause of death of these individuals is not yet known.
A joint report by Moderna and its partner in Japan, Takeda, said the source of contamination from one of the three recalled batches had been identified on a vaccine production line at a pharmaceutical factory in Spain operated by ROVI Pharma Industrial Services.
“The rare presence of stainless steel particles in the Modern COVID-19 vaccine does not pose an undue risk to patient safety and does not adversely affect the risk-benefit profile of the product,” the report said.
The companies added that metal particles of this size, injected intramuscularly with the vaccine, could cause a local reaction, but there would probably be no major effects.
“Stainless steel is often used for heart valves, prosthetic joints and metal connections and staples. Therefore, the injection of particles detected in these batches in Japan is not expected to lead to an increased medical risk, ”write Moderna and Takeda.
Moderna added that so far there is no evidence that the deaths of the two vaccinated men are in any way related to the vaccine they were given. “Currently, the connection is considered random,” the company wrote, but added that the investigation is ongoing.
Last week, Japan stopped vaccinating 1.63 million. Modern vaccine doses nationwide.
To date, about 46 percent have been vaccinated against the pandemic coronavirus. The Japanese population’s fight against the record wave of COVID-19 is due in part to a more contagious delta variant of the coronavirus.
About 16 thousand people died in the country. people infected with coronavirus. Strict epidemiological limitations remain in much of the country.
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