Covid-19 manufacturing roundup: Smuggled remdesivir seized en route to Mexico; As Sputnik awaits WHO approval, a Russian plant raises concerns
Unauthorized versions of the Covid-19 drug remdesivir bound for distribution in Mexico were seized by US federal authorities, The Wall Street Journal reported.
The drug, which is manufactured by Gilead, has been counterfeited and is arriving in the US on planes from Bangladesh and India for patients willing to pay exorbitant asking prices. US Customs and Border Protection has captured more than 100 shipments, sources told the Journal.
The Department of Homeland Security is testing the confiscated items to see if they are true counterfeits or an imposter solution. The demand for remdesivir is high, following the approval by the Mexican regulators in March. The drug brought in $2.8 billion in sales in 2020.
Law enforcement in Colombia seized containers of a generic version of remdesivir from a woman at an airport in January. Indian officials arrested people in connection to a few counterfeit remdesivir raids in April and May, the WSJ reports.
Russian Sputnik V plant raises concerns with WHO
A review of the manufacturing process for Russia’s Sputnik V vaccine has found issues with the vial filling procedures at a plant, the World Health Organization said.
The site in question previously said that it addressed all of the WHO’s concerns and that the issues do not have anything to do with safety or efficacy of the vaccine, the company said in a statement.
“We invite WHO for another inspection,” it said. “We remain fully transparent and will continue with the WHO pre-qualification process.”
The report also identified problems surrounding the appropriate measures to “mitigate the risks of cross contamination,” the WHO said. That includes the clothing worn by the employees during operation of the lines. Tracking and identifying batches of the vaccines was also a concern, the report said. The review was between May 31 and June 4, Reuters said.
Sputnik V is still awaiting emergency use listing from the WHO, after submitting an application in October 2020.