Covid-19 manufacturing roundup: Stainless steel identified as foreign item in Japanese Moderna lots; DoD contract enables pipette manufacturing
After more than 1.6 million doses of Moderna’s Covid-19 vaccine were suspended last week in Japan, the country’s health ministry has identified the suspect particles and said it will not pose a larger health risk.
Findings Wednesday revealed that the metallic material inside the vials of vaccines was stainless steel, a material Moderna says does not pose additional health risks to patients. Takeda plans to recall the three affected lots of the vaccine, Moderna said Wednesday.
“Stainless steel is routinely used in heart valves, joint replacements and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk,” Takeda and Moderna said in a joint statement to Reuters.
Three lots were suspended when 39 vials were found with the foreign substance inside. Those vials were all from the same lot, but the other two were held as a precaution. All three were bottled from Spanish pharma Rovi.
Takeda said that the cause of the contamination was friction between two pieces of metal in the machines that put stoppers on vitals. Two men in their 30s died in August just days after receiving the second dose of their shot, which was a part of the three lots that will be recalled. The cause of death is being investigated right now.
The Cambridge, MA-based biotech received emergency authorization in Japan in May. The recall will come at a tough time: Japan has been battling its worst surge of the pandemic, with daily cases topping 25,000 in August. Just about 47% of the population has been fully vaccinated. Prime minister Yoshihide Suga is aiming to have about 60% of the country’s population fully vaccinated by the end of September, and the Japanese health regulators have said that the recall will not hinder its vaccine rollout.
DoD contract enables pipette manufacturing
Thermo Fisher Scientific has landed a contract with the US Department of Defense to produce pipette tips used in research in diagnostics labs for Covid-19 testing.
The contract is worth $192.5 million, Thermo Fisher said Wednesday, and will be issued in coordination with the US Department of Health and Human Services. The line will be in North Carolina, and will be fully completed by Q3 2024. Manufacturing is set to start as soon as Q3 2023, the press release said.
Thermo Fisher has pumped $180 million into expanding laboratory plastics production since the start of the pandemic, the company said, and $600 million to increase bioprocessing capacity.
In a press release, COO Mark Stevenson said:
“This award and the resulting capacity ensure that future demand surges in the U.S., from the current COVID-19 pandemic to the next crisis, will be met with greater supply assurance. Supply chain agility is critical to our customers, our government and to the health and safety of our citizens, and we’re excited to bring this state-of-the-art capacity online, especially since its efficient design will also showcase our commitment to achieve net-zero carbon emissions by 2050.”