Covid-19 roundup: Pfizer tees up 500M vaccine doses for donation in expanded US pact; Early remdesivir helps stave off hospitalizations — study
Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.
The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.
Pfizer expects to center production for this order at its sites in Kalamazoo, MI, Andover, MA, Chesterfield, MO, and McPherson, KS, the drugmaker said.
“In the short term, we have pledged to deliver at least one billion doses this year and at least one billion doses next year to low- and middle-income countries,” BioNTech CEO Ugur Sahin said in a statement. “In parallel, we are exploring how to build a sustainable mRNA production infrastructure in low-income countries to democratize access to vaccines in the mid- and long-term. This applies to both individual production steps and complete manufacturing.”
Pfizer says it has committed 2 billion doses of its vaccine to low- and middle-income countries through 2022, much of that coming through its US agreement. The drugmaker, meanwhile, has inked direct supply agreements with individual country governments and separately with COVAX for 40 million doses in 2021.
Gilead’s remdesivir helps prevent hospitalizations with early use — study
Remdesivir has shown mixed results over the course of the pandemic in hospitalized Covid-19 patients, but Gilead could have a case for the antiviral’s use in the outpatient setting, new data show.
A three-day course of remdesivir cut the risk of Covid-19 hospitalization or all-cause death by 87% compared with placebo (p=0.008) at the 28-day mark in non-hospitalized, high-risk patients, according to results from a 562-patient Phase III study unveiled Wednesday. On a secondary endpoint reducing the risk of medical visits or all-cause death, remdesivir beat out placebo by 81% (p=0.002). There were no deaths reported in either arm of the study during the 28-day period.
It’s a big win for remdesivir, but it’s worth considering one big grain of salt: The study stopped enrolling patients in April, well below its target goal of 1,264, “reflecting the changing epidemiology and adoption of additional treatment options at the time,” Gilead said.
With that point in mind, remdesivir’s potential in the outpatient setting could be limited given the rapidly changing standard of care, the rise in vaccination rates and the emergence of the Delta variant. But Gilead is still touting the data as a win and a potential path forward for outpatient EUA.