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COVID-19 Treatment Remdesivir Reduces Hospitalizations by 87%
In other COVID news, Canada approves Moderna’s COVID-19 vaccine and Pfizer and BioNTech will supply more vaccine doses to the US for donation to low-and lower-middle-income countries.
Gilead recently announced that a three-day course of its COVID-19 treatment, remdesivir, elicited an 87 percent reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by Day 28.
In the Phase 3 trial, researchers randomly assigned 562 participants to receive remdesivir or placebo. Remdesivir elicited an 81 percent reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 compared to placebo.
Notably, there were no deaths reported in either arm by Day 28.
“Last summer, data from clinical trials demonstrated the benefit of remdesivir in patients hospitalized with COVID-19, even when not yet requiring oxygen. These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” Robert L. Gottlieb, MD, PhD, cardiologist and principal investigator at Baylor University Medical Center and Baylor Scott & White Research Institute, said in the announcement.
The safety profile between remdesivir and placebo in this trial was similar. And of the 279 patients who received remdesivir, there were no new safety signals identified. One death occurred in the study on Day 59.
Last October, FDA approved remdesivir as the first COVID-19 treatment for adults and pediatric patients 12 years of age or older infected with the coronavirus.
Gilead continues to study the safety and efficacy of remdesivir in hospitalized patient populations with ongoing unmet needs, including patients with renal impairment, children, and pregnant women.
Canada Approves Moderna’s COVID-19 Vaccine
Moderna recently announced that Health Canada approved the New Drug Submission for its COVID-19 vaccine.
COVID-19 Vaccine Moderna, now known as Spikevax, is intended for active immunization to prevent the coronavirus in individuals 12 years of age and older.
Health Canada based its approval on clinical data from the Phase 3 COVE study of the vaccine, which enrolled over 30,000 individuals in the US. In the trial, Spikevax demonstrated 93 percent efficacy for six months after the second dose.
“Health Canada’s approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank Health Canada for their hard work throughout the process,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
“I would also like to thank the Government of Canada for the partnership they have built with us and for their confidence in our mRNA platform in addressing the COVID-19 pandemic,” Bancel continued.
Pfizer, BioNTech Provide More Vaccine Doses to Low and Middle-Income Countries
Pfizer and BioNTech recently announced plans to expand their agreement with the US by providing an additional 500 million doses of their COVID-19 vaccine to low-and lower-middle-income countries and organizations that support them.
The US will allocate doses of the vaccine to 92 low-and lower-middle-income countries as defined by Gavi’s COVAX Advanced Market Commitment (AMC) and the 55 member states of the African Union. The doses will be available at a non-for-profit price for donation.
So far, Pfizer and BioNTech have shipped more than 1.5 billion COVID-19 vaccine doses worldwide. The expanded agreement brings the total number of COVID-19 vaccine doses in the US for donation to one billion.
The companies have also agreed to provide two billion doses to low- and middle-income countries in 2021 and 2022. This initiative includes direct supply agreements with individual country governments and a direct supply agreement with COVAX for 40 million doses in 2021.
“In just nine months, Pfizer and BioNTech have delivered our COVID-19 vaccine to 130 countries and territories in every region of the world — and our expanded collaboration with the US will help us bring even more doses to those in need,” Albert Bourla, chairman and chief executive officer at Pfizer, said in the announcement.
