Approval

1 In 5 Americans Have Had COVID-19, Veklury Approved In New Indication

January 25,2022 11:06 AM
- By Admin

It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.

The first confirmed case of COVID-19 in the U.S. was reported on January 21, 2020. Since then, there have been more than 70 million confirmed cases in the U.S., with 866,000 deaths as of Friday, January 21, 2022. However, the number is probably higher due to unreported asymptomatic cases. In addition, the Johns Hopkins Coronavirus Resource Center reported about 210 million people in the U.S. are fully vaccinated, or about 64% of the population. It varies significantly on region, as low as 49% in Alabama and Wyoming to 87% in Washington, DC.

Globally, there have been approximately 350 million cases of COVID-19, with more than 5.5 million deaths. The U.S. Centers for Disease Control and Prevention (CDC) reported that “As of January 19, 2022, the current 7-day moving average of daily new (U.S.) cases (744,616) decreased 5.0% compared with the previous 7-day moving average (783,922).”

What We Know About Omicron

The Omicron variant of SARS-CoV-2 now makes up more than 99.5% of new COVID-19 infections in the U.S. As reported, it is significantly more infectious than previous strains, including the Delta variant. In mid-January, there were 800,000 new cases of COVID-19 reported, more than three times as many at any other time in the pandemic. Early variants of the virus had an incubation period of approximately five days, but the Delta variant was about four days, and Omicron is about three days.

Although the data is not solid, Omicron seems less able to infect the deep lungs, but it may replicate faster in the upper respiratory tract. One small research study suggests that although an Omicron infection offers protection against Delta, a Delta infection doesn’t protect much against Omicron. These factors might be why Omicron appears to cause less severe disease and fewer hospitalizations, although another possible explanation is that the population has built up some immunity via vaccines and previous infections. However, unvaccinated individuals seem less likely to be hospitalized with Omicron than with Delta.

New data from the CDC shows that booster shots of the Pfizer-BioNTech and Moderna vaccines were 90% effective at preventing hospitalization after Omicron infection. They were also 82% effective at preventing emergency department and urgent care visits. CDC data also found that people who received three doses of either the mRNA vaccines were less likely to be symptomatic compared to people who only received the two primary doses.

FDA Approved Gilead’s Veklury for Non-Hospitalized High-Risk COVID-19 Patients

The U.S. Food and Drug Administration approved Gilead Sciences’ supplementary New Drug Application (sNDA) for Veklury (remdesivir) for adults and adolescents with COVID-19 who are not hospitalized but are at high risk of progression to severe COVID-19, hospitalization or death. The agency also expanded the pediatric Emergency Use Authorization (EUA) for the drug to include non-hospitalized children 12 years or younger at high risk of disease progression.

“Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease.