Merck’s COVID-19 pill cuts risk of death, hospitaliSation by 50% in study


Merck & Co Inc’s experimental oral drug for COVID-19, Molnupiravir, reduced by around 50% the chance of hospitalisation or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday.

Merck and partner Ridgeback Biotherapeutics plan to seek U.S. emergency use authorization for the pill as soon as possible, and to submit applications to regulatory agencies worldwide. Due to the positive results, the Phase 3 trial is being stopped early at the recommendation of outside monitors.

“This is going to change the dialogue around how to manage COVID-19,” Robert Davis, Merck’s chief executive officer, told Reuters.

If authorized, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

A planned interim analysis of 775 patients in Merck’s study found that 7.3% of those given molnupiravir were either hospitalized or had died by 29 days after treatment, compared with 14.1% of placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths of placebo patients.

Drug Cocktail Significantly Reduced Severe COVID, Death in Outpatients


A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly compared with placebo.

COVID-related hospitalization or death from any cause occurred in 18 of 1355 patients (1.3%) in the group getting 2400 mg infusions of the study drug compared with 62 (4.6%) of 1341 in the matching placebo group, indicating a relative risk reduction of 71.3%.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Florida, told Medscape Medical News that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”

US cases declined 26% across America over the last month with THIRTY TWO states reporting a drop in infections


COVID-19 cases are continuing to dramatically decline across the U.S. as the fourth wave of the pandemic fueled by the Delta variant tapers off.

On Tuesday, officials recorded 111,162 new cases of the virus with a seven-day rolling average of 117,223, according to data from Johns Hopkins University.

That figure is a decrease of 26 percent from the rolling average of 160,157 reported four weeks ago.

More than half of U.S. states, 32 in total, and the District of Columbia have seen Covid infections decline over the last week.

A pill to treat Covid-19: ‘We’re talking about a return to, maybe, normal life’


Within a day of testing positive for covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room.

When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: “I thought, ‘I hope to God we don’t wind up on ventilators. We have children. Who’s going to raise these kids?”

But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutch cancer research center that’s part of an international effort to test an antiviral treatment that could halt covid early in its course.

By the next day, the couple were taking four pills, twice a day. Though they weren’t told whether they had received an active medication or placebo, within a week, they said, their symptoms were better. Within two weeks, they had recovered.

“I don’t know if we got the treatment, but I kind of feel like we did,” Miranda Kelly said. “To have all these underlying conditions, I felt like the recovery was very quick.”

The Kellys have a role in developing what could be the world’s next chance to thwart covid: a short-term regimen of daily pills that can fight the virus early after diagnosis and conceivably prevent symptoms from developing after exposure.

“Oral antivirals have the potential to not only curtail the duration of one’s covid-19 syndrome, but also have the potential to limit transmission to people in your household if you are sick,” said Timothy Sheahan, a virologist at the University of North Carolina-Chapel Hill who has helped pioneer these therapies.

At least three promising antivirals for covid are being tested in clinical trials, with results expected as soon as late fall or winter, said Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, who is overseeing antiviral development.

“I think that we will have answers as to what these pills are capable of within the next several months,” Dieffenbach said.

COVID cases across Florida drop by 40% since last week; pandemic fatalities also down


The number of new COVID-19 cases reported in Florida continued to plummet this week and so, too, did the number of people getting vaccinated, according to Friday’s weekly update from the Florida Department of Health.

Another 54,109 people in the state tested positive for the coronavirus during the week ending Thursday, according to the report. That is a 40.4% drop from the 75,998 new cases reported the week before.

Another 2,340 deaths were reported, pushing the death toll to 53,580, state health officials said. During the previous week, a pandemic-high 2,468 fatalities were tallied.

US to send additional 500 million doses of Covid-19 vaccines to foreign nations in 2022


The United States is set to significantly increase the amount of Covid-19 vaccines it will ship to foreign nations beginning in 2022 in an effort to end the pandemic worldwide, President Joe Biden announced Wednesday.

As part of a virtual Covid-19 summit on the margins of the UN General Assembly, Biden announced that the US is purchasing an additional 500 million Pfizer Covid-19 vaccines to donate to low- and lower-middle-income countries around the world, a senior administration official said, previewing the summit. The newly announced 500 million doses are on top of the 500 million the US had already committed to sharing with other nations.

Those vaccines will begin shipping out in January, and from January through September of next year, the US will ship out 800 million vaccines to the world, the official said. These vaccines bring the United States total to over 1.1 billion vaccines donated to other countries.

L.A. County records big drop in COVID-19 hospitalisations


The number of people hospitalized with COVID-19 in Los Angeles County has dropped below 1,000 for the first time in two months — underscoring the region’s slow but steady progress in turning the tide of the latest coronavirus surge.

On Tuesday, 991 coronavirus-positive patients were receiving hospital care countywide. That’s down about 40% from the start of September, state data show.

In mid-August — the height of the current Delta-variant-fueled wave — nearly 1,800 people countywide were hospitalized with COVID-19 on some days.

The region has also seen a significant decline in the number of people ill enough to require intensive care. As of Tuesday, 305 patients were in intensive care units throughout the county, a 31% drop since the beginning of the month.

Johnson & Johnson says additional dose boosts Covid vaccine efficacy


Johnson & Johnson said Tuesday that a large, global study showed its Covid-19 vaccine is more effective when given as a two-dose regimen, and that other data indicate the efficacy of the vaccine does not wane.

The two-dose regimen prevented 75% of moderate to severe Covid cases in all countries where it was tested — and 94% of such cases in the United States, where the vaccine probably had to grapple with fewer variants of the SARS-CoV-2 virus. Importantly, the two-dose regimen was 100% effective against severe disease.

It appears J&J may use the data to argue in favor of making a booster broadly available to people who received the one-dose vaccine six months ago or more. A press release from the company did not say so explicitly, but stated J&J had submitted the data to the Food and Drug Administration and plans to submit them to other regulators and the World Health Organization.

Moderna vaccine protection staying especially strong


New research released by the Centers for Disease Control and Prevention on Friday shows that effectiveness of the Moderna vaccine is staying particularly strong.

Over the course of five months of research, from March to August, the effectiveness of all the vaccines at keeping people out of the hospital due to COVID among people without compromising conditions was highest for Moderna recipients, at 93%. Pfizer’s effectiveness was overall 88% and Johnson & Johnson’s was 71%.

Pfizer’s effectiveness decreased after 120 days of the study period, from 91% to 77%, while Moderna’s effectiveness did not see a similar decline. Initial effectiveness of 93% only declined to 92% with Moderna.

“Although these real-world data suggest some variation in levels of protection by vaccine, all FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization,” researchers concluded.