Drug maker Merck and its partner Ridgeback Biotherapeutics released data Friday showing their experimental pill to treat COVID-19 is less effective than early clinical trials predicted, a finding that emerged as the Food and Drug Administration raised questions about the drug.
Molnupiravir, a pill that could be taken at home, had shown promise in cutting the risk of hospitalization and death by half among high-risk patients in data released by the company in October. But according to the latest findings Merck presented to the FDA, the pill reduced the risk of hospitalization and death only by 30 percent, instead of 50 percent, as initially estimated.
The study by the drug makers found that, among participants receiving the pill, just one participant died during the trial, compared with nine deaths in the placebo group, the companies said in a news release Friday.
‘‘It’s still a 30 percent effect, which is still good for a high-risk population,’’ said David Boulware, an infectious-disease physician and professor of medicine at the University of Minnesota Medical School who was not involved in Merck’s research. ‘‘It’s better than zero, and it’s a starting point, but it’s a little bit more modest.’’
The FDA on Friday asked a panel of expert advisers to weigh the benefit of reduced hospitalizations and deaths in high-risk patients against potential risks associated with the drug. Because Merck and Ridgeback presented new clinical trial data to the agency after FDA scientists completed their review, regulators said their analysis may change ahead of a Tuesday meeting to consider the scientific evidence on the drug.
‘‘The review issues and benefit/risk assessments may therefore differ from the original assessments provided in the briefing document which was based on the interim analysis,’’ an addendum to the FDA briefing materials said.
Merck and Ridgeback are seeking emergency-use authorization for their COVID treatment, which would become the first easy-to-use pill to thwart the virus. The FDA advisory committee is expected to make a recommendation Tuesday, and agency officials typically follow the guidance of the advisers.
The agency reviewed data presented by the companies and determined that the clinical trial identified ‘‘no major safety concerns’’ related to adverse events. The most common side effects were mild to moderate diarrhea, nausea, and dizziness. Still, the FDA identified several areas of concern, including potential risks for pregnant people and the possibility the drug could cause the coronavirus to mutate.
Washington Post
Children in Southern US fall behind on inoculation
Many Southern states, especially Louisiana, Alabama, and Mississippi, have fallen behind the rest of the nation in vaccinating children as the threat of a winter surge casts a pall over the holiday season.
Those states also rank near the bottom for vaccinating adolescents and adults and have among the nation’s highest overall COVID-19 death rates, according to a review of state vaccination and death data by The Washington Post. Their slow adoption of children’s — as well as adults’ — vaccines have heightened fears that another pandemic wave could hit hard as families gather for the holidays and spend more time indoors.
‘‘I think it is a potentially dangerous situation,’’ said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. ‘‘You’re going to have a large number of susceptible people all in one place, especially in communities where vaccine rates are generally low and the transmission is higher.’’
Those concerns increase as colder weather drives families inside for social gatherings and playdates, Offit said, adding. ‘‘It is, at its heart, a winter virus.’’
Many parents rushed to get their young children vaccinated after federal officials approved the long-awaited pediatric dose of the Pfizer-BioNTech vaccine earlier this month. More than 3.6 million kids, nearly 13 percent of the nation’s children ages 5 to 11, have received a first dose since Nov. 2.
But state data show huge differences in the vaccine’s adoption that appear to mirror the distribution of adult vaccines: While parents in states such as Massachusetts and Rhode Island raced to get their children vaccinated, the pattern has been much slower in swaths of the South, as well as in states like Wyoming and South Dakota.
Vermont, which also leads the nation in adult vaccinations and booster shots, has already vaccinated more than a third of newly eligible children. But Mississippi, Alabama, and Louisiana have only immunized about 3 percent of children in that age group. Mississippi and Alabama have the highest overall COVID-19 death rates in the nation. Louisiana comes in fourth, after New Jersey.
‘‘I can’t tell you how discouraging and depressing I find that,’’ said Mark Kline, senior vice president, chief medical officer and physician in chief at Children’s Hospital New Orleans. ‘‘Two-to-three percent — that’s heartbreaking actually, when you stop to think that virtually all the disease, the hospitalizations, and certainly the deaths that we’re seeing now, are all preventable.’’
Kline said his hospital has seen many parents eager to get their kids vaccinated, but he has also counseled families that are split over the decision and tried to answer questions from those who are hesitant or skeptical.
Among the bottom 10 states for vaccines given to younger children, eight are in the South: Alabama, Mississippi, Louisiana, Georgia, Tennessee, West Virginia, Delaware, and Oklahoma. Meanwhile, Maryland, Virginia, and North Carolina are the only Southern states dispensing the shots at or above the national average.
Washington Post
COVID restrictions draw protest in Martinique
PARIS — Shots were fired overnight at security forces and journalists on the French Caribbean island of Martinique amid violent protests against COVID-19 restrictions, France’s interior minister said on Friday.
Several police officers have been injured, Interior Minister Gerald Darmanin tweeted. He added that 10 people have been arrested.
French government spokesman Gabriel Attal denounced the “unacceptable’’ violence.
Martinique’s protesters this week joined a movement launched by labor unions in the neighboring island of Guadeloupe to denounce France’s COVID-19 pass and mandatory vaccination for health care workers. The pass is required to access restaurants and cafes, cultural venues, sport arenas, and long-distance travel.
The French government on Friday decided to delay mandatory vaccinations until Dec. 31. The measure applies to hospitals and nursing homes’ staff, domestic helpers, and firefighters.
Associated Press
Belgium, EU facing return of COVID-related lockdown
KNOKKE-HEIST, Belgium — Life was finally starting to feel normal. An online flier for an October party in this Belgian beach town cursed the coronavirus and invited people to dance and drink again, to ‘‘get your clacker back from the attic’’ and kick off Carnival season.
Hundreds attended that event and another Carnival party the next night. Most of the town is vaccinated, and people were required to show proof, or a recent negative test, to enter. But it wasn’t enough. Coronavirus cases spiked the week after. Officials worried about pressure on the local hospital. And soon the town found itself under semi-lockdown once more.
As Americans catch up with family and friends this holiday week, with some trepidation about enduring risk, Europe is facing another wave of the virus — and a gloomy and frustrating second pandemic winter.
Despite vaccine supplies that are envied by much of the world, Europe is the only region where COVID deaths are on the rise, according to the World Health Organization.
Reported deaths reached nearly 4,200 a day last week, doubling since the end of September, for the 53 countries the WHO counts as part of the European region. The organization predicts ‘‘high or extreme stress’’ on intensive care units in 49 of those countries between now and March.
What’s driving the surge in infections? The WHO cites the prevalence of the highly contagious Delta variant, people gathering in indoors without the precautions they took when the virus was considered an emergency, pockets of people who remain unvaccinated, and declining protection among those who were vaccinated last winter or spring.
Europe has been behind the United States in its booster rollout. But otherwise, the same factors could shape the US situation in the weeks ahead.
The new wave in Europe has led towns, cities, and countries to bring back the sorts of restrictions that people hoped they were done with.
Washington Post