24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
Fax: (361)578-5500
Regular Hours: M-Fri 8am - 5pm
Every 3rd Thurs of the Month - Extended Hours Until 7 pm

Medical Disorders
Resources
Basic InformationLookupsLatest News
COVID Vaccine Won't Affect Fertility, But Getting COVID MightThree New Studies Confirm Power of Booster Shots Against OmicronHit Your Head? Look for These Warning Signs of ConcussionArthritis & the COVID Vaccine: What You Need to KnowCOVID Boosters Keep Older Americans Out of Hospitals: CDCCOVID Rapid Test Makers Struggling to Meet DemandAHA News: A Healthy Thyroid Can Be Key to a Healthy HeartAnother Study Finds Vaccine Booster 'Neutralizes' Omicron'Artificial Pancreas' Can Help Kids With Type 1 DiabetesGetting Back to Sports After Recovering from COVID-19Side Effects From New Cancer Meds Have Silver LiningDengue Virus Makes Mosquitoes Bite More OftenNew Clues to Why Some Develop 'Brain Fog' After COVIDVaccination Plus Prior Infection Best Defense Against COVIDBinge-Watching Could Raise Your Blood Clot RiskIs a Night in the Hospital Necessary After Hip, Knee Replacement?Crowded Emergency Rooms Cost Lives: StudyCOVID Restrictions Eased in EnglandNo Side Effects From Your COVID Vaccine? Don't Worry, It's Still WorkingNearly Half of Americans Gained Weight in Pandemic's First YearNo Evidence Breastfeeding Can Transmit CoronavirusWHO Says Worst of Pandemic Could Ease This Year if Vaccine Inequities ErasedBiden Plans to Send 400 Million N95 Masks to Americans for FreeHeart Function Rebounds for Kids With COVID-Linked MIS-CAHA News: What Heart and Stroke Patients Need to Know About COVID-19 in 2022Which Kids Are Most Vulnerable to Severe COVID-19?Vaping Might Worsen COVID-19 SymptomsToo Soon to Tell if Omicron Will End Pandemic: FauciWhite House Launches Website for Free Home COVID Tests One Day Ahead of SchedulePolitics Clouds Folks' Views on COVID Rules, Global Survey ConfirmsCOVID-19 Treatments: What You Need to KnowAt-Home COVID Tests Accurate for Ki​ds: StudyHere's How to Get Your Free Home COVID Test KitsInsurance Often Covers Ivermectin for COVID, Even Though Drug Doesn't WorkCOVID Cases Surge Again in U.S. Nursing HomesCBD and Cannabis Products for Acne, Psoriasis? Buyer Beware, Dermatologists SayCarbon Monoxide Deaths Soar During Power OutagesAHA News: Transplanting Pig Hearts Into Humans Offers Promise – and PerilCOVAX Program Has Now Sent 1 Billion COVID Vaccines to Poorer NationsCOVID Fatigue: Are You Among the 'Vaxxed & Done'?CDC Advises N95s as Best Masks Against CoronavirusYou Don't Have to Be a Smoker to Get Lung CancerSkipping COVID Vaccine in Pregnancy Brings Big Risks to Mothers, BabiesMasks Cut Distance Coronavirus Travels in Half, Study Finds1 in 10 People With COVID Still Infectious After 10 Days: StudyWorried About Omicron? Expert Offers Tips on Going Out SafelySupreme Court Blocks Biden's Vaccine Mandate for Large EmployersCould the 'Mono' Virus Help Trigger Multiple Sclerosis?AHA News: Obesity Harms Brain Health Throughout Life – Yet Scientists Don't Know WhyWhite House May Soon Offer 'High-Quality' Masks to Americans
Questions and AnswersLinks
Related Topics

Diabetes

FDA Panel Gives Support to Merck's COVID Antiviral Pill

HealthDay News
by Ernie Mundell and Robert Preidt and Robin Foster
Updated: Nov 30th 2021

new article illustration

TUESDAY, Nov. 30, 2021 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Tuesday voted narrowly to recommend emergency use of Merck's new antiviral pill to help prevent severe COVID-19 in high-risk patients.

By a 13-10 count, the panelists recommended molnupiravir for use by older COVID-19 patients or those who have medical conditions that make them especially susceptible to severe illness.

The decision clears the way for the FDA to approve the drug for such use within days, and it might be available to patients generally before year's end, according to the New York Times.

The FDA doesn't have to follow its advisory panels' recommendations, but it typically does.

The FDA may also soon approve an antiviral pill from Pfizer that appears to be significantly more powerful than Merck's pill, showing 89% efficacy in reducing hospitalizations and deaths among COVID-19 patients.

The panel's approval of molnupiravir wasn't guaranteed. There were already two strikes against the pill: Fresh data from Merck shows that molnupiravir isn't as effective as first reported; and FDA documents prepared for the panel meeting show the pill may pose a risk of birth defects.

Merck said Friday that final study results showed the pill reduced hospitalization and death by 30% among infected adults, which is much lower than the 50% reduction first announced by the company.

And an FDA safety review noted that animal studies suggest that high doses of the drug could trigger birth defects.

U.S. health officials have said they are considering banning the use of molnupiravir in pregnant women and are weighing other safeguards, including recommending contraceptives for some patients taking the medication, the Associated Press reported.

Why a risk of birth defects? Merck's drug disables the coronavirus by inserting tiny errors into its genetic code to stop the pathogen from reproducing. That mechanism of action has raised concerns that the drug could cause mutations in human fetuses or even spur more virulent strains of the virus.

Still, given the troubling emergence of the new Omicron variant, the FDA was widely expected to authorize emergency use of molnupiravir, which is already authorized for emergency use in the United Kingdom, the AP reported.

Experiments need to be conducted to see how well the pill works at disabling the Omicron variant, but there is reason to believe they would remain effective even if the new variant can evade vaccines, theTimes reported.

Omicron has more than 30 mutations on its so-called spike protein, and some of those mutations may make it hard for vaccine-produced antibodies to attack the virus. But Merck's antiviral pills do not target the spike protein. Instead, they weaken two proteins involved in the virus' replication machinery. Omicron carries only one mutation in each of those proteins, and neither looks as if it would stop the pills from doing their jobs, the Times reported.

In a presentation to the expert panel, Merck executive Daria Hazuda said molnupiravir's activity makes it likely to work against any new variants.

If molnupiravir is authorized in the United States, the Biden administration has ordered enough courses of treatment, at about $700 per person, for 3.1 million people, the Times reported. The treatment is to be given within five days of the start of symptoms and is taken as 40 pills over five days.

More information

Visit the U.S. Food and Drug Administration for more on COVID treatments.

SOURCES: Associated Press; The New York Times