Panel weighs safety, effectiveness of Merck’s COVID-19 pill – Community News

Panel weighs safety, effectiveness of Merck’s COVID-19 pill

WASHINGTON — Government health advisers Tuesday weighed up the benefits and risks of a closely watched Merck drug, which could soon become the first U.S.-approved pill patients can take at home to treat COVID-19.

The Food and Drug Administration asked its outside experts whether the agency should approve the pill, weighing new information that it is less effective than first reported and can cause birth defects. Voting was held on Tuesday afternoon. The panel’s recommendations are not binding, but often guide FDA decisions.

The meeting comes at a time when infections in the US are increasing again and health authorities worldwide are assessing the threat of the new ommicron variant.

If authorized, Merck’s Pill could be the first doctors could prescribe to patients to relieve symptoms and speed recovery, a major step toward reducing hospitalizations and deaths. The drug, molnupiravir, is already approved for emergency use in the UK

Given the ongoing threat, the FDA is widely expected to approve the use of Merck’s Pill in an emergency. But new data released last week painted a less convincing picture than when the company first released its first results in October.

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% in adults infected with the coronavirus, compared to adults taking a placebo. That effect was significantly less than the 50% reduction first announced based on incomplete results.

FDA scientists said Tuesday the reasons for the difference were unclear, but appeared to be due to higher-than-expected hospitalizations in patients taking the drug during the second half of the study. The effectiveness of Molnupiravir is an important consideration as panelists weigh whether the drug should be recommended and for whom.

Another question is whether pregnant women or women of childbearing age should avoid the drug.

FDA scientists said Tuesday that company studies in rats showed the drug caused toxicity and birth defects in the skeleton, eyes and kidneys. Taken together, FDA officials concluded that the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”

Regulators said they are considering banning or warning against the use of molnupiravir during pregnancy, but leaving it as an option in rare cases. The FDA also suggested that doctors check that patients are not pregnant before starting treatment and recommend contraception to certain patients.

In its own presentations, Merck said Tuesday it does not recommend using the drug in women who are pregnant or breastfeeding. But the drug manufacturer opposed a general restriction on prescribing to those patients, arguing that there may be certain instances where the benefit of the drug outweighs the risk.

The drug uses a new approach to fight COVID-19: it adds tiny flaws in the coronavirus genetic code to prevent it from reproducing. That genetic effect has raised concerns that the drug could stimulate more virulent strains of the virus. But FDA regulators said Tuesday the risk is theoretical and appears unlikely.

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Merck scientists said they believe their drug will be effective against the new ommicron variant. They said the drug worked against other variants, including the ruling delta strain.

Panelists are also weighing whether the pills should be offered to patients who have been vaccinated or have previously had COVID-19. Merck did not study the drug in vaccinated people, but data from a handful of patients with previous infections suggested it had little benefit. Still, it can be impractical for doctors to screen those patients. The Merck drug works best when given within five days of the first COVID-19 symptoms, underscoring the need for prompt treatment.

Merck tested the drug in adults with mild to moderate COVID-19 who were considered to be at higher risk due to health conditions such as obesity, diabetes or heart disease. That’s the same group that is currently receiving antibody drugs, which help the immune system fight the virus. The FDA has approved three antibody drugs for COVID-19, but all must be given by IV or injection in hospitals or clinics.

Merck was the first company to submit its COVID-19 pill to the FDA, but a rival drug from Pfizer is hot on its heels and also under review.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and have not been associated with the type of mutation concerns that was raised with Merck’s medicine.

Pfizer said this week that its drug should not be affected by the mutations of the omicron variant.

By Associated Press Health writer Matthew Perrone

• • •

How to get vaccinated?

The COVID-19 vaccine for children 5 years and older and booster shots for eligible recipients are administered at doctors’ offices, clinics, pharmacies, supermarkets and public vaccination sites. Many make it possible to book appointments online. Here’s how to find a branch near you:

Find a location: To find vaccination sites in your zip code, visit

More help: Call the national COVID-19 Vaccination Helpline.

Telephone: 800-232-0233. Help is available in English, Spanish and other languages.

TTY: 888-720-7489

Disabled information and access line: Call 888-677-1199 or email [email protected]

• • •

CHILDREN AND VACCINES: Do you have questions about vaccinating your child? Here are some answers.

BOOSTER SHOTS: Not sure which COVID booster to get? This guide will help.

PROTECTING SENIORS: This way seniors can be protected against the virus.

COVID AND THE FLU: Get a flu shot and the COVID vaccine to prevent ‘twin disease’.

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