FDA Says Merck COVID Pill Effective, Experts Will Review Safety

11/26/2021 6:42:00 PM

U.S. health officials say Merck's experimental COVID-19 pill is effective but they raised questions about its safety during pregnancy.

Coronavirus, Covıd-19

U.S. health officials say Merck 's experimental COVID-19 pill is effective but they raised questions about its safety during pregnancy.

U.S. health officials say Merck 's experimental COVID-19 pill is effective but they raised questions about its safety during pregnancy.

AdvertisementGiven the safety concerns, FDA said Merck agreed the drug would not be used in children.Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies.The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans.

Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to the point that it can’t reproduce itself.For its part, Merck says results from two company studies in rodents show “molnupiravir does not cause mutations or damage to DNA in these animal models.” The company said the rodents received higher doses for longer periods of time than humans who will take the drug.

Read more:
HuffPost »

NASA's SpaceX Crew-5 Mission Launches to the Space Station (Official NASA Broadcast)

Our #Crew5 mission to the International Space Station is targeted for liftoff at noon EDT (1600 UTC) Wednesday, Oct. 5, 2022, from Launch Complex 39A at NASA... Read more >>

Fortunately, the approved injectable vaccines are safe in pregnancy. So if the new oral version turns out, after research, to be contraindicated during pregnancy, physicians will choose what's safe. Biggest risk to a pregnancy? The mom-to-be not surviving! Get protected! Simple, if you’re pregnant dont take it

Only vaccines are well protected from any questions. Hello friends Help me start a charity or serve at the United Nations. My goal is to dedicate my life to serving humanity and the environment. My dream is to achieve world peace. 21 year old boy from the earth♥️🌍

FDA: Merck COVID pill effective, experts will review safetyU.S. health officials say Merck 's experimental COVID-19 pill is effective but they raised questions about its safety during pregnancy. Pfizer's lobbyist efforts will slow things down. Not to worry 30% is effective? That’s a pretty low threshold for the price of $700 per treatment. 🧐 Vaxart has a COVID19 💊 vaccine & booster that could stop infection and transmission! No 💉or cold storage. Why hasn’t the 🌍 invested in this scalable solution to end this pandemic?

New COVID-19 variant triggers global alarm as WHO urges cautionGlobal authorities reacted with alarm on Friday to a new coronavirus variant detected in South Africa, with the EU and Britain among those tightening border controls as researchers sought to find out if the mutation was vaccine-resistant. I bet it’s been in Europe for a month now and is what is driving the massive surge in numbers there. Why South Africa isn’t closing their border!! Just close their border, very simple

New Covid-19 Travel Restrictions Rattle Airline Industry, Hit SharesGovernments across Europe and Asia slapped new restrictions on flights and travelers from a swath of southern Africa, acting to stem the transmission of a new Covid-19 variant identified in the region The U.S. needs to do the same - why wait?

New Zealand PM Ardern says prepared for new COVID-19 variantsNew Zealand is well prepared for the discovery of new coronavirus variants that may be resistant to vaccines, Prime Minister Jacinda Ardern said on Friday, including the strain currently spreading in South Africa. Hmm how did it spread? 🤔 because we have vaccine mandates for traveling?! So the vaccinated gang are spreading it....so overly vaccinated with booster after booster that the virus built immunity... I see some people are having a melt down because one of the most successful countries against covid just said they are prepared for the mutation also.... Relax it's not about your feelings it's about new Zealand.... Please stop this. It’s irresponsible reporting. It’s not spreading in SA. SA have globally lauded scientists. They discovered it, unlike other countries who are either slack, or deliberately conceal, developments.

Explainer: What we know about the COVID-19 variant detected in South AfricaGlobal authorities have reacted with alarm to a coronavirus variant detected in South Africa, with the EU, Britain and India among those announcing stricter border controls as scientists seek to determine if the mutation is vaccine-resistant. 'It's pretty bad' ADE

COVID-19: Japan tightens border controls for arrivals from six countriesJapan will tighten border controls for people arriving from six African nations from midnight (1500 GMT on Friday) after a new and possibly vaccine-resistant coronavirus variant was detected in South Africa.

COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.Email this article The Associated Press FILE - This undated file image provided by Merck & Co.read more 'MOST SIGNIFICANT VARIANT' The variant has a spike protein that is dramatically different to the one in the original coronavirus that vaccines are based on, the UK Health Security Agency said, raising fears about how current vaccines will fare.new travel bans are limited to flights coming from a handful of countries that typically encompass a relatively low percentage of international travel.

The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice. U. Advertisement The FDA scientists said their review identified several potential risks, including possible toxicity and birth defects.1. Given those risks the FDA will ask its advisers whether the drug should never be given during pregnancy or whether it could be made available in certain cases. health officials say Merck's experimental COVID-19 pill is effective but raises safety issues for pregnant women. Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.

Given the safety concerns, FDA said Merck agreed the drug would not be used in children. 26, 2021 ahead of a public meeting next week where outside experts will debate the drug's benefits and risks. read more "At this point, implementing travel measures is being cautioned against," WHO spokesperson Christian Lindmeier told a U. Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. Theoretically, FDA cautioned, those changes could lead to dangerous new variants. via AP, File) Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems in pregnant women. Advertisement Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies. It would take several weeks to determine the variant's transmissibility and the effectiveness of vaccines, Lindmeier said, noting that 100 sequences of it had been reported so far. FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks. The agency isn’t required to follow the group’s advice.

All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U. Regulators also noted Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies. 1/5 Passengers wearing protective face masks, amid the coronavirus disease (COVID-19) pandemic, walk at the Haneda airport, in Tokyo, Japan June 13, 2021.S. patients could take at home to ease symptoms and speed recovery. If authorized, Merck’s drug would be the first that patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U. Belgium identified Europe's first case, adding to those in Botswana, Israel and Hong Kong.

K.K. The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans. Advertisement The drug, molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections.S. "We are currently on the verge of a state of emergency ," Prime Minister Naftali Bennett said in a statement. Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to the point that it can’t reproduce itself. But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or tumors. But the FDA review is key to determining who will be eligible and how widely it might be prescribed.

Pregnant women were excluded from Merck’s study. Bolsonaro has been widely criticized by public health experts for his management of the pandemic, railing against lockdowns and choosing not to get vaccinated. And both women and men in the study were instructed to use contraception or abstain from sex. ——— The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. For its part, Merck says results from two company studies in rodents show “molnupiravir does not cause mutations or damage to DNA in these animal models.” The company said the rodents received higher doses for longer periods of time than humans who will take the drug.. "Most likely this virus is already in other places. FDA reviewers also confirmed previously reported interim results from Merck that the pill cut the rate of hospitalization and death by about half among patients with early symptoms of COVID-19 who faced increased risk due to health problems.

However, on Friday morning Merck announced updated results from the same study that showed a smaller benefit from the drug. Among more than 1,400 adults in a company study, molnupiravir reduced the combined risk of hospitalization and death by 30%, less than the 50% initially reported based on incomplete results. read more Discovery of the new variant comes as Europe and the United States enter winter, with more people gathering indoors in the run-up to Christmas, providing a breeding ground for infection. Nearly 7% of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died. That compared to 10% of patients hospitalized who were taking the placebo and nine deaths. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The coronavirus has swept the world in the two years since it was first identified in central China, infecting almost 260 million people and killing 5.

The AP is solely responsible for all content. Suggest a correction .