Pfizer said Antiviral Pill is 89% Among High-Risk Adults

AHA Publisher — Thu, 16 Dec 2021 08:00:54 +0000

WASHINGTON (AP) via CBN News — Pfizer said Tuesday that its experimental pill to treat COVID-19 appears effective against the omicron variant. The company also said full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89% among high-risk adults when taken shortly after initial COVID-19 symptoms. Separate laboratory testing shows the drug retains its potency against the omicron variant, the company announced, as many experts had predicted. Pfizer tested the antiviral drug against a man-made version of a key protein that omicron uses to reproduce itself. The updates come as COVID-19 cases, deaths and hospitalization are all rising again and the U.S. topped 800,000 pandemic deaths. The latest surge, driven by the delta variant, is accelerating due to colder weather and more indoor gatherings, even as health officials brace for the impact of the emerging omicron mutant. The Food and Drug Administration is expected to soon rule on whether to authorize Pfizer’s pill and a competing pill from Merck, which was submitted to regulators several weeks earlier. If granted, the pills would be the first COVID-19 treatments that Americans could pick up at a pharmacy and take at home. President Joe Biden called Pfizer’s drug “another potentially powerful tool in our fight against the virus,” in a statement Tuesday. The U.S. government has agreed to purchase enough of Pfizer’s drug to treat 10 million people. But company executives have indicated that initial supplies will be limited, with only enough to treat tens of thousands of people before the end of the year. By March Pfizer hopes to ramp up production to provide millions of courses of treatment. Pfizer’s data could help reassure regulators of its drug’s effectiveness after Merck disclosed smaller-than-expected benefits for its drug in final testing. Late last month, Merck said that its pill reduced hospitalizations and deaths by 30% in high-risk adults. Both companies initially studied their drugs in unvaccinated adults who face the gravest risks from COVID-19, due to older age or health problems, such as asthma or obesity. Pfizer is also studying its pill in lower-risk adults — including a subset who are vaccinated — but reported mixed data for that group on Tuesday. In interim results, Pfizer said its drug failed to meet its main study goal: sustained relief from COVID-19 for four days during or after treatment, as reported by patients. But the drug did achieve a second goal by reducing hospitalizations by about 70% among that group, which included otherwise healthy unvaccinated adults and vaccinated adults with one or more health issues. Less than 1% of patients who got the drug were hospitalized, compared with 2.4% of patients who got a dummy pill. An independent board of medical experts reviewed the data and recommended Pfizer continue the study to get the full results before proceeding further with regulators. Across both of Pfizer’s studies, adults taking the company’s drug had a 10-fold decrease in virus levels compared with those on placebo. The prospect of new pills to fight COVID-19 can’t come soon enough for communities in the Northeast and Midwest, where many hospitals are once again being overloaded by incoming virus cases. Both the Merck and Pfizer pills are expected to perform well against omicron because they don’t target the coronavirus’ spike protein, which contains most of the new variant’s mutations. Centers for Disease Control and Prevention Director Rochelle Walensky, appearing on NBC’s “Today” on Tuesday, said the best way for people to protect themselves against COVID-19 is to get vaccinated and get a booster shot. She said the Pfizer pill if authorized by the FDA, “will be another great tool, but we need to diagnose people early.” To read the original article click here.

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UK Gives OK to Merck’s Breakthrough Anti-COVID Pill, Pfizer Announces Its Antiviral Pill Works Too

AHA Publisher — Mon, 08 Nov 2021 08:00:32 +0000

CBN News – The United Kingdom granted conditional authorization Thursday to the first pill officially shown to successfully treat COVID-19. It’s the first country to OK the treatment from drugmaker Merck, but it is not known when the pill will be available to the public. Those with mild to moderate COVID symptoms would take four pills of molnupiravir, twice a day for five days. Adults 18 or older who have tested positive for COVID-19 and who could be at risk for developing severe disease, including people with issues like obesity or heart disease, are slated to be the first patients to receive the pill. Molnupiravir is also pending review with regulators in the U.S., the European Union, and other countries. Merck has said it can produce 10 million treatment courses through the end of the year, but much of that supply has already been purchased by governments worldwide, so initial supplies of the pill could be limited. “Today is a historic day for our country, as the U.K. is now the first country in the world to approve an antiviral that can be taken at home for COVID-19,” British Health Secretary Sajid Javid said. “We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” he said in a statement, referring to the U.K.’s National Health Service. Doctors said the treatment would be particularly significant for people who don’t respond well to vaccination. Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results haven’t yet been peer-reviewed or published in a scientific journal. Pfizer Announces Another Pill to Fight COVID On Friday, Pfizer also announced it has successfully tested an experimental antiviral pill for COVID-19 as well. Pfizer claims its pill cut rates of hospitalization and death by nearly 90%. Fewer than 1% of patients taking the drug needed to be hospitalized and no one died. “We were hoping that we had something extraordinary, but it’s rare that you see great drugs come through with almost 90% efficacy and 100% protection for death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer. How Merck’s Drug Works The Merck drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors. Britain’s Medicines and Healthcare products Regulatory Agency said molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it wasn’t found to pose a risk to humans. “Studies in rats showed that (molnupiravir) may cause harmful effects to the unborn offspring, although this was at doses which were higher than those that will be given to humans, and these effects were not observed in other animals,” the agency said in an email. Last week, Merck agreed to allow other drugmakers to make its COVID-19 pill, in a move aimed at helping millions of people in poorer countries receive the pill. The Medicines Patent Pool, a U.N.-backed group, said Merck will not receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be a global emergency. The U.S. has agreed to pay roughly $700 per course of the drug for about 1.7 million treatments. Merck says it plans to use a tiered pricing strategy for developing countries. A review by Harvard University and King’s College London estimated the drug costs about $18 to make each 40-pill course of treatment. Will Merck’s Pill Be Approved in the US? As CBN News reported last month, Merck requested U.S. Food and Drug Administration authorization for its COVID pill. The FDA said it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness later this month. “Of importance is that in the placebo group there were eight deaths, and in the treatment group there were no deaths,” said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases. “That’s also very important and very good news.” Molnupiravir was initially studied as a potential flu therapy with funding from the U.S. government. Last year, researchers at Emory University decided to repurpose the drug as a potential COVID-19 treatment. They then licensed the drug to Ridgeback and partner Merck. To read the original article click here.

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Pfizer said Antiviral Pill is 89% Among High-Risk Adults

UK Gives OK to Merck’s Breakthrough Anti-COVID Pill, Pfizer Announces Its Antiviral Pill Works Too