Mexico said Friday it is already seeing black market or fake versions of molnupiravir circulating for sale, just one week after authorities approved the drug to treat those at risk of severe COVID-19. The real medication is produced by U.S. pharmaceutical company Merck. But Mexico’s health regulatory agency found versions labelled molnupiravir for sale from an array of companies like “Merit,” “Molaz” and “Azista.” The agency said Friday that it had no record of any permits for import or sales of those companies’ drugs and considered them a health risk. The Federal Commission for Health Protection wrote that, because molnupiravir is approved only for prescription use, “any product advertised as over-the-counter molnupiravir should be considered a health risk because of its dubious origin.” Also read: Merck agrees to let other drug makers make its COVID pill Mexico's government approved molnupiravir from Merck for use last week for adults with COVID-19 and “a high risk of complications.” On Friday the agency approved a second pill, Paxlovid, from Pfizer, for use on adult patients “at risk for complications.” Mexico has long been plagued by counterfeit medicines, corruption within the regulatory agency, and a penchant for self-medication due to the country's inadequate health care infrastructure. The country has seen coronavirus cases spike by over 200% in the last week, apparently due to the omicron variant, and faces a shortage of tests, which tends to drive consumers toward the black market. Also read: US panel backs first-of-a-kind COVID-19 pill from Merck Mexico does so little testing that, while test-confirmed COVID-19 deaths hover around 300,000, a government review of death certificates places the real toll at around 460,000.
A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. The Food and Drug Administration panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. “I see this as an incredibly difficult decision with many more questions than answers,” said panel chair Dr. Lindsey Baden of Harvard Medical School, who voted in favor of the drug. He said FDA would have to carefully tailor the drug’s use for patients who stand to benefit most. The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Most experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, such as pregnancy tests for women of child-bearing age. The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated people, who weren’t part of Merck’s research and haven’t been shown to benefit. Read: US expected to toughen testing requirement for travelers The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The antiviral is already authorized in the U.K. The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant. Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus. That uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans. “With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug. On Friday, Merck released updated data that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier. Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results. For many panelists, the modest effect wasn’t enough to outweigh the drug’s potential toxicity to human fetuses. “Given the large potential population affected, the risk of widespread effects on potential birth defects has not been adequately studied,” said Dr. Sankar Swaminathan of the University of Utah School of Medicine, who voted against the drug. Read: Authorities: Student kills 3, wounds 8 at Michigan school FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused birth defects when given at very high doses. FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.” The agency is weighing a blanket restriction against any use in pregnant women or allowing doctors to use the drug in rare cases. Some panelists said that option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options. Dr. Janet Cragan, who backed the drug, said that even with tight restrictions some pregnant women would inevitably take the antiviral. “I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” said Cragan, a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.” Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. FDA regulators said Tuesday that risk is theoretical but many panelists said it should be carefully tracked in follow-up studies. Antiviral pills have long been seen as a key advance beyond currently used antibody drugs, which must be injected or infused by health professionals. But given the shortcomings of Merck’s data, several experts said they would prioritize patients to receive the older drugs. While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill 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 haven’t been linked to the kind of mutation concerns raised with Merck’s drug. Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. Both drugs require patients to take multiple pills, twice a day for five days. The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir.
The Directorate General of Drug Administration (DGDA) has authorised two local pharmaceutical companies for marketing Molnupiravir, the first oral Covid-19 antiviral drug. Major General Md Mahbubur Rahman, Director General of the DGDA, came up with the information at a press briefing on Tuesday. “DGDA has approved Molnupiravir for emergency use but it’s not an alternative to vaccine. People must take Covid jabs. This oral medicine has to be taken as per the advice of physicians,” he said. Also read: Merck agrees to let other drug makers make its COVID pill “So far, 10 pharmaceutical companies have sought permission for marketing and we have authorised Beximco Pharmaceuticals and Eskayef Pharmaceuticals for marketing. The eight other companies awaiting approval are Square, General, Beacon, Reneta, Insepta, Acme, Health Care and Popular pharmaceuticals,” he added.
Pharmaceutical company Merck agreed to allow other drug makers to produce its COVID-19 pill, in a move aimed at helping millions of people in poorer countries get access to the potentially life-saving drug, a United Nations-backed public health organization said on Wednesday. The Medicines Patent Pool said in a statement that it had signed a voluntary licensing agreement for molnupiravir with Merck and its partner Ridgeback Biotherapeutics. The agreement will allow the Medicines Patent Pool to grant further licenses to qualified companies who are approved to make the drug. Neither drug maker will receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be global emergency. Molnupiravir is the first pill that has been shown to treat the disease. Read: Merck asks US FDA to authorize promising anti-COVID pill Charles Gore, the executive director of the Medicines Patent Pool, said the early results for molnupiravir were “compelling” and that he hoped this first voluntary licensing agreement for a COVID-19 treatment would lead to others. Despite repeated requests from governments and health officials, no vaccine makers have agreed to a similar deal. A hub set up by WHO in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical to join. Merck has requested its pill be licensed by both the U.S. Food and Drug Administration and the European Medicines Agency, decisions that could come within weeks. Merck reported this month that molnupiravir cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early. An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on hospitals and helping to curb outbreaks in poorer countries with weak health care systems. Read: Pfizer says COVID-19 vaccine more than 90% effective in kids It would also bolster a two-pronged approach to the pandemic: treatment by way of medication and prevention, primarily through vaccinations. The charity Doctors Without Borders welcomed the agreement Merck struck to share its COVID-19 pill, but said it didn’t go far enough. “The license excludes key upper-middle-income countries like Brazil and China from its territory, where there are strong, established capacity to produce and supply antiviral medicines,” said Yuanqiong Hu, a senior legal and policy adviser at Doctors Without Borders, who called the deal “disappointing.”