(July 21): Shionogi & Co’s experimental Covid-19 treatment Xocova failed to win the backing of health experts in Japan who said there wasn’t enough data to show the medicine’s efficacy.
The panel members didn’t recommend that Japan’s health ministry authorise emergency use of the therapy as there was a need to continue discussion on it, Hiroshi Kiyota, chairman of the expert committee said in a briefing Wednesday. The health ministry relies on the panel’s decision to give the approval.
Shionogi plummeted as much as 10% in Tokyo trading, the biggest intraday drop since June 23, while shares of Shionogi’s South Korean partner, Il Dong Pharmaceutical Co, fell as much as 30% in Seoul.
Japan so far has two pills to fight coronavirus and Shionogi’s therapy was seeking to be the third option. Approval for Shionogi’s medicine was keenly watched as it is easier to take than the two currently available drugs from US drugmakers. A course of Shionogi treatment consists of seven pills over five days — significantly fewer than Pfizer Inc’s Paxlovid and Merck & Co’s Lagevrio, which require between 30 pills and 40 pills over the same time period.
The panel decided that it will continue discussion on Xocova and await submission of Phase 3 trial data which is expected in November, according to a representative from Pharmaceutical and Medical Devices Agency, Japan’s drug regulator.
This stretches the wait for a domestic supply of an antiviral medicine in Japan that can help avert hospitalisations and deaths from Covid-19. Covid pills are becoming a crucial disease-fighting tool as the world transitions to living with the virus. Japan, already one of the oldest nations in the world, has also achieved one of the lowest death rates of the pandemic.
Second review
This was Xocova’s second panel review, as required for full transparency under the existing rules for the emergency authorisation process, according to Japan’s health minister Shigeyuki Goto. The company’s shares fell 5.6% after the first meeting in June which had a similar outcome when experts postponed their decision and said additional “careful discussion” was needed.
Japan’s government agreed in March to buy 1 million courses of the drug immediately after approval. The Osaka-based company, which already can make enough to treat one million people annually, says it plans to eventually produce enough supply for 10 million patients a year.
Shionogi’s easier-to-take pill has the potential to generate US$2 billion in annual sales, Chief Executive Officer Isao Teshirogi said in October. The company partnered with the AIDS Clinical Trial Group in March to run studies needed to get US approval.
The medicine is a protease inhibitor that works like Pfizer’s Paxlovid, and targets a different part of the virus replication process than Merck’s Lagevrio. It’s possible it could be given in combination with Merck’s treatment, something the companies have discussed, Teshirogi said.
The drugmaker is also seeking opportunities to sell the medicine in other parts of the world. It’s running a phase three trial in the US with the AIDS Clinical Trials Group, and has begun submitting data to regulators in China with its partner Ping An Life Insurance Company of China Ltd.
The rush to find a treatment for COVID-19 has cast a spotlight on the anti-parasitic drug ivermectin, but global health experts have warned that clinical trials were still needed to establish its efficacy.
Tuesday, Aug. 24, 12:47
The oral drug is based on a compound discovered by Omura Satoshi, a Distinguished Emeritus Professor at Kitasato University. He was awarded a Nobel Prize for the discovery.
Ivermectin is widely used to treat parasite-borne infectious diseases, mainly in Africa, while it is also approved in Japan to treat scabies.
A report published last year said cell-based lab experiments have shown that ivermectin can suppress multiplication of the coronavirus.
Some Latin American countries have approved the drug to treat COVID-19 patients. But studies are still ongoing around the world, as its efficacy and safety remain unproven.
In Japan, the Kitasato Institute has been conducting a clinical trial since last September, targeting coronavirus patients with mild to moderate symptoms, with blood oxygen levels of 95 percent of more.
In the US, the National Institutes of Health warned in February that ivermectin is not approved for the treatment of any viral infection.
It said it was impossible to draw definitive conclusions on the clinical efficacy of the drug for COVID-19 treatment. The reasons it cited included the limited sample size of studies, the lack of clarity on the severity of COVID-19 in study participants, and other incomplete information.
Ivermectin's US manufacturer Merck also said in February that there was "no scientific basis" for the drug's potential therapeutic effect against COVID-19.
In March, the World Health Organization advised that ivermectin should only be used to treat patients within clinical trials.
It said data from 16 trials involving 2,407 subjects showed that evidence on whether the drug reduces mortality or quickens improvement was of "very low certainty."
Japan's health ministry's COVID-19 treatment guidelines revised in July places ivermectin in a category of drugs whose efficacy and safety have not been established.
The guidelines refer to reports that the drug does not improve mortality, shorten hospitalization or hasten the reduction of viral loads in patients with mild symptoms.
Liver disorders are among the drug's possible side effects. The manufacturer also said it was unclear whether the product could be safely used among elderly people or pregnant women.
Ivermectin is also given in high doses to animals to treat parasitic diseases. The US Food and Drug Administration said in March that it has received multiple reports of patients who have been hospitalized after self-medicating with ivermectin intended for horses.
The FDA said, "You may have heard it's okay to take large doses of ivermectin. That is wrong." It added that overdosing could cause nausea, diarrhea, seizures or even death.
The FDA ramped up its warning via Twitter in August, saying, "You are not a horse. You are not a cow. Seriously y'all. Stop it."
News Navigator: What is ivermectin, and is it effective in treating COVID-19?
(Mainichi Japan)
This electron microscope photo provided by the National Institute of Infectious Diseases shows the coronavirus isolated at the facility. (Photo Courtesy of the National Institute of Infectious Diseases)
The Mainichi Shimbun answers some common questions readers may have about ivermectin, which is drawing attention as a possible cure for COVID-19.
Question: What kind of a medicine is ivermectin in the first place?
Answer: It has saved the lives of many people in Asia and Africa as a treatment for onchocerciasis, a parasitic disease that causes blindness, and lymphatic filariasis, which can lead to hardened and enlarged skin.
It is known that Japanese biochemist Satoshi Omura, a distinguished emeritus professor of Kitasato University who received the Nobel Prize in physiology or medicine in 2015, contributed to the medicine's development. In the 1970s, he discovered an antibiotic that is effective against parasites from the chemical substances produced by a new type of fungus in the soil around a golf course. Ivermectin was developed by changing a part of the structure of the substance.
Q: Why would a medicine for parasites be used to treat COVID-19?
A: Ivermectin attracted attention after experiments using cells confirmed that it was effective in suppressing the increase of the coronavirus. It is thought that the medicine prevents the coronavirus from interfering with the function of innate immunity that is inherent in humans. Ivermectin also seems to have the effect of decreasing inflammation that occurs in the body due to an excessive immune reaction.
Q: Is it being used to treat coronavirus patients?
A: Ivermectin is being used to treat COVID-19 patients in Brazil and Peru, among other places, but it has not yet been approved in Japan. In March, the World Health Organization recommended that it be used only in clinical trials as the evidence on its effects is "of very low certainty."
The U.S. Food and Drug Administration is concerned about side effects, and said it received "multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses."
Large-scale clinical trials are being conducted in the U.K., and pharmaceutical companies in Japan are also planning to engage in clinical trials. We are hoping for an early judgment as to whether ivermectin is effective in treating the coronavirus.
(Japanese original by Yuki Ogawa, Lifestyle and Medical News Department)
Another false hope in battle against Covid-19...What is Ivermectin?
Scientists from the UK, Italy, Spain and Japan claim a significant reduction in mortality, time to recovery and viral clearance in COVID-19 patients treated with Ivermectin but WHO has recommended against its general use
BusinessToday.In
May 11, 2021
Goa has also announced that all over the age of 18 years will be allowed to use Ivermectin drug irrespective of their coronavirus status to bring down mortality
The World Health Organisation (WHO) has recommended against the general use of Ivermectin for Covid-19 treatment. The drug is typically used for treatment of parasitic roundworm infections. However, some health experts believe it has shown benefits against Covid-19 too. Scientists from the UK, Italy, Spain and Japan claim a significant reduction in mortality, time to recovery and viral clearance in COVID-19 patients treated with Ivermectin. A scientific research paper has also claimed that global Ivermectin use can break the coronavirus chain and reduce the risk of contracting the deadly virus. Meanwhile, German healthcare giant Merck, echoing WHO, has said no scientific basis has been found on Ivermectin's potential therapeutic effect against COVID-19.
What is Ivermectin?
Ivermectin has been approved by the US Food and Drug Administration (FDA) as a prescription medicine against parasitic roundworm infections. Mostly, it's administered to patients with intestinal strongyloidiasis and onchocerciasis. The common antiparasitic Ivermectin is being hailed as a possible cure for Covid-19 by doctors and other care experts across the world. A peer-reviewed research paper, written by three US government senior scientists, published in the American Journal of Therapeutics (AJT), claimed that Ivermectin is effective prophylaxis and treatment for Covid-19.
Scientists claim the regular use of Ivermectin can cut the risk of contracting coronavirus. The AJT research paper, which is the most comprehensive review of the data available on Ivermectin so far, also suggests the regular use of Ivermectin can reduce the risk of contracting Covid-19 . The research paper analysed three RCTs (randomised controlled trials) and five observational controlled trials, including 2,500 patients. Scientists also claim Ivermectin can lead to a significant reduction in mortality, recovery time and viral clearance.
How safe is Ivermectin?
Though approval for the drug as a possible cure against coronavirus is still at the research level. The FDA is yet to review the data related to Covid-19 patients given Ivermectin. Also, the FDA has warned against the consumption of Ivermectin in large quantities.
Dr Soumya Swaminathan, WHO chief scientist, said safety and efficacy are important when using any drug for a new indication, which is why it recommends against using Ivermectin. "Safety and efficacy are important when using any drug for a new indication. WHO recommends against use of 'ivermectin' for COVID-19 except within clinical trials," she tweeted.
German healthcare and life sciences giant Merck also issued similar warning, saying scientists are still examining the findings of all available and emerging studies of Ivermectin against Covid-19. "...to-date, our analysis has identified: No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; no meaningful evidence for clinical activity or efficacy in patients with COVID-19 disease, and; a concerning lack of safety data in the majority of studies," it said.
Goa to offer Ivermectin to all adults
All over the age of 18 years in Goa will be allowed to use Ivermectin drug irrespective of their coronavirus status to bring down mortality, state health minister Vishwajit Rane has said. The minister said this treatment would not prevent COVID-19 infection but it can help reduce the severity. "The Ivermectin 12 mg tablet will be made available in all the district, sub-district, PHCs, CHCs, sub-health centres, rural dispensaries for people to collect and start treatment immediately, irrespective of any symptoms or anything," Rane said. Goa on Monday recorded 2,804 new cases of coronavirus, taking its tally to 1,21,650, while 50 more fatalities pushed the toll to 1,729.
Japan has put a batch of Moderna's Covid-19 vaccine on hold after a foreign substance was found in a vial.
BBC 1 Sep 2021 6 hours ago
A pharmacist saw several black particles in one vial of the vaccine in Kanagawa Prefecture, according to authorities.
Some 3,790 people had already received shots from the batch. The rest of the batch has now been put on hold.
It comes less than a week after Japan suspended the use of about 1.63 million Moderna doses due to contamination.
The pharmacist found the black particles while checking for foreign substances before the vaccine's use.
The jab's domestic distributor has collected the vial suspected to be contaminated.
Local media reports say there is no evidence so far of any health hazards caused by the potentially contaminated vaccine.
Takeda Pharmaceutical, which sells and distributes the vaccine in Japan, had just last week put three batches of the vaccine on hold after "foreign materials" were found in some doses of a batch of roughly 560,000 vials.
Spanish pharmaceutical firm Rovi, which bottles the vaccine, said in a statement that a manufacturing line in Spain could be the cause of the issue.
It added that it was conducting an investigation.
On Tuesday, Japan's health minister said foreign matter found in jabs in the southern prefecture of Okinawa were due to needles being incorrectly inserted into vials.
Japan is battling a spike in Covid cases while it hosts the Paralympic Games.
Its vaccination roll-out has been relatively slow, with just over 40% of Japanese people fully vaccinated and around 50% having received one dose.
TOKYO (Kyodo) -- Japan will donate 1 million coronavirus vaccine doses to Vietnam on Wednesday, Japanese Foreign Minister Toshimitsu Motegi said.
Tokyo is also mulling donating amounts of COVID-19 vaccine to Indonesia, Malaysia, the Philippines and Thailand in July, Motegi said in a news conference on Tuesday.
"After considering comprehensively the infection situation (in Vietnam), the shortage of vaccines and relationship with Japan, we have come to that decision," Motegi said.
The provision of the vaccine developed by Britain's AstraZeneca and produced under license in Japan came in response to a request from Vietnam. It follows Japan's donation of 1.24 million shots to Taiwan earlier in the month. Vietnam has been facing a resurgence of infections since April, with its health authorities reporting a hybrid coronavirus variant that combines characteristics of strains first detected in Britain and India.
While Japan has secured enough AstraZeneca vaccine doses for 60 million people and approved their use last month, it does not intend to use them immediately in public inoculation programs due to rare cases of blood clots reported overseas.
Japan announced today it will release 1.25 million tons of treated wastewater contaminated by the wrecked Fukushima Daiichi Nuclear Power Plant into the Pacific Ocean. The government said it is the best way to deal with tritium and trace amounts of other radionuclides in the water.
Contaminated wastewater fills more than 1000 tanks at the site of the Fukushima Daiichi nuclear plant.
THE YOMIURI SHIMBUN VIA AP IMAGES
“Releasing the treated water into the sea is a realistic solution,” Prime Minister Yoshihide Suga said at a Cabinet meeting endorsing the plan. “We will do our utmost to keep the water far above safety standards.” A Japanese government official later clarified that details of the release need to be worked out and approved. Gradual, trial releases could start in 2 years and might take 40 years to complete.
Industry groups and nuclear scientists say other nuclear plants have disposed of wastewater this way with minimal impacts. But environmental groups, fisheries organizations, and neighboring countries immediately condemned the decision, citing the vast amounts involved. Marine scientists expressed concerns about the possible impact of the discharge on marine life and on fisheries.
The announcement was long anticipated. Three nuclear reactors at the Fukushima plant suffered meltdowns in the wake of an earthquake and tsunami on 11 March 2011. Molten fuel debris burned through steel containment vessels and into the concrete bases of the reactor buildings. Ever since, workers have pumped water through the ruins to prevent the debris from overheating and causing further damage. They have also collected all the contaminated water: It now fills more than 1000 steel tanks crammed onto the Fukushima campus.
The only practical options for disposing of the water “are discharge into the sea and vapor release, both of which have preceding practices,” concluded a governmental advisory committee made up of academics and citizen group representatives in February 2020. Nuclear power plants the world over regularly release water containing trace amounts of tritium into the environment under monitored and controlled conditions. And vaporization ultimately took care of about 9000 tons of contaminated water resulting from the accident at the Three Mile Island Nuclear Generating Station in March 1979. The International Atomic Energy Agency (IAEA) “considers the disposal options as technically feasible and in line with international practice,” IAEA Director General Rafael Grossi said during a February 2020 visit to Fukushima.
Tokyo Electric Power Co. (TEPCO) runs the water through a complex chain of filters it calls the Advanced Liquid Processing System (ALPS). The treatment captures 62 kinds of radionuclides, but not tritium, a radioactive isotope of hydrogen with a 12.3-year half-life that occurs naturally in trace amounts in seawater and the atmosphere. It is extremely difficult to remove as it replaces hydrogen atoms in water molecules. Because tritium emits only low-energy beta particles, it poses a modest health risk. And the plan is to dilute the water until the tritium concentration is one-fortieth of what Japan allows in drinking water.
Although “the optics are terrible,” releasing the water into the Pacific Ocean is the right thing to do, says Nigel Marks, a nuclear materials scientist at Curtin University, in a statement released by the Australian Science Media Centre. By diluting, the “radioactivity can be reduced to safe levels” comparable to exposures from medical imaging and airline travel, he says.
But in addition to tritium, more dangerous isotopes with longer radioactive lifetimes, such as ruthenium, cobalt, strontium, and plutonium, sometimes slip through the ALPS process, something TEPCO only acknowledged in 2018. The company now says these additional nuclides are present in 71% of the tanks. “These radioactive isotopes behave differently than tritium in the ocean and are more readily incorporated into marine biota or seafloor sediments,” says Ken Buesseler, a marine chemist at the Woods Hole Oceanographic Institution.
The government official says the Fukushima water will be “repurified” to meet regulatory standards for these nuclides. Buesseler notes that those limits were put in place for operational nuclear power plants, not for the deliberate release of contaminated water from a nuclear disaster. “Would this open the door for any country to release radioactive waste to the ocean that is not part of normal operations?” he asks.
Shigeyoshi Otosaka, a marine geochemist at the University of Tokyo, worries about the accumulation of the isotopes in seafloor sediments, where they can get picked up by marine biota. The possibility is limited, “but it’s important to evaluate it appropriately,” he says. For one thing, the TEPCO “repurification” has only been tested on a small volume of water. The company needs to verify “whether the processing performance can be maintained for a long period of time,” he says.
Although TEPCO claims it will run out of room to store additional water by the middle of 2022, environmental organizations say there is space for additional tanks on land adjacent to the Fukushima campus. That storage would allow the radioactive isotopes to naturally decay while buying time to develop new treatment techniques.
Any additional release of radiation will come on top of the estimated 538.1 petabecquerels of radioactivity emitted into the atmosphere by the explosions that blew apart the three reactor buildings in the days after the earthquake. That amount was about one-tenth of the estimated radiation released by the Chernobyl nuclear disaster of 1986. The Fukushima radiation had a minimal impact on humans, though the precautionary evacuations did cause unexpected social and health problems.
Much of the radioactive material fell into the Pacific Ocean because of prevailing winds. Concerns over contaminated fish devastated the regional fishing industry. Demand for seafood from the region has gradually recovered, but fisheries officials fear releasing contaminated water will rekindle public fears about seafood from the region.
