Sunday, October 29, 2023
Why COVID sufferers in the US can’t get ensitrelvir, the antiviral drug better than Paxlovid
For people suffering through a bout of COVID-19, the antiviral Paxlovid has been a godsend. The medication emerged as the go-to antiviral treatment during the pandemic after the Food and Drug Administration granted it emergency-use authorization in December 2021.
Now, there’s a new antiviral that’s superior to Paxlovid — but Americans can’t get it, as it’s being held up in the lengthy FDA-approval process.
Ensitrelvir, marketed as Xocova in Japan — the only country where it’s legally available — has several advantages over Paxlovid.
However, experts lament that the newer, better drug probably won’t be available in the US until the end of 2024. The FDA seems to be “slow walking” the approval process for ensitrelvir, infectious disease specialist Dr. David Boulware, a professor medicine at the University of Minnesota, told the Atlantic.
And because the COVID-19 emergency was declared over in May of this year, ensitrelvir probably won’t be granted the same emergency-use authorization that Paxlovid received.
Nonetheless, the FDA has granted the new drug “fast-track” status, meaning its review process will be expedited once the drug’s manufacturer, Shionogi of Osaka, Japan, submits the required documentation.
People who take the drug test negative almost two days sooner than people who take a placebo. Symptoms like fever, congestion, sore throat, cough and fatigue disappear faster among some groups of people than with Paxlovid.
“Rebound” infections, in which symptoms recede and then seem to come back — common among Paxlovid users — have been rare among users of ensitrelvir. In addiction, the taste of ensitrelvir is unremarkable, according to anecdotal reports, whereas patients on Paxlovid have described the aftertaste as “a mouthful of dirty pennies and rotten soy milk.”
And ensitrelvir is easier to take, as it requires just once-a-day dosing, whereas Paxlovid users must take three pills twice daily for five days.
The two drugs have never been compared in head-to-head trials, however, so medical experts are reserving their enthusiasm for ensitrelvir until more data is available.
Loss of smell and taste
Despite this, a new study found that ensitrelvir effectively diminishes one of the most annoying and problematic effects of a COVID infection: loss of smell and taste.
After seven days, the percentage of study participants with smell or taste loss was 39% lower in a group taking ensitrelvir than in a placebo group.
“Most people will eventually recover on their own, but we know that some people have had long-term issues with smell and taste,” Dr. Yohei Doi, an infectious-disease researcher at Fujita Health University in Japan who worked on the ensitrelvir study, told Nature.
“When the omicron variants became dominant, the loss of taste and smell started to become less and less common,” Dr. Amesh Adalja, an infectious-disease specialist at the Johns Hopkins Center for Health Security, explained to Nature.
“But it still occurs, and it is a distressing symptom,” Adalja added. “What we’re trying to do is not just minimize severe disease, hospitalization and death, but also to minimize the disruption that an infection has on people’s activities.”
The drugmaker Shionogi is continuing to conduct clinical trials into the safety and effectiveness of ensitrelvir among different user groups.
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Sore Arm After COVID-19 Vaccine Could Indicate Serious Complication: Doctor
Individuals who experience a sore arm after taking a COVID-19 shot may be at risk of facing cardiac issues, according to cardiologist Peter A. McCullough.
“I always ask patients if they had a sore arm or more severe reaction within the few days of the shot. It may be a harbinger of future cardiovascular serious adverse events, including myocarditis and sudden cardiac death,” Dr. McCullough said in an Oct. 27 Substack post. Myocarditis is an inflammation of a heart muscle called myocardium, which can reduce the heart’s ability to pump blood. Dr. McCullough cited a Sept. 19 study published in the Radiology journal, which states that 458 out of the 700 participants, or 65.4 percent, reported pain in the arm after COVID-19 vaccination.
“The myocardial visual score was higher in patients who reported a sore arm compared with those who did not,” the study said. The participants in the study were “competitive and recreational athletes” from Italy.
The cardiologist pointed to a July 20 study published by Taylor & Francis, which found this specific pain among the majority of participants who took COVID-19 vaccination.
Among the 460 participants in the study, 81.3 percent reported arm pain at the injection site after receiving the first dose of a COVID-19 shot. Following the second dose, 24.9 percent reported arm pain. “Male gender was more likely to present arm pain after the first and the second vaccinations,” it said.
“In our study population, arm pain was inversely associated with SARS-CoV-2 infection before vaccination.” Athletes who were previously infected with COVID-19 were found to be “less likely to present arm pain after the first-dose vaccination.”
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A November 2022 study cited by Dr. McCullough looked at autopsy data from 25 individuals who had “died unexpectedly” within 20 days after COVID-19 vaccination.
Five individuals in the study received mRNA COVID-19 vaccines and died within a week of taking the shots. Four people died after the first injection, while the fifth died after the second dose.
In 80 percent of mRNA vaccine recipients, the study identified “acute (epi-)myocarditis without detection of another significant disease or health constellation that may have caused an unexpected death.”
The researchers discovered simultaneous vaccine-induced inflammation in the heart muscles and deltoid muscles crowning the shoulder. In the heart, the inflammation was found in the epicardium—the outermost protective layer of the organ located above the myocardium.
Dr. McCullough also highlighted a December 2022 report published at the National Library of Medicine, which brought attention to the issue of rising cardiac arrests among athletes.
During a two-year period “from January 2021 to the time of writing, 1,598 athletes suffered cardiac arrest, 1,101 of which with deadly outcome,” it said, citing a study.
This is a higher rate of death compared to a 38‐year timespan between 1966 and 2004 when “1,101 athletes under the age of 35 died (~29/years) due to various heart‐related conditions.”
Citing another study on 301 teenagers between the ages of 13 and 18 who received two doses of the Pfizer vaccine, the report said “29.24 percent of participants experienced cardiovascular complications such [as] tachycardia, palpitations, and 2.33 percent suffered myopericarditis.”
“It is noteworthy that no statistically significant increase in the incidence of myocarditis or pericarditis was observed in un‐vaccinated subjects after SARS‐CoV‐2 infection, in a large population study.”
On the basis of these studies, Dr. McCullough determined that a sore arm can be a “harbinger of future cardiovascular serious adverse events.”
The cardiologist said that he was “amazed at how many people have taken one or more of the COVID-19 vaccines are completely free of side effects.” He suggested that many of the vials of the vaccine may have had “little or no viable mRNA.”
A study from Germany published in the British Journal of Pharmacology journal this month found that both Pfizer and Moderna’s mRNA COVID-19 vaccines formed spike proteins in the human heart cells within 48 hours of injection. Both Pfizer and Moderna triggered different cell abnormalities.
Responding to the study, Dr. McCullough suggested that the different responses the cells had to the two mRNA vaccines could point to an mRNA toxicity reaction in these cells.
Despite studies suggesting the risk of medical complications, some experts continue to advise people to get COVID-19 jabs. According to John Hopkins Medicine, both Pfizer and Moderna are “highly effective in preventing serious disease, hospitalization, and death from COVID-19.”
It recommended people to get a COVID-19 shot as “we believe that their benefits outweigh their risks.”
However, Dr. McCullough advises people to avoid it. He wrote in an Oct. 29 Substack post: “I am not recommending COVID-19 XBB.1.5 boosters, influenza, or respiratory syncytial virus vaccines for healthy adults or children. None of these vaccines are compelling and conditions are easily treatable.”
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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