According to a statement by the company, Pfizer has stopped COVID pill trial after the latest results showed that it did not reduce symptoms, hospitalizations and deaths.
Pfizer has stated it will halt participation in a clinical trial for Paxlovid, its COVID-19 antiviral medication, for standard-risk COVID-19 patients after the most recent findings revealed the medication did not numerically greatly lower symptoms, hospitalizations, or fatalities.
In more than 65 nations, including the United States, Paxlovid, a combination of the antivirals nirmatrelvir and ritonavir, is presently approved or authorized for conditional or emergency use in the treatment of COVID-19 patients at high risk of developing severe illness, including hospitalization or death.
According to a statement made by Pfizer on June 14, it will “cease enrollment into the EPIC-SR trial due to low rate of hospitalization or death in the standard-risk population.”
The business asserted that it will nonetheless incorporate the new information in its impending application to the U.S. Food and Drug Administration (FDA) to request complete authorization for the administration of Paxlovid to high-risk COVID-19 individuals.
“The company will focus efforts on generating further data on PAXLOVID in vulnerable populations, including longer treatment durations in immunocompromised individuals, as well as exploring other clinical development opportunities, such as its potential use in hospitalized patients with severe disease,” Pfizer added.
Patients with COVID-19 who do not have risk factors for serious illness are referred to be standard-risk patients. They may or may not have received vaccinations.
Results From Trial
Paxlovid and a placebo were compared in the August 2021 beginning of the EPIC-SR study in adult patients with symptomatic COVID-19 who are not hospitalized and “are at low risk of progressing to severe illness.”
Pfizer revealed that Paxlovid results fell short of the study’s objective of “self-reported, sustained alleviation of all symptoms for four consecutive days, as compared to placebo” in December 2021.
When contrasted to the placebo group (10 out of 426 hospitalized, with no deaths), the Paxlovid group’s hospitalizations were reduced by 70% (3 out of 428 hospitalizations, with no deaths). But because the findings were not statistically significant, it is possible that chance played a role.
On June 14, Pfizer revealed that an updated assessment of 1,153 patients who had been enrolled through December 2021 had revealed a 51 percent difference between the two groups in terms of hospitalization or death, with five out of 576 patients in the Paxlovid group and 10 out of 569 in the placebo group necessitating hospitalization or passing away. Once more, the outcomes lacked statistical significance.
According to the manufacturer, there was just one death in the placebo group whereas there were none among the patients who took Paxlovid.
People who had received all of their vaccinations and had at least one risk factor for developing severe COVID-19 were initially included in the EPIC-SR investigation; however, after Paxlovid was approved for the cohort in December 2021, this cohort was no longer included in the study. Pfizer then changed its research eligibility requirements to permit participants whose most recent vaccination was 12 months or more ago.
There was a 57 percent risk reduction for hospitalization or death, with three out of 361 in the Paxlovid group and seven out of 360 in the placebo group requiring to be hospitalized or passing away, according to a sub-group analysis of 721 vaccinated individuals with at least one risk factor for progression to severe COVID-19. Pfizer reported that the results were not statistically significant.
Additionally, Paxlovid exhibited a non-significant 62 percent daily reduction in COVID-19-related medical visits across all patients as compared to placebo.
According to a statement from Pfizer’s CEO and chairman, Albert Bourla, the company’s preliminary research findings “support the efficacy and safety profile for PAXLOVID in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status.”
“With up to 40–50 [percent] of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of PAXLOVID,” he added.
Paxlovid decreases COVID-19 hospitalization and mortality by 46%, according to data from a retrospective cohort study conducted in Israel in early June among a highly immunized community. The study said the drug was “more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease.”
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The antiviral medication Paxlovid was not successful in avoiding symptomatic COVID-19 infection in household contacts of the COVID-19 patient who took the tablet, according to a second study in which it failed to yield a statistically significant outcome. Pfizer made this announcement in April.
The United States ended up spending more than $10 billion to purchase 20 million courses of Paxlovid from Pfizer, and the White House has been requesting additional funding from Congress to sustain the purchase of additional courses of the antiviral medication, as well as other treatments and booster doses of vaccines.
The Centers for Disease Control and Prevention (CDC) issued a warning in late May that a few individuals taking Paxlovid may encounter a rebound in COVID-19 symptoms, which means they may experience symptoms again after their symptoms have subsided or test positive for COVID-19 after testing negative.
When the rebound occurred, the CDC stated that it might not have been caused by the medication and that it “may be part of the natural history of SARS-CoV-2” in certain individuals, “independent of treatment with Paxlovid and regardless of vaccination status.”
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Five Things New “Preppers” Forget When Getting Ready for Bad Times Ahead
The preparedness community is growing faster than it has in decades. Even during peak times such as Y2K, the economic downturn of 2008, and Covid, the vast majority of Americans made sure they had plenty of toilet paper but didn’t really stockpile anything else.
Things have changed. There’s a growing anxiety in this presidential election year that has prompted more Americans to get prepared for crazy events in the future. Some of it is being driven by fearmongers, but there are valid concerns with the economy, food supply, pharmaceuticals, the energy grid, and mass rioting that have pushed average Americans into “prepper” mode.
There are degrees of preparedness. One does not have to be a full-blown “doomsday prepper” living off-grid in a secure Montana bunker in order to be ahead of the curve. In many ways, preparedness isn’t about being able to perfectly handle every conceivable situation. It’s about being less dependent on government for as long as possible. Those who have proper “preps” will not be waiting for FEMA to distribute emergency supplies to the desperate masses.
Below are five things people new to preparedness (and sometimes even those with experience) often forget as they get ready. All five are common sense notions that do not rely on doomsday in order to be useful. It may be nice to own a tank during the apocalypse but there’s not much you can do with it until things get really crazy. The recommendations below can have places in the lives of average Americans whether doomsday comes or not.
Note: The information provided by this publication or any related communications is for informational purposes only and should not be considered as financial advice. We do not provide personalized investment, financial, or legal advice.
Secured Wealth
Whether in the bank or held in a retirement account, most Americans feel that their life’s savings is relatively secure. At least they did until the last couple of years when de-banking, geopolitical turmoil, and the threat of Central Bank Digital Currencies reared their ugly heads.
It behooves Americans to diversify their holdings. If there’s a triggering event or series of events that cripple the financial systems or devalue the U.S. Dollar, wealth can evaporate quickly. To hedge against potential turmoil, many Americans are looking in two directions: Crypto and physical precious metals.
There are huge advantages to cryptocurrencies, but there are also inherent risks because “virtual” money can become challenging to spend. Add in the push by central banks and governments to regulate or even replace cryptocurrencies with their own versions they control and the risks amplify. There’s nothing wrong with cryptocurrencies today but things can change rapidly.
As for physical precious metals, many Americans pay cash to keep plenty on hand in their safe. Rolling over or transferring retirement accounts into self-directed IRAs is also a popular option, but there are caveats. It can often take weeks or even months to get the gold and silver shipped if the owner chooses to close their account. This is why Genesis Gold Group stands out. Their relationship with the depositories allows for rapid closure and shipping, often in less than 10 days from the time the account holder makes their move. This can come in handy if things appear to be heading south.
Lots of Potable Water
One of the biggest shocks that hit new preppers is understanding how much potable water they need in order to survive. Experts claim one gallon of water per person per day is necessary. Even the most conservative estimates put it at over half-a-gallon. That means that for a family of four, they’ll need around 120 gallons of water to survive for a month if the taps turn off and the stores empty out.
Being near a fresh water source, whether it’s a river, lake, or well, is a best practice among experienced preppers. It’s necessary to have a water filter as well, even if the taps are still working. Many refuse to drink tap water even when there is no emergency. Berkey was our previous favorite but they’re under attack from regulators so the Alexapure systems are solid replacements.
For those in the city or away from fresh water sources, storage is the best option. This can be challenging because proper water storage containers take up a lot of room and are difficult to move if the need arises. For “bug in” situations, having a larger container that stores hundreds or even thousands of gallons is better than stacking 1-5 gallon containers. Unfortunately, they won’t be easily transportable and they can cost a lot to install.
Water is critical. If chaos erupts and water infrastructure is compromised, having a large backup supply can be lifesaving.
Pharmaceuticals and Medical Supplies
There are multiple threats specific to the medical supply chain. With Chinese and Indian imports accounting for over 90% of pharmaceutical ingredients in the United States, deteriorating relations could make it impossible to get the medicines and antibiotics many of us need.
Stocking up many prescription medications can be hard. Doctors generally do not like to prescribe large batches of drugs even if they are shelf-stable for extended periods of time. It is a best practice to ask your doctor if they can prescribe a larger amount. Today, some are sympathetic to concerns about pharmacies running out or becoming inaccessible. Tell them your concerns. It’s worth a shot. The worst they can do is say no.
If your doctor is unwilling to help you stock up on medicines, then Jase Medical is a good alternative. Through telehealth, they can prescribe daily meds or antibiotics that are shipped to your door. As proponents of medical freedom, they empathize with those who want to have enough medical supplies on hand in case things go wrong.
Energy Sources
The vast majority of Americans are locked into the grid. This has proven to be a massive liability when the grid goes down. Unfortunately, there are no inexpensive remedies.
Those living off-grid had to either spend a lot of money or effort (or both) to get their alternative energy sources like solar set up. For those who do not want to go so far, it’s still a best practice to have backup power sources. Diesel generators and portable solar panels are the two most popular, and while they’re not inexpensive they are not out of reach of most Americans who are concerned about being without power for extended periods of time.
Natural gas is another necessity for many, but that’s far more challenging to replace. Having alternatives for heating and cooking that can be powered if gas and electric grids go down is important. Have a backup for items that require power such as manual can openers. If you’re stuck eating canned foods for a while and all you have is an electric opener, you’ll have problems.
Don’t Forget the Protein
When most think about “prepping,” they think about their food supply. More Americans are turning to gardening and homesteading as ways to produce their own food. Others are working with local farmers and ranchers to purchase directly from the sources. This is a good idea whether doomsday comes or not, but it’s particularly important if the food supply chain is broken.
Most grocery stores have about one to two weeks worth of food, as do most American households. Grocers rely heavily on truckers to receive their ongoing shipments. In a crisis, the current process can fail. It behooves Americans for multiple reasons to localize their food purchases as much as possible.
Long-term storage is another popular option. Canned foods, MREs, and freeze dried meals are selling out quickly even as prices rise. But one component that is conspicuously absent in shelf-stable food is high-quality protein. Most survival food companies offer low quality “protein buckets” or cans of meat, but they are often barely edible.
Prepper All-Naturals offers premium cuts of steak that have been cooked sous vide and freeze dried to give them a 25-year shelf life. They offer Ribeye, NY Strip, and Tenderloin among others.
Having buckets of beans and rice is a good start, but keeping a solid supply of high-quality protein isn’t just healthier. It can help a family maintain normalcy through crises.
Prepare Without Fear
With all the challenges we face as Americans today, it can be emotionally draining. Citizens are scared and there’s nothing irrational about their concerns. Being prepared and making lifestyle changes to secure necessities can go a long way toward overcoming the fears that plague us. We should hope and pray for the best but prepare for the worst. And if the worst does come, then knowing we did what we could to be ready for it will help us face those challenges with confidence.
