The FDA has authorized an early COVID treatment protocol

By James Stansbury, AM THINKER

After nearly a year-and-a-half and over 618,000 recorded COVID-related deaths in the U.S. alone, the FDA has finally released an emergency use authorization for REGEN-COV, a new drug that was being tested in 2020 (pre-Biden). Primary care physicians can now use it as an early treatment option. Before now, the only authorized COVID-19 early treatment my family doctor had, per the July 2021 update to NIH guidelines, was to recommend quarantine and then wait until symptoms go away or report to a hospital if they get worse. Of note, these updated guidelines continue to identify hydroxychloroquine (HCQ) as a prohibited drug – although this should not be a surprise considering the war on HCQ began soon after President Trump dared to recommend it.

REGEN-COV, however, is no simple take-home medicine like the familiar Tamiflu frequently prescribed in the past for the seasonal flu. For example, in the “old days” that ended in March 2020, my wife and I both caught the seasonal flu. Our doctor immediately prescribed Tamiflu and azithromycin because he knew that delaying even a few days would make Tamiflu less effective. Like Tamiflu, REGEN-COV is similarly recommended only for early use before severe symptoms can develop.

Once the initial surge of COVID-19 cases and deaths started in March-April 2020, the seasonal flu magically vanished along with Tamiflu despite some early indications it works on COVID. Coincidentally with its approving a new drug, the CDC is finally pulling the plug on the PCR test for COVID-19. The PCR test often gave false positives and can misidentify the seasonal flu as COVID-19 (although it will remain in use through the end of 2021).

According to the FDA fact sheet on REGEN-COV, the intravenous infusion process it requires appears time-consuming (it can take 20 to 50 minutes or more, with a one-hour monitoring period immediately after). For now, the FDA recommends it for use only on confirmed COVID-19 patients over the age of 12 who are at high risk of developing severe symptoms. However, the fact sheet permits some flexibility in using it as a preventative to especially high-risk patients. It sounds so promising that the FDA was careful to say it is not a substitute for the vaccines.

The FDA has known from the beginning that early treatment of COVID-19 is essential, yet it chose to ignore India’s great success with its initial early treatment protocol that initially included HCQ. However, when the Delta variant arrived in India, it appeared more resistant to HCQ, so India immediately approved and widely distributed a new more potent outpatient COVID kit consisting of Ivermectin, Doxycycline, and Zinc. This less-than-$3 kit quickly reversed the Delta variant death trend there. dose of REGEN-COV proved more elusive; ranging from $10 to $2,100 per dose. Grab your “Good Rx” card, just in case.

REGEN-COV and all the medications used in India appear to work similarly by calming the characteristic overreaction of the body’s auto-immune system (cytokine storm) that COVID-19 can trigger in some patients with compromised immune systems. Advanced age is a major factor, notably from Vitamin D deficiency. If the cytokine storm can be controlled early, the immune system can work properly and produce the antibodies that kill the virus.

To oversimplify the process, the virus triggers an overproduction of white blood cells that mistakenly attack the body instead of the virus. The resulting internal inflammation is the primary cause of severe symptoms and deaths — usually pneumonia, but a secondary contributor is a blood clotting response affecting critical organs, including the lungs.

Never forget that this war against these inexpensive drugs was not limited to the US. It was also fought in most western countries, including the UK and Sweden. However, Sweden, known for its risky minimal mask and lockdowns mandates, has apparently achieved herd immunity. (Its average daily deaths since mid-July 2021 have remained below 0.1 and are continuing steady at 0.01 in mid-August.) Sweden achieved this herd immunity in time to avoid new deaths from the Delta variant.

By comparison, neither the US nor UK have avoided the Delta variant, despite their more rigid mask rules, lockdowns, and higher vaccination rates. In fact, the lockdowns may have delayed achieving herd immunity in time to avoid the spread of the new Delta variant. India with fewer than 10% vaccinated is also nearing herd immunity and has had far fewer per capita deaths than most for the entire pandemic. You can monitor the death trends of these four countries here.

Having spent most of my career as an analyst, I wondered what the outcome would have been if Sweden, the UK, and the US had discovered something like REGEN-COV when the pandemic started or had the courage to permit using India’s inexpensive early outpatient treatment protocols. This question can be simplistically answered by using India’s reported 331 cumulative deaths per million as the best possible expected outcome (assuming the results for REGEN-COV would have been similar) and multiplying that same number of deaths (311/million) by the populations of the three western countries:

The potentially avoidable death counts in the last column (in red) are beyond alarming. The results in the next to last column (in green) resemble the expected deaths in a normal seasonal flu year. Obviously, the skeptics will reject this result by saying that there are many other factors that would have ruled out this overly optimistic result. Examples include questioning the accuracy of India’s data, the difference in average ages of each country’s population (India has far more young people), and the lack of domestic manufacturing and supply chain resources to produce and distribute the needed drugs.

Nevertheless, the results do raise questions about the wisdom of the government medical establishment’s decision to delay authorizing any early treatment protocols and, instead, gambling on the vaccines’ timely arrival or the hope that something new (and more profitable), such as REGEN-COV, would magically appear. We cannot change history, but we should have the wisdom to learn from it.

August 20, 2021 | 14 Comments »

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  1. Anyone thinking that the CDC is monitoring breakthrough cases should read this article. None of this should be surprising, but I believe few people are aware of the unfortunate truth that the CDC purposely stopped monitoring breakthrough cases months ago, so that they didn’t portray the vax as unreliable. Here are some highlights from the article cited below:

    The nation is flying blind yet again, critics say, because on May 1 of this year — as the new variant found a foothold in the U.S. — the Centers for Disease Control and Prevention mostly stopped tracking COVID-19 in vaccinated people, also known as breakthrough cases, unless the illness was severe enough to cause hospitalization or death.

    Individual states now set their own criteria for collecting data on breakthrough cases, resulting in a muddled grasp of COVID-19’s impact, leaving experts in the dark as to the true number of infections among the vaccinated, whether or not vaccinated people can develop long-haul illness, and the risks to unvaccinated children as they return to school.

    Under pressure from some health experts, the CDC announced Wednesday that it will create a new outbreak analysis and forecast center, tapping experts in the private sector and public health to guide it to better predict how diseases spread and to act quickly during an outbreak.

    Tracking only some data and not releasing it sooner or more fully, critics say, leaves a gaping hole in the nation’s understanding of the disease at a time when it most needs information….

    “I was shocked,” said Dr. Leana Wen, a physician and visiting professor of health policy and management at George Washington University. “I have yet to hear a coherent explanation of why they stopped tracking this information.”

    The CDC said in an emailed statement to ProPublica that it decided to focus on the most serious cases because officials believed more targeted data collection would better inform “response research, decisions, and policy.”
    ….

    When the CDC halted its tracking of all but the most severe cases, local and state health departments were left to make up their own rules.

    There is now little consistency from state to state or even county to county on what information is gathered about breakthrough cases, how often it is publicly shared, or if it is shared at all.
    ….

    “We’ve had a patchwork of information between states since the beginning of the pandemic,” said Jen Kates, senior vice president and director of global health and HIV policy at Kaiser Family Foundation.

    She is co-author of a July 30 study that found breakthrough cases across the U.S. remained rare, especially those leading to hospitalization or death. However, the study acknowledged that information was limited because state reporting was spotty. Only half the states provide some data on COVID-19 illnesses in vaccinated people.

    “There is no single, public repository for data by state or data on breakthrough infections, since the CDC stopped monitoring them,” the report said.

    https://www.propublica.org/article/the-cdc-only-tracks-a-fraction-of-breakthrough-covid-19-infections-even-as-cases-surge

  2. From the Israeli-Pfiezer contract as found by the @Ehden @ T.ME/EH_DEN who exposed the Pfiezer contracts

    The Israeli MoH is “allowed” to communicate to the public anything OTHER THAN what they “measure and analyze (in the) epidemiological data arising from the Product rollout”

    So all epidemiological info relating to the results/side-effects of the Israeli medical experiment are only to be released if Pfiezer agrees. This is likely why the US data is not being collected or reported as well.

  3. FDA approving Pfizer(39% effective per Bloomberg) in the US on Mon. per NYT and Reuters. This would halt all other vax which are still under EUA, unless normal protocol is not followed, so, who know.

    U.S. FDA aims to give full approval to Pfizer vaccine on Monday -NYT
    Reuters

    2 minute read
    Doses of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine are seen at a COVID-19 vaccination centre in Seoul, South Korea, March 10, 2021. REUTERS/Kim Hong-Ji

    Doses of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine are seen at a COVID-19 vaccination centre in Seoul, South Korea, March 10, 2021. REUTERS/Kim Hong-Ji

    WASHINGTON, Aug 20 (Reuters) – The U.S. Food and Drug Administration is aiming to give full approval to Pfizer’s (PFE.N) COVID-19 vaccine on Monday, the New York Times reported on Friday.

    Regulators were aiming to complete the process by Friday, but were still working through “a substantial amount of paperwork and negotiation with the company,” the Times said, citing people familiar with the planning who were not authorized to speak publicly about it.

    The agency declined to comment.

    It had set an unofficial deadline for approval of around Labor Day on Sept. 6, the report said.

    The approval could boost the vaccination campaign by convincing more unvaccinated Americans that Pfizer’s shot is safe and effective and also make local officials more comfortable in implementing vaccine mandates. read more

    The U.S. military is expected to require that service members get vaccinated soon after Pfizer’s shot is authorized and other major U.S. employers could follow suit. read more

    Vaccine hesitancy has been a major hurdle to the White House’s goal of getting all eligible Americans vaccinated against the coronavirus.

    Only around 60% of adults aged 18 and over have been fully vaccinated even as the new Delta variant of COVID-19 has contributed to a surge in cases.

    Full approval of Pfizer’s shot would also make it easier for physicians to prescribe a third booster shot to people who could benefit from an additional dose.

    The FDA has authorized Pfizer’s shot as a booster for people with weakened immune systems, but the White House plans to offer them much more widely in the coming months. read more

    The White House earlier this week said it plans to give out 100 million booster shots, many supplied by Pfizer, to at-risk Americans, including anyone whose initial inoculation is more than 8 months old, starting in September.

    Some experts, including at the World Health Organization say there is not yet enough data be certain boosters are needed.

    Pfizer’s vaccine was authorized for emergency use in December and more than 203 million people in the United States have so far received it. None of the three authorized COVID-19 vaccines have received full FDA approval.
    Reporting by Katanga Johnson, Michael Erman and Manojna Maddipatla; Editing by Arun Koyyur, Daniel Wallis and Chris Reese

  4. 1.5million vaccine injuries and 15,472 deaths in just 27 of 50 European countries!!

    Shock: European Union Reports 1.5 Million Vaccine Injuries, 15,472 Deaths

    The European database of suspected drug reaction reports is EudraVigilance, which also tracks reports of injuries and deaths following the experimental COVID-19 “vaccines.”

    A subscriber from Europe recently emailed us and reminded us that this database maintained at EudraVigilance is only for countries in Europe who are part of the European Union (EU), which comprises 27 countries.

    The total number of countries in Europe is much higher, almost twice as many, numbering around 50, although there are some differences of opinion as to which countries are technically part of Europe.

    So as high as these numbers are, they do NOT reflect all of Europe. The actual number in Europe who are reported dead or injured due to COVID-19 shots would be much higher than what we are reporting here.

    The EudraVigilance database reports that through June 19, 2021 there are 15,472 deaths and 1,509,266 injuries reported following injections of four experimental COVID-19 shots:

    COVID-19 MRNA VACCINE MODERNA (CX-024414)
    COVID-19 MRNA VACCINE PFIZER-BIONTECH
    COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)
    COVID-19 VACCINE JANSSEN (AD26.COV2.S)

    From the total of injuries recorded, half of them (753,657) are serious injuries.

    “Seriousness provides information on the suspected undesirable effect; it can be classified as ‘serious’ if it corresponds to a medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation, results in another medically important condition, or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.”

    A Health Impact News subscriber in Europe ran the reports for each of the four COVID-19 shots we are including here. This subscriber has volunteered to do this, and it is a lot of work to tabulate each reaction with injuries and fatalities, since there is no place on the EudraVigilance system we have found that tabulates all the results.

    Since we have started publishing this, others from Europe have also calculated the numbers and confirmed the totals.[1]

    The full article can be found at
    https://www.technocracy.news/shock-european-union-reports-1-5-million-vaccine-injuries-15472-deaths/

  5. The report about Jesse Jackson that I just clipped is from The Hill.

    I find it interesting that Jackson and his wife are ill enough to hospitalized, although apparently fully vaccinated.

  6. Civil rights leader Jesse Jackson hospitalized with COVID-19
    Celine Castronuovo08/21/21 08:57 PM EDT
    Civil rights leader Jesse Jackson hospitalized with COVID-19
    © Getty Images

    The Rev. Jesse Jackson and his wife have both been hospitalized with COVID-19, according to a statement from the civil rights leader’s Chicago-based nonprofit organization.

    The Rainbow PUSH Coalition said in a statement that Jackson, who previously received the COVID-19 vaccine, was being treated at Northwestern Memorial Hospital in Chicago, along with his 77-year-old wife, Jacqueline.

    “Doctors are currently monitoring the condition of both,” the statement said of Jackson, 79, and his wife, according to The Associated Press.

    While the organization did not provide any additional details on the couple’s conditions, it urged anyone who has had close contact with either of them within the past five or six days to follow guidelines from the Centers for Disease Control and Prevention (CDC).

    The CDC currently advises that unvaccinated individuals who have come into contact with someone who tested positive for COVID-19 should quarantine for 14 days, but can end their quarantine if they have no symptoms and test negative after the seventh day.

    Those fully vaccinated who have come into contact with an infected person are advised to wait three to five days before taking a COVID-19 test, and do not need to quarantine following exposure.

    The AP said that the organization noted there were “no further updates at this time,” but that more details would be provided “as they become available.”

    The Hill has reached out to the coalition for additional information.

    Jackson, an apprentice of the Rev. Martin Luther King, Jr., and a central leader of the modern civil rights movement, received his first dose of the COVID-19 vaccine in January in a publicized event to help promote vaccinations among Black and other minority communities.

    “I was honored to receive my first dose, and I strongly urge others to join me,” he said in a statement at the time.

    Jackson announced in 2017 that he had Parkinson’s disease, a chronic neurological disorder that causes movement and mobility challenges.

    According to Chicago NBC affiliate WMAQ, the civil rights leader was admitted to Northwestern’s hospital in January for “abdominal discomfort” and underwent gallbladder surgery.

  7. @Raphael
    It is used for other diseases such as lupus, and this poitical debate has made it difficult to obtain for those who have had prescriptions for years, as some pharmacists in the US have been motivated to challenge and deny filling such prescriptions. So, you have to contact a doctor willing to prescribe it and a pharmacy willing to fill it. If you need a doctor that will provide treatment, you can go to americasfrontlinedoctors.org and they can provide you with a doctor or telemedicine appt. to get treatment, if it is warranted.

    Dr. Urso has 30+ drugs including Budesimide that he reports very good results with different combinations. The key is treating early with an appropriate combination of drugs and immune supportive nutrients.

  8. What ever happened to Hyroxy… after it was banned? Can it be prescribed for anything? Just wondering.

    It seems that Iverm… gets used in some cases.

    This leaves me wondering how one would actually go about getting the type of treatment that they desire, (after consultation with their doctor, of course).

    I was interested to see an article, recently, (maybe here on Israpundit?), which told of an Israeli study which found at least 18 existing drugs which have a positive effect on the virus.

    FWIW, a close friend who is over 70, got C_v_id, and went out state to TX, where a doctor prescribed a cocktail of vitamins, minerals, and the drug Budesinide. It fixed him up in just a few days.

    So, why all of this falldeerah about dangerous, untested, vaccinations, when there are, apparently, plenty of possible treatments for the disease?

  9. The timely and judicious use of HCQ and Ivermectin with other supplements (other antibiotics, vits, etc.) are very effective but too CHEAP!

  10. This just in from CNN:

    Sens. Hickenlooper, Wicker and King test positive for Covid after being fully vaccinated
    Thomas Franck
    Sen. Angus King, I-Maine, left, Sen. Roger Wicker (R-MS)
    Sen. Angus King, I-Maine, left, Sen. Roger Wicker (R-MS)
    Bill Clark/CQ-Roll Call, Inc via Getty Images; Tom Williams-Pool | Getty Images
    Sens. Roger Wicker, Angus King, and John Hickenlooper, who are all vaccinated for the coronavirus, tested positive for Covid-19 on Thursday after experiencing symptoms.

    Wicker, King and Hickenlooper are the latest in a string of prominent politicians to announce positive coronavirus tests in recent weeks despite being fully vaccinated. Others include Republicans Sen. Lindsey Graham of South Carolina and Gov. Greg Abbott of Texas.

    “Senator Wicker is fully vaccinated against COVID-19, is in good health, and is being treated by his Tupelo-based physician,” Phillip Waller, Wicker’s communications director, said in a statement. The 70-year-old Wicker “is isolating, and everyone with whom Senator Wicker has come in close contact recently has been notified.”

    The Senate is in recess this week, and many of the chamber’s members are in home states either preparing for 2022 elections or checking in with district offices. Wicker is a Republican from Mississippi, King is an independent from Maine and Hickenlooper is a Democrat from Colorado.

    Former Colorado Governor John Hickenlooper delivers a 20-minute campaign speech at the Des Moines Register Political Soapbox at the Iowa State Fair August 10, 2019 in Des Moines, Iowa.

    Chip Somodevilla | Getty Images

    “Despite all my efforts, when I began feeling mildly feverish yesterday, I took a test this morning at my doctor’s suggestion, and it came back positive,” King, 77, said in a statement. “While I am not feeling great, I’m definitely feeling much better than I would have without the vaccine.”

    The three positive tests came as the Biden administration ramps up efforts to encourage Americans to seek booster shots starting next month amid a growing pool of data that shows vaccine protections fade over time.

    “After experiencing mild symptoms, I tested positive for a breakthrough case of COVID-19,” Hickenlooper said in a statement Thursday afternoon. “I’m feeling much better and will continue to isolate at the direction of the Congressional Attending Physician. I’m grateful for the vaccine (and the scientists behind it) for limiting my symptoms and allowing us to continue our work for Colorado.”

    Three of Washington’s top health experts on Wednesday provided further details on how the immune system’s protections wane over time.

    It’s now “very clear” that immunity starts to fall after the initial two doses, and with the dominance of the delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease,” according to a statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.

    Sen. Angus King (I-Maine) holds a chart as bipartisan members of the Senate and House gather to announce a framework for fresh coronavirus relief legislation at a news conference on Capitol Hill on Dec. 1, 2020.

    Kevin Lemarque | Reuters

    New Covid-19 cases are emerging at their highest rates since winter as the delta variant of the coronavirus sweeps across the U.S. Health experts blame its rapid spread for the uptick in case counts and deaths as a growing number of so-called “breakthrough” cases show fully vaccinated people are still at risk.

    More than 140,000 new cases and 822 deaths were reported in the U.S. on Monday, according to the Centers for Disease Control and Prevention. The number of new daily deaths has more than doubled since the start of August.

    The situation in Florida and Texas is especially grim, with case counts in both states blowing past records and overwhelming hospital systems.

  11. @peloni Peloni, you put the reply on the right page. From listening to one of Dr. McCullough’s videos on his site and YouTube,, his testimony before the Texas Senate’s committee on public health, he said that he recommended this and other medications only in “coktails’ of meds, not for use alone. He also mentioned another med prominently–not hydroxiqloriqine or ivermectin, but another one that he has had much success with treating patients at Baylor Medical Center at Texas A&M.

    However, he stressed that all of the meds he recommends have to be used as “cocktails” with other meds, vitamin supplements and minerals-zinc, vitamin supplements, and a mild antibiotic as prophylaxis in most of these “cocktails.

    It is possible to find physicians in most parts of the country who are able to obtain these medications and are competent to prescribe them, Dr. McCullough says, in a directory made available on the web site of the Association of American Physicians and surgeons.

  12. @Adam
    It’s not a new treatment. These are monoclonal antibodies that have been available to everyone since last year when they were developed. They are part of Dr. McCullough’s outpatient treatment plan that he wrote last year. The FDA has only now authorize their emergency use.

    Covid is a thromboembolic-inflammatory disease. ie a disease of bloodclots and inflammation. These antibodies do not eliminate either of these processes. It only prevents free floating viruses from floating freely, and only if the antibodies are capable of recognizing this recent variant, as it was developed over 1yr ago – probably against what they are calling Alfa, I believe. The antibodies are not useful to stop any viral replication. It doesn’t block viral uptake into cells, it doesn’t block the virus taking over the cell’s manufacturing capablities(analogy), it doesn’t prevent massive virus replication from taking place and it doesn’t address the inflammatory cytokine storm and inflammation that results in blood clots, other disease complications and death.

    To use this as the only treatment for Covid would be very limited care, indeed. If the antibodies are effective and clear the free floating virus, the inflammation and blood clots will still remain unhindered. So it is no cure, but can help. Dr. McCullough does recommend the use of these antibodies, as their use is intended to rid the free floating virus from freely circulating, but his view is that it can help and can’t hurt, ie unknown efficacy(sound familiar). The use of these antibodies has been kept silent from the public over the past year, ie no govt advocacy of their use, which McCullough has been calling for over the past year. So, it is good that they have finally found something beyond the useless(and some claim harmful) Remdisavir to recommend to treat Covid with, but it is a very small step towards treatment. Still their EUA may be helpful to alert the general public of their existence, every hospital has had them available, but no doctor was authorized to recommend them to you, ie you had to ask for them to be used. I suspect Pharma/FDA are likely hoping to stave off any debate about early treatment by abcuring the subject with this “early treatment” which is quite an incomplete(at best) treatment to Covid.

    It should be noted that these antibodies are contra-indicated if ADE(antibody dependent enhancement) is found to be present(recall this is where the immune system protects the virus and carries it to hard to reach parts of the body). Partially effective antibodies are the very thing that creates and sustains ADE, which is the problem with continuing to use leaky vaccines, a very dangerous possibility that has very clearly been seen in animal testing this past Jan.

    Sorry, posted on wrong page.