Pfizer’s Paxlovid was granted emergency use authorization for the treatment of mild to moderate COVID-19 in December 2021.first The drugs include nirmatrelvir tablets – the antiviral ingredient – and ritonavir tablets, which are meant to slow the breakdown of nirmatrelvir.2
What started out as a slow rollout – with just 40,000 or fewer prescriptions written in the US each week through April 2022 – has been a success, with more than 160,000 Paxlovid prescriptions now being released each week.3 As of June 30, 2022, 1.6 million courses of Paxlovid have been prescribed in the United States since emergency use approval in December.4
However, this increase in prescriptions may be contributing to one of the drug’s dramatic declines – creating selective pressure on SARS-CoV-2, promoting mutations that could make it resistant. medicine.5 The US Centers for Disease Control and Prevention also issued a warning to healthcare providers and public health departments about the potential for a resurgence of COVID-19 following treatment with Paxlovid. .6
This recently happened to Dr Anthony Fauci, Director of the US National Institute of Allergy and Infectious Diseases (NIAID), who experienced a return of COVID-19 symptoms after taking Paxlovid. He then took a second drug, which can trigger more mutations in the virus.
Paxlovid triggers Fauci .’s COVID-19 recovery
Fauci said he tested positive for COVID-19, with only minimal symptoms. As his symptoms increased, he took Paxlovid for 5 days, then he tested negative for 3 days in a row. On the fourth day of testing, he tested positive for COVID-19 again, with symptoms worse than the first.
“That’s what people are referring to as a Paxlovid recovery,” he said. “…About the next day or so, I started to feel really bad, much worse than when I was walking for the first time.”7 He was then prescribed a second course of Paxlovid.
On June 30, he said, “I’m back in Paxlovid, and right now I’m on the fourth day of a five-day course of my second Paxlovid course. Fortunately, I feel reasonable. I mean, I’m not completely symptom-free, but I certainly don’t feel very ill.”8 In the CDC’s health advice regarding COVID-19 recovery after treatment with Paxlovid, it states:9
“Recent case reports document that some patients with a normal immune response who completed a 5-day course of Paxlovid for laboratory-confirmed infection may have relapsed. sick 2 to 8 days later, including those vaccinated and/or booster…
These COVID-19 recoveries tested negative after Paxlovid treatment and had a positive viral antigen and/or reverse transcriptase polymerase chain reaction (RT-PCR) test result afterwards. “.
COVID-19 Still Spreading During Paxlovid Recovery
People taking Paxlovid can still transmit COVID-19 to others, even if they have no symptoms, according to an earlier study.ten Study author Dr. Michael Charness of the Veterans Administration Medical Center in Boston told CNN, “People who undergo recovery are at risk of transmitting the disease to others, even though they are outside of those areas. what people accept as the usual window to be able to transmit.”11
CDCtwelfth and Pfizer13 has suggested that sometimes COVID-19 spontaneously returns after a person tests negative, implying that the COVID-19 recovery is spontaneous and not necessarily related to Paxlovid. However, Charness and colleagues did not find this to be the case. When they analyzed 1,000 confirmed cases of COVID-19 among members of the National Basketball Association – none of whom took Paxlovid – no recovered cases of COVID-19 were found.14
The study was published in the Journal of Clinical Infectious Diseases15 looked at why Paxlovid could lead to rebound symptoms and showed it could be the result of insufficient exposure to the drug.16 “Not enough drug reaches infected cells to stop all viral replication,” UC San Diego Health reports, UC San Diego Health reports. “They suggest this could be because the drug is metabolized more quickly in some people or the drug needs to be delivered over a longer treatment period.”17
Pfizer seeks FDA approval for Paxlovid
Despite many questions regarding Paxlovid’s association with recurrent infections, Pfizer proceeded and sought full approval of the drug from the FDA.18 A drug’s emergency use license restricts to whom the drug can be sold and marketed. Once fully approved by the FDA, Pfizer can market the drug directly to consumers.
Paxlovid’s emergency use authorization allows it to be prescribed to adults and children 12 years of age and older who are at high risk of developing severe COVID-19.19 Pfizer estimates that up to 60% of the U.S. population meets these criteria and has at least one risk factor for severe illness, such as obesity or diabetes, that makes them eligible for the drug.20
However, concerns have grown about whether Paxlovid, thought to be able to reduce the risk of hospitalization or death by 86% in high-risk patients, when taken within five days of symptoms symptoms begin,21 effective in people who are not at high risk.
In fact, Pfizer stopped a large trial of Paxlovid in standard-risk patients because it did not show significant protection against hospitalization or death in this group.22 According to a news release from Pfizer:23
“In previously reported interim analyses, the company revealed that the new primary criterion of self-report, continuous relief of all symptoms for four consecutive days was not met and the level of A relative insignificant 70% risk reduction was observed at the important secondary endpoint. hospitalization or death (treatment arm: 3/428; placebo: 10/426).
An updated analysis of 1,153 patients enrolled through December 2021 showed a 51% relative risk reduction (treatment arm: 5/576; placebo: 10/569). A subgroup analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a relatively insignificant 57% reduction in risk for hospitalization or death (treatment arm). : 3/361; placebo: 7/360). “
Does Paxlovid cause SARS-CoV-2 mutations?
Early reports suggested that SARS-CoV-2 did not mutate and become resistant to Paxlovid, but some experts believe it is only a matter of time before this happens – and new research suggests it has. happen.
David Ho, a virologist at the Aaron Diamond Center for AIDS Research at Columbia University, was one of the first to document resistance mutations in HIV 30 years ago and believes the same could happen with HIV. SARS-CoV-2.24 He has also experienced firsthand the recovery from Paxlovid COVID-19. Bloomberg reported:25
“Cough said he took COVID on April 6… The doctor prescribed Paxlovid, and within a few days of taking it, his symptoms disappeared and the tests turned negative. . But 10 days after first getting sick, his symptoms returned and his test turned positive in two more days.
Ho said he sequenced his own virus and discovered that both infections were from the same strain, confirming that the virus had not mutated and became resistant to Paxlovid. A second family member who also contracted the disease at the same time also had symptoms and the virus recurred after Paxlovid, Ho said.
“It surprised me,” he said. ‘Until that time, I had not heard of such cases elsewhere.’ While the reason for the recovery remains unclear, Ho hypothesized that it may occur when a small percentage of cells infected with the virus may persist and continue pumping out generations of virus. after treatment is stopped. “
Studies show that the COVID-19 Virus is developing resistance to Paxlovid
Two separate studies cultured SARS-CoV-2 in the lab and exposed it to low levels of nirmatrelvir, which can kill some, but not all, of the virus. “Such trials are intended to simulate what might happen in an infected person who is not on the full drug regimen or an immunocompromised patient who has difficulty clearing the virus,” Science reports. .26
One of the studies revealed that SARS-CoV-2 developed three mutations after 12 rounds of nirmatrelvir treatment — “at positions 50, 166, and 167 in the amino acid sequence that makes up MPRO.”27 The mutations reduce the virus’s susceptibility to nirmatrelvir 20-fold.28 Other research29 also found mutations at positions 50 and 166, suggesting that when they occur together, SARS-CoV-2 becomes 80 times less susceptible to nirmatrelvir. Base on the research:30
“Reverse genetic studies in a homologous infection cell culture system showed 80-fold increased resistance due to the combination of L50F and E166V substitutions. Resistance variants have high fitness that increases the likelihood of emergence and spread of resistance. “
Study lead author Judith Margarete Gottwein from the University of Copenhagen told Science, “This tells us which mutations we should look for. [in patients]. “thirty first Ho, who was not involved in these studies, agrees that the occurrence of mutations is an inevitable outcome.
He told Science, “when you put pressure on the virus it comes out… With the amount of infections out there, it’s coming.”32 It’s also completely unknown what can happen when two courses of Paxlovid are given in quick succession to treat a COVID-19 recovery – as happened with Fauci. It is possible to create COVID-19 variants that are always mutating.
Other antiviral drugs on the market to treat COVID-19 have also led to concerns about mutations. Molnupiravir (sold under the brand name Lagevrio) was developed by Merck and Ridgeback Therapeutics and was approved by the FDA for emergency use on December 23, 2021, for high-risk patients with COVID symptoms from mild to moderate.
However, it can not only contribute to cancer and birth defects, but it can also increase the rate at which the virus mutates inside patients, leading to newer and more resistant variants.33
Other early COVID-19 treatments ignored
Using drugs that cause high rates of organ failure, like remdesivir, and drugs that cause the virus to flare up again with the intent of revenge, like Paxlovid, and capable of causing mutations do not appear to be beneficial. for public health. The fact that US health authorities have focused on these drugs to the exclusion of all others, including older drugs with high rates of effectiveness and superior safety, sends out a very disturbing message.
A Cornell University investigation, posted on the school’s preprint server on January 20, 2022, found that ivermectin outperformed 10 other drugs against COVID-19, making it the most effective against COVID-19 the Omicron variant.34 It even outperformed Paxlovid, but it has been vilified by health officials and the mainstream media.
Remdesivir costs from $2,340 to $3,120,35 and nirmatrelvir costs $529 for each five-day treatment,36 while the average cost of treatment for ivermectin is $58.37 Do you think this has something to do with the defamation of ivermectin?
Paxlovid alone cost US taxpayers $5.29 billion,38 while safer and less expensive options still exist. Pierre Kory, a member of the team that formed the Frontline COVID-19 Critical Care Working Group (FLCCC) to promote early treatments for COVID-19, pleaded with the US government from the outset. During the pandemic, a review of the extensive data on ivermectin to prevent COVID-19, keep people with initial symptoms from progressing, and help critically ill patients recover – to no avail.39,40
However, if you want to learn more about its potential applications for SARS-CoV-2, you can download the full FLCCC I-MASK+ protocol,41 provides you with step-by-step instructions on how to prevent and treat early symptoms of COVID-19.
