Is Pfizer’s New Antiviral Drug Dangerous for the Vaccinated?

The company excluded patients who had been vaccinated against Covid-19 from its clinical trial of Paxlovid. Now some vaccinated Covid patients who take the drug are having trouble clearing the virus.

Hat tip to Igor Chudov, who covered this story on his Substack page nearly two weeks ago.  Members of the mainstream media are finally catching up and reporting today that some patients who take Paxlovid, a Pfizer antiviral for Covid that was authorized by the FDA in December, are suddenly relapsing with Covid symptoms after appearing to be recovered.  Genomic sequencing indicates that these patients are not being reinfected.  Nor is there any evidence that the virus has suddenly mutated to make it resistant to the drug.  Rather, the patients simply are struggling to clear the virus.    

As Chudov noted: “It turns out that Paxlovid reduces symptoms, and maybe reduces viral load at day 5, but at the same time it does not clear the virus! Not only that, but the patients cannot clear it for extended periods AFTER Paxlovid administration is over.” [1]

Chudov’s excellent Substack piece included numerous online anecdotes of Covid patients who took the drug and seemed to recover from Covid, only to relapse days later with sometimes-serious symptoms.  Most of the patients in these anecdotes described themselves as being fully vaccinated. Some said they were boosted.  

According to a CNN article published online today, Pfizer claims that “a small number” of patients in both the treatment and placebo arms of the clinical trial for Paxlovid experienced higher viral loads 10 to 14 days after starting treatment relative to their viral loads at Day Five.  The company said that because it happened in both arms of the trial, the finding was unrelated to the drug.

However, what both Pfizer and CNN failed to note is that Pfizer excluded Covid-vaccinated patients from its clinical trial of the drug:

Inclusion/exclusion criteria specified that subjects had to have at least one of the following risk factors for progression to severe disease: ≥60 years of age; BMI >25; current smoker; immunosuppressive disease or immunosuppressive treatment; chronic lung disease; hypertension; cardiovascular disease; diabetes; chronic kidney disease; sickle cell disease; neurodevelopmental disorders; active cancer; medical related technological dependence. Individuals who had a history of prior COVID-19 infection or vaccine were excluded. [2]

The CNN article quoted Dr. Michael Charness, a Boston neurologist who said he had observed the same mysterious phenomenon in his practice. Once again, the case he described involved a patient who was fully vaccinated, but Charness did not associate the problem with the vaccine.

From the article: 

“His patient was a 71-year-old man with asthma who started taking Paxlovid the first day he had symptoms because of his age and underlying medical condition…

The medication worked fast. By the second day, his patient's symptoms were almost completely gone. His patient finished the pills after five days and was testing negative on home tests by day seven. On the ninth day after his first positive test, the man's symptoms -- including a runny nose, sore throat and wheezing -- returned. He tested positive once again…

His patient, who was fully vaccinated and boosted and in good overall health, was tested for Covid-19 multiple times throughout his treatment and then shortly after his symptoms returned.” [3]

So here are my questions:

• Is Paxlovid interacting in some way with the immune systems of the vaccinated to cause patients to relapse?  

• Is this yet another example of Pfizer testing its product on one population, then selling it to a completely different population, with deleterious results? 

• If the drug was going to be recommended for the vaccinated and unvaccinated alike, why did the company exclude the vaccinated from its clinical trial?

It is imperative that investigators now determine whether unvaccinated patients who take Paxlovid are just as likely to relapse, or whether this risk exists exclusively for the vaccinated.  Pfizer has an obligation to inform patients who are considering taking any of its products (though why anyone would at this point, I do not know) of the full range of risks as well as any benefits.  

---

[1] Paxlovid, "Snake Oil" of the 21st Century? - by Igor Chudov (substack.com)

[2] download (fda.gov)

[3] Covid-19 cases that return after Paxlovid antiviral treatment puzzle doctors (msn.com)