Friday, May 20, 2022
Concerns grow that COVID-19 may ‘rebound’ after taking antiviral Paxlovid
Pfizer’s COVID-19 antiviral drug Paxlovid has been hailed as a breakthrough in the fight against the disease, promising fast, convenient and dramatic protection from severe illness in older adults and others at higher risk from the virus.
But in recent weeks, there have been growing concerns that some people who finish the five-day course of prescription pills are becoming ill and testing positive again soon after. Among them this week was Dr. Peter Hotez, dean of the National School of Tropical Medicine at Houston’s Baylor College of Medicine, an expert often featured on national news broadcasts.
“We all thought COVID was over,” Hotez tweeted Tuesday, reporting that five days after completing his Paxlovid course, he had a runny nose, sore throat and “antigen test screaming +” for COVID-19. “We’ll eventually figure this out, but still a puzzle.”
UC San Francisco medical department chair Dr. Bob Wachter, who shared his wife’s journey through COVID-19 illness and Paxlovid treatment on social media with her permission, added Wednesday that they were concerned enough about the odds of a “rebound infection” that they watched TV together wearing masks — with their windows open.
Is the virus, whose mutated variants have partly evaded vaccine protection and prompted calls for multiple rounds of boosters, also finding ways to defeat the latest miracle treatment, authorized for emergency use only five months ago? Is Paxlovid still worth taking?
Medical experts say they don’t know for sure why some people who beat back a COVID-19 infection with the help of Paxlovid test positive for the virus and feel crummy again shortly after completing the medication. But they say it’s well worth taking the antiviral therapy, regardless.
White House officials reported Wednesday that the drug has become an increasingly important weapon in the fight against coronavirus, with 20,000 prescriptions a day being written across the country. They too urged people not to overreact to reports of rebound infections.
“My worry about this whole conversation is that people will lose the forest for the trees, and lose the benefit of Paxlovid,” said Dr. Peter Chin-Hong, a professor of medicine and infectious disease specialist at UCSF. “It seems to be the exception rather than rule, and so far most people get better on Paxlovid, and faster.”
Chin-Hong and others have described Paxlovid and another antiviral, Merck’s molnupiravir authorized around the same time, as game-changers in the COVID-19 fight, offering a safe, effective and convenient way to reduce risk of an infected person becoming severely ill or dying.
The antivirals are authorized for people 12 and older who are considered at higher risk from COVID-19, either due to health conditions such as obesity or diabetes, or simply because they are older.
At a time when vaccine protection is waning against new variants and monoclonal antibodies requiring intravenous infusion are losing their effectiveness, antivirals prescribed at the onset of symptoms and taken at home can help beat back infection. Pfizer’s drug blocks an enzyme the virus needs to reproduce, and was found to cut risk of hospitalization or death in high-risk adults by 89%. The Merck drug’s effectiveness is 30%.
The Bay Area and the rest of the country are seeing cases rise anew. Federal and state officials continue to urge Americans to get booster shots and wear face masks in crowded settings.
“It’s nothing to be alarmed at, at this moment,” Gov. Gavin Newsom said of the rising case counts as he received his second Moderna booster shot Wednesday in Bakersfield.
“This waning immunity is a thing of — I don’t want to say of concern — but something we need to monitor,” Newsom said. “The best protection against serious illness and hospitalization is getting vaccinated and boosted.”
Both Pfizer and the Food and Drug Administration have noted that during clinical trials, around 1-2% of patients who completed the five-day Paxlovid treatment tested positive again after initially testing negative, or showed increased levels of virus. But they said the same thing happened at similar rates among those given a placebo instead of the drug. And none of the reported rebounds led to serious illness.
“So it is unclear at this point that this is related to drug treatment,” Dr. John Farley, director of the FDA’s Office of Infectious Diseases, said in guidance to health providers posted online. “Most importantly, there was no increased occurrence of hospitalization or death or development of drug resistance.”
Chin-Hong said the rebound phenomenon isn’t new, and has been seen in other viral infections. But why it’s occurring with COVID-19 and Paxlovid is a mystery, he said.
“So many people have had such a great experience with it,” Chin-Hong said. “In my experience, maybe one person had a rebound, and they did fine, and it was milder.”
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Wachter said it was “absolutely” worth it for his wife to take Paxlovid — they are in their 60s — despite the chance of a rebound. Would taking the pills longer reduce that chance? “I wouldn’t take another course of Paxlovid, until we see real data to support it,” he said in a Twitter thread.
Pfizer spokesman Kit Longley said that “while further evaluation is needed,” and the company is monitoring data from ongoing clinical trials and safety surveillance. “We remain very confident in its clinical effectiveness at preventing severe outcomes from COVID-19 in high-risk patients.”
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Document Release Shows Pfizer Anticipated Vaccine Adverse Events
A court-ordered FOIA document release reveals Pfizer hired 600 additional full-time employees to prepare for reports of adverse events of the COVID-19 vaccines.
Within the 10,000 pages filed with the U.S. Food and Drug Administration that were released on April 1 under the Freedom of Information Act, Pfizer disclosed to the agency that not only had it hired 600 additional full-time employees to process adverse event reports in the three months following the Emergency Use Authorization (EUA) for its mRNA Covid-19 vaccine, it anticipated the need for an additional 1,800 of staff workers by the end of June 2021. The documents did not reveal how many Pfizer workers had been assigned to this task at the time the EUA was issued.
One document dated April 30, 2021, titled, “Cumulative Analysis of Post-Authorization Adverse Event Reports” and marked “confidential,” states “Pfizer has also taken multiple actions [sic] to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.”
Background
On January 7, 2022, U.S. District Judge Mark Pittman of the Northern District of Texas, an appointee of President Trump in 2019, ordered the documents to be released in a FOIA request brought by a group of doctors and scientists. The plaintiffs had been seeking 450,000 pages of material about the vaccine and the process by which it was authorized,
Pfizer had insisted that it could produce no more than 500 pages per month, which would have meant some 75 years would have been required to satisfy the FOIA request. The judge instead ordered Pfizer to release the documents at a rate of 55,000 pages per month. The hiring disclosures were included in the first cache released on April 1.
Other Significant Disclosures
The FOIA document release also revealed that Pfizer disclosed that within the initial three months of the vaccine’s use, a total of 158,893 adverse events had been logged from approximately 126,212,580 doses shipped. That means that the adverse event reporting rate was approximately one for every 800 doses.
The running tally of adverse events related to Covid-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS) between Dec. 14, 2020, and March 25, 2022, totaling 1,205,755, now easily surpasses the 930,952 total adverse events previously reported on all other vaccines in the 32-year history of the database.
Nondisclosure
Pfizer’s attempt to forestall disclosure of the documents included in the FOIA document release request beyond the lifespan of many or most persons having received its vaccine appears to be part of a pattern of nondisclosure with respect to its brand-name, non-EUA Covid vaccine called Comrinaty.
Pfizer appeared to enjoy insulation from the usual ethical requirements of disclosure, according to Barbara Loe Fisher, the co-founder, and president of the National Vaccine Information Center.
“Pfizer’s published clinical trial data did not provide evidence for the safety or efficacy of administering Comrinaty vaccine simultaneously with other vaccines, but the CDC (Centers for Disease Control and Prevention), and medical trade associations like the American Academy of Pediatrics (AAP) are recommending the vaccine be given at the same time as other vaccines to children and adults,” said Fisher.
“There are almost no CDC or Pfizer approved contraindications to receiving Comrinaty vaccine, even though clinical trial data demonstrate that the majority of clinical adult and child trial participants experienced one or more adverse events, especially after the second dose,” said Fisher. “It has long been recognized that strong reactions to pharmaceutical products can be a reason to exercise caution, especially with repeat doses.”
Experimental and Control Group
President and co-founder of Citizens Council for Health Freedom, Twila Brase says the documents raise red flags.
“Clearly Pfizer didn’t want the data to come out,” said Brase. “It could have shut down the vaccination effort, caused courts to stand up for human rights, put egg on the face of their FDA collaborator, and caused their stockholders to flee. But the way they tried to prevent public access showed they had something to hide. Thankfully, the court refused to let them leave the public in the dark about the facts.”
The FOIA document release reveals there was a disconnect between what the company and the federal health agencies were saying about the vaccines and what they knew behind the closed doors, says Brase.
“Given the overwhelming narrative that the vaccines are safe, the right thing to do would have been to stand up and tell the truth. Having a single statement, notifying the patient that the product has not been approved, in a two-to-four-page document at the time of injection is insufficient warning about the realities and possible side effects,” said Brase.
“The people of the world have become subjects in the largest experiment ever, and it’s not just an experiment on Covid, it’s an experiment on mRNA. It’s a genetic trial. Those who refused to take the shot are the controls. Those who got the shots are yet to find out what, if any, impacts they may experience now and in the coming years, or whether it will impact their yet-to-be-born children.”
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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)
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