Virus Outbreak COVID Pill
A lab technician visually inspects COVID-19 Paxlovid tablet samples in Freiburg, Germany. Photo: Pfizer via AP, File
health

Cases of COVID returning pose questions for Pfizer pill

22 Comments
By MATTHEW PERRONE

As more doctors prescribe Pfizer's powerful COVID-19 pill, new questions are emerging about its performance, including why a small number of patients appear to relapse after taking the drug.

Paxlovid has become the go-to option against COVID-19 because of its at-home convenience and impressive results in heading off severe disease. The U.S. government has spent more than $10 billion to purchase enough pills to treat 20 million people.

But experts say there is still much to be learned about the drug, which was authorized in December for adults at high risk of severe COVID-19 based on a study in which 1,000 adults received the medication.

WHY DO SOME PATIENTS SEEM TO RELAPSE?

Doctors have started reporting rare cases of patients whose symptoms return several days after completing Paxlovid's five-day regimen of pills. That's prompted questions about whether those patients are still contagious and should receive a second course of Paxlovid.

Last week, the Food and Drug Administration weighed in. It advised against a second round because there’s little risk of severe disease or hospitalization among patients who relapse.

Dr. Michael Charness reported last month on a 71-year-old vaccinated patient who saw his symptoms subside but then return, along with a spike in virus levels nine days into his illness.

Charness says Paxlovid remains a highly effective drug, but he wonders if it might be less potent against the current omicron variant. The $500 drug treatment was tested and OK'd based on its performance against the delta version of the coronavirus.

“The ability to clear the virus after it’s suppressed may be different from omicron to delta, especially for vaccinated people,” said Charness, who works for Boston's VA health system.

Could some people just be susceptible to a relapse? Both the FDA and Pfizer point out that 1% to 2% of people in Pfizer’s original study saw their virus levels rebound after 10 days. The rate was about the same among people taking the drug or dummy pills, “so it is unclear at this point that this is related to drug treatment,” the FDA stated.

Some experts point to another possibility: The Paxlovid dose isn’t strong enough to fully suppress the virus. Andy Pekosz of Johns Hopkins University worries that could spur mutations that are resistant to the drug.

“We should really make sure we’re dosing Paxlovid appropriately because I would hate to lose it right now,” said Pekosz, a virologist. “This is one of the essential tools we have to help us turn the corner on the pandemic.”

HOW WELL DOES PAXLOVID WORK IN VACCINATED PEOPLE?

Pfizer tested Paxlovid in the highest-risk patients: unvaccinated adults with no prior COVID-19 infection and other health problems, such as heart disease and diabetes. The drug reduced their risk of hospitalization and death from 7% to 1%.

But that doesn’t reflect the vast majority of Americans today, where 89% of adults have had at least one shot. And roughly 60% of Americans have been infected with the virus at some point.

“That’s the population I care about in 2022 because that’s who we’re seeing -- vaccinated people with COVID -- so do they benefit?” asked Dr. David Boulware, a University of Minnesota researcher and physician.

There's no clear answer yet for vaccinated Americans, who already have a hospitalization rate far below 1%.

That may come from a large, ongoing Pfizer study that includes high-risk vaccinated people. No results have been published; the study is expected to wrap up in the fall.

Pfizer said last year that initial results showed Paxlovid failed to meet the study’s goals of significantly resolving symptoms and reducing hospitalizations. It recently stopped enrolling anyone who's received a vaccination or booster in the past year, a change Boulware says suggests those patients aren’t benefitting.

At a minimum, the preliminary data should be released to federal officials, Boulware said. “If the U.S. government is spending billions of dollars on this medicine, what’s the obligation to release that data so that they can formulate a good policy?"

CAN PAXLOVID BE USED TO HELP PREVENT COVID-19 INFECTION?

Pfizer recently reported that proactively giving Paxlovid to family members of people infected with COVID-19 didn’t significantly reduce their chances of catching it. But that's not the end of the story. Pfizer is studying several other potential benefits of early use, including whether Paxlovid reduces the length and severity of COVID-19 among households.

“It's a high bar to protect against infection but I’d love to see data on how Paxlovid did against severe disease because it may be more effective there,” said Pekosz.

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22 Comments

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 That's prompted questions about whether those patients are still contagious and should receive a second course of Paxlovid.

And after the second course, "experts" will start offering a 3rd course.

They're obviously shooting from the hip which is why I ignore all their advice and stick with grandma's lemon and honey tea recipe.

-2 ( +10 / -12 )

They're obviously shooting from the hip

Yeah, like experts... what do they know, right? On the other hand, a nameless person on the net says:

which is why I ignore all their advice and stick with grandma's lemon and honey tea recipe

which is a lot more sensible advice than all the "experts" put together. Funny that granny is mentioned because in general, if you're experiencing mommy issues in one way or another, your relationship with your mother or another adult female figure in your life was likely lacking.

Go figure.

0 ( +10 / -10 )

After reading this attempt to frame another drug that doesn't work as 'effective', I would put money on ivermectin being vindicated by future historians

-3 ( +9 / -12 )

I'll take it all @Wobot. You want odds?

2 ( +9 / -7 )

Oh, you’re one of those binary thinkers that something either works or doesn’t. 

An example of binary thinking is that taking pharmacological product is 100% correct and not taking it makes you an "anti-vaxxer" and thus you are 100% wrong.

Why can't there be any middle ground, or grey zone or even discussion about the risks and drawbacks?

Take any major issue of our time (Covid, Ukainian civil war, Jan.6 etc) and you'll see that the media slots into a binary.

Opinion A is 100% correct while opinion B is 100% wrong and the people that support opinion B need to be cancelled, shunned and kept out of society.

-3 ( +7 / -10 )

And after the second course, "experts" will start offering a 3rd course.

In the article it is clear that the experts recommend against the second course, why would they recommend a third?

After reading this attempt to frame another drug that doesn't work as 'effective', I would put money on ivermectin being vindicated by future historians

If your argument is reduced to make imaginary bets where you risk nothing that is a very clear indication you have no argument in the first place. How about dealing with the actual scientific evidence that proves ivermectin is even worse than doing nothing?

Why can't there be any middle ground, or grey zone or even discussion about the risks and drawbacks?

The discussion is there, it has never stopped, the difference is that the discussion do not include flawed arguments and false information that you would like to use against safe and effective drugs and vaccines. For that kind of invalid, unproductive kind of "discussion" it is fine that is not being conducted, it would lead to nothing positive.

Opinion A is 100% correct while opinion B is 100% wrong and the people that support opinion B need to be cancelled, shunned and kept out of society.

None of that if you read the academic discussion about this drug (or any other), the opinions that should be cancelled and shunned are those that use false and misleading arguments, but that is desirable and true for every kind of discussion ever.

1 ( +9 / -8 )

@Bronco - Incorrect. I gave Ivermectin and HCQ a fair hearing early on in the Pandemic until the VAST majority of Doctors/Scientists worldwide proved it worthless. Some of the oddities such as Kory just refused to admit they were wrong.

4 ( +9 / -5 )

Pfizer said last year that initial results showed Paxlovid failed to meet the study’s goals of significantly resolving symptoms and reducing hospitalizations. It recently stopped enrolling anyone who's received a vaccination or booster in the past year, a change Boulware says suggests those patients aren’t benefitting.

If vaccinated gets no benefit then obviously should be used for the unvaccinated only. 11% of adult population unvaccinated is still sizable.

5 ( +6 / -1 )

theResidentToday  11:10 am JST

@Bronco - Incorrect. I gave Ivermectin and HCQ a fair hearing early on in the Pandemic until the VAST majority of Doctors/Scientists worldwide proved it worthless. Some of the oddities such as Kory just refused to admit they were wrong.

Wrong. A huge number of scientists, doctors and nurses were threatened with losing their jobs and/or registration if they prescribed IVM and HCQ instead of pushing the vaccines, even though IVM and HCQ work particularly well when given early or as prophylactics, whereas the vaccines have highly questionable safety and efficacy.

Paxlovid may be useful and effective, but has been developed quickly. Even still, it seems to be getting a free run in the press and the medical establishment. Time will tell if it's safe, or whether Pfizer and their lapdogs in the FDA will try to bury the clinical testing results for 75 years.

-8 ( +4 / -12 )

 A huge number of scientists, doctors and nurses were threatened with losing their jobs and/or registration if they prescribed IVM and HCQ instead of pushing the vaccines,

First time I've heard of this blatant egregious crime.

And they only reported this to the antivaxer conspiracy sites?

That won't help much, they need to report to the authorities and media

6 ( +10 / -4 )

Why don't you tell the doctors to write it's for parasites in the prescription?

That way they can elude the tracking of big pharma

1 ( +5 / -4 )

Wrong. A huge number of scientists, doctors and nurses were threatened with losing their jobs and/or registration if they prescribed IVM and HCQ instead of pushing the vaccines, even though IVM and HCQ work particularly well when given early or as prophylactics, whereas the vaccines have highly questionable safety and efficacy.

Anybody that choose to give a drug that not only bring no benefit for the patients but instead gives them extra risk and increase the chances of them getting complications and even dying should lose their jobs, that is what happened with ivermectin and HCQ, it has already proved beyong any reasonable doubt that they are worthless agains COVID and instead bring known toxicities. People still trying to deceive patients to deceive them are acting unethically and unprofessionally and it is grounds for being accused of medical malpractice.

The vaccines do not have questionable safety nor efficacy, that is just propaganda from antiscientific antivaxxer groups. No medical institution of the world support this view because the evidence clearly demonstrates the opposite.

Paxlovid may be useful and effective, but has been developed quickly

So what? if people are at higher risk of having complications and dying without it that means it is better to have it as a therapeutic option. Letting people die just because of the possibility of something not indicated by any of the data of the clinical trials is not a valid stance, in fact it would be unethical to do it because the patients would not be getting the best standard of care possible. That is what the approval for use helps deciding.

If vaccinated gets no benefit then obviously should be used for the unvaccinated only. 11% of adult population unvaccinated is still sizable.

That could be the case, but for clinical studies it may just be that the number of people that you enroll in order to find differences is just prohibitively high, so they focused on the population that gives significant differences while using more manageable number of people.

Lets say that for unvaccinated people you can get significative results with 1,000 people because the risk of hospitalization is 10%. To get the same results with vaccinated people with a risk of 1% they would need to enroll 10,000 volunteers.

0 ( +8 / -8 )

Paxlovid may be useful and effective, but has been developed quickly.

Indeed, it is very common for drugs that go through the normal testing process (non emergency) to get FDA approval and then later taken off the market after serious side effects are discovered. I wouldn't be surprised if the same happens with Paxlovid, considering its chemical structure. In contrast, IVM and HCQ have a well-established safety profile after billions of doses administered. IVM is extremely safe. HCQ is also very safe as long as you don't greatly exceed the recommend dose (as they did in those trials that were designed to fail).

-6 ( +4 / -10 )

@virusrex

The vaccines do not have questionable safety nor efficacy, that is just propaganda from antiscientific antivaxxer groups. No medical institution of the world support this view because the evidence clearly demonstrates the opposite.

Again, look at the VAERS data. The COVID vaccines have the more than double the adverse effects and deaths than ALL the vaccines combined in 22 years. VAERS data is not misinformation or propaganda. Healthcare workers are required by law to report adverse effects and deaths to VAERS. It is a government website that has penalties under the law for posting false information.

You also say that any view that vaccines are not working as planned is propaganda from anti-scientific antivaxxer groups. I have a science degree and used to work in science research. I am hardly anti-science. Educate me on your data and studies. Where is all your links to scientific studies that are not funded by the vaccine companies? You never post any links to scientific studies and data to back up your claims.

-2 ( +6 / -8 )

Indeed, it is very common for drugs that go through the normal testing process (non emergency) to get FDA approval and then later taken off the market after serious side effects are discovered. 

So what serious side effects have been discovered for this? just arguing that something "may" be found in the future is not an argument to demonstrate the testing done for something was not adequate, for that you need objective parameters that have not been fulfilled, "not enough time" is just a personal bias that have no real value.

IVM and HCQ have a well-established safety profile after billions of doses administered. 

And also a well stablished lack of effectiveness against covid according to many well conducted studies, what is the point to give something with well known toxic properties if it is not going to help the patient? that is just unethical and counterproductive. Both drugs have negative toxic effects without benefits.

Again, look at the VAERS data. *

You mean the data that all experts have seen and analyzed reaching the conclusion that the vaccines are safe and effective? there is a consensus about it, just saying that everybody is wrong is easy, demonstrating it is what is actually necessary.

The COVID vaccines have the more than double the adverse effects and deaths than ALL the vaccines combined in 22 years.

The adverse effects are present in the same rates on unvaccinated people, so unless you can explain how vaccines magically affect the same people even if they are not vaccinated you are still wrong.

The explanation is much simpler, the COVID vaccines have been used in a huge number of people that have preexisting conditions and elevated age, something that did not happen with previous vaccines (except on very limited numbers) if you vaccinate a hundred times more people with diabetes, heart conditions, cancer, etc. then you are going to observe a hundred times more problems related to diabetes, heart conditions, cancer, etc. etc.

 It is a government website that has penalties under the law for posting false information.

No it is not. The system relies on people reporting even obviously false things just so anything can be registered first, analysis will be done later to actually curate the reports.

James Laidler had absolutely no repercussions from reporting the adverse effect of becoming Hulk.

https://www.beckershospitalreview.com/healthcare-information-technology/some-self-reported-cdc-data-fueling-the-anti-vaccination-movement.html

. I have a science degree and used to work in science research.

Appeals to authority are meaningless from anonymous accounts, as long as someone openly use antiscientific fallacies and lack scientific support for opinions contradicting the well stablished scientific findings then it can be qualified as antiscientific.

Where is all your links to scientific studies that are not funded by the vaccine companies? You never post any links to scientific studies and data to back up your claims.

When your whole point depends on every scientific and medical institute of the world being wrong (because none support your views) you are already accepting you have an antiscientific bias, it is very easy to find sources that prove the safety and efficacy of vaccines for example, because that is what is the basis for the consensus.

https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-(covid-19)-vaccines

https://vaccinateyourfamily.org/vaccines-diseases/covid19/

https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html

Each reference come with dozens of primary scientific studies that support what is written, the vast majority of those sources are not related to "vaccine companies".

1 ( +7 / -6 )

So what serious side effects have been discovered for this? just arguing that something "may" be found in the future is not an argument to demonstrate the testing done for something was not adequate, for that you need objective parameters that have not been fulfilled, "not enough time" is just a personal bias that have no real value.

Just denying other people's assertions without any rational support is not an argument at all. It is broken down to, "I'm right, you're wrong" just because.

Appeals to authority are meaningless from anonymous accounts, as long as someone openly use antiscientific fallacies and lack scientific support for opinions contradicting the well stablished scientific findings then it can be qualified as antiscientific.

Someone who never provides and authority, a source, or data to make up their claims is accusing someone of making an appeal to authority?

How rich.

When your whole point depends on every scientific and medical institute of the world being wrong (because none support your views) you are already accepting you have an antiscientific bias, it is very easy to find sources that prove the safety and efficacy of vaccines for example, because that is what is the basis for the consensus.

How about when you say every medical expert in the world agrees with you, and then you fail to provide any source or data from those so-called experts?

Sorry but a nameless person on the internet saying the experts are wrong is not a valid argument, nor believable. Show your data that contradicts them.

-5 ( +5 / -10 )

Indeed, it is very common for drugs that go through the normal testing process (non emergency) to get FDA approval and then later taken off the market after serious side effects are discovered. 

So what serious side effects have been discovered for this? just arguing that something "may" be found in the future is not an argument to demonstrate the testing done for something was not adequate, for that you need objective parameters that have not been fulfilled, "not enough time" is just a personal bias that have no real value.

If one has a choice between a rushed investigational drug that has only been approved for emergency use and a drug that has been given safely to billions of people over decades...

IVM and HCQ have a well-established safety profile after billions of doses administered. 

And also a well stablished lack of effectiveness against covid according to many well conducted studies,

What you call "well conducted studies" are those that involve conflicts of interest and were designed to fail (e.g. massive doses given too late).

IVM and HCQ have been demonstrated to be effective when used properly.

-5 ( +5 / -10 )

Sorry but a nameless person on the internet saying the experts are wrong is not a valid argument, nor believable.

Poetic stuff. It is the kettle calling the pot black...

5 ( +9 / -4 )

@Algernon LaCroix

A huge number of scientists, doctors and nurses were threatened with losing their jobs and/or registration if they prescribed IVM and HCQ instead of pushing the vaccines

Really? I haven't heard of any doctors losing their jobs because of prescribing either drug. Al I know is, that they have now been proven worthless. As for NOT pushing the vaccines, well your timeline doesn't fit, does it?

1 ( +9 / -8 )

Just denying other people's assertions without any rational support is not an argument at all

The rational support is included even in your quote. If you can't even argue against it that would mean it is perfectly valid still.

Someone who never provides and authority, a source, or data to make up their claims is accusing someone of making an appeal to authority?

The sources are there in the comment, what is the point of making criticism that has been debunked even before you wrote it?

How about when you say every medical expert in the world agrees with you, and then you fail to provide any source or data from those so-called experts?

Sorry but a nameless person on the internet saying the experts are wrong is not a valid argument, nor believable. Show your data that contradicts them.

The sources are there in the comment, pretending something is missing where everybody can just scroll up a little to find it is not a very strong argument.

Too bad that perfectly valid criticism for any baseless thing you tried to use were so effective, but claiming there are no sources a few lines from precisely those sources at best would show you are just repeating something that you could not undestand.

0 ( +6 / -6 )

I am not doubting either drugs safety btw - or their effectiveness for what they were approved for. But for Covid19? Useless and possibly dangerous because of your relentless promotion for the wrong purposes!

2 ( +7 / -5 )

If one has a choice between a rushed investigational drug that has only been approved for emergency use and a drug that has been given safely to billions of people over decades...

That makes no sense, the only two things that matters are if the drug help the patients and if there are identified toxic effects that could complicate their situation.

Paxlovid have shown to improve the outcome and this benefit outweigh the risks.

Ivermectin and HCQ have demonstrated to be worthless against COVID and their toxic properties increase the risk of patients getting further complications and dying in exchange for nothing.

The choice is clear and that is why the scientific and medical communities of the world are in consensus, the drugs you would like to see used have no role treating COVID.

What you call "well conducted studies" are those that involve conflicts of interest and were designed to fail (e.g. massive doses given too late).

No, that is just something you arbitrarily impose to anything that you don't want to recognize as valid, studies have been conducted even before the infection showing no benefit at all against COVID.

IVM and HCQ have been demonstrated to be effective when used properly.

Using them against COVID is using them improperly, because they have no efficacy against it.

1 ( +6 / -5 )

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