Pfizer's COVID treatment pill authorized by FDA
By: ABC News’ Dr. Navjot Kaur Sobti contributed to this report.
Good news..........................
S E E D E D C O N T E N T
An at-home treatment for COVID-19 that can prevent serious illness was authorized by the Food and Drug Administration on Wednesday, offering a note of optimism for the future of the pandemic as the world faces the omicron variant.
When taken early, Pfizer's pill was 89% effective at reducing the risk of severe illness and death from COVID-19, according to the company, and was effective against omicron.
Pfizer CEO Albert Bourla estimated that 1,200 deaths and 6,000 hospitalizations would be prevented for every 100,000 COVID-19 patients who take the pills.
MORE: COVID-19 live updates: Booster shots 'will really help us' with omicron: CDC director
The FDA said the pill, Paxlovid, was authorized for the treatment of mild-to-moderate coronavirus disease in anyone 12 years and older who weighs at least about 88 pounds. Patients must test positive and be at high risk for progression to severe COVID-19, including hospitalization or death.
The treatment course requires taking several pills, twice per day, for five days.
Tens of thousands of courses of the medication will be available this month, and by January that number will grow to the hundreds of thousands. Within the first quarter of 2022, Pfizer expects to be producing millions a month.
The U.S. government has already contracted with Pfizer to purchase at least 10 million courses by the end of next year at $530 a course.
There is not expected to be any direct cost to patients.
But supply is expected to be limited for months as production ramps up and cases surge worldwide over the winter, already leading to concerns about equitable distribution.
Still, the pills offer hope, particularly as the omicron variant spreads rapidly across the U.S.
Vaccination and booster shots are the best defense against omicron, offering up to 80% protection by some estimates, and unvaccinated Americans will be hit hardest by the surge. But there will also be more breakthrough infections among vaccinated people because of omicron's mutations.
"While not a replacement for vaccines, the emergence of new variants has highlighted the need for new therapeutic lines of defense," said Dr. John Brownstein, an epidemiologist at Boston Children's Hospital and ABC News contributor.
"The combination of low friction access and high efficacy means that we finally have a therapy that can make a real impact on the trajectory of this pandemic," he said.
Public health experts and the pharmaceutical companies who make the pills also have been firm that the treatments alleviate illness -- they do not prevent it. Vaccines do, and they’re still the safest, most effective option to stay out of the hospital.
"I want to emphasize that no one should use the existence of the pill as an excuse to avoid vaccination," Bourla, Pfizer’s CEO, said.
The U.S. will also likely face some hurdles in the initial rollout -- another reason they shouldn’t be relied upon as an alternative to vaccination.
MORE: COVID-19 pills could be game-changer, but doctors worry about early access, uptake
One concern is that the pills need to be taken early, which means patients will need a positive test and a doctor’s appointment very soon after they get sick. Testing delays and overburdened hospital systems could make that more challenging.
They are most effective "before a person becomes critically ill," said Dr. Paul Currier, director of the Respiratory Acute Care Unit at Massachusetts General Hospital. "Once a patient becomes critically ill, the virus has already caused a lot of inflammation in the body that likely cannot be stopped by medicines that only target the virus itself."
But pharmaceutical executives are optimistic that the pills will make a significant dent in the pandemic.
Pfizer's pill has the "potential to save the lives of patients around the world," Bourla said.
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Excellent. Now to ramp up that production..........................
... right after an anonymous story is leaked to the Q-nuts about a nano-tech tracking device in every pill.
You let the secret out....
another 4 or 5 variants before the midterms should do the trick...
Heck, there’s a lot more room to install a really powerful tracking device in a pill than there is through a tiny needle.
Or . . .
Explosives!
They'll take Ivermectin over this. Morons
Have you listened to AC/DC's Dirty Deeds Done Dirt Cheap today?
I thought that it Dirty Deeds Done With Sheep?
Expect Brandon to ration it to red states.
So basically a treatment for people already positive.
Sounds like it. But it beats the hell out of the ICU.
And I agree with that. Anything to keep people out of the hospital
Exactly. A step to use before resorting to monoclonal antibodies. A much less expensive one. Merck is supposed to have one about ready too.
Yeah, which is huge.
This is far more significant than the vaccines.
I will still rather not get it to begin with.
It seems like a really good thing though if it keeps people from getting sick or worse.
Now I bet some will refuse to take them though.
Obviously, but the drug potentially represents a permanent end to lockdowns, business interruptions, school closures, vaccine mandates and pretty much everything else we hate about Covid.
Some probably will. I oppose forcing them, simply on gene-pool improvement principles.
That basically sounds like herd immunity...
Kinda sounds like giving up. A drug where people can get it but not be sick...Like they can't stop it so try to combat it other ways.
Then again, a one two punch might be what is needed.
I was watching an interview and there can be some strong side effects with this drug. Of course, many seniors are on a number of medications so this can be an area to watch.
My understanding is that you have to have a positive COVID test before you can get the RX. Currently getting tested can be a problem because of very long wait times.
They stated they will have 120 million kits (2 pills) by the end of the year.
It will be interesting to see the cost of the pills.
I doubt it. How many if given the opportunity refuse Tamiflu for a viral flu?
How many refuse a flu shot? A lot...
People will find a way to horde this. Or we’ll get some expansion on the conspiracy theory that this is more government control and people won’t want to take it.
Or both.
It is by prescription only. Just how would anyone horde it?
Just wait till there is a version for pigs!
Seeing multiple doctors that has been something that has been going on for decades with many other RX.
Good point.
Or the infamous ''pill mill'' which was/is quite prevalent in FL.
I suspect there will be far too many doses to hoard.
I think eventually that will be true, but look at the runs we have seen on toilet paper, hand sanitizer, horse wormer . . .
I think that this and the Merck pill will end the pandemic along with Omicron wiping out the other strains and being so mild as to need nothing more than a few doses of the new Pfizer or Merck pill. Except in blue cities and states the China virus is essentially about over.
Why are you ok with these pills, but not the vaccine?
Besides that, the course costs $530.00 and you have to have a prescription. Not sure what the co-pay would be if any IF insurance would cover it.
Whoever told you I was not ok with the vaccine? Inquiring minds want to know! I’ve always favored it and advocated that others make the free will choice to get it. I am vaccinated. My issue is with mandates and coercion and I will move Heaven and earth to oppose those and say and do whatever I legally can to prevent passage of mask or vaccine mandates come what may. On that issue a bigger enemy of blue state and city and federal enforcers than any anti vax Person will be
I seem to remember you endorsing a religious objection to the vaccine based on it relying on abortions or something.
That is an objection that many use, but I didn’t use it. That does apply to the J&J vaccine and others used elsewhere which heavily relied on embryonic stem cells in the research to produce it. The other two to my knowledge Moderna and Pfizer used a different research model. I didn’t get the J&J vaccine.
The cells used in testing are thousands of generations removed from the original at this point. What’s more, many hundreds of drugs and vaccines are tested using those stems cells. If one were to forego the Covid vaccines on those grounds, they would also need to forego vaccines for measles and mumps, or stop taking Advil or Tylenol.
But you don’t see people doing that, which is why I know the “religious” objection is bogus.
worrying about that seems to be an irrational belief
Most of those were developed before test tube babies were available to offer as human sacrifices to medical research
An individual’s particular religious belief is not subject to such a judgement
That has no connection to the facts I have described.
Curious: Do you refuse to take Ibuprofen?
No. I don’t refuse to take it. I prefer to use good old Aspirin for most minor issues. I would not say or do anything regarding one who did refuse for some religious reason. I won’t judge them.
12/31/21 Florida had 76,000 new covid cases. How do you explain that, XX?
According to the FDA, here are the ingredients used in the J&J vaccine: recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride. Fetal cell lines is not the same as aborted fetal stem cells, as some seem to think the vaccines were made with aborted fetal stem cells. Both Moderna & Pfizer used fetal cell lines during their testing stages. All finished vaccines do not contain any fetal cells or tissues. Not that it makes a difference to me if it did or not. Fetal stem cell study and therapy has the potential to revolutionize medicine. It's too bad we have not sought to reach the full potential of such therapy because some people have irrational hang ups regarding fetal stem cells.
The point is consistency. The same people who claim a Covid vaccine violates their morals are taking lots of other drugs that would violate that same code on the same basis. So they’re hypocrites or they’re liars. One or the other.
Cases…..Any increase in intensive care use or fatalities? Blue states that operate as fascist dictatorships on the issue are doing even worse.
You're wrong. Here is the stats:
Nine large, hard-hit states account for more than half of those deaths, according to figures from the Centers for Disease Control and Prevention: California (74,685 deaths), Texas (73,409), Florida (62,073), New York (57,745), Pennsylvania (34,618), Georgia (30,860), Illinois (29,954), New Jersey (28,589) and Ohio (27,371)
It's the unvaxxed that lead in deaths, not a party. Viruses don't recognize parties.
Test tube babies? That term hasn't been used by scientists in 30 years. It was replaced with in vitro fertilization, aka IVF. And PS: It's been almost 20 years since scientists discovered how to extract the cells necessary for research and medical treatment without damaging the embryo.
Source
Why do you avoid my stats on Florida [DELETED] Hospitalizations have gone from less then a thousand to over 5,000 currently. Deaths, well no one is sure because DeSantis doesn't allow the health department to post deaths on a daily basis it is now done weekly.
Stop the lying and spreading misinformation, XX.
My next seed will show that Florida is doing much better than large blue states are on the issue.
The omicron variant attacks the twice vaccinated with a booster as if they’d done nothing.
I just realized that this seed is over 2 weeks old. Also, I'm not surprised by the name of the community member who drug this discussion out of the dust bin.
I unlocked it upon returning from a week spent at the competition. It said it was locked by author which was simply not true. I didn’t lock it.