
Federal regulators Wednesday authorized the first easy-to-take pill to treat covid-19, a five-day regimen developed by Pfizer that will help refill the nation’s medicine cabinet even as the omicron variant has thwarted most other options.
Tens of thousands of pill packs of Pfizer’s Paxlovid are sitting in a Pfizer warehouse in Memphis, ready to be loaded onto trucks and planes in anticipation of the green light from the Food and Drug Administration. But as omicron cases skyrocket nationwide, doctors are expected to quickly burn through that initial supply of Paxlovid, which has shown to be 89% effective at keeping high-risk patients from developing severe illness when given within three days of symptoms starting.
Antiviral pills have been highly anticipated as a potential turning point in the pandemic, a new class of drugs that will help transform life-threatening covid-19 infections into a nuisance. But instead of reinforcing a growing arsenal of drugs, the pills are now urgently needed to help replace workhorse treatments that have for more than a year helped keep sick people out of hospitals but have been knocked out by omicron.
The fast-spreading variant is resistant to two key drugs from a different class of medicines known as monoclonal antibodies that have been the backbone of treatments, leaving only a third antibody drug, sotrovimab, that is in severe shortage. Paxlovid – and another antiviral pill from Merck also expected to be authorized shortly – will be used to fill the gaps. A newly authorized monoclonal antibody from AstraZeneca, used to prevent infections in people who don’t respond to vaccines, may also remain effective against omicron.
“There’s no question that it appears we’re in a canoe that is about to go over a significant waterfall,” said Bruce Farber, chief of infectious diseases at Northwell Health, a New York health care system that includes 22 hospitals. Farber said that in November and December, requests for monoclonal antibody treatments reached 200 or more per day, but by the end of the week, Northwell will run out of doses.
The Pfizer pill could help meet some of that demand, but it is estimated there will be enough medication through the end of the year for only 180,000 patients. With coronavirus cases in the United States projected to potentially hit 1 million per day, those pills could be used up quickly, even though they are authorized only for people 12 and older at high risk of severe covid-19 because of age or underlying medical conditions.
Pfizer has been working to scale up to produce 120 million pill packs in 2022, but those doses won’t be available all at once. Mike McDermott, Pfizer’s president of global supply, said the current goal is to have about 30 million treatments available by the middle of next year, but the company is looking for ways to speed up and increase production.
The United States has made an advance purchase of 10 million packs of Paxlovid and about 3.1 million treatment courses of the Merck drug, molnupiravir.
McDermott said thousands of people are working on Paxlovid but that the complex chemistry involved in creating the active pharmaceutical ingredient in the pill means a production run for a batch takes about six to eight months from start to finish. The company creates the active ingredient in giant 10,000- and 20,000-liter tanks, and the process takes a succession of steps, many of which require five to 10 days, with quality checks in between.
“We have experience at this scale, this is not unusual for us. The urgency is unusual, for sure,” McDermott said. He drew a parallel to auto racing, in which pit crews and materials are in place at pit stops to make sure no minutes are lost.
Six months ago, when Pfizer started making Paxlovid before knowing whether it would prove successful, the production goal was to churn out 20 million pill packs in 2022. When the first clinical results showed the drug drastically cut the risk of death or hospitalization by close to 90%, the company bumped up production to 50 million pill packs. Two weeks later, McDermott said, production was increased to 80 million. When the emergency authorization was announced, Pfizer increased that to 120 million packs.
Each pill pack will contain 30 tablets to be taken over five days, so Pfizer is working furiously to produce 3.6 billion tablets next year. The company is leveraging existing infrastructure in Ireland and Germany to make the key ingredient in the pill and to create the tablets, as well as working with contractors. Pfizer has entered into licensing agreements to allow other companies to produce the pills for lower-income countries.
Much of the excitement about the pills stems from their ease of use. The monoclonal antibodies that have been pillars of treatment require intravenous infusions or injections. Pills taken at home would be far simpler.
But Paxlovid must be given shortly after symptoms develop, so the treatment will depend on people getting tested and receiving results quickly – a potential bottleneck as the omicron surge has created a shortages of rapid tests. The clinical trial testing the medicine showed that if given within five days, the drug reduced the risk of hospitalization and death by 88% in people with a risk factor for severe disease, including age or underlying medical conditions.
Paxlovid is a combination of two drugs, one called nirmatrelvir that was designed to interfere with an enzyme the coronavirus uses to make copies of itself. The other drug, ritonavir, is an antiviral that slows down the body’s metabolism of the other medication. Ritonavir can react with other commonly taken medications, so the drug’s use will have to be managed by physicians and pharmacists.
Ralph Madeb, co-chief medical officer at New York Community Hospital, said antiviral pills could be “revolutionary” but noted their limitations. Because they have to be given early in infection, they are just one part of the treatment tool kit. And they are arriving as hospitals are battling for more tools.
Madeb said that this week, he requested 900 doses of sotrovimab, the antibody that remains effective against omicron. That would be enough, he says, for nine days.
“Demand right now is just infinite,” Madeb said. “It’s something I’ve never seen before.”
(c) 2021, The Washington Post · Carolyn Y. Johnson
{Matzav.com}
Hurray!
Summary of main differences between Pfizer’s new drug “Paxlovid” and the HCQ protocols:
1) HCQ+Zinc seems to be more effective:
Paxlovid is (amazingly) 89% effective in reducing hospitalizations and deaths in high-risk patients.
HCQ+Z has demonstrated, in real-world analysis (Doctors’ testimonials and in the nursing home were i’m employed) to be 99.5% effective.
2) Paxlovid will cost 500-700 bucks per 1 full treatment.
HCQ+Z full treatment is less than 30 dollars. (Including the zinc.)
So anybody uninsured, or those that have insurance deductibles, should try to obtain a prescription for HCQ. Albeit insurance won’t cover off-label medications. So you’ll hafta shell-out 25-30 dollars out-of-pocket. (That’s still better than a 500$ deductible…)
3) Paxlovid must be taken within 5 days of symptoms. But doctors cannot prescribe it until after a positive covid test. So it’s a race against time, considering now, with the higher rate of cases, it takes 2-3 days for test results.
HCQ+Z also needs to be taken within 5 days, (Ideally within 3 days!) But has still been proven effective at saving lives if taken within 7 days.
4) HCQ+Z can be taken safely prophylactically. Which means a person can safely take it (even while pregnant) even if they just suspect they have covid.
Notes:
As per a 2018 FDA report i saw (and other medical reports) Hydroxychloroquine has an exceptional 65-years-old safety record.
(I purposely checked for a pre-covid FDA report. BEFORE the left designated HCQ on par with cyanide…)
Only people with stents or heart-conditions may not take HCQ. But it’s OK for people with Pace-makers.
(People that cannot take HCQ can use Ivermectin instead. Or, at least, OTC Quercetin. But be advised, Quercetin may not be taken during pregnancy.)
5) Pfizer’s treatment requires taking 6 pills per day.
HCQ+Z requires only 3.
6) The articles state that people with kidney problems may not take paxlovid.
In my N.H. covid patients on dialysis were treated with the HCQ+Z and quickly recovered.
7) I don’t think this paragraph applies to HCQ:
(But of course check with the doctor.)
Summary of main differences between Pfizer’s new drug “Paxlovid” and the HCQ protocols:
1) HCQ+Zinc seems to be more effective:
Paxlovid is (amazingly) 89% effective in reducing hospitalizations and deaths in high-risk patients.
HCQ+Z has demonstrated, in real-world analysis (Doctors’ testimonials and in my nursing home) to be 99.5% effective.
2) Paxlovid will cost 500-700 bucks per 1 full treatment.
HCQ+Z full treatment is less than 30 dollars. (Including the zinc.)
So anybody uninsured, or those that have insurance deductibles, should try to obtain a prescription for HCQ. Albeit insurance won’t cover off-label medications. So you’ll hafta shell-out 25-30 dollars out-of-pocket. (That’s still better than a 500$ deductible…)
3) Paxlovid must be taken within 5 days of symptoms. But doctors cannot prescribe it until after a positive covid test. So it’s a race against time, considering now, with the higher rate of cases, it takes 2-3 days for test results.
HCQ+Z too needs to be taken within 5 days, (Ideally within 3 days!) But has still been proven effective at saving lives if taken within 7 days.
4) HCQ+Z can be taken safely prophylactically. Which means a person can safely take it (even while pregnant) even if they just suspect they have covid.
Notes:
As per a 2018 FDA report i saw (and other medical reports) Hydroxychloroquine has an exceptional 65-years-old safety record.
(I purposely checked for a pre-covid FDA report. BEFORE the left designated HCQ on par with cyanide…)
Only people with stents or heart-conditions may not take HCQ. But it’s OK for people with Pace-makers.
(People that cannot take HCQ can use Ivermectin instead. Or, at least, OTC Quercetin. But be advised, Quercetin may not be taken during pregnancy.)
5) Pfizer’s treatment requires taking 6 pills per day.
HCQ+Z requires only 3.
6) The article states that people with kidney problems may not take paxlovid.
In my N.H. covid patients on dialysis were treated with the HCQ+Z and quickly recovered.
7) I don’t think the following problem, mentioned in this article, applies to HCQ:
(But of course check with your doctor!)
Paxlovid is a combination of two drugs,.. The other drug, ritonavir, is an antiviral that slows down the body’s metabolism of the other medication. Ritonavir can react with other commonly taken medications, so the drug’s use will have to be managed by physicians and pharmacists.
Hatzluchah!
How ’bout Ivermectin?
OOPS!
Sorry for the repetition.
Musta clicked the wrong key.
No worries.