Pfizer says its Covid pill will protect against severe disease, even from Omicron.

[BumRushDaShow]

Source: New York Times

A highly anticipated study of Pfizer’s Covid pill confirmed that it helps stave off severe disease, the company announced on Tuesday. Pfizer also said its antiviral pill worked in laboratory studies against the Omicron variant, which is surging in South Africa and Europe and is expected to dominate U.S. cases in the weeks ahead. “We are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic,” Albert Bourla, Pfizer’s chief executive, said in a statement. Last month, Pfizer asked the Food and Drug Administration to authorize the pill, known as Paxlovid, based on a preliminary batch of data.

The new results will undoubtedly strengthen the company’s application, which could mean that Americans infected with the virus may have access to the pill within weeks. In Tuesday’s announcement, Pfizer said that if given within three days of the onset of symptoms, Paxlovid reduced the risk of hospitalization and death by 89 percent. If given within five days, the risk was reduced almost as much, to 88 percent. The results, based on an analysis of 2,246 unvaccinated volunteers at high risk of severe disease, largely match the company’s initial, smaller analysis of the clinical trial, released last month. Pfizer said that 0.7 percent of patients who received Paxlovid were hospitalized within 28 days of entering the trial, and none died.

By contrast, 6.5 percent of patients who received a placebo were hospitalized or died. Pfizer also released preliminary data from a separate trial looking at people with a lower risk. These volunteers including vaccinated people who carried a risk factor for severe disease, as well as unvaccinated patients with no risk factors. mong this group of 662 volunteers, Paxlovid reduced the risk of hospitalization and death by 70 percent, the company said. Mikael Dolsten, the chief scientific officer of Pfizer, was exuberant about the results after having overseen the development of the drug since the spring of 2020, with more than 200 company scientists crafting the molecule and then testing it in animals and people. While the drug was in development, Dr. Dolsten held out hope that it might be 60 percent effective. Its true potency left him stunned. “We really hit the top of the board,” he said in an interview.

In both trials, most of the volunteers were infected with the Delta variant. But Pfizer said on Tuesday that in laboratory experiments, Paxlovid also performed well against the highly mutated Omicron variant. The drug jams into one of Omicron’s key proteins — called a protease — just as effectively as it does with other variants, Pfizer found. Pfizer’s good news came as its rival, Merck, awaited word on authorization of its own antiviral pill, known as molnupiravir. In October, Merck and its partner Ridgeback Biotherapeutics announced that the pill reduced the risk of hospitalization and death from Covid-19 by 50 percent if taken within five days of the onset of symptoms.

Read more: https://www.nytimes.com/2021/12/14/health/pfizer-covid-pill-paxlovid.html

[Sherman A1]

1. Good news

[janterry]

2. This remains what I am waiting for

in terms of great news (excellent treatment for covid). If this is it - what a relief.

[DFW]

4. Not quite clear from the article

How often must the pill be taken?
What does it cost per dose?
Any widely noticed side effects?

[BumRushDaShow]

5. I was trying to find what I had posted sometime last month

but here is quick recap of Pfizer's treatment (I don't think FDA's ADAC has scheduled a review meeting for it yet and we are right at the holidays, so it might end up happening in January unless they really get pressure to round people up for it) -

How Covid antiviral pills work and what that could mean for the pandemic
Oral antivirals show huge promise for treating Covid-19. Here’s what they do in the body to fight the virus.

Nov. 12, 2021, 5:00 AM EST / Updated Nov. 18, 2021, 2:09 PM EST
By Kimberly Hickok

(snip)

Pfizer’s drug, Paxlovid, takes a different approach.

The drug consists of two components: an experimental molecule called PF-07321332 and an existing drug called ritonavir. Both are protease inhibitors, which means they block a different enzyme (called a protease) that cuts apart long strands of nonfunctional viral proteins into smaller, functional proteins. PF-07321332 is the star of the show in the drug duo, working on the virus itself, while ritonavir stops other enzymes from destroying PF-07321332. Ritonavir plays the same defensive role in antiviral drug cocktails that treat HIV.

For both drugs, starting treatment early is important. In the clinical trials, Merck and Pfizer started the treatments within five days of symptoms’ starting.

https://www.nbcnews.com/health/health-news/covid-antiviral-drugs-merck-pfizer-pills-work-rcna5317

Here was an article on the costs and treatment length, approx. base cost, and side-effects -

November 5, 20214:55 PM EDT Last Updated a month ago
Healthcare & Pharmaceuticals
Pfizer says its antiviral pill slashes risk of severe COVID-19 by 89%


By Deena Beasley

(snip)

Bourla added that for high-income countries Pfizer expects to price its treatment close to where Merck has priced its drug. Merck's U.S. contract price is around $700 for a five-day course of therapy. For low-income countries, Bourla said Pfizer is considering several options, with the goal of "no barrier for them as well to have access."

(snip)

Pfizer did not detail side any effects but said adverse events happened in about 20% of both treatment and placebo patients. Possible side effects include nausea and diarrhea.

(snip)

https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-says-antiviral-pill-cuts-risk-severe-covid-19-by-89-2021-11-05/

Pfizer recently said they would allow licensing of it too reduce the cost - https://www.democraticunderground.com/10142827455

Here in the U.S., HHS purchased doses of it (it's actually a cocktail of medications) - https://www.hhs.gov/about/news/2021/11/18/biden-administration-secures-10-million-courses-pfizers-covid-19-oral-antiviral-medicine-as-additional-tool-reduce-hospitalizations-save-lives.html

(the below noted "The company recently announced the results of a pivotal phase 2/3 clinical trial which found that a treatment course of one dose every 12 hours for five days")

FOR IMMEDIATE RELEASE
November 18, 2021
Contact: HHS Press Office
202-690-6343
[e-mail]
Biden Administration Secures 10 Million Courses of Pfizer’s COVID-19 Oral Antiviral Medicine as Additional Tool to Reduce Hospitalizations and Save Lives

Pending EUA, U.S. will receive doses starting in 2021 and throughout 2022 as part of contract agreement with Pfizer

As part of its ongoing efforts to curb the pandemic, reduce hospitalizations, and save lives, the Biden Administration has secured 10 million treatment courses of Pfizer’s promising COVID-19 oral antiviral drug, contingent on emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA).

The investigational drug, Paxlovid, is being developed to treat non-hospitalized, symptomatic adults diagnosed with COVID-19 who are at increased risk of progressing to severe illness that could lead to hospitalization or death. The company recently announced the results of a pivotal phase 2/3 clinical trial which found that a treatment course of one dose every 12 hours for five days reduced the rate of hospitalization due to COVID-19 or death by nearly 90 percent in patients treated within three days of symptom onset. Similar results were found when treated within five days of symptom onset.

“This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with COVID-19,” said HHS Secretary Xavier Becerra. “With President Biden’s leadership, we are using all resources at our disposal to prepare for any future pandemic needs. Getting vaccinated remains the most important action anyone can take to help protect themselves and others and end this pandemic, but for people who do get sick in the future and are at risk of severe outcomes, having pills they can take to keep them out of the hospital could be a lifesaver. This agreement would help ensure millions of doses of this drug would be available to the American people if it is authorized.”

Paxlovid is a protease inhibitor designed to block an enzyme the SARS-CoV-2 virus needs to replicate in human cells. Protease inhibitors are a class of drugs that prevent viruses from replicating within cells in the human body, which renders them unable to multiply and spread within the body. In laboratory studies, Paxlovid blocked not only SARS-CoV-2 replication but also other coronaviruses. If the drug is found to be effective in treating SARS-CoV-2 infections, future clinical trials could test the drug’s efficacy against other coronaviruses.

Ritonavir is expected to help Paxlovid remain in the human body for longer periods of time to allow the drug to maintain higher concentrations to help combat the virus, and previously has been used in combination with other antivirals for that reason.

Through the purchase agreement, the U.S. government will receive 10 million treatment courses for $5.295 billion, with the first courses delivered by the end of 2021, pending EUA. The Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), collaborated with the Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army Contracting Command, on the agreement.

The contract with Pfizer is the latest in the Administration’s antiviral efforts to reduce hospitalizations from COVID-19 and save lives. HHS announced in June it was investing $3 billion from the American Rescue Plan to accelerate the discovery, development and manufacturing of antiviral medicines as part of the Biden Administration’s whole-of-government strategy to develop the next generation of COVID-19 treatments. HHS and DOD also collaborated on an agreement with Merck in June for an antiviral drug to treat non-hospitalized patients who are at high risk for severe illness.

About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 61 FDA approvals, licensures or clearances. To learn more about BARDA's COVID-19 Portfolio and BARDA’s COVID-19 Response, visit www.medicalcountermeasures.gov/.

About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus exit disclaimer icon or follow JPEO-CBRND on social media at @JPEOCBRND.

###

[riversedge]

10. getting a perscription will be a problem for many--and a hassle to say the least.

[LisaL]

11. Not sure what is the solution to that.

The initial supply of the drug will be limited. If you allow it without a prescription, people with cold like symptoms will start taking it-who might or might not have covid.

[StarryNite]

6. But we still need affordable, readily available rapid tests.

Time is of the essence if the pill protocol is to work.

[BumRushDaShow]

8. I think that was supposed to start happening in January

however there are issues with the "health insurance reimbursement" means for it. Apparently the cost of federal kits was going to be exorbitant. There will definitely need to be some major tweaking of the plans going forward (particularly with many still uninsured).

And I agree 1000%. It has been a bear trying to find test kits anywhere - whether in a pharmacy or online. I managed to finally snag some but at ~$14 per 2-test kit (where the 2 tests in each kit are supposed to be used for 1 person as a "first test" and then a "confirmation test" a few days later (at least 36 hours later)), it makes it an unaffordable "luxury", basically requiring someone to try to find "free testing" in their county.

[CTyankee]

7. So glad we got the Pfizer shots last February when we didn't know this.

Not only did the shot not register ANY pain, I had NO side effects. And just a few weeks ago my local pharmacy gave me my booster. I have great peace of mind!

[Grasswire2]

9. the new cases showing up in a Western state today all happening to fully vaccinated people.

Can't be totally safe with a virus that keeps modifying.

[DFW]

12. That is the scary part

We're protected only until the newest mutation comes along.

It's starting here, too. People I know who are fully vaccinated and cautious are starting to test positive. We will have to be cautious before our trip to the USA in 11 days, or we'll have to call it off, and THAT would suck royally.