Scivillage.com Casual Discussion Science Forum

Pfizer says its COVID-19 antiviral pill reduces risk of serious illness: What we know about US approval
https://www.cnet.com/health/medical/pfiz...-approval/

INTRO: A day after Merck and Ridgeback Biotherapeutics received approval in the UK for their COVID-19 antiviral pill, Pfizer said Friday it has an antiviral drug that can cut the risk of hospitalization or death from COVID by 89%, according to data from clinical trials.

Called Paxlovid, Pfizer's pill would be taken orally to fight the severe symptoms. Currently, the only antiviral medication authorized in the US requires a health care professional to administer the medication intravenously, through a needle, over five to 10 days. An easy-to-take pill could become part of a growing toolkit that doctors could use to fight COVID, which already includes the three COVID vaccines authorized for use in the US.

In September, data from Johns Hopkins University showed that around 1 in 500 Americans have died from the coronavirus. While the available COVID-19 vaccines are highly effective, millions of Americans have not been vaccinated. According to a September report from the Centers for Disease Control and Prevention, unvaccinated people are over 10 times more likely to get hospitalized and die from the disease than fully vaccinated people.

Here's what we know about Pfizer's antiviral pill. We'll update this story as more details emerge. For more on COVID-19, here's the latest on vaccine mandates, keeping your vaccine card hanovembndy and this year's flu season... (MORE)

---

Pfizer says COVID-19 pill cut hospital, death risk by 90 percent
https://www.pbs.org/newshour/health/pfiz...risk-by-90

EXCERPT: . . . Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. Once Pfizer applies, the FDA could make a decision within weeks or months.

Since the beginning of the pandemic last year, researchers worldwide have been racing to find a pill to treat COVID-19 that can be taken at home to ease symptoms, speed recovery and keep people out of the hospital.

Having pills to treat early COVID-19 “would be a very important advance,” said Dr. John Mellors, chief of infectious diseases at the University of Pittsburgh, who was not involved in the Pfizer study. “If someone developed symptoms and tested positive we could call in a prescription to the local pharmacy as we do for many, many infectious diseases,” he said.

On Friday, Pfizer released preliminary results of its study of 775 adults. Patients who received the company’s drug along with another antiviral shortly after showing COVID-19 symptoms had an 89 percent reduction in their combined rate of hospitalization or death after a month, compared to patients taking a dummy pill. Fewer than 1 percent of patients taking the drug needed to be hospitalized and no one died. In the comparison group, 7 percent were hospitalized and there were seven deaths.

“We were hoping that we had something extraordinary, but it’s rare that you see great drugs come through with almost 90 percent efficacy and 100 percent protection for death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer, in an interview... (MORE)

8 lingering questions about the new Covid pills from Merck and Pfizer
https://www.statnews.com/2021/11/15/8-li...nd-pfizer/

INTRO: The past two months have brought extremely good news in the fight against Covid-19. Two different oral treatments have proved effective at both preventing people newly diagnosed with Covid-19 from entering the hospital and from dying.

“We’re accelerating our path out of this pandemic,” President Biden said after data on the second Covid pill became available. The wide availability of oral drugs could make Covid-19 less lethal, making it less risky for people to return to in-person work and to their normal lives.

The first results, from Merck and Ridgeback Therapeutics, were released in October and will be considered by an advisory panel to the Food and Drug Administration in December. That could lead to an emergency use authorization in the U.S. by the end of the year. That drug, molnupiravir, reduced hospitalizations by 50% and prevented deaths entirely a large randomized clinical trial when it was given within five days of when symptoms began. The pill is given as a five-day course during which patients take a total of 40 pills.

In November, Pfizer announced that its Covid pill, Paxlovid, reduced hospitalizations by 89% and also prevented deaths in its own large randomized study. As with the Merck drug, Paxlovid is given as a five-day course. It must be given with a second medicine, a booster, called ritonavir, which is made by AbbVie, another large drug firm. The Pfizer regimen involves taking 30 pills over a five-day period.

Though the topline results are similar, the medicines could have different risks and benefits. The companies have only issued data in press releases, not scientific articles, and doctors need to know a lot more about both. Here is an overview of what we still don’t know about the Covid pills and when we might learn it... (MORE - details)

The BBC reported:

Quote:The UK government has not disclosed how much its initial contract for 480,000 courses of molnupiravir is worth. But US authorities recently made an advance purchase of 1.7 million courses at a cost of roughly $1.2 billion, or $700 (£513) for each patient.

https://www.bbc.co.uk/news/health-59163899

At £500 a go this .. is expensive.